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Carmellose Sodium 1%W/V Eye Drops

Informations for option: Carmellose Sodium 1%W/V Eye Drops, show other option
Document: leaflet MAH BRAND_PLPI 15184-1090 change

Ref: 1090/090715/1/F

Celluvisc ® 1% w/v Eye Drops

(carmellose sodium)

Patient Information Leaflet

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

This medicine is available without prescription. Always use this medicine exactly as described in this leaflet or as your pharmacist or nurse has told you.

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

•    Ask your pharmacist if you need more information or advice.

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

•    You must talk to a doctor if you do not feel better or if you feel worse.

Your medicine is called Celluvisc 1% w/v Eye Drops but will be referred to as Celluvisc throughout the leaflet.

What is in this leaflet

^ What Celluvisc is and what it is used for ^ What you need to know before you use Celluvisc

^ How to use Celluvisc ^4 Possible side effects

85 How to store Celluvisc

Contents of the pack and other information

Pregnancy and breast-feeding

Celluvisc can be used during pregnancy and breast-feeding.

Driving and using machines

Celluvisc may cause short-lasting blurring of vision typically lasting 1 - 15 minutes. If you do experience temporary blurring, do not drive or use machines until your sight is clear.

How to use Celluvisc

Celluvisc is for ocular use (applied on the eye). Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

The recommended dose is 1 -2 drops of Celluvisc in the affected eyes as needed.

Make sure that the single-dose container is intact before use.

The solution should be used immediately after opening. To avoid contamination or possible eye injury, do not let the open-end of the single-dose container touch your eye or anything else. Wash your hands before use.




What Celluvisc is and what it is used for

Celluvisc is a tear substitute and contains the lubricant called carmellose sodium. It is used for the treatment of the symptoms of dry eye (such as soreness, burning, irritation or dryness).

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 Celluvisc

Do not use Celluvisc

•    If you are allergic (hypersensitive) to carmellose sodium or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

•    If you wear contact lenses, these should be removed before using Celluvisc. The lenses can be put back again 15 minutes after you have applied your drops.

Other medicines and Celluvisc

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

If you are using other eye drops, leave at least 15 minutes before putting in Celluvisc.

1.    Tear one single-dose container from the strip.

2.    Hold the single-dose container upright (with the cap uppermost) and twist off the cap.

3.    Gently pull down the lower eyelid to form a pocket. Turn the single-dose container upside down and squeeze it to release one drop into each eye. Blink your eyes a few times.

Do not re-use the single-dose container even if there is some solution left. It is most important that you throw it away and do not keep it.

If irritation, pain, redness or changes in vision occur or if you feel your condition is getting worse, stop taking this medicine and consult your doctor or pharmacist.

P


If you use more Celluvisc than you should

It will not cause you any harm. If you are worried, talk to your doctor or pharmacist.

If you forget to use Celluvisc

Apply your next dose as required or at the normal time as directed by your pharmacist or doctor. Do not take a double dose to make up for forgotten individual doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following adverse reactions or medically relevant adverse events were reported during clinical trials:

Common side effects (occurring in between 1 and 10 patients in every 100) are:

Eye irritation (including burning and discomfort), eye pain, itchy eyes, visual disturbance

Post-Marketing Data

The following adverse reactions or medically relevant adverse events have been reported since the drug has been marketed:

Uncommon side effects (occurring in between 1 and 10 patients in every 1000) are:

Allergic reactions (including eye or eyelid swelling), blurring of vision, increase in tear production (also known as tearing), sticky eye, crusting of the eyelid and/or drug residue, a feeling that something is in your eye, redness of the eye/eyelid, eyesight worsening, eye injury to the surface of the eye due to the tip of the vial touching the eye during use.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

UK

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

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 store above 25°C.

•    Use immediately after opening. Any unused solution should be discarded.

•    Remember this medicine is for you. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours.

•    This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. He/she will have additional information about this medicine and will be able to advise you.

   Do not use this medicine after the expiry date shown on the vial label or carton label. Do not use the product if you notice that the vial cap has already broken-off. If your doctor tells you to stop using this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to. If your eye drops show any signs of deterioration consult your pharmacist for advice.

^ Contents of the pack and other information

What Celluvisc contains

Each ml of soultion contains 10mg of carmellose sodium as the active ingredient. Celluvisc also contains the following inactive ingredients; sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate and purified water.

What Celluvisc looks like and contents of the pack

Celluvisc is a clear, colourless viscous solution in a small, plastic and see-through (bubble-like) casing (known as a vial). Each vial contains 0.4ml of solution and has a twist-off cap. Each vial also has a plastic tab telling you the name of the product on one side and the expiry/use by date on the other. Celluvisc is available in packs of 30 or 60 x 0.4ml single-use vials.

Manufacturer and Licence Holder

Celluvisc is manufactured by Allergan Pharmaceuticals Ireland, Westport, County Mayo, Ireland and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

Celluvisc is a registered trademark of Allergan Inc.

PL 15184/1090

Leaflet revision date: 09/07/15

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

Carmellose Sodium 1% w/v Eye Drops

Patient Information Leaflet

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

This medicine is available without prescription. Always use this medicine exactly as described in this leaflet or as your pharmacist or nurse has told you.

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

•    Ask your pharmacist if you need more information or advice.

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

•    You must talk to a doctor if you do not feel better or if you feel worse.

Your medicine is called Carmellose sodium 1 % w/v Eye Drops but will be referred to as Carmellose sodium throughout the leaflet.

What is in this leaflet:

What Carmellose sodium is and what it is used for

What you need to know before you use Carmellose sodium How to use Carmellose sodium Possible side effects ^ How to store Carmellose sodium “ Contents of the pack and other information

^ What Carmellose sodium is and what it is used for

Carmellose is a tear substitute and contains the lubricant called carmellose sodium. It is used for the treatment of the symptoms of dry eye (such as soreness, burning, irritation or dryness).

You must talk to a doctor if you do not feel better or if you feel worse.

r2 What you need to know before you use Carmellose sodium

Do not use Celluvisc

•    If you are allergic (hypersensitive) to carmellose sodium or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

•    If you wear contact lenses, these should be removed before using Celluvisc. The lenses can be put back again 15 minutes after you have applied your drops.

Other medicines and Carmellose

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

If you are using other eye drops, leave at least 15 minutes before putting in Carmellose.

Pregnancy and breast-feeding

Celluvisc can be used during pregnancy and breastfeeding.

Driving and using machines

Celluvisc may cause short-lasting blurring of vision typically lasting 1 - 15 minutes. If you do experience temporary blurring, do not drive or use machines until your sight is clear.

How to use Carmellose sodium

Carmellose is for ocular use (applied on the eye). Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

The recommended dose is 1-2 drops of Carmellose in the affected eyes as needed.

Make sure that the single-dose container is intact before use. The solution should be used immediately after opening. To avoid contamination or possible eye injury, do not let the open-end of the single-dose container touch your eye or anything else. Wash your hands before use.

1 .Tear one single-dose container from the strip.

2.    Hold the single-dose container upright (with the cap uppermost) and twist off the cap.

3.    Gently pull down the lower eyelid to form a pocket. Turn the single-dose container upside down and squeeze it to release one drop into each eye. Blink your eyes a few times.

Do not re-use the single-dose container even if there is some solution left. It is most important that you throw it away and do not keep it.

If irritation, pain, redness or changes in vision occur or if you feel your condition is getting worse, stop taking this medicine and consult your doctor or pharmacist

If you use more Carmellose sodium than you should

It will not cause you any harm. If you are worried, talk to your doctor or pharmacist.

If you forget to use Carmellose sodium

Apply your next dose as required or at the normal time as directed by your pharmacist or doctor. Do not take a double dose to make up for forgotten individual doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following adverse reactions or medically relevant adverse events were reported during clinical trials:

Common side effects (occurring in between 1 and 10 patients in every 100) are:

Eye irritation (including burning and discomfort), eye pain, itchy eyes, visual disturbance.

Post-Marketing Data

The following adverse reactions or medically relevant adverse events have been reported since the drug has been marketed:

Uncommon side effects (occurring in between 1 and 10 patients in every 1000) are:

Allergic reactions (including eye or eyelid swelling), blurring of vision, increase in tear production (also known as tearing), sticky eye, crusting of the eyelid and/or drug residue, a feeling that something is in your eye, redness of the eye/eyelid, eyesight worsening, eye injury to the surface of the eye due to the tip of the vial touching the eye during use.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

UK

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

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 store above 25°C.

   Use immediately after opening. Any unused solution should be discarded.

   Remember this medicine is for you. Never give your medicine to other people. It may harm them, even if their symptoms are the same as yours.

•    This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. He/she will have additional information about this medicine and will be able to advise you.

•    Do not use this medicine after the expiry date shown on the vial label or carton label. Do not use the product if you notice that the vial cap has already broken-off. If your doctor tells you to stop using this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to. If your eye drops show any signs of deterioration consult your pharmacist for advice.

[ft Contents of the pack and other information

What Carmellose sodium contains

Each ml of soultion contains 10mg of carmellose sodium as the active ingredient. Carmellose sodium also contains the following inactive ingredients; sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate and purified water.

What Carmellose looks like and contents of the pack

Carmellose sodium is a clear, colourless viscous solution in a small, plastic and see-through (bubble-like) casing (known as a vial). Each vial contains 0.4ml of solution and has a twist-off cap. Each vial also has a plastic tab telling you the name of the product on one side and the expiry/use by date on the other. Carmellose sodium is available in packs of 30 or 60 x 0.4ml single-use vials.

Manufacturer and Licence Holder

Carmellose sodium is manufactured by Allergan Pharmaceuticals Ireland, Westport, County Mayo, Ireland and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

PL 15184/1090

Leaflet revision date: 09/07/15

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

Ref: 1090/090715/2/B