Earex Ear Drops

1. Name Of The Medicinal Product

Earex Ear Drops

Boots Ear Wax Remover

2. Qualitative And Quantitative Composition

Almond oil	33.33%v/v
Arachis oil (peanut oil)	33.33%v/v
Rectified camphor oil	33.33%v/v

3. Pharmaceutical Form

Ear drops

4. Clinical Particulars

4.1 Therapeutic Indications

For the easy removal of ear wax.

4.2 Posology And Method Of Administration

Adults, children and the elderly:

1. Incline the head to one side.

2. Insert four drops with the applicator supplied.

3. Insert a piece of cotton wool.

4. Repeat night and morning for up to four days until wax is cleared.

Route of administration: Installation into the ear.

4.3 Contraindications

Do not use if the ear is inflamed or infected. Do not use where the eardrum is not whole.

4.4 Special Warnings And Precautions For Use

Never use force or instruments in the ear. Violent nose blowing should always be avoided. Wisdom or any decayed teeth should be examined in all cases of ear trouble.

Earex Ear Drops contain Arachis oil (peanut oil) and should not be applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Earex Ear Drops.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

Unlikely with this dosage form. Gastric lavage may be used in cases of accidental ingestion.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Not applicable.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Not applicable.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months unopened.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Carton containing an amber glass bottle containing 10ml of product with a polypropylene/HDPE tamper evident closure, an acrylonitrile butadiene rubber (A7975C) teat and integral polypropylene dropper containing 10ml of product.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Pharmalab Ltd

Venus

1 Old Park Lane

Trafford Park

Manchester

M41 7HA

8. Marketing Authorisation Number(S)

PL 12048/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

30/3/92 / 19/12/97

10. Date Of Revision Of The Text

16/05/2011