Summary of Product Characteristics (SmPC) - Sodium Cromoglicate 2% w/v eye drops solution (eye drops)

1 NAME OF THE MEDICINAL PRODUCT

Sodium Cromoglicate 2% w/v Eye Drops, Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of eye drops contains

Active substance: 20 mg sodium cromoglicate (2.0% w/v), (one drop contains 0.7mg sodium cromoglicate).

Excipient with known effect: 0.1mg benzalkonium chloride

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Eye Drops, Solution (eye drops)

Clear colourless to pale yellow solution

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

Sodium cromoglicate 2%w/v eye drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist.

Ocular use

Adults and Children over 6 years:

One or two drops to be administered into each eye four times daily.

Children under 6 years

There is no relevant indication for use of sodium cromoglicate in children. Sodium cromoglicate is contraindicated in children under 2 years of age.

Elderly

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

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

Discard any remaining contents four weeks after opening the bottle.

Sodium cromoglicate eye drops contains benzalkonium chloride.

May cause eye irritation.

Avoid contact with soft contact lenses.

Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

Known to discolour soft contact lenses.

The carton and patient information leaflet will state:

The patient should consult a doctor or pharmacist if symptoms do not start to improve within 48 hours
Hayfever 2% 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

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

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 fetal 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

Sodium cromoglicate may interfere with the ability to drive and use machines.

Installation 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.

4.8 Undesirable effects

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

4.9 Overdose

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

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals; 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.

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

There are no data of relevance to the prescriber that are not already included elsewhere in the SmPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium edetate

Benzalkonium chloride

Water for Injections

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months.

After first opening the bottle: 4 weeks

Discard any remaining solution four weeks after first opening.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

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

Pack sizes: 1x5ml and 1x10ml

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

Before using the medication for the first time, be sure that the tamper-proof seal on the bottle neck is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.

7 MARKETING AUTHORISATION HOLDER

Aspire Pharma Limited

Unit 4, Rotherbrook Court

Bedford Road

Petersfield

Hampshire

GU32 3QG

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 35533/0084

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

07/02/2025

10 DATE OF REVISION OF THE TEXT