Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - emadine

Document Subject

Generated Narrative: MedicinalProductDefinition mpbf83463883d97743be055a0192c94a53

identifier: http://ema.europa.eu/identifier/EU/1/98/095/001-2

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: EMADINE 0.5 mg/ml, eye drops, solution

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-bf83463883d97743be055a0192c94a53

identifier: http://ema.europa.eu/identifier/EU/1/98/095/001-2

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - emadine

Attesters

What is in this leaflet

1. What EMADINE is and what it is used for
2. What you need to know before you use EMADINE
3. How to use EMADINE
4. Possible side effects
5. How to Store EMADINE
6. Contents of the pack and other information

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.

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

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.

Only use the drops in your eyes.

Turn the page for more advice

Now turn over>

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.
• 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.

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.

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

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 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.

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.

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.