MOBIFLEX Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Mobiflex Tablets 20mg.
Qualitative and quantitative composition
Each tablet contains 20mg tenoxicam. For a full list of excipients, see 6.1.
Pharmaceutical form
Film-coated tablet. A greyish yellow, film-coated oval tablet imprinted 20 on one face with a break line on the other.
Therapeutic indications
Mobiflex is indicated for the relief of pain and inflammation in osteoarthritis and rheumatoid arthritis. It is also indicated for the short term management of acute musculoskeletal disorders including ...
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
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastro-intestinal bleeding (melaena, haematemesis), perforation related ...
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). The use of Mobiflex ...
Interaction with other medicinal products and other forms of interaction
<u>Other analgesics including cyclooxygenase-2 selective inhibitors:</u> Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (see section 4.4). ...
Fertility, pregnancy and lactation
Fertility The use of tenoxicam, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. In women who have ...
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
Usually the undesirable effects reported were mild and transient. In a small proportion of patients the interruption of treatment due to undesirable effects was necessary. Within the system organ classes, ...
Overdose
Symptoms In general, symptoms of NSAID overdosage usually include nausea, vomiting, epigastric pain, rarely diarrhoea, gastrointestinal bleeding, tinnitus, headache, blurred vision and dizziness. There ...
Pharmacodynamic properties
Antirheumatic, anti-inflammatory and analgesic agent ATC code: M01AC02 Mechanism of action Mobiflex is a non-steroidal anti-inflammatory drug (NSAID) which has anti-inflammatory, analgesic, antipyretic ...
Pharmacokinetic properties
Absorption Mobiflex is long-acting; a single daily dose is effective. After oral administration, Mobiflex is rapidly and completely absorbed as unchanged drug. Concomitant food reduces the rate, but not ...
Preclinical safety data
Carcinogenicity Tenoxicam showed no carcinogenic effects in animals. Mutagenicity Tenoxicam showed no mutagenic effects in animals. Impairment of fertility See section 4.6. Teratogenicity Tenoxicam showed ...
List of excipients
Lactose Maize starch Magnesium stearate Talc Hypromellose Titanium dioxide E171 Yellow iron oxide E172
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Do not store above 30°C.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0134
Date of first authorization / renewal of the authorization
10<sup>th</sup> August 1988/11<sup>th</sup> November 2009
Date of revision of the text
February 2018
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