SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Aspire Allergy Relief 2% w/v eye drops, Solution (eye drops)

Optrex Allergy 2% w/v Eye Drops, Solution (eye drops)

EM Pharma Allergy Relief 2%w/v Eye Drops

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 Clear colourless to pale yellow solution

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

Topical ophthalmic administration

One or two drops in each eye four times a day or as indicated by the doctor.

Older people

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.

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

Sodium cromoglicate can be used prophylactically. Patients should seek advice before they discontinue use of the product.

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 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

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.

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 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: , 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

None.

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.

Special precautions for storage

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.

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

Bellamy House

Winton Road

Petersfield

Hampshire

GU32 3HA

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 35533/0033

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

22/08/2014

10    DATE OF REVISION OF THE TEXT

27/01/2016