Opticrom Hayfever 2% W/V Eye Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Opticrom™ Hayfever 2.0% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium cromoglicate 2.0% w/v.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye Drops, Solution (Eye Drops)
A clear colourless or pale yellow liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief and treatment of the eye symptoms of hayfever.
4.2 Posology and method of administration
Opticrom Hayfever Eye Drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist.
Adults and Children over 6 years:
One or two drops to be administered into each eye four times daily.
Elderly
There is no evidence to suggest that dosage alteration is required for elderly patients.
4.3
Contraindications
The product is contraindicated in patients who have shown hypersensitivity to Sodium cromoglicate, Benzalkonium chloride or Disodium edetate.
4.4 Special warnings and precautions for use
Soft contact lenses should not be worn during treatment with sodium cromoglicate eye drops.
The carton label and patient information leaflet will state:
• the patient should consult a doctor or pharmacist if symptoms do not start to improve within 48 hours,
• Opticrom Hayfever Eye Drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
Pregnancy
As with all medication, caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with Sodium cromoglicate suggests that it has no adverse effects on foetal development. It should be used in pregnancy only where there is a clear need.
Lactation
It is not known whether Sodium cromoglicate is excreted in human breast milk but, on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest the use of Sodium cromoglicate has any undesirable effects on the baby.
4.7 Effects on ability to drive and use machines
As with all eye drops, instillation of Opticrom may cause a transient blurring of vision or local irritation that could impact driving or operating machinery. Do not drive or operate machinery if affected.
4.8 Undesirable effects
Eye Disorders
Transient stinging, burning and blurring of vision may occur after instillation. Other symptoms of local irritation have been reported rarely.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals; Other antiallergics, ATC Code: S01GX01
The solution exerts its effect locally in the eye.
In vitro and in vivo animal studies have shown that Sodium cromoglicate inhibits the degranulation of sensitised mast cells which occurs after exposure to specific antigens. Sodium cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators from the mast cell.
Sodium cromoglicate has demonstrated the activity in vitro to inhibit the degranulation of non-sensitised rat mast cells by phospholipase A and subsequent release of chemical mediators. Sodium cromoglicate did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.
Sodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.
5.2 Pharmacokinetic properties
Sodium cromoglicate is poorly absorbed. When multiple doses of Sodium cromoglicate ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of Sodium cromoglicate is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the Sodium cromoglicate does penetrate into the aqueous humour and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.
In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of Sodium cromoglicate is absorbed following administration to the eye.
Sodium cromoglicate is not metabolised.
5.3 Preclinical safety data
None.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium edetate Benzalkonium chloride Purified water.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months unopened, 28 days opened
6.4 Special precautions for storage
Store below 30oC and protect from direct sunlight. Discard any remaining contents four weeks after opening.
6.5 Nature and contents of container
Low density polyethylene bottle without lauric diethanolamide and plug with a polypropylene cap with a shrink-type security seal containing 5 ml or 10 ml solution.
6.6 Special precautions for disposal
None.
MARKETING AUTHORISATION HOLDER
7
Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Or trading as:
Sanofi-aventis or Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 04425/0628
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16/02/2009
10 DATE OF REVISION OF THE TEXT
09/01/2014