Earcalm Spray

1. Name Of The Medicinal Product

EarCalm Spray.

2. Qualitative And Quantitative Composition

Acetic Acid (Glacial) Ph. Eur., 2.0% w/w

3. Pharmaceutical Form

Ear spray for auricular use.

4. Clinical Particulars

4.1 Therapeutic Indications

EarCalm Spray is indicated for the treatment of superficial infections of the external auditory canal.

4.2 Posology And Method Of Administration

Route of administration: Topical. For external aural use to the external auditory canal only.

Adults, children, aged 12 years and above, and the elderly.

For treatment of superficial infections of the outer ear: one metered dose (60 milligrams) to be administered directly into each effected ear at least three times daily (morning, evening and after swimming, showering or bathing). Maximum dosage frequency one spray every 2-3 hours.

Treatment should be continued until two days after symptoms have disappeared but no longer than 7 days.

Before using the product for the first time, prime the pump by depressing the actuator 6-10 times until a fine spray is obtained. Use within 1 month of first actuation. If more than one week has elapsed since the last use, dispose of the content of the pump chamber by 1 or 2 depressions of the actuator.

4.3 Contraindications

The product should not be used in patients with a known sensitivity to any of the ingredients.

Not recommended for children under 12 years of age without medical advice.

4.4 Special Warnings And Precautions For Use

Do not use for more than 7 days. Avoid spraying near the eyes.

If pain occurs during use, or if symptoms worsen or do not improve within 48 hours, or if your hearing becomes impaired, stop treatment and consult your doctor.

Patients who are known to have a perforated ear drum should only use the product under medical supervision.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There are no known restrictions to the use of the product in pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

Unresolved ear problems could themselves effect driving ability.

4.8 Undesirable Effects

Some patients may experience a transient stinging or burning sensation after dosing for the first few days of treatment.

4.9 Overdose

Overdosage by this route is extremely unlikely.

If Earcalm should be accidentally swallowed, neutralisation with milk or water may be required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Acetic acid possesses antibacterial activity.

It is reported to be active against: Haemophilus and Pseudomonas species, Candida and Trichomonas.

5.2 Pharmacokinetic Properties

EarCalm Spray is applied topically to the external auditory meatus and acts locally.

5.3 Preclinical Safety Data

Acetic acid is widely available and toxicity problems at this concentration are unlikely.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol (2) stearyl ether

Macrogol (20) stearyl ether

Stearyl alcohol

Methyl parahydroxybenzoate

Propyl parahydroxybenzoate

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life in the product as packaged for sale: 18 months from the date of manufacture.

Shelf-life after first opening of the container: Use within one month of first use.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep container upright in the outer carton.

6.5 Nature And Contents Of Container

5 ml of the product is supplied in a 8.5ml capacity amber glass bottle fitted with a spray device.

6.6 Special Precautions For Disposal And Other Handling

Shake the bottle well before use. Before first use, press actuator down several times to obtain a fine spray. Each press then delivers one metered dose. Do not inhale the spray. Administer spray directly by placing nozzle tip into ear opening and pressing down once on the actuator.

Use within one month of first use. If there is a period of more than one week since last use, press actuator down a few times before using again.

7. Marketing Authorisation Holder

Stafford-Miller Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as GlaxoSmithKline Consumer Healthcare, Brentford TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00036/0072

9. Date Of First Authorisation/Renewal Of The Authorisation

8 June 1999

10. Date Of Revision Of The Text

26 February 2002