Earex Plus Ear Drops

1. Name Of The Medicinal Product

Earex Plus Ear Drops.

2. Qualitative And Quantitative Composition

Choline Salicylate Solution BP 43.22% w/v; and Glycerol BP 12.62% w/v.

3. Pharmaceutical Form

Solution for topical administration to the ear.

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of ear pain in acute and chronic otitis media and externa. Patients with ear pain should always seek medical advice. Softening of ear wax as an aid to ear wax removal.

4.2 Posology And Method Of Administration

Auricular Use. Adults, the elderly and children: For pain relief: With the head tilted to one side, the external ear canal is filled completely with Earex Plus Ear Drops using the dropper provided. The ear should be plugged with cotton wool soaked with the ear drops. A wick may be inserted, if preferred, using the ear drops to keep it moist. Earex Plus Ear Drops should be instilled every three to four hours. For the softening of ear wax: Apply as described above, twice daily, for four days.

4.3 Contraindications

Not to be used in children under one year of age without medical advice being sought. Salicylate sensitivity. Perforated ear drum. Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

None stated.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

There is no known hazard with the use of this product during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

Each bottle of Earex Plus Ear Drops contains 1.6g of choline salicylate, equivalent to 1.2g of aspirin. Accidental or deliberate ingestion of the contents of a bottle of Earex Plus Ear Drops is therefore only of concern in small infants. In such cases, signs of intoxication may include dizziness, tinnitus, sweating, vomiting, confusion and hyperventilation. Gross overdosage may lead to central nervous system depression. Management should include, as appropriate, induced vomiting, correction of fluid and electrolyte balance and measurement of plasma salicylate levels. At concentrations in excess of 300mg/litre measures such as forced alkaline diuresis and haemodialysis to enhance clearance may be appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Choline salicylate ATC code: N02BA03.

Choline salicylate has actions similar to those of aspirin, that is analgesic, anti-inflammatory and antipyretic actions considered to be due to inhibition of the biosynthesis of prostaglandins. Glycerol softens ear wax due to its water-retaining and emollient properties.

5.2 Pharmacokinetic Properties

Not applicable as Earex Plus Ear Drops are applied topically.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethylene Oxide Polyoxypropylene Glycol; Chlorbutol (Hemihydrate); Hydrochloric Acid; Propylene Glycol.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

Three years unopened.

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

Cartoned amber glass bottle with screw cap and integral dropper containing 10ml of product.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

SSL International PLC. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.

8. Marketing Authorisation Number(S)

PL 17905/0018

9. Date Of First Authorisation/Renewal Of The Authorisation

21/08/2006

10. Date Of Revision Of The Text

21/08/2006