Opticrom Aqueous 2% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium cromoglicate

Available from:

Mawdsley-Brooks & Company 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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Cromoglicate 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.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may
harm them, even if their signs of illness are the same as yours.
• 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.
What is in this leaflet:
1. What this medicine is and what it is used for
2. What you need to know before you use this medicine
3. How to use this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
This medicine contains sodium cromoglicate which belongs to a group of
medicines
called anti-allergics.
It works by stopping the release of the natural substances in your
eyes that can lead to
an allergic reaction. Signs of an allergic reaction include itchy,
watery, red or inflamed
eyes and puffy eyelids.
This medicine is used for the prevention, relief and treatment of eye
allergies.
This includes:
• Short and long term allergic conjunctivitis (inflammation of parts
of the eye)
• More severe cases of conjunctivitis (‘vernal
keratoconjunctivitis’). Signs include
bumps inside the upper eyelid, sensitivity to light and severe
itching.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE
Do not use this medicine:
• If you are allergic (hypersensitive) to sodium cromoglicate or any
of the other
ingredients of this medicine (listed in Section 6)
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling
of your lips, face, throat, tongue and worsening of redness, itching
or swelling of the eye
or eyelid.
Do not use this medicine

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sodium Cromoglicate 2% w/v Eye Drops, Solution
Opticrom Aqueous 2% w/v Eye Drops, Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of eye drops contains
Active substance: 20 mg sodium cromoglicate (2.0% w/v), (one drop
contains 0.7mg
sodium cromoglicate).
Excipients with known effect: 0.1mg benzalkonium chloride
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Eye Drops, Solution
A clear colourless to pale yellow solution for administration to the
eye.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the
prophylaxis and symptomatic
treatment
of
acute
allergic conjunctivitis,
chronic allergic conjunctivitis and vernal keratoconjunctivitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ocular use
Adults and Children:
One or two drops to be administered into each eye four times daily or
as indicated by
the doctor.
Elderly
There is no evidence to suggest that dosage alteration is required for
elderly patients.
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
Discard any remaining contents four weeks after opening the bottle.
This medicine contains Benzalkonium Chloride
As with other ophthalmic solutions containing Benzalkonium chloride,
soft contact
lenses should not be worn during treatment period.
From the limited data available, there is no difference in the adverse
event profile in
children compared to adults.
Generally, however, eyes in children show a stronger reaction for a
given stimulus
than the adult eye. Irritation may have an effect on treatment
adherence in children.
Benzalkonium chloride has been reported to cause eye irritation,
symptoms of dry
eyes and may affect the tear film and corneal surface. Should be used
with caution in
dry eye patients and in patients where the cornea may be compromised.
Patients should be monitored in case of prolonged use
4.5
INTERACTION WITH OTHER MEDICINAL PRODUC