Emadine - Consumer Medicine Information
|Class:||Ophthalmic antihistamines and decongestants|
|Form:||Eye drops (ophthalmic)|
|Ingredients:||emadastine, 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|
0.5 mg/ml Eye Drops, solution
What EMADINE is and what it is used for
EMADINE is a medicine for the treatment of seasonal allergic conjunctivitis of the eye (allergic conditions of the eye). It works by reducing the intensity of the allergic reaction.
Allergic conjunctivitis. Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye.
You must talk to a doctor if you do not feel better or if you feel worse.
What you need to know before you use EMADINE
Do not use EMADINE
- if you are allergic to emedastine or any of the other ingredients of this medicine listed in section 6.
Ask your doctor for advice.
Warning and precautions
- Do not use EMADINE in children under the age of 3 years.
- If you wear contact lenses please see section ‘EMADINE contains benzalkonium chloride below’.
- EMADINE is not recommended for use in patients over 65 years of age, as it has not been studied in clinical trials in this age group.
- EMADINE is not recommended for use in patients with kidney or liver problems.
Talk to your doctor or pharmacist before using EMADINE.
Other medicines and EMADINE
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”.
Pregnancy, breast feeding and fertility
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.
Driving and using machines
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.
EMADINE contains benzalkonium chloride
A preservative in EMADINE (benzalkonium chloride) may cause eye irritation and is known to discolour soft contact lenses. Therefore do not wear contact lenses whilst using EMADINE. Wait 15 minutes after using EMADINE before putting your lenses back in.
How to use EMADINE
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.
Only use the drops in your eyes.
- 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.
- Don’t touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops left in the bottle.
- Gently press on the base of the bottle to release one drop of EMADINE at a time.
- Don’t squeeze the bottle, it is designed so that just a gentle press on the bottom is needed (picture 2).
- If you use drops in both eyes, repeat the steps for your other eye.
- Put the bottle cap back on firmly immediately after use.
The recommended dose ◄see side 1
If you accidentally swallow EMADINE or inject it contact a doctor immediately. It may affect your heart rhythm.
If a drop misses your eye, try again.
If you get too much in your eyes, rinse it all out preferably with sterile saline or, if not available, with warm water. Don’t put in any more drops until it’s time for your next regular dose.
If you forget to use EMADINE, use one drop as soon as you remember, and then go back to your normal routine. Do not use a double dose to make up for the one missed.
If you are using other eye drops, leave at least 10 minutes between using EMADINE and the other drops. Eye ointments should be used last.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
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 1 in 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
(frequency cannot be estimated from the available data)
General side effects: increased heart rate
Reporting of side effects
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517 Website: www.hpra.ie
How to store EMADINE
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.
You must throw away the bottle four weeks after you first opened it, to prevent infections. Write down the date you opened each bottle in the space below and in the space on the bottle label and box.
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.
Contents of the pack and other information
What EMADINE contains
- 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
What EMADINE looks like and the contents of the pack
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.
Marketing Authorisation Holder
Alcon Laboratories ( UK ) Ltd., Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, United Kingdom.
S.A. Alcon-Couvreur N.V., Rijksweg 14, B-2870 Puurs, Belgium.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Alcon Laboratories ( UK ) Ltd
☏ + 44 ( 0 ) 871 376 1402
( United Kingdom )