VIVIDRIN EYE DROPS, VIVIDRIN HAY FEVER EYE DROPS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Vividrin Hay Fever Eye Drops

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium cromoglicate (equivalent to 20.0 mg/ml anhydrous sodium cromoglicate).

[Sodium cromoglicate 2.0% w/v]

Excipient with known effect: Benzalkonium Chloride (0.01%)For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Sodium cromoglicate 2% w/v eye drops are a clear solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief and treatment of the eye symptoms of hay fever

4.2 Posology and method of administration

Method of Administration:

For topical administration to the eye.

Adults, Elderly and Children over 6 years

One or two drops into each eye four times daily.

Vividrin Hayfever Eye Drops should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist.

4.3 Contraindi­cations

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

4.4 Special warnings and precautions for use

The solution should be discarded 1 month after first opening the bottle or if any turbidity develops. Do not use if the bottle has been opened prior to receipt.

Vividrin Hayfever Eye Drops contains benzalkonium chloride

This medicinal product contains 0.00306 mg benzalkonium chloride in each drop (0.0306ml) which is equivalent to 0.1 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should remove contact lenses before using this medicine and put them back 15minutes afterwards.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Vividrin Hayfever Eye Drops 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.

The carton label and patient information leaflet will state:

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

Vividrin Hayfever 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

None known.

4.6 Fertility, pregnancy and lactation

Pregnancy

Vividrin Hayfever Eye Drops should be used cautiously during pregnancy and lactation. The widespread use of sodium cromoglicate has yet to reveal any adverse effects to mother or child during pregnancy.

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 that the use of sodium cromoglicate has any undesirable effects on the baby

4.7 Effects on ability to drive and use machines

Transient stinging or blurred vision may occur on instillation. Do not drive or operate machinery until proper vision is restored.

4.8 Undesirable effects

Transient stinging and blurring 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

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

4.9 Overdose

As sodium cromoglicate is absorbed only to a very limited extent from eye drops, no action other than medical observation should be necessary. In the event of accidental ingestion, symptomatic treatment is recommended.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmcaotherapeutic group: Ophthalmologicals; Other antiallergics, ATC Code: S01GX01

Sodium cromoglicate has neither anti-histaminic nor anti-inflammatory activity. Evidence suggests that sodium cromoglicate inhibits the release of mediators of the allergic reaction by stabilising the membranes of sensitised mast cells.

5.2 Pharmacokinetic properties

Due to lipid insolubility, sodium cromoglicate is poorly absorbed following administration to the eye. In normal volunteers approximately 0.03% is systemically absorbed. Absorbed sodium cromoglicate is excreted unchanged in the bile and urine.

Trace amounts of sodium cromoglicate have been detected in the aqueous humor of rabbits for up to 24 hours after treatment.

5.3 Preclinical safety data

The results of the studies do not add to the information needed by the prescriber, consequently, they are not repeated in the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzalkonium chloride EP

Edetic acid disodium salt 2H20 EP

Polysorbate 80 EP

Sorbitol EP

Sodium hydroxide BP

Purified water EP

6.2 Incompatibilities

Sodium cromoglicate forms insoluble complexes with metal ions resulting in solution turbidity.

6.3 Shelf life

Unopened: 36 months.

Once opened for the first time: 4 weeks.

6.4 Special precautions for storage

Store below 25°C, out of direct sunlight

6.5 Nature and contents of container

Vividrin Hay Fever Eye Drops – 10.0ml polyethylene multidose eye dropper bottle with polyethylene cap.

6.6 Special precautions for disposal and handling

The following instructions for use are included in the patient leaflet.

1. Before using your Vividrin Hayfever Eye Drops you should wash your hands.

2. You may find it helps to sit in front of a mirror, so that you can see what you are doing. Tilt your head backwards, gently pull down your lower eyelid and carefully place one or two Vividrin Hayfever Eye Drops in the space between the eyelid and the eye. Take care not to touch the dropper with your eye or fingers.

3. Release the eyelid and blink a few times to make sure the liquid covers the whole surface of the eye.

4. Repeat the procedure with the other eye and then replace the cap on the bottle.

Bausch & Lomb (UK) Ltd

Bausch &Lomb House 106 London Road Kingston-Upon-Thames Surrey KT2 6TN

UK