Opticrom Allergy Single Dose 2% w/v eye drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sodium cromoglicate

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

S01GX; S01GX01

INN (International Name):

Sodium cromoglicate

Dosage:

2 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other antiallergics; cromoglicic acid

Authorization status:

Marketed

Authorization date:

2015-01-23

Patient Information leaflet

ALLERGY SINGLE DOSE 2 % W/V
EYE DROPS SOLUTION
SODIUM CROMOGLICATE
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 the other
ingredients of this m

Summary of Product characteristics

Health Products Regulatory Authority
02 December 2019
CRN008WD2
Page 1 of 4
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% 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 Allergy 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.
Health Products Regulatory Authority
02 December 2019
CRN008WD2
Page 2 of 4
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Opticrom Allergy 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.