Sodium cromoglicate 2 %w/v Eye drops, Solution_PL 25298/0305

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

Ocular use

Adults and Children:

One or two drops to be administered into each eye four times daily or as indicated by the doctor.

Elderly

There is no evidence to suggest that dosage alteration is required for elderly patients.

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

Discard any remaining contents four weeks after opening the bottle.

This medicine contains Benzalkonium chloride.

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

From the limited data available, there is no difference in the adverse event profile in children compared to adults.

Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.

Patients should be monitored in case of prolonged use.

No interaction studies have been performed.

Fertility:

It is not known whether sodium cromoglicate has any effect on fertility.

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.

Sodium cromoglicate has a minor influence on the 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 vision returns to normal.

Eye disorders

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 Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

Pharmacotherapeutic group: Opthalmologicals; Other antiallergics,, ATC code: SO1GX01

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.

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.

None stated.

Disodium edetate

Benzalkonium chloride

Water for Injections

Not applicable.

24 months.

After first opening the bottle: 4 weeks

Discard any remaining solution four weeks after first opening.

Before first opening the bottle: This medicinal product does not require any special storage conditions

After first opening the bottle: Do not store above 25° C.

LDPE Blow Fill Seal (BFS) container with white polypropylene spiked screw cap having a tamper-proof base ring.

Low density polyethylene (LDPE) bottle with a low density polyethylene/ high density polyethylene tamper proof cap containing either 5ml or 10ml of solution.

LDPE bottle with a HDPE tamper proof cap containing 13.5ml of solution.

Pack sizes: 1x5ml, 1x10ml and 1x13.5ml

Not all pack sizes may be marketed.

No special requirements

For 5 ml and 10 ml Pack:

Opening the dropper container before first use

Note: The dropper container should not be used if the tamper-proof base ring with cap is broken before you first use it.

1. Turn the cap in counter clockwise direction. This will break the tamper-proof base ring (Fig.1).

2. Remove the tamper-proof base ring by retaining the cap on the container (Fig.2).

3. Tighten the cap on the nozzle so that the edge of the cap and the edge of bottle neck are totally aligned. Turning the screw cap clockwise will pierce the tip of the dropper container (Fig.3).

4. To open the dropper container, remove the cap by turning it in the counter clockwise direction (Fig.4).

5. Tighten the cap on the container after every use (Fig.5).

For 13.5 ml Pack:

Note: The dropper container should not be used if the tamper-proof seal on the bottle neck is broken before you first use it.

Opening the dropper container before first use

1. Before using the medicine for the first time, be sure the tamper evident ring between the dropper container and the cap is unbroken (Fig.1).

2. Before opening the dropper container for the first time, tear off the tamper evident ring to break the seal (Fig.2).

3. To open the dropper container, remove the cap by turning it in the counter clockwise direction (Fig.3).

4. Tighten the cap on the container after every use (Fig.4).