Celluvisc 1.0% w/v Eye drops, solution, unit dose

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Carmellose sodium
Available from:
Imbat Limited
ATC code:
S01XA; S01XA20
INN (International Name):
Carmellose sodium
Dosage:
1 percent weight/volume
Pharmaceutical form:
Eye drops, solution
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Other ophthalmologicals; artificial tears and other indifferent preparations
Authorization status:
Authorised
Authorization number:
PPA1151/102/001
Authorization date:
2009-08-28

Page 1 of 2

Celluvisc

®

1.0% w/v Eye drops, solution, unit dose

(carmellose sodium)

PACKAGE LEAFLET: INFORMATION FOR THE USER

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, or 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:

1.

What Celluvisc is and what it is used for

2.

What you need to know before you use Celluvisc

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, 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.

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

Celluvisc is for ocular use (applied on the eye).

Always use this medicine exactly as described in this leaflet or as your doctor, or pharmacist or nurse

has told you. Check with your doctor or, 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.

Tear one single-dose container from the strip.

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

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 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.

Page 2 of 2

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

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.

5.

HOW TO STORE CELLUVISC

Keep 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 date refers to the last day of that month.

Do not store above 25

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

The active substance is 10mg/ml carmellose sodium.

One drop (≈ 0.05 ml) contains 0.5mg of carmellose sodium.

The other ingredients are sodium chloride, sodium lactate, potassium chloride, calcium chloride

and purified water.

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 0.4ml of solution.

Each pack contains 60 single-dose containers.

Manufacturer

Manufactured by: Allergan Pharmaceuticals Ireland, Westport, Co. Mayo, Ireland.

Procured from within the EU by the PPA holder: Imbat Ltd, Unit L2, North Ring Business Park,

Santry, Dublin 9.

Repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster,

South Yorkshire, DN3 1QR, UK.

Distributed by: Eurodrug Ltd, Santry, Dublin 9.

PPA No: 1151/102/1

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark

Celluvisc

Finland

Celluvisc 1.0% Silmätipat, liuos

Germany

Celluvisc 1% Augentropfen

Greece

Celluvisc 1.0% w/v Oφθαλμικές σταγόνες, διάλυμα

Ireland

Celluvisc 1.0% w/v Eye drops, solution, unit dose

Portugal

Celluvisc, colírio, solução a 1,0%

Spain

Viscofresh 10 mg/ml Colirio en solución

Celluvisc 1.0% w/v Eye drops, solution, unit dose

Leaflet revision & issue date (Ref): 14.01.15

Celluvisc

is a registered trademark of Allergan, Inc.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Celluvisc 1.0% w/v Eye drops, solution, unit dose

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1ml contains 10mg carmellose sodium

One drop ( approx 0.05ml) contains 0.5mg of carmellose sodium

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Eye drops, solution

Product imported from France and the UK:

A clear, colourless to slightly yellow viscous solution

4 CLINICAL PARTICULARS

As per PA0148/059/001

5 PHARMACOLOGICAL PROPERTIES

As per PA0148/059/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Chloride

Sodium Lactate

Potassium Chloride

Calcium Chloride

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf-life expiry date of this product is the date shown on each, single dose container and outer carton of the

product as marketed in the country of origin.

The eye drop solution should be used immediately after opening. Any unused solution should be discarded.

6.4 Special precautions for storage

Do not store above 25

6.5 Nature and contents of container

Clear, single-dose containers formed with a twist-off tab in an over labelled outer container.

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Each unit is filled with 0.4ml of solution.

Pack sizes: 60 single-dose containers

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

Ensure that the single dose container is intact before use. Discard any unused solution (ie once opened do not re-use

container for subsequent doses)

7 PARALLEL PRODUCT AUTHORISATION HOLDER

Imbat Ltd

Unit L2

North Ring Business Park

Santry

Dublin 9

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1151/102/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 28th August 2009

10 DATE OF REVISION OF THE TEXT

January 2015

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