B. PACKAGE LEAFLET

Package leaflet: Information for the patient

EMADINE 0.5 mg/ml eye drops, solution emedastine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or your pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them

even if their signs of illness are the same as yours.

- If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

1. 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.

2. 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

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.

3. 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.

Turn the page for more advice

Now turn over>

3. How to use EMADINE (continued)12

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.

4. 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 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.

5. 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.

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.

6. 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

Immedica Pharma AB

SE-113 29 Stockholm

Sweden

Manufacturer

S.A. Alcon-Couvreur N.V.,

Rijksweg 14,

B-2870 Puurs,

Belgium

Manufacturer

Alcon Cusí, S.A.,

Camil Fabra 58,

08320 El Masnou,

Spain

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

.

Package leaflet: Information for the patient

EMADINE 0.5 mg/ml eye drops, solution, single-dose container emedastine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or your pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them

even if their signs of illness are the same as yours.

- If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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 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 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.

2. 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.
• 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.

3. 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.

Turn the page for more advice

Now turn over>

3. How to use EMADINE (

continued)

12

The recommended dose

< see side 1

Do not use a container you’ve already opened. Do not use any sealed containers from a foil wrapper that was opened more than a week ago.

• Tear off the foil wrapper and take out the strip of 5 containers.
• Do not use if the solution is cloudy or has bits in it.
• Hold the strip with the long flat end uppermost and separate off one container by pulling it towards you while holding the others firm. You will need to snap it apart where it joins the others (picture 1).
• Keep the single container out. Put the others back in the foil wrapper.
• Make sure you have a mirror handy and wash your hands.
• Hold the long flat end of the container between your thumb and forefinger and open it by twisting off the other end (picture 2).
• 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.
• Hold the container between your thumb and fingers with the open end pointing down.
• Bring the container 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 container tip.

It could infect the drops.

• Gently squeeze the container to release one drop into the pocket between the eyelid and eye (picture 3).
• If your doctor has told you to use drops in both eyes, repeat the steps for your other eye-using the same container.
• Throw away the container and any leftover solution at once.
• Throw away any unused containers one week after opening the foil wrapper-even if the containers are still sealed.

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.

4. 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

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.

5. 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 30°C.

You must throw away the container as soon as you have used it. Once the foil wrapper has been opened any unused containers must be thrown away one week after you first opened it.

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 enviroment.

6 Contents of the pack and other information

What EMADINE contains

• – The active substance is emedastine 0.5 mg/ml as difumarate.

• – The other ingredients are 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

Immedica Pharma AB

SE-113 29 Stockholm

Sweden

Manufacturer

S.A. Alcon-Couvreur N.V.,

Rijksweg 14,

B-2870 Puurs,

Belgium

Manufacturer

Alcon Cusí, S.A.,

Camil Fabra 58,

08320 El Masnou,

Spain

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

.

Package leaflet: Information for the patient

EMADINE 0.5 mg/ml eye drops, solution, single-dose container emedastine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or your pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them

even if their signs of illness are the same as yours.

– If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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 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 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.

2. 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.
• 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.

3. 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.

Turn the page for more advice

Now turn over>

The recommended dose

< see side 1

Do not use a container you’ve already opened. Do not use any sealed containers from a foil wrapper that was opened more than a week ago.

• Tear off the foil wrapper and take out the strip of 5 containers.
• Do not use if the solution is cloudy or has bits in it.
• Hold the strip with the long flat end uppermost and separate off one container by pulling it towards you while holding the others firm. You will need to snap it apart where it joins the others (picture 1).
• Keep the single container out. Put the others back in the foil wrapper.
• Make sure you have a mirror handy and wash your hands.
• Hold the long flat end of the container between your thumb and forefinger and open it by twisting off the other end (picture 2).
• 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.
• Hold the container between your thumb and fingers with the open end pointing down.
• Bring the container 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 container tip.

It could infect the drops.

• Gently squeeze the container to release one drop into the pocket between the eyelid and eye (picture 3).
• If your doctor has told you to use drops in both eyes, repeat the steps for your other eye-using the same container.
• Throw away the container and any leftover solution at once.
• Throw away any unused containers one week after opening the foil wrapper-even if the containers are still sealed.

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.

4. 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

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.

5. 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 30°C.

You must throw away the container as soon as you have used it. Once the foil wrapper has been opened any unused containers must be thrown away one week after you first opened it.

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 enviroment.

6 Contents of the pack and other information

What EMADINE contains

• – The active substance is emedastine 0.5 mg/ml as difumarate.

• – The other ingredients are trometamol; sodium chloride; hypromellose; purified water. Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added to keep acidity levels (pH levels) normal.