Emadine 0.5 mg/ml eye drops solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
EMADINE 0.5 mg/ml eye drops solution.
emedastine
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What EMADINE is and what it is used for
- What you need to know before using EMADINE
- How to use EMADINE
- Possible side effects
- How to store EMADINE
- Contents of the pack and other information
1. What EMADINE is and what it is used for
EMADINE is a medicine for the treatment of seasonal allergic conjunctivitis in the eyes (allergic eye conditions). It works by reducing the intensity of the allergic reaction.
Allergic conjunctivitis. Certain elements (allergens), such as pollen, house dust, or animal hair, can cause allergic reactions leading to itching, redness, and inflammation of the surface of the eyes.
You should consult a doctor if your condition worsens or does not improve.
2. What you need to know before using EMADINE
Do not use EMADINE
- If you are allergic to emedastine or to any of the other ingredients of this medicine (listed in section 6).
Consult your doctor.
Warnings and precautions
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Do not use EMADINE in children under 3 years of age.
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If you wear contact lenses, see section “EMADINE contains benzalkonium chloride”.
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It is not recommended to use EMADINE in patients over 65 years of age, as this age group has not been studied in clinical trials.
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It is not recommended to use EMADINE in patients with liver or kidney problems.
Consult your doctor or pharmacist before starting to use EMADINE.
Other medicines and EMADINE
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are using other eye drops at the same time as EMADINE, follow the recommendation 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 become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Immediately after applying EMADINE, you may experience blurred vision. Do not drive or operate machinery until your vision is clear.
EMADINE contains benzalkonium chloride
This medicine contains 0.5 mg of benzalkonium chloride in each 5 ml, equivalent to 0.1 mg/ml.
The preservative in EMADINE, benzalkonium chloride, can be absorbed by soft contact lenses and may change the colour of contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign sensation, stinging, or eye pain after using this medicine.
3. How to use EMADINE
Follow exactly the instructions for the administration of EMADINE provided by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults and children over 3 years of age is: One drop in the eye, twice daily.
Follow exactly the instructions for use of the medicine contained in this leaflet or those given by your doctor. If in doubt, ask your doctor or pharmacist.
These drops must be used only in the eyes.
1 2
- Take the EMADINE bottle and position yourself in front of a mirror.
- Wash your hands.
- Take the bottle and unscrew the cap.
- After opening the bottle for the first time, remove the safety seal ring before using the medicine.
- Hold the bottle upside down between your thumb and little finger.
- Tilt your head backward. Gently pull down the eyelid to form a pouch, into which the drop should be instilled (Figure 1).
- Bring the tip of the bottle close to the eye. Using a mirror may help.
- Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper, as the drops in the bottle could become contaminated.
- Gently press the base of the bottle to release one drop of EMADINE at a time.
- Do not squeeze the bottle; it is designed so that a gentle pressure on the base is sufficient (Figure 2).
- If applying drops to both eyes, repeat the above steps for the other eye.
- Immediately after use, tightly screw the cap back onto the bottle.
If EMADINE has been accidentally swallowed or injected, contact your doctor immediately. It could affect your heart rhythm.
If a drop falls outside the eye, try again.
If too much has been applied, you may remove the excess by rinsing the eye, preferably with sterile saline solution, or, if not available, with lukewarm water. Do not instill any additional drops until it is time for your next scheduled dose.
If you forget to use EMADINE when you should have, apply one drop as soon as you remember, then continue with your regular treatment schedule. Do not use a double dose to make up for the missed dose.
If you are using another eye drop, wait at least 10 minutes between applying EMADINE and the other drops. Ointments should be administered last.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
Unless the effects are severe, continue treatment as usual. If you are concerned about any of these effects, consult your doctor or pharmacist.
Frequent adverse effects (may affect up to 1 in 10 people)
- Eye effects: eye pain, itchy eyes, eye redness
Uncommon adverse effects (may affect up to 1 in 100 people)
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Eye effects: corneal disorder, abnormal sensation in the eye, increased tear production, tired eyes, eye irritation, blurred vision, corneal deposits, dry eye.
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Other effects: headache, difficulty sleeping, headache around the nasal sinuses, bad taste, rash
Frequency not known (cannot be estimated from available data)
- Other effects: increased heart rate
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of EMADINE
Keep this medicine out of the sight and reach of children.
Do not use EMADINE after the expiry date stated on the bottle and on the carton after "EXP". The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
To prevent infection, the bottle must be discarded four weeks after first opening. Please write the date of opening in the space provided on the carton.
Date of opening:
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the container and other information
Composition of EMADINE
- The active substance is emedastine 0.5 mg/mL as difumarate.
- The other components are benzalkonium chloride, tromethamine, sodium chloride, hypromellose, and purified water. Very small amounts of hydrochloric acid and/or sodium hydroxide are added to maintain normal acidity levels (pH levels).
Appearance of the product and contents of the pack
EMADINE is a liquid (a solution) supplied in a box containing a 5 ml plastic bottle with a screw cap. Only certain pack sizes may be marketed.
Marketing Authorization Holder
Immedica Pharma AB
SE-113 63 Stockholm
Sweden
Manufacturer
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Manufacturer
Siegfried El Masnou, S.A.
Camil Fabra 58,
08320 El Masnou
Barcelona
Spain
Manufacturer
Immedica Pharma AB
SE-113 63 Stockholm
Sweden
Date of the most recent revision of this leaflet:
Other sources of information
Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu