This information is intended for use by health professionals

1. Name of the medicinal product

OpticromTM 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 these eye drops may cause a transient blurring of vision or local irritation. 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 30°C 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 and other handling

None.

7. Marketing authorisation holder

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

9 January 2014

Legal classification

GSL