Celluvisc 1% w/v Eye drops, solution, unit dose

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Carmellose sodium
Available from:
PCO Manufacturing Ltd.
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:
PPA0465/259/001
Authorization date:
2011-04-15

PACKAGE LEAFLET: INFORMATION FOR THE USER

Celluvisc

®

1% w/v Eye drops,

solution, unit dose

Carmellose sodium

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. 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:

What Celluvisc is and what it is used for

What you need to know before you use Celluvisc

How to use Celluvisc

Possible side effects

How to store Celluvisc

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 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.

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 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.

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 or

pharmacist. 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 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 date refers to the last day of that

month.

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

The active substance is carmellose sodium 10 mg/ml.

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 0.4 ml of solution.

Each pack contains 30 single-dose containers.

Product Authorisation Number:

PPA 465/259/1

Manufacturer:

Allergan Pharmaceuticals Ireland, Westport, Co. Mayo,

Ireland.

Product is procured from within the EU, repackaged and

distributed by the PPA Holder: PCO Manufacturing, Unit

10, Ashbourne Business Park, Rath, Ashbourne,

Co. Meath

Celluvisc is a registered trademark of Allergan, Inc.

This medicinal product is authorised in the Member

States of the EEA under the following names:

Denmark

Celluvisc

Finland

Celluvisc 1.0% Silmatipat, liuos

Germany

Celluvisc 1% Augentropfen

Greece

Celluvisc 1.0% w/v Οφθαλμικές

σταγόνες, διάλυμα

Ireland

Celluvisc 1.0% w/v Eye drops, solution,

unit dose

Portugal

Celluvisc, colirio, solucao a 1,0%

Spain

Viscofresh 10 mg/ml Colirio en solucion

Celluvisc 1.0% w/v Eye drops, solution,

unit dose

Date of leaflet preparation by PCO Manufacturing:

December 2016

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Celluvisc 1% w/v Eye drops, solution, unit dose

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains 10 mg carmellose sodium.

One drop (

0.05 ml) contains 0.5 mg of carmellose sodium.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Eye drops, solution.

Product imported from France;

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 shall be the date shown on the container and outer package of the product on

the market 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 25ºC.

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6.5 Nature and contents of container

Clear, single-dose containers made from low density polyethylene formed with a twist-off tab.

Each unit is filled with 0.4 ml of solution.

Pack sizes: 30 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 (i.e. once opened do not re-use container for subsequent doses).

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10

Ashbourne Business Park

Rath

Ashbourne

Co. Meath

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/259/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15th April 2011

10 DATE OF REVISION OF THE TEXT

July 2015

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