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

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Carmellose sodium

Saatavilla:

PCO Manufacturing Ltd.

ATC-koodi:

S01XA20

INN (Kansainvälinen yleisnimi):

Carmellose sodium

Annos:

1 percent weight/volume

Lääkemuoto:

Eye drops, solution

Prescription tyyppi:

Product not subject to medical prescription

Terapeuttinen alue:

artificial tears and other indifferent preparations

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-04-15

Pakkausseloste

_ _
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:
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 bre

Valmisteyhteenveto

Health Products Regulatory Authority
10 June 2022
CRN00CZ7G
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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
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 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 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.
Keep the single dose containers in the pouch and place 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.
Health Products Regulatory Authority
10 June 2022
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Each unit is filled with 0.4 ml of solution.
Pack sizes: 30 or 60 foil pouched single-dose containers. Each foil
pouch contains 10 single-dose containers. Not all pack size
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 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
As