Emadine
emedastine
emedastine
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours.
If you get any of the side effects talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What EMADINE is and what it is used for
What you need to know before you use EMADINE
How to use EMADINE
Possible side effects
How to Store EMADINE
Contents of the pack and other information
You must talk to a doctor if you do not feel better or if you feel worse.
Ask your doctor for advice.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
If you are using other eye drops at the same time as EMADINE, follow the advice at the end of section 3 “How to use EMADINE”.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You may find that your vision is blurred for a time just after you use EMADINE. Do not drive or use machines until your vision is clear.
This medicine contains 0.5 mg or 1 mg benzalkonium chloride in each 5 or 10 ml, which are equivalent to 0.1 mg/ml.
The preservative in EMADINE, benzalkonium chloride, may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
Always use EMADINE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The recommended dose is in adults and children over 3 years: One drop in the eye, twice a day. Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
1 2
The recommended dose
< see side 1
Get the EMADINE bottle and a mirror.
Wash your hands.
Take the bottle and twist off the cap.
After cap is removed, if tamper evident snap collar is loose, remove before using product.
Hold the bottle, pointing down, between your thumb and middle finger.
Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here (picture 1).
Bring the bottle tip close to the eye. Use the mirror if it helps.
If you use drops in both eyes, repeat the steps for your other eye.
Put the bottle cap back on firmly immediately after use.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can carry on taking the drops, unless the effects are serious, If you are worried, talk to your doctor or pharmacist.
Common side effects (may affect up to 1in 10 people )
Effects in the eye: eye pain, itchy eye, eye redness
Uncommon side effects (may affect up to 1 in 100 people)
Effects in the eye: corneal disorder, abnormal eye sensation, increased tear production, tired eyes, eye irritation, blurred vision, corneal staining, dry eye.
General side effects: headache, difficulty sleeping, sinus headache, bad taste, rash
Not Known (frequency cannot be estimated from the available data)
General side effects: increased heart rate
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use EMADINE after the expiry date which is stated on the bottle and box after “EXP”. The expiry date refers to the last day of the month.
Do not store above 25°C.
Opened:
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is emadastine 0.5 mg/ml as difumarate.
The other ingredients are benzalkonium chloride, trometamol; sodium chloride; hypromellose; purified water. Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added to
keep acidity levels (pH levels) normal
EMADINE is a liquid (a solution) supplied in a pack containing a 5 ml or 10 ml plastic (DROP-TAINER) bottle with a screw cap. Not all pack sizes may be marketed.
Immedica Pharma AB SE-113 29 Stockholm
Sweden
S.A. Alcon-Couvreur N.V., Rijksweg 14,
B-2870 Puurs, Belgium
Siegfried El Masnou, S.A., Camil Fabra 58,
08320 El Masnou,
Spain
SE-113 29, Stockholm Sweden