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ALLERCROM 2% W/V EYE DROPS

Active substance(s): SODIUM CROMOGLICATE / SODIUM CROMOGLICATE

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Transcript
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:


4.5

the patient should consult a doctor or pharmacist if symptoms do not start to
improve within 48 hours,

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

Overdose
Overdosage is very unlikely. In the event of accidental ingestion, symptomatic
treatment is recommended.

5

PHARMACOLOGICAL PROPERTIES

5.1

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.

5.2

Pharmacokinetic properties
Limited systemic absorption may be expected via the ocular mucosa. Sodium
Cromoglicate is not metabolised.

5.3

Preclinical safety data
Pre-clinical safety data does not add anything of further significance to the prescriber.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Benzalkonium chloride
Disodium edetate
Sodium chloride
Polysorbate 80
Water for injection

6.2

6.3

6.4

Incompatibilities
None known.

Shelf life
Unopened:

24 months

Opened:

1 month

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.

6.6

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

MARKETING AUTHORISATION NUMBER(S)
PL 15872/0008

9.

DATE OF FIRST
AUTHORISATION

AUTHORISATION/RENEWAL

16 May 2007 / 05 March 2012

OF

THE

10

DATE OF REVISION OF THE TEXT
28/02/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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