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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carmellose sodium

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

S01XA; S01XA20

INN (International Name):

Carmellose sodium

Dosage:

1 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Other ophthalmologicals; artificial tears and other indifferent preparations

Authorization date:

2011-06-17

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, 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:
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
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. 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

Summary of Product characteristics

Health Products Regulatory Authority
23 February 2022
CRN00CT8T
Page 1 of 2
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 for 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 25°C.
Store in the original pack to protect from light.
Health Products Regulatory Authority
23 February 2022
CRN00CT8T
Page 2 of 2
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. Strips of 5 containers
Pack size 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
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/016/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of