CELLUVISC 1 %w/v Eye Drops Solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

CARMELLOSE SODIUM

Boleh didapati daripada:

LTT Pharma Limited

Kod ATC:

S01XA20

INN (Nama Antarabangsa):

CARMELLOSE SODIUM

Dos:

1 %w/v

Borang farmaseutikal:

Eye Drops Solution

Jenis preskripsi:

Product not subject to medical prescription

Kawasan terapeutik:

Other ophthalmologicals

Status kebenaran:

Authorised

Tarikh kebenaran:

2011-06-17

Risalah maklumat

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.
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
Further 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 min

Ciri produk

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 28/05/2015_
_CRN 2159934_
_page number: 1_
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original pack to protect from light.
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 subs