This information is intended for use by health professionals

1. Name of the medicinal product

Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution

2. Qualitative and quantitative composition

Each single dose container contains 2% w/v of sodium cromoglicate.

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Eye drops, solution in single-dose container

A clear colourless or pale yellow liquid.

pH: 5.0 to 7.0

Osmolality: 280 to 340 mOsmol/kg

4. Clinical particulars
4.1 Therapeutic indications

For the relief and treatment of seasonal and perennial allergic conjunctivitis.

4.2 Posology and method of administration

Posology

Adults and children

The recommended dose is one or two drops in each eye four times a day.

Opticrom Single Dose should be used regularly to ensure optimal control of symptoms. It is recommended that treatment is continued during the period of exposure to allergen.

Special population

Older people

No current evidence for alteration of the dose.

Paediatric

In children, caregiver supervision and/or assistance may be required

Method of administration

For ocular use only.

It should be administered in the conjunctival sac of the affected eye.

To avoid contamination, the tip of the container should not touch the eye or any surface (see section 4.4).

As with most ophthalmic preparations, contact lenses should be removed before each application and may be inserted after 15 minutes.

In case of concomitant treatment with other eye drops, instillations should be 15 minutes apart.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Opticrom Single Dose is sterile, preservative-free, and presented in a single-dose container which should be used immediately after opening and any remaining contents discarded after use.

Patients wearing contact lenses: see section 4.2.

4.5 Interaction with other medicinal products and other forms of interaction

No interactions studies have been performed.

4.6 Fertility, 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.

Breast-feeding

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.

Fertility

Animal studies did not show any effect on fertility. It is not known if sodium cromoglicate has an effect on human fertility.

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. Patients are advised not to drive or operate machinery if affected, until their normal vision has been re-established.

4.8 Undesirable effects

Frequencies are based on the MedDRA frequency convention and defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Eye Disorders

Not known: transient stinging and burning may occur after instillation. Other symptoms of local irritation have been reported.

Immune System Disorders

Not known: hypersensitivity reactions have been reported

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 release phospholipase A on its specific substrate.

Sodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.

5.2 Pharmacokinetic properties

In normal volunteers, analysis of urinary excretion of the medicinal product indicates that only a very small proportion of the dose will drain into the nasal cavity and eventually into the gastrointestinal tract from where absorption is also low.

The medicinal product has a high systemic clearance (plasma clearance 7.9 ± 0.9ml min-1.kg-1), so that any absorbed medicinal product is rapidly cleared from the circulation and accumulation does not occur.

Sodium cromoglicate is reversibly bound to plasma proteins (≈65%) and is not metabolised, being excreted unchanged in the bile and urine in approximately equal proportions.

5.3 Preclinical safety data

Non-clinical data are limited, however they do not reveal any special hazard for humans based on studies of repeated dose toxicity, genotoxicity, toxicity to reproduction and development.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium chloride

Purified water

6.2 Incompatibilities

None known

6.3 Shelf life

Unopened: 3 years

After opening the sachet: 28 days

After opening the single-dose container: the medicinal product must be used immediately

6.4 Special precautions for storage

Before opening single-dose container:

Store below 25°C. Keep the single dose containers in the aluminium sachet in order to protect from light.

After opening single-dose container:

Discard any remaining contents after use.

6.5 Nature and contents of container

Low density polyethylene single-dose containers containing 0.3ml solution.

Packaging: 10 or 20 single-dose containers packaged in an aluminium sachet.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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 04425/0688

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 22 December 2014.

10. Date of revision of the text

22 December 2014

Legal classification

P