Celluvisc 0.5 %w/v eye drops solution, unit dose

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Carmellose sodium

MAH:

Allergan Pharmaceuticals Ireland

ATC_code:

S01XA; S01XA20

INN:

Carmellose sodium

dosage:

0.5 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_date:

2006-11-10

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
CELLUVISC
®
0.5% 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 from pharmacies.
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 substitute for tears, 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) caused by you not producing enough
tears to keep the
eye wet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CELLUVISC
®
DO NOT USE CELLUVISC
®

If you are hypersensitive (allergic) to carmellose sodium or any of
the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS

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.
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 between
putting in the other
drops and CELLUVISC
®
.
PREGN

SPC

Health Products Regulatory Authority
10 September 2019
CRN0099LK
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celluvisc 0.5 %w/v eye drops solution, unit dose
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 5mg carmellose sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container.
Clear, colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tear substitute. Treatment of the symptoms of dry eye.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Instil 1-2 drops in the affected eye/s 4 times a day or as needed.
Ensure that the single-dose container is intact before use. The eye
drop solution should be used immediately after opening.
To avoid contamination or possible eye injury, do not touch tip of the
bottle or vial to any surface and avoid contact with the
eye.
If Celluvisc is concomitantly used with other ocular eye medications
there must be an interval of at least 15 minutes between
the two medications (as displacement of a medication may occur).
The eye drops may be used with contact lenses.
_Paediatric population _
The safety and efficacy of Celluvisc in children and adolescents have
been established by clinical experience, but no clinical trial
data are available. The posology recommended in adults is recommended
in the paediatric population.
4.3 CONTRAINDICATIONS
Hypersensitivity to carmellose sodium or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation, pain, redness or changes in vision occur or if the
patient’s condition worsens, treatment discontinuation should be
considered and a new assessment made.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
For the use of concomitant ocular products, see section 4.2.
4.6 FERTILITY, PREGNANCY AND LACTATION
Health Products Regulatory Authority
10 September 2019
CRN0099LK
Page 2 of 4
Pregnancy and Breast-feeding
Due to the negligibl