Mylan Allercrom 2% W/V Eye Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Allercrom 2% w/v Eye Drops Mylan Allercrom 2% w/v Eye Drops Murine Hayfever Relief 2% w/v Eye Drops Lloyds Pharmacy Hayfever Relief 2% w/v Eye Drops Careway Allergy & Hayfever 2% w/v Eye Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium cromoglicate (equivalent to 20.0 mg/ml anhydrous Sodium Cromoglicate).
[Sodium Cromoglicate 2.0% w/v]
For a full list of excipients, see 6.1
3 PHARMACEUTICAL FORM
Eye drops
Sodium cromoglicate 2% w/v eye drops are a clear solution.
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
Allercrom 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
Known hypersensitivity to any ingredient, including sodium cromoglicate, Benzalkonium Chloride and Disodium Edetate.
4.4 Special warnings and precautions for use
This formulation of Sodium Cromoglicate Eye Drops contains benzalkonium chloride as a preservative. Benzalkonium chloride may be deposited in soft contact lenses. Hence, soft contact lenses should not be worn during treatment with sodium cromoglicate eye drops. Other types of contact lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use.
Patients should also be instructed that ocular solutions, if handled improperly can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Patients should also be advised that if they develop any intercurrent ocular condition (e.g. trauma, ocular surgery or infection), they should immediately seek their physician's advice concerning the continued use of present multi-dose container. There have been reports of bacterial keratitis associated with the use of topical ophthalmic products.
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,
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. However, as with all medicines, caution should be exercised during pregnancy, and it should be used in pregnancy only when there is a clear need.
It is not known whether sodium cromoglicate is excreted in breast milk but on the basis of its physico-chemical 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
Transient stinging or blurring of vision may occur on instillation of the drops.
Do not drive or use machinery until normal vision is restored.
4.8
Undesirable effects
Transient stinging and burning on instillation of the drops. Rarely , other symptoms of local irritation.
Reporting of suspected adverse reactions
Reporting 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 Yellow card scheme at www.mhra.gov.uk/yellowcard.
4.9
5
5.1
5.2
5.3
6
6.1
Overdose
Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
The solution exerts its effect locally in the eye.
Sodium cromoglicate inhibits the release from sensitised mast cells of mediators of the allergic reaction.
Pharmacokinetic properties
Limited systemic absorption may be expected via the ocular mucosa. Sodium Cromoglicate is not metabolised.
Preclinical safety data
Pre-clinical safety data does not add anything of further significance to the prescriber.
PHARMACEUTICAL PARTICULARS
List of excipients
Benzalkonium chloride
Disodium edetate Sodium chloride Polysorbate 80 Water for injection
6.3
6.4
Special precautions for storage
Do not store above 30oC. Protect from direct sunlight.
To avoid contamination do not touch dropper tip to any surface
6.5
Nature and contents of container
Low Density Polyethylene BFS bottles with a polystyrene spiked cap which contains 5 mL and 10 mL of Sodium Cromoglicate 2 % w/v Eye Drops solution.
Not all pack sizes may be marketed.
Special precautions for disposal
No special instructions.
7
MARKETING AUTHORISATION HOLDER
FDC International Ltd Unit 6 Fulcrum 1,
Solent Way,
Whiteley,
Fareham,
Hampshire PO15 7FE UK
8
16 May 2007 / 05 March 2012
10 DATE OF REVISION OF THE TEXT
28/02/2016