Opticrom Allergy Single Dose 2%w/v Eye Drops, solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CROMOGLICATE SODIUM

Available from:

Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy

ATC code:

S01GX01

INN (International Name):

CROMOGLICATE SODIUM 2 % (W/V)

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

CROMOGLICATE SODIUM 2 % (W/V)

Prescription type:

OTC

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2006-03-06

Patient Information leaflet

A.
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTICROM ALLERGY SINGLE DOSE, 2 % W/V EYE DROPS SOLUTION
sodium cromoglicate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist 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. 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 Opticrom Single Dose is and what it is used for
2.
What you need to know before you use Opticrom Single Dose
3.
How to use Opticrom Single Dose
4.
Possible side effects
5.
How to store Opticrom Single Dose
6.
Contents of the pack and other information
1.
WHAT OPTICROM SINGLE DOSE IS AND WHAT IT IS USED FOR
Opticrom Allergy Single Dose, 2 % w/v Eye Drops solution (called
Opticrom Single Dose in this
leaflet) contains a medicine called sodium cromoglicate. This belongs
to a group of medicines called
anti-allergics.
WHAT OPTICROM SINGLE DOSE IS USED FOR
Opticrom Single Dose is used to relieve and treat eye allergies in
adults and children.
There are two types of eye allergy:
•
‘perennial allergic conjunctivitis’ – this can happen at any
time of the year
•
‘hay fever’ or ‘seasonal allergic conjunctivitis’ – this
happens in different seasons and is caused
by different pollens.
Signs of allergies include itchy, watery, red or inflamed eyes and
puffy eyelids.
HOW OPTICROM SINGLE DOSE WORKS
Opticrom Single Dose works by stopping the release of the natural
substances in your eyes – these are
the cause of the allergic reaction.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPTICROM SINGLE DOSE
DO NOT USE OPTICROM SINGLE DOSE:
•
if you are allergic to sodium cromoglicate or any of t

Summary of Product characteristics

ANNEX 1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Opticrom Allergy Single Dose 2%w/v Eye Drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose container contains 2.0% w/v of sodium cromoglicate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Eye drops, solution
A clear colourless or pale yellow liquid.
pH: 5.0 to 7.0
Osmolality: 280 to 340 mOsmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief and treatment of seasonal and perennial allergic
conjunctivitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and children _
The recommended dose is one or two drops in each eye four times a day.
Opticrom Single Dose should be used regularly to ensure optimal
control of symptoms. It is
recommended that treatment is continued during the period of exposure
to allergen.
Special population
_Older people _
No current evidence for alteration of the dose.
_Paediatric _
In children, caregiver supervision and/or assistance may be required.
Method of administration
For ocular use only.
It should be administered in the conjunctival sac of the affected eye.
To avoid contamination, the tip of the container should not touch the
eye or any surface (see
section 4.4).
As with most ophthalmic preparations, contact lenses should be removed
before each
application and may be inserted after 15 minutes.
In case of concomitant treatment with other eye drops, instillations
should be 15 minutes
apart.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Opticrom Single Dose is sterile, preservative-free, and presented in a
single dose container
which should be used immediately after opening and any remaining
contents discarded after
use.
Patients wearing contact lenses: see section 4.2.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
No interactions studies have been performed.
4.6
FERTILITY, PREGNA