This information is intended for use by health professionals

1. Name of the medicinal product

Opticrom Aqueous 2% w/v Eye Drops, Solution

2. Qualitative and quantitative composition

Sodium cromoglicate 2.0% w/v.

3. Pharmaceutical form

Eye Drops, Solution

A clear colourless to pale yellow solution for administration to the eye.

4. Clinical particulars
4.1 Therapeutic indications

For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal kerato conjunctivitis.

4.2 Posology and method of administration
 

Adults and children:

one or two drops into each eye four times daily or as indicated by the doctor.

Elderly:

no current evidence for alteration of the dose.

Route of administration:

topical ophthalmic.

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

Discard any remaining contents four weeks after opening the bottle.

As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

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 clinical need.

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

Transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported rarely.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

No action other than medical observation should be necessary.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals; Other antiallergics, ATC Code: S01GX01

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.

5.3 Preclinical safety data

None stated.

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.

The eye drops should be used within 4 weeks of opening the container. Any remaining after this time should be discarded.

6.4 Special precautions for storage

Store below 30°C.

Protect from direct sunlight.

6.5 Nature and contents of container

Low density polyethylene bottle and plug with a polypropylene or elf atochem ATO Apply 13020 SM3 or Solvay Chemical Ltd Eltex PKL104 cap with a shrink type security seat containing either 10 or 13.5 ml.

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 04425/0324

9. Date of first authorisation/renewal of the authorisation

28 February 2003

10. Date of revision of the text

9 January 2014

Legal classification

POM