This information is intended for use by health professionals

1. Name of the medicinal product

Rapitil 2.0% w/v Eye Drops, Solution

2. Qualitative and quantitative composition

Active substance

nedocromil sodium 2.0% w/v.

Excipient with known effect

benzalkonium chloride

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Eye drops, solution

Clear, yellow solution, substantially free from particles.

4. Clinical particulars
4.1 Therapeutic indications

For the prevention, relief and treatment of allergic conjunctivitis, including seasonal allergic conjunctivitis, allergic conjunctivitis and vernal-kerato conjunctivitis.

4.2 Posology and method of administration

Adults (including the elderly) and children aged 6 years and over:

In seasonal allergic conjunctivitis: one drop into each eye twice daily, increasing when necessary to four times daily. In seasonal allergic conjunctivitis therapy should be restricted to 12 weeks.

In vernal kerato-conjunctivitis: one drop into each eye four times daily.

Adults (including the elderly):

In perennial allergic conjunctivitis: one drop into each eye twice daily, increasing when necessary to four times daily.

Rapitil should be used regularly to ensure optimum control of symptoms.

There is only limited clinical trial evidence with Rapitil in children aged below 6 years, therefore use in this age range cannot be recommended.

4.3 Contraindications

Rapitil Eye Drops is contraindicated in patients with known hypersensitivity to nedocromil sodium, benzalkonium chloride or other constituents of the formulation.

4.4 Special warnings and precautions for use

Patients should be advised not to wear soft contact lenses during treatment with Rapitil Eye Drops. Benzalkonium chloride, a constituent of the formulation, may accumulate in soft contact lenses. This preservative, when slowly released, could possibly irritate the cornea.

In patients who continue to wear hard or gas-permeable contact lenses during Rapitil Eye Drops treatment, the lenses should be taken out of the eye prior to instillation of the drops. They should be inserted again not earlier than 10 minutes after administration, in order to allow an even conjunctival distribution of the solution.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.

4.5 Interaction with other medicinal products and other forms of interaction

No harmful interactions with other drugs have been reported in humans or in animals.

Specifically, no interactions with other topical ophthalmic or nasal therapies, oral antihistamine therapy or inhaled/oral asthma therapy have been reported.

4.6 Pregnancy and lactation

Studies in pregnant and lactating animals have failed to reveal a hazard with nedocromil sodium. However, as with all medications caution should be exercised during pregnancy (especially during the first trimester) and whilst breast feeding.

On the basis of animal studies and its physicochemical properties it is considered that only negligible amounts of nedocromil sodium may pass into human breast milk. There is no information to suggest that the use of nedocromil sodium by nursing mothers has any undesirable effects upon the baby.

4.7 Effects on ability to drive and use machines

Rapitil Eye Drops has no known effect on the ability to drive or operate machinery.

Additionally, no sedative effects have been reported following the administration of Rapitil Eye Drops.

4.8 Undesirable effects

The following frequency rating has been used, when applicable:

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 (frequency cannot be estimated from the available data).

In clinical studies conducted in patients treated with nedocromil sodium 2% eye drops, the following adverse events have been reported at the corresponding frequencies:

System organ class

Very common

(≥ 10 %)

Common

(≥ 1 % and < 10 % )

Uncommon

(≥ 0.1 % and < 1 %)

Rare

(≥ 0.01 % and < 0.1 %)

Very rare

(< 0.01%)

Frequency not known (cannot be estimated from available data)*

Eye disorders

Burning in eye, eye stringing, soreness in eyes

Eye irritation

Nervous system disorder

Dysgeunsia

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: www.mhra.gov.uk/yellowcard

4.9 Overdose

Animal studies have not shown evidence of significant toxic effects with nedocromil sodium even at high doses, nor have extended human studies with nedocromil sodium revealed any safety hazard with the drug. Overdosage is, therefore, unlikely to cause problems. However, if overdosage is suspected, treatment should be supportive and directed to the control of the relevant symptoms.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Decongestant and other antiallergics

ATC code: S01G X04

Rapitil, the ophthalmic preparation of nedocromil sodium, displays specific anti-allergic and anti-inflammatory properties. Nedocromil sodium has been shown to prevent the release of inflammatory mediators from a range of inflammatory cell types.

5.2 Pharmacokinetic properties

Following topical ophthalmic administration, less than 4% of the dose is absorbed following multiple dosing. Absorption occurs primarily through the nasal mucosa as approximately 80% of the ophthalmic dose drains into the nose via the naso-lachrymal duct, although 1-2% of the dose may be absorbed orally.

Nedocromil sodium is reversibly bound to plasma proteins and is not metabolised, but is excreted unchanged in bile and urine. The drug is rapidly cleared from the plasma (plasma clearance 10.2 + 1.3 ml/min/kg - elimination half-life 5.3 + 0.9 min) and accumulation does not occur.

5.3 Preclinical safety data

Animal studies have failed to reveal toxic effects with nedocromil sodium even at high doses.

6. Pharmaceutical particulars
6.1 List of excipients

benzalkonium chloride,

sodium chloride,

disodium edetate.

water for injections

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years.

Discard any remaining contents four weeks after opening the bottle.

6.4 Special precautions for storage

Store below 25°C, keep bottle in the outer carton.

For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container

A plastic dropper bottle containing 3ml or 5ml of sterile, aqueous solution for administration to the eye.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

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 04425/0285

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 30 March 1995

Date of latest renewal: 15 May 2001

10. Date of revision of the text

24 July 2015

Legal category

POM