FROBEN Coated tablet (2019)
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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. <u>Diuretics, ACE inhibitors and Angiotensin II Antagonists:</u> NSAIDs may ...
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
<u>Blister pack:</u> 36 months (unopened). <u>Bulk pack:</u> 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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