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

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Carmellose sodium

Beszerezhető a:

Allergan Pharmaceuticals Ireland

ATC-kód:

S01XA; S01XA20

INN (nemzetközi neve):

Carmellose sodium

Adagolás:

1 percent weight/volume

Gyógyszerészeti forma:

Eye drops, solution

Recept típusa:

Product not subject to medical prescription

Terápiás terület:

Other ophthalmologicals; artificial tears and other indifferent preparations

Engedélyezési státusz:

Marketed

Engedély dátuma:

1997-04-23

Betegtájékoztató

1
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

Termékjellemzők

Health Products Regulatory Authority
15 May 2020
CRN009DX9
Page 1 of 4
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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
A clear, colourless to slightly yellow viscous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of the symptoms of dry eye.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Instil one or two drops in the affected eye/s as needed.
Ensure that the single-dose container is intact before use. The eye
drop solution should be used immediately after opening.
_Paediatric population_
The safety and efficacy of Celluvisc in Paediatric population have not
been established. No data are available.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation, pain, redness and changes in vision occur or worsen,
treatment should be discontinued and a new assessment
considered.
Contact lenses should be removed before each application and may be
inserted after 15 minutes.
Concomitant ocular medication should be administered 15 minutes prior
to the instillation of Celluvisc.
To avoid contamination or possible eye injury, do not touch the tip to
the bottle or vial to any surface and avoid contact with
the eye. Discard open single dose container after use.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No interaction studies have been performed
1. No interactions have been observed with Celluvisc. Given the
formulation of Celluvisc, no interactions are anticipated.
2. If this product is used concomitantly with other topical eye
medications there must be an interval of at least 15 minutes
between the two medications.
Health Products Regulatory Authority
15 May 2020
C