Wednesday, October 5, 2016

Iopidine 5mg / ml






IOPIDINE 5 mg/ml



Eye Drops, Solution



Apraclonidine (as hydrochloride)



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


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


  • Keep this leaflet. You may need to read it again. If you still have questions after reading it, please ask your doctor or your pharmacist.



The active substance is apraclonidine 5 mg/ml (as hydrochloride).



Other ingredients: benzalkonium chloride 0.1 mg/ml as a preservative, sodium acetate, sodium chloride and purified water. Very small amounts of hydrochloric acid and/or sodium hydroxide may have been added to regulate the acidity/alkalinity of the product to ensure comfort in the eye.




The marketing authorization holder for IOPIDINE 5 mg/ml is




Alcon Laboratories (UK) Ltd.,

Boundary Way

Hemel Hempstead

Herts

HP2 7UD

United Kingdom




The maker of IOPIDINE 5 mg/ml is




ALCON-COUVREUR NV

Rijksweg 14

B-2870 Puurs

Belgium




WHAT IOPIDINE 5 mg/ml IS AND WHAT IT IS USED FOR


IOPIDINE 5 mg/ml eye drops contain apraclonidine which is an alpha agonist used to treat chronic glaucoma. This means that it decreases fluid production in the eye.


IOPIDINE 5 mg/ml is used to delay the need for pressure relieving surgery in the eye. If you are using IOPIDINE 5 mg/ml then you will also be receiving other medicines for the treatment of your glaucoma.


It is essential that you continue to use all medicines prescribed by your doctor unless otherwise instructed by your doctor.


IOPIDINE 5 mg/ml is a clear, colourless to pale yellow solution contained in a 5 ml or 10 ml plastic dropper bottle.




BEFORE YOU USE IOPIDINE 5 mg/ml


In some circumstances, this medicine may not be suitable for you.


IT IS ESSENTIAL TO INFORM YOUR DOCTOR BEFORE STARTING TO USE THIS MEDICINE:


  • If you have a history of, or are taking medicine to treat, any of the following :

    • any heart disease (including chest pain, heart attacks or heart failure)
    • high blood pressure
    • circulatory problems including stroke
    • kidney or liver problems
    • depression
    • Parkinson's disease

  • If you have ever had to stop taking a medicine because you were allergic to it.

  • If you are pregnant or intending to become pregnant.

  • If you are breastfeeding a baby.

Also, IOPIDINE 5 mg/ml may have effects on other medicines, so make sure that your doctor knows all the other medicines that you are taking.


Do not use the drops while your contact lenses are in your eyes. Wait at least 15 minutes after using the eye drops before putting your lenses back into your eyes. A preservative in IOPIDINE 5 mg/ml (benzalkonium chloride) may cause eye irritation and is also known to discolour soft contact lenses.


This type of medicine may cause you to feel sleepy. If so, you should not drive or operate machinery.




HOW TO USE IOPIDINE 5 mg/ml



Adults and elderly:


IOPIDINE 5 mg/ml is packaged in a container specially designed for ease of use. You should put one drop into your affected eye(s) three times each day as directed by your doctor.


Since you will be using other eye drops to treat glaucoma, you should wait five minutes before putting in any other eye drops to prevent the previous eye drops spilling out of your eye(s). If, for any reason, the drop of IOPIDINE 5 mg/ml does not remain in your eye, then repeat the dose by placing another drop in your eye.


Routine eye examinations by your doctor are critical to ensure that the pressure in your eye(s) remains under control. Although some patients have received successful treatment with IOPIDINE 5 mg/ml for longer periods, the benefit for most patients is less than one month.




Children:


The safe use of this medicine in children under 12 years of age has not been shown. Therefore, this medicine is not recommended for use in children under 12 years of age.



Only use IOPIDINE 5 mg/ml for dropping in your eyes.




How to put the drops in your eye


By following the 11 steps outlined below, you will ensure that IOPIDINE 5 mg/ml is being used correctly to best effect.



  • 1. Wash your hands before using IOPIDINE 5 mg/ml.

  • 2. Sit down in front of a mirror so that you can see what you are doing.

  • 3. Remove the cap from the bottle.

  • 4. Make sure the dropper tip does not touch anything as this may contaminate the contents.

  • 5. Hold the bottle upside down in one hand between your thumb and middle finger.

  • 6. Using the forefinger of your other hand, gently pull down the lower eyelid of the affected eye.

  • 7. Place the dropper bottle tip close to, but not touching, your eye and gently tap the base of the bottle with your forefinger so that one drop falls into the gap between the eye and the lower lid.

  • 8. Now release the lower eyelid, and blink a few times to make sure the whole of the eye is covered by the liquid.

  • 9. After using IOPIDINE, press a finger to the corner of your eye, by the nose. This helps to stop IOPIDINE getting into the rest of the body.

  • 10. Repeat steps 5 to 8 above, for the other eye, if necessary.

  • 11. Replace and tightly close the cap on the dropper bottle.



What you should do if you miss a dose of IOPIDINE 5 mg/ml


If you miss a dose, DO NOT WORRY. Just put in the next dose when it is due.




What you should do if you put too much IOPIDINE 5 mg/ml in your eye


If you put too much of this medicine in your eye(s), it can be washed out with cool water.





Iopidine 5mg/ml Side Effects


You may experience some or all of the following reactions in your eye(s) :


  • Very Common (≥10%) : increased redness, itching.

  • Common (≥1% - <10%) : discomfort, increased tear production, swelling of the eyelids, blurred vision, gritty feeling in the eye, dry eye, inflammation of the conjunctiva, discharge or whitening of the eye.

  • Uncommon (≥0.1% - <1%): crusting on the eyelids, bumps under the eyelids, swelling of the eye, abnormal vision, pain, inflammation and irritation of the eye or eyelids, corneal (the front part of your eye) surface damage, sensitivity to light, redness of the eyelid, raising or pulling up of the eyelids.

You may also experience reactions in other areas of your body including:


  • Very Common (≥10%): dry mouth

  • Common (≥1% - <10%) : dry nose, weakness, headache, unusual taste.

  • Uncommon (≥0.1% - <1%): chest pain, swelling of your hands, feet or extremeties, irregular heart beat, constipation, nausea, feeling tired, throat inflammation, running nose, muscle aches, abnormal coordination, sleepiness, dizziness, tingling feeling, feeling nervous, depression, difficulty sleeping, shortness of breath or difficulty breathing, unusual sense of smell, facial swelling, dermatitis.

If you experience an allergic reaction, feel unusually dizzy or lightheaded, or experience irregular heartbeats, you should stop using IOPIDINE 5 mg/ml and contact your doctor immediately.


If you experience any of the reactions listed above, or any others not listed, after using IOPIDINE 5 mg/ml, tell your doctor and follow his/her advice.




STORING IOPIDINE 5 mg/ml


  • Keep IOPIDINE 5 mg/ml in a safe place out of the reach and sight of children.

  • Do not store above 25°C. Do not refrigerate or freeze. In order to protect from light, keep the container in the outer carton.

  • Do not use this medicine after the expiry date shown as "EXP" on the bottle and carton.

  • This medicine must not be used for more than one month after first opening.

This leaflet was last changed November 2004.




Further information


If you have any other questions about your medicines you should ask a doctor or pharmacist.







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