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SPC, UK: FROBEN Coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Froben Tablets 50 mg. Flurbiprofen 50 mg coated tablets.

Qualitative and quantitative composition

Froben Tablets 50mg contain 50 mg flurbiprofen EP. Flurbiprofen 50 mg coated tablets contain 50 mg flurbiprofen EP. Excipients with known effect: Sucrose Glucose Lactose

Pharmaceutical form

The tablets are 7.6 mm in diameter, sugar-coated and white in colour.

Therapeutic indications

For the treatment of rheumatoid disease, osteoarthritis, ankylosing spondylitis, musculoskeletal disorders and trauma such as periarthritis, frozen shoulder, bursitis, tendinitis, tenosynovitis, low back ...

Posology and method of administration

For oral administration. To be taken preferably with or after food. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see ...

Contraindications

Flurbiprofen is contraindicated in patients with hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the inactive ingredients. Flurbiprofen is contraindicated in patients ...

Special warnings and precautions for use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.2 and GI and cardiovascular risks below). On prolonged use ...

Interaction with other medicinal products and other forms of interaction

Care should be taken in patients treated with any of the following drugs as interactions have been reported in some patients. Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce ...

Fertility, pregnancy and lactation

Impaired female fertility The use of flurbiprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation ...

Effects on ability to drive and use machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.

Undesirable effects

Gastrointestinal disorders The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see ...

Overdose

Symptoms Symptoms of overdosage may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroidal; propionic acid derivatives ATC code: M01AE09 Flurbiprofen has analgesic, anti-inflammatory and antipyretic properties. ...

Pharmacokinetic properties

Flurbiprofen is readily absorbed from the gastrointestinal tract, with peak plasma concentrations occurring about 90 minutes after ingestion. It is about 99% protein-bound and has an elimination half-life ...

Preclinical safety data

Not applicable.

List of excipients

Maize starch Lactose Povidone Magnesium stearate Stearic acid Sandarac gum Sucrose Talc Liquid glucose Titanium dioxide Colloidal silica Carnauba wax

Incompatibilities

None known.

Shelf life

Shelf life Blister pack: 36 months (unopened). Bulk pack: 12 months (unopened).

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

A blister pack consisting of a PVC blister heat sealed to hard temper aluminium foil packed in a cardboard carton. Each blister contains 10 tablets. Pack sizes: 10, 20, 30, 100 and 500 tablets. Also a ...

Special precautions for disposal and other handling

None stated.

Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization number(s)

Froben Tablets 50 mg: Flurbiprofen 50 mg coated tablets: PL 46302/0013

Date of first authorization / renewal of the authorization

21/07/1995

Date of revision of the text

15 January 2019

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