This information is intended for use by health professionals

1. Name of the medicinal product

Cromolux 2% Hay fever Eye Drops

Tesco Allergy Eye Drops sodium cromoglicate 2%

Boots Allergy Relief 2% w/v Eye Drops

2. Qualitative and quantitative composition

Each one ml of solution contains 20 mg of Sodium Cromoglicate

Pack size: 10.0 ml

For excipients, see section 6.1

3. Pharmaceutical form

Eye drops solution A clear, colourless solution

4. Clinical particulars
4.1 Therapeutic indications

For the treatment of Hayfever. For the treatment of acute seasonal and perennial allergic conjunctivitis

4.2 Posology and method of administration

Adults (including elderly) and children: One or two drops in each eye four times daily

4.3 Contraindications

Sodium cromoglicate eye drops are contraindicated in patients with sensitivity to any ingredient, including sodium cromoglicate, benzalkonium chloride and sodium edetate

4.4 Special warnings and precautions for use

Soft contact lenses should not be worn during treatment.

Sodium cromoglicate is to be used prophylactically. Therefore patients should be advised not to discontinue use of the product unless advised to do so

4.5 Interaction with other medicinal products and other forms of interaction

None Known

4.6 Pregnancy and lactation

As with all medications during pregnancy, this product should be used with caution especially during the first trimester. There do not appear to be foetal abnormalities in toxicity studies, but this should not mitigate the care to be used with this product. The product should therefore only be used in pregnancy where there is a clear need.

There is no information to indicate that the use of sodium cromoglicate has any undesirable effects on the baby.

It is unlikely that this product would be excreted in breast milk but this has not been fully investigated

4.7 Effects on ability to drive and use machines

Instillation of drops may cause transient alteration of vision. Patients should be advised not to drive or operate machinery until clarity of vision is restored.

4.8 Undesirable effects

Stinging, blurring of vision and burning may occur briefly after instillation, as may local irritation.

4.9 Overdose

Sodium cromoglicate is poorly absorbed through the gastrointestinal tract. In cases of overdosage, no action other than medical observation should be necessary.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Both in-vitro and in-vivo studies suggest that sodium cromoglicate prevents the release of granules that produce allergen-mediated inflammatory reaction in the eye. Sodium cromoglicate appears to inhibit reactions caused by both antigenic and non antigenic stimuli. Sodium cromoglicate has no intrinsic antihistaminic or anti-inflammatory action. Evidence suggests that the effects of the drug may be due to mast cell membrane stabilisation, although the precise mechanism is not known.

5.2 Pharmacokinetic properties

Sodium cromoglicate is poorly absorbed from the gastrointestinal tract, with less than 1% being made available by this route.

Systemically absorbed sodium cromoglicate is not metabolised and drug is excreted unchanged in the bile and urine. The drug does not cross the blood- brain barrier.

5.3 Preclinical safety data

There is no published information on either mutagenicity or carcinogenicity testing with this drug.

6. Pharmaceutical particulars
6.1 List of excipients

Benzalkonium Chloride

Disodium Edetate

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years unopened. 28 days once opened

6.4 Special precautions for storage

Do not store above 25° C

6.5 Nature and contents of container

Bottle and tip are made of low density Polyethylene with white coloring.

Pack size 10.0 ml.

6.6 Special precautions for disposal and other handling

None

7. Marketing authorisation holder

Bausch & Lomb (UK) Ltd

Bausch &Lomb House

106 London Road

Kingston-Upon-Thames

Surrey

KT2 6TN

UK

8. Marketing authorisation number(s)

PL03468/0023

9. Date of first authorisation/renewal of the authorisation

1st August 2010

10. Date of revision of the text

July 2015