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:

Clonmel Healthcare Ltd

ATC code:

S01GX; S01GX01

INN (International Name):

Sodium cromoglicate

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Other antiallergics; cromoglicic acid

Authorization status:

Marketed

Authorization date:

2015-01-23

Summary of Product characteristics

Health Products Regulatory Authority
27 October 2023
CRN00DTT2
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
27 October 2023
CRN00DTT2
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.
4.