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:
Allergan Pharmaceuticals Ireland
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:
Marketed
Authorization number:
PA0148/059/001
Authorization date:
1997-04-23

Package leaflet: Information for the user

Celluvisc

1.0 % 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, 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:

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, 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.

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.

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:

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.

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, the foil

pouch and the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25

Keep the single dose containers in the pouch and place the pouch back in the outer carton. Pouch is

required to prevent moisture loss.

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 10, 20, 30, 40, 60 or 90 foil-pouched single-dose containers.

Each foil pouch contains 10 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 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 Οφθαλμικές 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

This leaflet was last revised in 09/2019.

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: Carmellose

sodium 1.0% reference number PL

41443/0001.

This is a service provided by the

Royal National Institute of Blind People.

© 2013 Allergan, Inc., Irvine CA 92612

® Marks owned by Allergan, Inc.

Health Products Regulatory Authority

15 May 2020

CRN009DX9

Page 1 of 4

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 the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Eye drops, solution

A clear, colourless to slightly yellow viscous solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Treatment of the symptoms of dry eye.

4.2 Posology and method of administration

Instil one or two drops in the affected eye/s as needed.

Ensure that the single-dose container is intact before use. The eye drop solution should be used immediately after opening.

Paediatric population

The safety and efficacy of Celluvisc in Paediatric population have not been established. No data are available.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

If irritation, pain, redness and changes in vision occur or worsen, treatment should be discontinued and a new assessment

considered.

Contact lenses should be removed before each application and may be inserted after 15 minutes.

Concomitant ocular medication should be administered 15 minutes prior to the instillation of Celluvisc.

To avoid contamination or possible eye injury, do not touch the tip to the bottle or vial to any surface and avoid contact with

the eye. Discard open single dose container after use.

4.5 Interaction with other medicinal products and other forms of interactions

No interaction studies have been performed

1. No interactions have been observed with Celluvisc. Given the formulation of Celluvisc, no interactions are anticipated.

2. If this product is used concomitantly with other topical eye medications there must be an interval of at least 15 minutes

between the two medications.

Health Products Regulatory Authority

15 May 2020

CRN009DX9

Page 2 of 4

4.6 Fertility, pregnancy and lactation

Pregnancy and Breast-feeding

The constituents of Celluvisc have been used as pharmaceutical agents for many years with no untoward effects. No special

precautions are necessary for the use of Celluvisc in pregnancy and lactation.

4.7 Effects on ability to drive and use machines

Celluvisc has minor or moderate influence on the ability to drive and use machines as it may cause transient blurring of vision

which may impair the ability to drive or operate machines. Do not drive or use machinery unless vision is clear.

4.8 Undesirable effects

The frequency of undesirable effects is defined as follows:

The following adverse reactions have been identified during clinical studies of 0.5% w/v and 1.0% w/v Celluvisc Eye drops,

solution, unit dose.

Eye disorders:

Common: Eye irritation (including burning and discomfort), eye pain, eye pruritus, visual disturbance.

Postmarketing Experience

The following additional adverse reactions have been identified during postmarketing use of Celluvisc 1.0% in clinical practice.

Immune System Disorders

Uncommon : Hypersensitivity including eye allergy with symptoms of eye swelling or eyelid edema.

Eye Disorders

Uncommon : Lacrimation increased, vision blurred, eye discharge, eyelid margin crusting and/or medication residue, foreign

body sensation in eye, ocular hyperemia, visual impairment.

Injury, Poisons and Procedural Complications

Uncommon : Superficial injury of eye (from the vial tip touching the eye during administration) and/or corneal abrasion.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected

adverse reactions 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.

4.9 Overdose

Accidental overdose will present no hazard.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other ophthalmologicals

ATC code: S01XA20

Carmellose sodium has no pharmacological effect. Carmellose sodium has a high viscosity resulting in an increased retention

time on the eye.

5.2 Pharmacokinetic properties

Due to the high molecular weight (approx. 90,000 Daltons) carmellose sodium is unlikely to penetrate the cornea.

5.3 Preclinical safety data

No additional information of relevance for the doctor has been obtained from the preclinical testing.

Health Products Regulatory Authority

15 May 2020

CRN009DX9

Page 3 of 4

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

2 years.

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°C.

Keep the single dose containers in the pouch and place the pouch back in the outer carton. Pouch is required to prevent

moisture loss.

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:

Carton containing 10, 20, 30, 40, 60 or 90 foil pouched single-dose containers. Each foil pouch contains 10 single-dose

containers.

Not all pack sizes may be marketed.

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 MARKETING AUTHORISATION HOLDER

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0148/059/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:23

April 1997

Date of last renewal: 3

October 2008

Health Products Regulatory Authority

15 May 2020

CRN009DX9

Page 4 of 4

10 DATE OF REVISION OF THE TEXT

May 2020

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