Prospect: information for the user

EMADINE 0.5mg/mleye drops in solution.

emedastine

Read this prospect carefully before starting to use this medication, because it containsimportant information for you.

-Keep this prospect,as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.

1.What is EMADINE and what is it used for

2.What you need to knowbefore starting to use EMADINE

3.How to use EMADINE

4.Possible adverse effects

5.Storage of EMADINE

6.Contents of the package and additional information

EMADINE is a medicationfor the treatment of seasonal allergic conjunctivitis in the eyes (allergic eye conditions). It works by reducing the intensity of the allergic reaction.

Seasonal allergic conjunctivitis.Some elements (allergens) such as pollen, household dust or animal hair can cause allergic reactions that lead to itching and redness as well as inflammation of the surface of their eyes.

You should consult a doctor if it worsens or does not improve.

Do not use EMADINE

• If you are allergicto emedastine or to any of the other ingredients ofthis medication (listed in section 6).

Consult your doctor.

Warnings and precautions

• Do not use EMADINE in children under 3years.

• If you wear contact lensessee section “EMADINE contains benzalkonium chloride”.

• EMADINE is not recommended for use in patients over 65years, as this age group was not studied in clinical trials.

• Do not use EMADINE in patients with liver or kidney problems.

Consult your doctor or pharmacist before starting to use EMADINE.

Other medications and EMADINE

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If you use other eye drops at the same time as EMADINE, follow the recommendation at the end of section3 “How to use EMADINE”.

Pregnancy, breastfeeding, and fertility

If you are pregnantor breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

After applying EMADINE, you may notice that your vision becomes blurry. Do not drive or use machines until your vision is clear.

EMADINE contains benzalkonium chloride

This medication contains 0.5mg of benzalkonium chloride in each 5 ml, equivalent to 0.1mg/ml.

The preservative in EMADINE, benzalkonium chloride, can be absorbed by soft contact lenses and may alter the color of the lenses. Remove your contact lenses before using this medication and wait 15minutes before reinserting them. Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you experience any unusual sensation, stinging, or eye pain after using this medication.

Follow exactly the administration instructions for EMADINE as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is for adults and children over 3 years:One drop in the eye, twice a day.

Follow exactly the administration instructions contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.

These drops must be used onlyin the eyes.

12

• Take the EMADINE bottle and stand in front of a mirror.
• Wash your hands.
• Take the bottle and unscrew the cap.
• After opening the bottle for the first time, you must remove the safety seal ring before using this medication.
• Hold the bottle, upside down, between your thumb and index finger.
• Incline your head back. Gently separate your eyelid from your eye with a finger, until a pouch forms, in which the drop should fall (Figure1).
• Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
• Do not touch the eye, eyelid, nearby areas or other surfaces with the dropper,because the drops remaining in the bottle could become infected.
• Press gently on the baseof the bottle so that one drop of EMADINE falls each time.
• Do not squeeze the bottle, it is designed so that a gentle pressure on the base is enough (Figure2).
• If drops are applied to both eyes, repeat the previous steps for the other eye.
• Tighten the cap on the bottle immediately after using the product.

If you accidentally ingest or inject EMADINE, contact your doctor immediately.It may alter your heart rate.

If a drop falls outside the eye,try again.

If you have applied too much,you can remove it by washing your eyes preferably with sterile saline solution or, if this is not possible, with lukewarm water. Do not apply more drops until it is back in place.

If you forgot to apply EMADINEwhen it was due, apply onedrop as soon as you remember and then continue with your regular treatment regimen.Do not apply adouble doseto compensate for the missed doses.

If you are using another eye drop,wait at least 10minutes between the application of EMADINE and the other drops. Ointments should be administered last.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationmay causeadverse effects, although not everyone will experience them.

Unless the effects are severe, continue with the treatment as usual. If these effects concern you, consult your doctor or pharmacist.

Frequent adverse effects (may affect up to 1in 10people)

• Eye effects:eye pain, eye itching, eye redness

Less frequent adverse effects (may affect up to 1in 100people)

• Eye effects:corneal alteration,abnormal sensation in the eye, increased tear production, tired eyes, eye irritation, blurred vision, corneal spots, dry eye.

• Other effects: headache, difficulty sleeping, headache (around the nasal sinuses), bad taste, rash

Unknown frequency (cannot be estimated from available data)

• Other effects: increased heart rate

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use EMADINE after the expiration date that appears on the bottle and on the box after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

To prevent infections,you must discard the bottle fourweeks after having opened it for the first time.Note the opening date in the space provided on the box.

Opening date:

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and the medicines that you no longer need. In this way, you will help protect the environment.

Composition of EMADINE

• The active ingredient is emedastine 0.5 mg/ml as difumarate.
• The other components are benzalkonium chloride, trometamol, sodium chloride, hypromellose, and purified water. Small quantities of hydrochloric acid and/or sodium hydroxide are added to maintain normal pH levels.

Appearance of the product and contents of the packaging

EMADINE is a liquid (a solution) presented in a box containing a 5 ml plastic bottle with a screw cap.Only some packaging sizes may be marketed.

Marketing Authorization Holder

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Responsible for Manufacturing

S.A. Alcon-Couvreur N.V.

Rijksweg 14

B-2870 Puurs

Belgium

Responsible for Manufacturing

Siegfried El Masnou, S.A.

Camil Fabra 58,

08320 El Masnou

Barcelona

Spain

Responsible for Manufacturing

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Last review date of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu