TROPEX Ear drops, solution (2020)

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Περιεχόμενα

1. Name of the medicinal product

Tropex 5% w/v Ear Drops Solution.

2. Qualitative and quantitative composition

Each 1 ml of solution contains Phenazone 50mg (5% w/v). Excipient(s) with known effect: Each ml also contains 1mg methylparahydroxybenzoate. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Ear drops, solution. Clear, colourless solution.

4.1. Therapeutic indications

For the management of the symptoms of otitis media and other inflammatory conditions of the ear. Also for the softening and removal of earwax.

4.2. Posology and method of administration

Route of administration: For auricular use. Recommended Dosage Schedule: 4-6 drops to be introduced into the ear three to four times a day according to the severity of the inflammation. ...

4.3. Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 Tropex should not be used in patients who have perforated eardrums.

4.4. Special warnings and precautions for use

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Tropex should not be used in patients who have perforated eardrums.

4.5. Interaction with other medicinal products and other forms of interaction

Oral phenazone affects the metabolism of drugs broken down by liver enzymes. However, little absorption is expected from topical application into the auditory canal.

4.6. Pregnancy and lactation

There is no information to contraindicate the use of Tropex during pregnancy or lactation.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

Phenazone may give rise to skin eruptions and hypersensitivity reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is ...

4.9. Overdose

Not applicable.

5.1. Pharmacodynamic properties

Pharmacotherapeutic classification (Group + ATC code): Analgesic and Antipyretic: S02DA03 Phenazone has analgesic and antipyretic properties. Topically, solutions containing 5% of phenazone have ...

5.2. Pharmacokinetic properties

Phenazone is readily absorbed from the gastro-intestinal tract and is distributed throughout the body fluids. Peak plasma concentrations are usually obtained in 1 to 2 hours. Less than 10% is bound to ...

5.3. Preclinical safety data

Not applicable.

6.1. List of excipients

Glycerol Methyl parahydroxybenzoate (E218)

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Do not store above 25°C. Do not refrigerate.

6.5. Nature and contents of container

Tropex is filled into 10 ml amber glass bottles equipped with a dropper attachment consisting of a black polyethylene screw cap with a hole in the centre inserted with a red rubber teat. The rubber teat ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland

8. Marketing authorization number(s)

PA0074/002/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 24 March 1976 Date of last renewal: 24 March 2006

10. Date of revision of the text

January 2020

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