MOTIFENE Capsule, hard (2020)
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Περιεχόμενα
1. Name of the medicinal product
Motifene 75 mg Capsules.
2. Qualitative and quantitative composition
Each capsule contains 75 mg diclofenac sodium (25 mg as gastro-resistant pellets and 50 mg as prolonged release pellets). For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard. Size 2 hard gelatin capsule with a light blue opaque cap and colourless transparent body, containing white to cream-coloured pellets. The capsules are printed D75M in white.
4.1. Therapeutic indications
Motifene is indicated for the treatment of rheumatoid arthritis; osteoarthrosis; low back pain; acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, ...
4.2. Posology and method of administration
Posology For oral administration. The capsules should be swallowed whole with a liberal quantity of liquid. To be taken preferably with or after food. Undesirable effects may be minimised by using the ...
4.3. Contraindications
Hypersensitivity to diclofenac sodium or to any of the excipients listed in section 6.1. Previous hypersensitivity reactions (eg asthma, urticaria, angioedema or rhinitis) in response to ibuprofen, aspirin ...
4.4. Special warnings and precautions for use
In all patients 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). ...
4.5. Interaction with other medicinal products and other forms of interaction
Other analgesics including cyclo-oxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (see section 4.4). Diuretics ...
4.6. Fertility, pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...
4.7. Effects on ability to drive and use machines
Motifene has minor or moderate influence on the ability to drive and use machines. Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances, vertigo, somnolence or other central ...
4.8. Undesirable effects
If serious side-effects occur, Motifene should be withdrawn. The most commonly reported adverse reactions are gastrointestinal in nature. Adverse reactions from Motifene in clinical trials and epidemiological ...
4.9. Overdose
Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Acetic acid derivatives and related substances <b>ATC code:</b> M01AB05 Motifene is a non-steroidal agent with marked analgesic/anti-inflammatory properties. It is an ...
5.2. Pharmacokinetic properties
Diclofenac sodium is rapidly absorbed from the gut and is subject to first-pass metabolism. Therapeutic plasma concentrations occur about ½ hour after administration of Motifene. The active substance is ...
5.3. Preclinical safety data
Not applicable.
6.1. List of excipients
<u>Gastro-resistant pellets:</u> Microcrystalline cellulose Povidone K25 Colloidal anhydrous silica Methacrylic acid ethyl acrylate copolymer Propylene glycol Talc <u>Prolonged release pellets:</u> Microcrystalline ...
6.2. Incompatibilities
None known.
6.3. Shelf life
4 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
The capsules are blister packed in PVC/PDVC and aluminium foil and are packed into folding cardboard cartons. Motifene is available in packs of 2, 4, 28 and 56 capsules. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
PL 08265/0003Daiichi Sankyo UK Ltd., 1<sup>st</sup> Floor, Building 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH
8. Marketing authorization number(s)
PL 08265/0003
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 5 August 1994 Date of latest renewal: 9 September 2004
10. Date of revision of the text
September 2020
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