Opticrom Allergy 2% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium cromoglicate

Available from:

Thornton & Ross Ltd

ATC code:

S01GX01

INN (International Name):

Sodium cromoglicate

Dosage:

20mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11040200; GTIN: 5017923001217 5017923001439

Patient Information 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 contact your doctor if your symptoms worsen or do not
improve.
WHAT IS IN THIS LEAFLET
1. What Opticrom Allergy Single Dose is and what it is used for
2.
What you need to know before you use Opticrom Allergy Single Dose
3. How to use Opticrom Allergy Single Dose
4. Possible side effects
5. How to store Opticrom Allergy Single Dose
6. Contents of the pack and other information 1. WHAT OPTICROM ALLERGY SINGLE DOSE IS AND WHAT IT IS USED FOR
Opticrom Allergy Single Dose 2% w/v Eye Drops, solution (called
Opticrom Allergy Single Dose in this leaflet) contains a medicine
called sodium cromoglicate. This belongs to a group of medicines
called anti allergics.
WHAT OPTICROM ALLERGY SINGLE DOSE IS USED FOR
Opticrom Allergy 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 ALLERGY SINGLE DOSE WORKS
Opticrom Allergy 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 ALLERGY
SINGLE DOSE
DO NOT USE OPT

Summary of Product characteristics

OBJECT 1
OPTICROM ALLERGY SINGLE DOSE 2% W/V EYE DROPS,
SOLUTION
Summary of Product Characteristics Updated 11-May-2015 | SANOFI
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 in single-dose container
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 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 Interaction with other medicinal products