Sunday, September 23, 2012

Propine





PROPINE



Dipivefrine hydrochloride 0.1% (w/v), eye drops, solution




Read all of this leaflet carefully before you start using this medicine.



  • Keep this leaflet. You may need to read it again.


  • If you have any further questions, ask your doctor or pharmacist.


  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




In this leaflet:



  • 1. What PROPINE is and what it is used for

  • 2. Before you use PROPINE

  • 3. How to use PROPINE

  • 4. Possible side effects

  • 5. How to store PROPINE

  • 6. Further information





What Propine Is And What It Is Used For



PROPINE is an eye drop solution. It is used to treat a certain type of glaucoma (disease where the pressure in the eyeball is abnormally high) called “open angle” glaucoma (see paragraph below).



Your eyeball contains a watery liquid, which is constantly being drained out of the eye, and new liquid is made to replace this. “Open angle” glaucoma occurs when the liquid cannot drain out quickly enough. This leads to raised pressure within the eyeball which can eventually damage your sight. PROPINE works by reducing the production of liquid and also by increasing the amount of liquid that is drained. This reduces the pressure inside the eye.





Before You Use Propine




Do NOT use PROPINE:



  • if you are allergic (hypersensitive) to dipivefrine, benzalkonium chloride, or any of the other ingredients of PROPINE listed in Section 6, “What PROPINE contains”.

  • if you are suffering from “closed angle” glaucoma (a type of glaucoma where the pressure rapidly builds up in the eyeball, causing redness and pain).




Take special care with PROPINE



Tell your doctor before you start using PROPINE if you:



  • have or have had a heart condition


  • have or have had high blood pressure


  • have or have had an overactive thyroid gland (“hyperthyroidism”) which can cause increased appetite, weight loss or sweating


  • have “narrow angle” glaucoma, since this glaucoma type may lead to “closed angle” glaucoma (see explanation above under “Do not use PROPINE”).


  • have had your eye lens removed during surgery to treat a cataract.


If you wear soft contact lenses: you must remove them before using PROPINE eye drops. After using PROPINE, wait at least 15 minutes before putting your lenses back in. See also at the end of this section, “Important information about some of the ingredients of PROPINE”.





Using other medicines



Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.



Tell your doctor before you start using PROPINE if you:



  • are taking or have taken within the last 14 days, the following medicines used to treat depression: mono-amine oxidase inhibitors or tricyclic antidepressants.


  • are due to have an operation for which a general anaesthetic may be required.




Pregnancy and breast-feeding



Tell your doctor before you start using PROPINE if you are pregnant or planning to become pregnant or if you are breast-feeding.



Your doctor will decide if you should use PROPINE during pregnancy or breast-feeding.



Ask your doctor or pharmacist for advice before using any medicine.





Driving and using machines



PROPINE may cause sensitivity to bright light, due to an increase in the size of the pupil. Should you experience this, do not drive or use tools or machinery until this symptom has cleared.





Important information about some of the ingredients of PROPINE



If you wear soft contact lenses you must remove them before using PROPINE eye drops. After using PROPINE, wait at least 15 minutes before putting your lenses back in.



This is important because one of the ingredients of PROPINE, called benzalkonium chloride, may cause eye irritation and can also change the colour of soft contact lenses.






How To Use Propine



Always use PROPINE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.



The usual dose is 1 drop into each eye that needs treatment, every 12 hours, for example in the morning and then in the evening.




Instructions for use



Do not use the bottle if the seal on the bottle neck is broken before you first open it.



Use your eye drops in the following way:





  • 1. Wash your hands before opening the bottle. Tilt your head back and look at the ceiling.


  • 2. Gently pull down the lower lid of the eye that needs treatment until there is a small “pocket”.


  • 3. Turn the bottle upside down. Squeeze it to release 1 drop into the “pocket”.


  • 4. Whilst keeping the eye closed, press your finger against its corner (where the eye meets the nose) and hold for 30 seconds.


  • 5. Repeat steps 2 to 4 for the other eye, if it also needs treatment.

If a drop misses your eye, try again.



To keep the eye drops free from contamination, do not let the tip of the dropper touch your eye or anything else. Straight after use, put the cap back on and tighten it to close the bottle. Wipe off any excess liquid from your cheek with a clean tissue.



After you have opened the bottle (broken the seal), you must not use it longer than 28 days.





If you drink PROPINE by accident



If anyone drinks the eye drops by accident, contact your doctor straight away.





If you use more PROPINE than you should



If you use more drops of PROPINE than you should it is unlikely to cause you any harm. If you have put too many drops in your eye(s), wash your eyes with fresh water. Then, use your next dose at the usual time.





If you forget to use PROPINE



If you forget a dose, use PROPINE as soon as you remember, unless it is almost time for your next dose. In this case you should miss out the forgotten dose. Then, use your next dose at the usual time and continue with your normal routine.



Do not use a double dose to make up for a forgotten dose.





If you stop using PROPINE



Do not stop using PROPINE until your doctor tells you to, since your symptoms may get worse.




If you have any further questions on the proper use of this product, ask your doctor or pharmacist.





Propine Side Effects



Like all medicines, PROPINE can cause side effects, although not everyone gets them. The following side effects are known to occur.




Contact your doctor or go to a hospital immediately if you experience the following side effects:



  • fast heart beat


  • irregular heart beat


  • high blood pressure

The above side effects are serious and in rare cases can be life-threatening.





Contact your doctor if any of the following side effects worsens, causes you concern or is long-lasting:



  • redness of the eye


  • eye burning or eye stinging for a short while just after putting in the drops


  • sensitivity to bright light (due to an increase in the size of the pupil)


  • inflammation of the surface of the eye or eyelids (“red eye”)


  • allergic reactions in the eye


  • dark spots in the eye


  • headache



If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.





How To Store Propine



Keep out of the reach and sight of children.



Do not use an unopened bottle of PROPINE after the expiry date which is stated on the bottle label and on the carton after “EXP”. The expiry date refers to the last day of that month.



Do not store above 25°C.



Throw away the bottle 28 days after first opening, even if there is some solution left.



Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.





Further Information




What PROPINE contains



  • The active substance is dipivefrine hydrochloride, 1 mg/ml.
    The other ingredients are benzalkonium chloride (a preservative), disodium edetate, sodium chloride, hydrochloric acid (to adjust pH) and purified water.




What PROPINE looks like and contents of the pack



PROPINE is a clear, colourless solution in a white plastic bottle with a screw cap.



Each pack contains 1 or 3 plastic bottles.



Each bottle contains either 5 or 10 ml of solution. A bottle containing 5 ml of solution is about half full, a bottle containing 10 ml of solution is about two-thirds full.



Not all pack sizes may be marketed.





Marketing Authorisation Holder




Allergan Limited

Marlow International

The Parkway

Marlow

Bucks

SL7 1YL

United Kingdom

Tel:01628 494026

Fax:01628 494057



Manufacturer




Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

County Mayo

Ireland



Further information about glaucoma is available from:




International Glaucoma Association (IGA)

Tel:01233 64 81 70

Fax:01233 64 81 79

Email:info@iga.org.uk




(The IGA is an organisation which helps glaucoma patients and their relatives, and is not associated with Allergan.)



This leaflet was last approved in August 2008.



To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).



Please be ready to give the following information: Dipivefrine 0.1% reference number PL 00426/0040.



This is a service provided by the Royal National Institute of Blind People.



© 2008 Allergan, Inc., Irvine CA 92612



Marks owned by Allergan, Inc.







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