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

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Carmellose sodium

Dostupno od:

IMED Healthcare Ltd.

ATC koda:

S01XA; S01XA20

INN (International ime):

Carmellose sodium

Doziranje:

1 percent weight/volume

Farmaceutski oblik:

Eye drops, solution

Područje terapije:

Other ophthalmologicals; artificial tears and other indifferent preparations

Datum autorizacije:

2009-08-28

Uputa o lijeku

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, 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 br

Svojstava lijeka

Health Products Regulatory Authority
22 April 2022
CRN00CWY6
Page 1 of 2
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_:
A clear, colourless to slightly yellow viscous solution
4 CLINICAL PARTICULARS
As per PA1824/016/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1824/016/001
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
°
C
6.5 NATURE AND CONTENTS OF CONTAINER
Clear, single-dose containers formed with a twist-off tab in an over
labelled outer container.
Each unit is filled with 0.4ml of solution.
Pack sizes: 60 single-dose containers
Health Products Regulatory Authority
22 April 2022
CRN00CWY6
Page 2 of 2
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
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/147/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28th August 2009
10 DATE OF REVISION OF THE TEXT
Ap