FENBID 5% w/w Gel (2021)

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Περιεχόμενα

1. Name of the medicinal product

Ibuprofen 5% gel, Fenbid gel, Phorpain Gel, Flexigel, Ibuprofen Pain relief gel 5% w/w.

2. Qualitative and quantitative composition

5% w/w Ibuprofen Ph.Eur. Excipient(s) with known effect: Each 100mg of gel contains 1mg of Benzyl alcohol. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Gel for topical application. Clear or slightly opalescent, colourless or almost colourless gel with Isopropanol odour.

4.1. Therapeutic indications

Pharmacy Only Indications: Topical analgesic and anti-inflammatory for backache, pain of non-serious arthritic conditions, muscular pain, sprains, strains, sports injuries and neuralgia. General ...

4.2. Posology and method of administration

Strength 5% maximum. Posology Adults, the elderly and children over 12 years Squeeze 50 to 125mg (4 to 10cm) of the gel from the tube and lightly rub into the affected area until absorbed. The dose should ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to aspirin, or other non-steroidal anti-inflammatory drugs Patients with asthma, rhinitis or ...

4.4. Special warnings and precautions for use

Apply with gentle massage only. Avoid contact with eyes, mucous membranes and inflamed or broken skin. Discontinue if rash develops. Hands should be washed immediately after use. Not for use with occlusive ...

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

Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically ...

4.6. Fertility, pregnancy and lactation

Not to be used during pregnancy or breast-feeding. Pregnancy Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed and ...

4.7. Effects on ability to drive and use machines

Not relevant.

4.8. Undesirable effects

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Uncommon (≥1/1,000 to <1/100) Not known (Frequency cannot be estimated ...

4.9. Overdose

Overdosage with a topical presentation of ibuprofen gel is unlikely. Symptoms Symptoms of severe ibuprofen overdosage (eg following accidental oral ingestion) include headache, vomiting, drowsiness and ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory preparations, non-steroids for topical use ATC code: M02AA13 The gel is for topical application. It contains the active ingredient, ibuprofen, ...

5.2. Pharmacokinetic properties

Absorption and Distribution Specially formulated for external application, the active ingredient penetrates through the skin rapidly and extensively (approximately 22% of a finite dose within 48 hours), ...

5.3. Preclinical safety data

There is no new data published on the active ingredient.

6.1. List of excipients

Ethylhydroxycellulose EP Sodium hydroxide EP Benzyl alcohol EP Isopropyl alcohol EP Purified water EP

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Aluminium tube with internal epoxy phenolic coating with Polypropylene cap containing 15g (trial size/starter pack) and 30/35/50/100g of Fenbid Gel/Phorpain Gel. The 100g pack size is restricted to Pharmacy ...

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

7. Marketing authorization holder

Mercury Pharma Group Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

8. Marketing authorization number(s)

PL 10972/0045

9. Date of first authorization / renewal of the authorization

26 April 1996

10. Date of revision of the text

04/02/2021

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