Insert - CELLUVISC® 1% Unit Dose - UK, Ireland - MoH Submission

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ALLERGAN

Package leaflet: Information for the user

CELLUVISC

1.0% w/v eye drops, so

Carmellose sodium

®

ution, unit dose

Read all of this leaflet careful medicine because it contains

y before you start using this 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.

What is in this leaflet:

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.

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.

3.    How to use Celluvisc

2.

3.

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 conta

ner even if there is some solution

is used for i you use Celluvisc

1.    What Celluvisc is and what il

2.    What you need to know befor

3.    How to use Celluvisc

4.    Possible side effects

5.    How to store Celluvisc

6.    Contents of the pack and other information

1. 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, burn ng, irritation or dryness).

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

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.

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 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 medicine, ask your doctor, pharmacist or nurse.

4. 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.

Artwork is created at 100%

Drop keylines and notes before printing Part Number: 71688MD313F Drawing Number: 0238501

1

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 ser ous, or if you notice any side effects not listed in this leaflet, phase 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 car help provide more information on the safety of this medicine.

5. How to store Celluvisc

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 single-dose container tab and the carton after EXP:. The expiry

Do not store above 25°C.

Do not use if the packaging shows evidence of tampering. Do not use if solution changes colour or becomes cloudy.

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 pack and other information What Celluvisc contains

carmellose

The active substance is The other ingredients are sodium potassium chloride, calcium chlo

sodium 10 mg/ml. chloride, sodium lactate, ride and purified water.

This medicinal product is autho of the EEA under the following

rised in the Member states n names:

date refers to the last day of that

month.

The ingredients in Celluvisc were designed to match your natural tear composition.

What Celluvisc looks like and contents of the pack

Celluvisc is an eye drop solution. It is presented as a clear, colourless to pale yellow solution in a small see-through (bubble-like) casing (known as a ‘single-dose container’). The single-dose container has a twist-off cap. Each single-dose container contains 0.4 ml of solution.

Each pack contains 5, 10, 20, 30, 40, 60 or 90 single-dose containers. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Allergan Pharmaceuticals Ireland,

Westport,

Co. Mayo,

Ireland.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Allergan Ltd The Parkway,

Marlow,

Bucks, SL7 1YL United Kingdom Tel: +44 (0)1628 494026 e-mail: uk_medinfo@allergan.com

This leaflet was last revised in

1/2014.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (uK only). Please be ready to give the following

information: Carmello reference number PL

se sodium 1.0% 41443/0001.

ded by the e of Blind People.

71688MD313F