Monday, October 8, 2012

Clotrim Antifungal Topical



Generic Name: clotrimazole (Topical route)

kloe-TRIM-a-zole

Commonly used brand name(s)

In the U.S.


  • Clotrim Antifungal

  • Cruex Prescription Strength

  • Lotrimin

  • Lotrimin AF

  • Mycelex

In Canada


  • Canesten

  • Clotrimaderm

  • Desenex

  • Myclo-Derm

  • Neo-Zol

Available Dosage Forms:


  • Lotion

  • Solution

  • Cream

Therapeutic Class: Antifungal


Chemical Class: Imidazole


Uses For Clotrim Antifungal


Clotrimazole topical preparations are used to treat fungus infections on the skin.


This medicine is available both over-the-counter (OTC) and with your doctor's prescription.


Before Using Clotrim Antifungal


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical clotrimazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Fentanyl

  • Tacrolimus

  • Trimetrexate

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Proper Use of clotrimazole

This section provides information on the proper use of a number of products that contain clotrimazole. It may not be specific to Clotrim Antifungal. Please read with care.


Apply enough clotrimazole to cover the affected and surrounding skin areas, and rub in gently.


Keep this medicine away from the eyes.


When clotrimazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.


To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For topical dosage forms (cream, lotion, and solution):
    • Fungal infections (treatment):
      • Adults and children—Use two times a day, morning and evening.



Missed Dose


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Clotrim Antifungal


If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your doctor.


Clotrim Antifungal Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


  • Skin rash, hives, blistering, burning, itching, peeling, redness, stinging, swelling, or other sign of skin irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Clotrim Antifungal Topical resources


  • Clotrim Antifungal Topical Use in Pregnancy & Breastfeeding
  • Clotrim Antifungal Topical Support Group
  • 2 Reviews for Clotrim Antifungal Topical - Add your own review/rating


Compare Clotrim Antifungal Topical with other medications


  • Cutaneous Candidiasis
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Tinea Versicolor
  • Vaginal Yeast Infection

Sunday, October 7, 2012

Lohist PD Drops


Pronunciation: brome-fen-EER-ah-meen/soo-doe-eh-FED-rin
Generic Name: Brompheniramine/Pseudoephedrine
Brand Name: Bromhist Pediatric


Lohist PD Drops are used for:

Relieving symptoms of sinus congestion, pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.


Lohist PD Drops are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.


Do NOT use Lohist PD Drops if:


  • you are allergic to any ingredient in Lohist PD Drops

  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

  • you take sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.



Before using Lohist PD Drops:


Some medical conditions may interact with Lohist PD Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a fast, slow, or irregular heartbeat; heart blood vessel problems; or other heart problems

  • if you have a history of asthma; lung problems (eg, emphysema); adrenal gland problems (eg, adrenal gland tumor); high blood pressure; diabetes; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate; seizures; or an overactive thyroid

Some MEDICINES MAY INTERACT with Lohist PD Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Lohist PD Drops may be increased

  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

  • Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Lohist PD Drops

  • Guanadrel, guanethidine, methyldopa, mecamylamine, or reserpine because effectiveness may be decreased by Lohist PD Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lohist PD Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Lohist PD Drops:


Use Lohist PD Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Lohist PD Drops may be taken with or without food.

  • Use the dropper that comes with Lohist PD Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Lohist PD Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lohist PD Drops.



Important safety information:


  • Lohist PD Drops may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Lohist PD Drops. Using Lohist PD Drops alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

  • Do not take diet or appetite control medicines while you are taking Lohist PD Drops without checking with your doctor.

  • Lohist PD Drops contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.

  • Do NOT exceed the recommended dose or take Lohist PD Drops for longer than prescribed without checking with your doctor.

  • If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

  • Lohist PD Drops may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Lohist PD Drops. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

  • If you are scheduled for allergy skin testing, do not take Lohist PD Drops for several days before the test because it may decrease your response to the skin tests.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Lohist PD Drops.

  • Use Lohist PD Drops with caution in the ELDERLY because they may be more sensitive to its effects.

  • Caution is advised when using Lohist PD Drops in CHILDREN because they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Lohist PD Drops, discuss with your doctor the benefits and risks of using Lohist PD Drops during pregnancy. It is unknown if Lohist PD Drops are excreted in breast milk. Do not breast-feed while taking Lohist PD Drops.


Possible side effects of Lohist PD Drops:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Lohist PD side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Lohist PD Drops:

Store Lohist PD Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lohist PD Drops out of the reach of children and away from pets.


General information:


  • If you have any questions about Lohist PD Drops, please talk with your doctor, pharmacist, or other health care provider.

  • Lohist PD Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lohist PD Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Lohist PD resources


  • Lohist PD Side Effects (in more detail)
  • Lohist PD Use in Pregnancy & Breastfeeding
  • Lohist PD Drug Interactions
  • Lohist PD Support Group
  • 0 Reviews for Lohist PD - Add your own review/rating


Compare Lohist PD with other medications


  • Hay Fever
  • Nasal Congestion

Thursday, October 4, 2012

Guaifenesin/Potassium Guaiacolsulfonate


Pronunciation: gwye-FEN-eh-sin/poe-TASS-ee-um gwye-a-kole-SUL-foe-nate
Generic Name: Guaifenesin/Potassium Guaiacolsulfonate
Brand Name: Allfen and Humibid LA


Guaifenesin/Potassium Guaiacolsulfonate is used for:

Relieving symptoms of cough and mucus in the chest due to respiratory infections, asthma, colds, or hay fever. It may also be used for other conditions as determined by your doctor.


Guaifenesin/Potassium Guaiacolsulfonate is a combination of 2 expectorants. It works by thinning mucus (phlegm) in the lungs and making it less sticky and easier to cough up. This reduces chest congestion by making coughs more productive.


Do NOT use Guaifenesin/Potassium Guaiacolsulfonate if:


  • you are allergic to any ingredient in Guaifenesin/Potassium Guaiacolsulfonate

Contact your doctor or health care provider right away if any of these apply to you.



Before using Guaifenesin/Potassium Guaiacolsulfonate:


Some medical conditions may interact with Guaifenesin/Potassium Guaiacolsulfonate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a chronic cough that occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Guaifenesin/Potassium Guaiacolsulfonate. Tell your health care provider if you are taking any other medicines. However, no specific interactions with Guaifenesin/Potassium Guaiacolsulfonate are known at this time.


This may not be a complete list of all interactions that may occur. Ask your health care provider if Guaifenesin/Potassium Guaiacolsulfonate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Guaifenesin/Potassium Guaiacolsulfonate:


Use Guaifenesin/Potassium Guaiacolsulfonate as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Guaifenesin/Potassium Guaiacolsulfonate may be taken with or without food.

  • Drinking extra fluids while you are taking Guaifenesin/Potassium Guaiacolsulfonate is recommended. Check with your doctor for instructions.

  • Swallow Guaifenesin/Potassium Guaiacolsulfonate whole. Do not break, crush, or chew before swallowing.

  • If you miss a dose of Guaifenesin/Potassium Guaiacolsulfonate and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Guaifenesin/Potassium Guaiacolsulfonate.



Important safety information:


  • Guaifenesin/Potassium Guaiacolsulfonate may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Guaifenesin/Potassium Guaiacolsulfonate. Using Guaifenesin/Potassium Guaiacolsulfonate alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.

  • If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition.

  • Guaifenesin/Potassium Guaiacolsulfonate may interfere with some lab tests. Make sure your doctor and lab personnel know you are taking Guaifenesin/Potassium Guaiacolsulfonate.

  • Use Guaifenesin/Potassium Guaiacolsulfonate with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Guaifenesin/Potassium Guaiacolsulfonate during pregnancy. It is unknown if Guaifenesin/Potassium Guaiacolsulfonate is excreted in breast milk. If you are or will be breast-feeding while you are using Guaifenesin/Potassium Guaiacolsulfonate, check with your doctor or pharmacist to discuss the risks to your baby.


Possible side effects of Guaifenesin/Potassium Guaiacolsulfonate:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Dizziness; headache; nausea; upset stomach; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); lower back or side pain.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .


See also: Guaifenesin/Potassium Guaiacolsulfonate side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Guaifenesin/Potassium Guaiacolsulfonate:

Store Guaifenesin/Potassium Guaiacolsulfonate at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Guaifenesin/Potassium Guaiacolsulfonate out of the reach of children and away from pets.


General information:


  • If you have any questions about Guaifenesin/Potassium Guaiacolsulfonate, please talk with your doctor, pharmacist, or other health care provider.

  • Guaifenesin/Potassium Guaiacolsulfonate is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Guaifenesin/Potassium Guaiacolsulfonate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Guaifenesin/Potassium Guaiacolsulfonate resources


  • Guaifenesin/Potassium Guaiacolsulfonate Side Effects (in more detail)
  • Guaifenesin/Potassium Guaiacolsulfonate Use in Pregnancy & Breastfeeding
  • Guaifenesin/Potassium Guaiacolsulfonate Drug Interactions
  • Guaifenesin/Potassium Guaiacolsulfonate Support Group
  • 0 Reviews for Guaifenesin/Potassium Guaiacolsulfonate - Add your own review/rating


Compare Guaifenesin/Potassium Guaiacolsulfonate with other medications


  • Cough

Monday, October 1, 2012

Gynodiol


Generic Name: estrogen (Oral route, Parenteral route, Topical application route, Transdermal route)


Commonly used brand name(s)

In the U.S.


  • Alora

  • Cenestin

  • Climara

  • Divigel

  • Elestrin

  • Emcyt

  • Enjuvia

  • Esclim

  • Estinyl

  • EstroGel

  • Evamist

  • Femtrace

  • Gynodiol

  • Menest

  • Menostar

  • Ogen .625

  • Ogen 1.25

  • Ogen 2.5

  • Premarin

  • Vivelle

  • Vivelle-Dot

In Canada


  • Estraderm

  • Estradot Transdermal

  • Estradot Transdermal Therapeutic System

  • Estradot Transdermal Therapeutic System

  • Estrogel

  • Oesclim

  • Rhoxal-Estradiol Derm 50

  • Rhoxal-Estradiol Derm 75

  • Roxal-Estradiol Derm 100

  • Vivelle 100 Mcg

  • Vivelle 25 Mcg

Available Dosage Forms:


  • Tablet

  • Patch, Extended Release

  • Gel/Jelly

  • Spray

  • Emulsion

  • Tablet, Enteric Coated

  • Capsule

Uses For Gynodiol


Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.


The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.


Estrogens are prescribed for several reasons:


  • To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).

  • To help prevent weakening of bones (osteoporosis) in women past menopause.

  • In the treatment of selected cases of breast cancer in men and women.

  • In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.


There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.


Estrogens are available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, estrogen is used in certain patients with the following medical conditions:


  • Gender identity disorder, male-to-female transsexualism (person who is born as a man but adapts to a woman's lifestyle, sees himself as a woman, and feels like a woman instead of a man.

  • Osteoporosis caused by lack of estrogen before menopause.

  • Turner's syndrome (a genetic disorder).

Before Using Gynodiol


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Use of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.


This medicine may be used to start puberty in teenagers with some types of delayed puberty.


Geriatric


Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.


Pregnancy


Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.


Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.


Breast Feeding


Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.


  • Rotavirus Vaccine, Live

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Adenovirus Vaccine Type 4, Live

  • Adenovirus Vaccine Type 7, Live

  • Bacillus of Calmette and Guerin Vaccine, Live

  • Boceprevir

  • Felbamate

  • Influenza Virus Vaccine, Live

  • Isotretinoin

  • Measles Virus Vaccine, Live

  • Mumps Virus Vaccine, Live

  • Paclitaxel

  • Paclitaxel Protein-Bound

  • Rotavirus Vaccine, Live

  • Rubella Virus Vaccine, Live

  • Smallpox Vaccine

  • St John's Wort

  • Theophylline

  • Tizanidine

  • Tranexamic Acid

  • Typhoid Vaccine

  • Varicella Virus Vaccine

  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


For all patients


  • Asthma or

  • Calcium, too much or too little in blood or

  • Diabetes or

  • Epilepsy or seizures or

  • Heart problems or

  • Kidney problems or

  • Liver tumors, benign or

  • Lupus erythematosus, systemic or

  • Migraine headaches—Estrogens may worsen these conditions.

  • Blood clotting problems, or history of during previous estrogen therapy—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.

  • Breast cancer or

  • Bone cancer or

  • Cancer of the uterus or

  • Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.

  • Bulging eyes or

  • Double vision or

  • Migraine headache or

  • Vision changes, sudden onset including or

  • Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

  • Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.

  • Endometriosis or

  • Gallbladder disease or gallstones, or history of or

  • High cholesterol or triglycerides, or history of or

  • Liver disease, or history of or

  • Pancreatitis (inflammation of pancreas) or

  • Porphyria—Estrogens may worsen these conditions. Although estrogens can improve blood cholesterol, they can worsen blood triglycerides for some people.

  • Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

For males treated for breast or prostate cancer:


  • Blood clots or

  • Heart or circulation disease or

  • Stroke—Males with these medical problems may be more likely to have clotting problems while taking estrogens; the high doses of estrogens used to treat male breast or prostate cancer have been shown to increase the chances of heart attack, phlebitis (inflamed veins) caused by a blood clot, or blood clots in the lungs.

Proper Use of estrogen

This section provides information on the proper use of a number of products that contain estrogen. It may not be specific to Gynodiol. Please read with care.


Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.


This medicine usually comes with patient information or directions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.


For patients taking any of the estrogens by mouth or by injection:


  • Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch):


  • Wash and dry your hands thoroughly before and after handling the patch.

  • Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.

  • Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.

  • Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.

  • If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.

  • Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion):


  • Washing and drying hands thoroughly before each application.

  • Apply while you are sitting comfortably. Apply one pouch to each leg every morning.

  • Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.

  • Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.

  • Rub any remaining emulsion on both hands on the buttocks.

  • Washing and drying hands thoroughly after application.

  • To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

If you are using the Evamist® transdermal spray:


  • Spray the medicine on your skin on the inside of your forearm, between the elbow and the wrist.

  • Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid to come nearer with your child, wear clothes with long sleeves to cover the application site.

  • If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.

  • Do not allow your pets to lick or touch the arm where the medicine was sprayed.

Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For conjugated estrogens

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least 3 months.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.


    • For treating ovary problems (female hypogonadism or for starting puberty):
      • Adults and teenagers—0.3 to 0.625 milligram (mg) a day. Your doctor may want you to take the medicine only on certain days of the month.


    • For treating ovary problems (failure or removal of both ovaries):
      • Adults—1.25 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—1.25 to 2.5 milligram (mg) three times a day.



  • For injection dosage form:
    • For controlling abnormal bleeding of the uterus:
      • Adults—25 milligrams (mg) injected into a muscle or vein. This may be repeated in six to twelve hours if needed.



  • For esterified estrogens

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least three months.


    • For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
      • Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (failure or removal of both ovaries):
      • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (female hypogonadism):
      • Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating symptoms of menopause:
      • Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—1.25 to 2.5 mg three times a day.



  • For estradiol

  • For oral dosage form:
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least 3 months.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
      • Adults—At first, 1 to 2 milligrams (mg) one time per day for at least 3 months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication.


    • For treating prostate cancer:
      • Adults—1 to 2 milligrams (mg) three times a day.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.5 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.



  • For topical emulsion dosage form (skin lotion):
    • For treating symptoms of menopause:
      • Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.



  • For transdermal dosage form (skin patches):
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
      • For the Climara patches

      • Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.

      • For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches

      • Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.



  • For estradiol cypionate

  • For injection dosage form:
    • For treating ovary problems (female hypogonadism):
      • Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.


    • For treating symptoms of menopause:
      • Adults—1 to 5 milligrams (mg) injected into a muscle every 3 to 4 weeks.



  • For estradiol valerate

  • For injection dosage form:
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—10 to 20 milligrams (mg) injected into a muscle every 4 weeks as needed.


    • For treating prostate cancer:
      • Adults—30 milligrams (mg) injected into a muscle every 1 or 2 weeks.



  • For estrone

  • For injection dosage form:
    • For controlling abnormal bleeding of the uterus:
      • Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.1 to 0.5 milligram (mg) injected into a muscle 2 or 3 times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—0.1 to 1 milligram (mg) a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.


    • For treating prostate cancer:
      • Adults—2 to 4 milligrams (mg) injected into a muscle 2 or 3 times a week.



  • For estropipate

  • For oral dosage form (tablets):
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—1.5 to 9 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.75 milligram (mg) a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.



  • For ethinyl estradiol

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—1 milligram (mg) three times a day.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—0.05 milligram (mg) one to three times a day for 3 to 6 months. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—0.15 to 3 milligrams (mg) a day.


    • For treating symptoms of menopause:
      • Adults—0.02 to 0.05 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.



  • For ethinyl estradiol and norethindrone

  • For oral dosage form (tablets):
    • For treating symptoms of menopause:
      • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.


    • To prevent loss of bone (osteoporosis):
      • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Gynodiol


It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.


In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.


Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb). Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.


If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.


Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.


Tell the doctor in charge that you are using this medicine before having any laboratory test because some results may be affected.


Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to Evamist® transdermal spray.


Do not allow your pets to lick or touch the arm where Evamist® transdermal spray was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.


Gynodiol Side Effects


Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:


The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.


Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Breast pain (in females and males)

  • fast heartbeat

  • fever

  • hives

  • hoarseness

  • increased breast size (in females and males)

  • irritation of the skin

  • itching of the skin

  • joint pain, stiffness, or swelling

  • rash

  • redness of the skin

  • shortness of breath

  • swelling of the eyelids, face, lips, hands, or feet

  • swelling of the feet and lower legs

  • tightness in the chest

  • troubled breathing or swallowing

  • weight gain (rapid)

  • wheezing

Less common or rare
  • Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)

  • chest pain

  • chills

  • cough

  • heavy non-menstrual vaginal bleeding

  • lumps in, or discharge from, breast (in females and males)

  • pains in the stomach, side, or abdomen

  • yellow eyes or skin

Rare - for males being treated for breast or prostate cancer only
  • Headache (sudden or severe)

  • loss of coordination (sudden)

  • loss of vision or change of vision (sudden)

  • pains in the chest, groin, or leg, especially in the calf of leg

  • shortness of breath (sudden and unexplained)

  • slurring of speech (sudden)

  • weakness or numbness in the arm or leg

Incidence not known
  • Abdominal or stomach bloating

  • abdominal or stomach cramps

  • acid or sour stomach

  • anxiety

  • backache

  • belching

  • blindness

  • blistering, peeling, or loosening of the skin

  • blue-yellow color blindness

  • blurred vision

  • change in vaginal discharge

  • changes in skin color

  • changes in vision

  • chest discomfort

  • clay-colored stools

  • clear or bloody discharge from nipple

  • confusion

  • constipation

  • convulsions

  • dark urine

  • decrease in the amount of urine

  • decreased vision

  • depression

  • diarrhea

  • difficulty with breathing

  • difficulty with speaking

  • dimpling of the breast skin

  • dizziness

  • double vision

  • dry mouth

  • eye pain

  • fainting

  • fluid-filled skin blisters

  • full feeling in upper abdomen or stomach

  • full or bloated feeling or pressure in the stomach

  • headache

  • heartburn

  • inability to move the arms, legs, or facial muscles

  • inability to speak

  • incoherent speech

  • increased urination

  • indigestion

  • inverted nipple

  • irregular heartbeats

  • light-colored stools

  • lightheadedness

  • loss of appetite

  • loss of bladder control

  • lump under the arm

  • metallic taste

  • migraine headache

  • mood or mental changes

  • muscle cramps in the hands, arms, feet, legs, or face

  • muscle pain

  • muscle spasm or jerking of all extremities

  • muscle weakness

  • nausea

  • noisy breathing

  • numbness or tingling of the hands, feet, or face

  • pain in the ankles or knees

  • pain or discomfort in the arms, jaw, back or neck

  • pain or feeling of pressure in the pelvis

  • pain, tenderness, swelling of the foot or leg

  • painful or tender cysts in the breasts

  • painful, red lumps under the skin, mostly on the legs

  • pains in the chest, groin, or legs, especially calves of the legs

  • partial or complete loss of vision in the eye

  • pelvic pain

  • persistent crusting or scaling of nipple

  • pinpoint red or purple spots on the skin

  • prominent superficial veins over affected area

  • red, irritated eyes

  • redness or swelling of the breast

  • sensitivity to the sun

  • severe headaches of sudden onset

  • skin thinness

  • skin warmth

  • slow speech

  • sore on the skin of the breast that does not heal

  • sore throat

  • sores, ulcers, or white spots in the mouth or on the lips

  • stomach discomfort, upset, or pain

  • sudden loss of consciousness

  • sudden loss of coordination

  • sudden onset of shortness of breath for no apparent reason

  • sudden onset of slurred speech

  • sudden vision changes

  • swelling of the abdominal or stomach area

  • swelling of the fingers or hands

  • thirst

  • tremor

  • unpleasant breath odor

  • unusual tiredness or weakness

  • vomiting

  • vomiting of blood

  • weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Abnormal growth filled with fluid or semisolid material

  • accidental injury

  • bladder pain

  • bloated full feeling

  • bloody or cloudy urine

  • body aches or pain

  • coating or white patches on tongue

  • congestion

  • cough producing mucus

  • decrease in amount of urine

  • difficult, burning, or painful urination

  • discouragement

  • dryness of the throat

  • ear congestion or pain

  • excess air or gas in the stomach or intestines

  • fear

  • feeling of warmth

  • feeling sad or empty

  • frequent urge to urinate

  • general feeling of discomfort or illness

  • headache, severe and throbbing

  • increased clear or white vaginal discharge

  • irritability

  • itching of the vaginal, rectal or genital areas

  • lack of appetite

  • lack or loss of strength

  • loss of interest or pleasure

  • mild dizziness

  • neck pain

  • nervousness

  • pain

  • pain during sexual intercourse

  • painful or difficult urination

  • pain or tenderness around the eyes and cheekbones

  • passing gas

  • redness of the face, neck, arms, and occasionally, upper chest

  • runny nose

  • skin irritation or redness where skin patch was worn

  • shivering

  • sleeplessness

  • sneezing

  • sore mouth or tongue

  • stuffy nose

  • sudden sweating

  • tender, swollen glands in the neck

  • thick, white vaginal discharge with no odor or with a mild odor

  • tiredness

  • trouble concentrating

  • trouble sleeping

  • unable to sleep

  • voice changes

Less common
  • Blemishes on the skin

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • burning or stinging of the skin

  • diarrhea (mild)

  • difficulty with moving

  • dizziness (mild)

  • increased hair growth, especially on the face

  • lower abdominal or stomach pain or pressure

  • mood or mental changes

  • muscle stiffness

  • painful cold sores or blisters on the lips, nose, eyes, or genitals

  • pimples

  • pounding in the ears

  • problems in wearing contact lenses

  • slow heartbeat

  • tooth or gum pain

  • unusual decrease in sexual desire (in males)

  • unusual increase in sexual desire (in females)

  • white or brownish vaginal discharge

Incidence not known
  • Abnormal turning out of cervix

  • changes in appetite

  • dull ache or feeling of pressure or heaviness in the legs

  • flushed, dry skin

  • fruit-like breath odor

  • increased hunger

  • irritability

  • large amount of triglyceride in the blood

  • leg cramps

  • patchy brown or dark brown discoloration of the skin

  • poor insight and judgment

  • problems with memory or speech

  • trouble recognizing objects

  • trouble thinking and planning

  • trouble walking

  • twitching, uncontrolled movements of the tongue, lips, face, arms, or legs

  • unexpected or excess milk flow from the breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).


This medicine may cause loss or thinning of the scalp hair in some people.


Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



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