0.5 mg / ml eye drops , solution
emedastine
1. What EMADINE is and what it is used for
EMADINE is a medicine used to treat seasonal allergic conjunctivitis of the eye (allergic condition of the eye). It works by reducing the intensity of one of the allergic reactions.
Allergic conjunctivitis. Some substances ( allergens ) such as pollen, dust, or animal hair can cause allergic reactions in the eye, which causes itching, redness, and swelling on the surface of the eye.
You need to talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before using 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.
Warnings and cautions
- Do not use EMADINE in children under 3 years of age.
- If you wear contact lenses, see the section “EMADINE contains benzalkonium chloride” below.
- EMADINE is not recommended for use in patients over 65 years of age, as the product has not been studied in clinical trials in this age group.
- EMADINE is not recommended for patients with renal or hepatic impairment.
Talk to your doctor or pharmacist before using EMADINE.
Other medicines and EMADINE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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, breastfeeding, 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
If you experience temporary blurred vision or discomfort after taking EMADINE, wait until your vision clears before driving or operating machinery.
EMADINE contains benzalkonium chloride
This medicine contains 0.5 mg or 1 mg benzalkonium chloride per 5 ml or 10 ml equivalent to 0.1 mg / ml.
The preservative in EMADINE, benzalkonium chloride, can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses. Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
3. How to use EMADINE
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults and children over 3 years: One drop in the eye, twice daily.
Always take this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.
Use EMADINE only to drip into the eyes.
1.
2.
- Get the EMADINE bottle and a mirror
- Wash your hands
- Take the bottle and unscrew the hat.
- If the safety collar is loose after removing the hat, remove the collar before using the product.
- Hold the bottle upside down between your thumb and forefinger.
- Tilt your head back. Pull the eyelid down with a clean finger, so that a “pocket” is formed between the eyelid and your eye. The drop should end up in the pocket (see figure 1).
- Move the tip of the bottle close to the eye. Use the mirror if it facilitates.
- Do not touch the eye or eyelid, surrounding areas, or other surfaces with the bottle tip. This can contaminate the drops.
- Gently press the bottom of the bottle with your index finger to release one drop of EMADINE at a time.
- Do not squeeze the bottle it is designed so that a light pressure at the bottom is sufficient (see figure 2).
- If you drip in both eyes, repeat the procedure in your other eye.
- Screw the cap onto the bottle firmly immediately after use.
If you accidentally swallow EMADINE or inject it, contact a doctor immediately. It can affect your heart rate.
If a drop misses the eye, try again.
If you have used too much EMADINE, rinse everything off, preferably with sterile saline solution or lukewarm water if no saline solution is available. Do not add more drops until it is time for the next dose.
If you forget to use EMADINE, take a drop as soon as you remember and then return to your normal schedule. Do not take a double dose to make up for a forgotten dose.
If you use other eye drops, wait at least 10 minutes between EMADINE and the other drops. Eye ointments should be used last.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can usually continue to take the drops unless the side effects are severe. If you have any further questions, ask your doctor or pharmacist.
Common side effects are (may affect up to 1 in 10)
- Effects on the eye: Eye pain, itching, redness of the eyes.
Less common side effects are (may affect up to 1 in 100)
- Effects on the eye: Corneal diseases, abnormal sensation in the eye, increased tear production, tired eyes, eye irritation, blurred vision, corneal discoloration, dry eyes.
- General side effects: Headache, sleep problems, sinus headache, bad taste in the mouth, rash.
Unknown(frequency cannot be determined from available data)
- General side effects: Increased heart rate.
5. How to store EMADINE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
You must discard the bottle four weeks after you first opened it to protect against infection. Write down the date you opened each bottle in the space below and the area of each bottle and carton.
Opened:
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is emedastine 0.5 mg / ml as difumarate.
- The other ingredients are benzalkonium chloride, trometamol, sodium chloride, hypromellose, purified water. Small amounts of hydrochloric acid or sodium hydroxide are sometimes added to keep the acidity ( pH ) normal.
What the medicine looks like and the contents of the pack
EMADINE is a liquid (solution) provided in a pack containing a 5 ml or 10 ml plastic bottle (DROP TRAINER) with a screw cap. Not all packaging may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
SA Alcon-Couvreur NV
Rijksweg 14
B-2870 Puurs
Belgium
Manufacturer
Alcon Cusí, SA
Camil Fabra 58
08320 El Masnou
Spain
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA “Novartis Baltics” Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
| Czech RepublicNovartis sroTel: +420 225 775 111 | HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 26 37 82 111 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: + 421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| LatviaSIA “Novartis Baltics”Tel: +371 67 887 070 | United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370 |