MOTIFINE Capsule, hard (2022)
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Περιεχόμενα
1. Name of the medicinal product
MOTIFINE 75 mg capsules.
2. Qualitative and quantitative composition
Each capsule contains 75 mg diclofenac sodium (25 mg as enteric coated pellets and 50 mg as sustained release pellets). Sugar free. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsules, hard. Hard gelatine capsules (size 2) with light blue opaque cap and colourless transparent body marked in white print D75M.
4.1. Therapeutic indications
MOTIFINE is indicated for the emergency treatment of acute gout attacks.
4.2. Posology and method of administration
Posology Use the lowest effective dose for the shortest possible duration of treatment. Adults One capsule daily. Dose may be increased to two capsules daily if necessary, with a maximum daily dose of ...
4.3. Contraindications
Hypersensitivity to diclofenac sodium or to any of the excipients listed in section 6.1. Previous hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) in response to ibuprofen, aspirin ...
4.4. Special warnings and precautions for use
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2). Allergic reactions, including anaphylactic/anaphylactoid reactions, ...
4.5. Interaction with other medicinal products and other forms of interaction
NSAIDs The use of two or more NSAIDs concomitantly could result in an increase in side effects. Corticosteroids Increased risk of gastrointestinal perforation, ulceration or bleeding (PUBs). Anti-coagulants ...
4.6. Fertility, pregnancy and lactation
Pregnancy MOTIFINE should not be used in pregnancy (see section 4.3). Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiological ...
4.7. Effects on ability to drive and use machines
Patients who experience dizziness, drowsiness, fatigue and visual disturbances, vertigo, somnolence or other central nervous system disturbances while taking MOTIFINE, should refrain from driving a vehicle ...
4.8. Undesirable effects
The most commonly observed adverse events are gastrointestinal in nature. Blood and lymphatic system disorders <u>Less frequent:</u> Leucopoenia, neutropenia, thrombocytopenia, aplastic anaemia, haemolytic ...
4.9. Overdose
Symptoms included headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, and occasional convulsions. ...
5.1. Pharmacodynamic properties
<b>Category and class:</b> A.3.1 Antirheumatics (anti-inflammatory agents) <b>Pharmacotherapeutic group:</b> Acetic acid derivatives and related substances <b>ATC code:</b> M01AB05 Diclofenac is a nonsteroidal ...
5.2. Pharmacokinetic properties
Diclofenac is well absorbed after oral administration. Therapeutic plasma concentrations occur about ½ hour after administration of MOTIFINE. There is a substantial first-pass effect (only 50% of diclofenac ...
6.1. List of excipients
<u>Enteric coated pellets:</u> Microcrystalline cellulose Povidone Colloidal anhydrous silica Methacrylic acid ethyl acrylate copolymer Propylene glycol Talc <u>Sustained release pellets:</u> Microcrystalline ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
48 months.
6.4. Special precautions for storage
Store at or below 25°C. Protect from moisture. The capsules should be stored in the blister strips until required for use.
6.5. Nature and contents of container
The capsules are blister packed in white opaque PVC/PVDC and silver aluminium foil and packed into outer cardboard cartons. <u>Pack size:</u> 6 capsules.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Biotech Laboratories (Pty) Ltd, Ground Floor, Block K West, Central Park, 400 16th Road, Randjespark, Midrand 1685, South Africa
8. Marketing authorization number(s)
45/3.1/1150
10. Date of revision of the text
8 July 2022
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