VOLTAROL RAPID Coated tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Voltarol Rapid Tablets 50mg.
2. Qualitative and quantitative composition
Each tablet contains 50mg of diclofenac potassium. Chemical name: Potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Coated tablet.
4.1. Therapeutic indications
Rheumatoid arthritis Osteoarthrosis Low back pain Migraine attacks Acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, ...
4.2. Posology and method of administration
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use). For oral administration. ...
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients. Active, gastric or intestinal ulcer, bleeding or perforation. History of gastrointestinal bleeding or perforation, relating to previous ...
4.4. Special warnings and precautions for use
General Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 Posology and method of administration and GI and ...
4.5. Interaction with other medicinal products and other forms of interaction
The following interactions include those observed with diclofenac gastro-resistant tablets and/or other pharmaceutical forms of diclofenac. Lithium: If used concomitantly, Voltarol may increase plasma ...
4.6. 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 or ...
4.7. Effects on ability to drive and use machines
Patients who experience visual disturbances, dizziness, vertigo, somnolence, central nervous system disturbances, drowsiness, or fatigue while taking NSAIDs should refrain from driving or operating machinery. ...
4.8. Undesirable effects
Adverse reactions are ranked under the heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, ...
4.9. Overdose
Symptoms There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Nonsteroidal anti-inflammatory drug (NSAID) Voltarol Rapid tablets contain the potassium salt of diclofenac, a nonsteroidal compound with pronounced and clinically demonstrable ...
5.2. Pharmacokinetic properties
Absorption Diclofenac is rapidly and completely absorbed from sugar-coated tablets. Food intake does not affect absorption. Peak plasma concentration after one 50 mg sugar-coated tablet was 3.9 µmol/l ...
5.3. Preclinical safety data
Relevant information on the safety of Voltarol Rapid is included in other sections of the Summary of Product Characteristics.
6.1. List of excipients
Silica, colloidal anhydrous (Aerosil 200) Calcium phosphate Magnesium stearate Maize starch Povidone (polyvinylpyrrolidone K30 PH) Sodium starch glycollate (Sodium carboxymethyl starch) Cellulose, microcrystalline ...
6.2. Incompatibilities
None.
6.3. Shelf life
Shelf life: 36 months.
6.4. Special precautions for storage
Store in original packaging below 30°C and protect from moisture.
6.5. Nature and contents of container
PVC/PE/PVdC blister strips containing 2, 3, 28 or 30 tablets. (PVC 237.5-262.5 micron, PE 22.5-27.5 micron, PVdC 68.3-75.4 micron, aluminium foil 26-34 micron)
6.6. Special precautions for disposal and other handling
Medicines should be kept out of the reach of children.
7. Marketing authorization holder
Novartis Pharmaceuticals UK Limited, Trading as Geigy Pharmaceuticals, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
8. Marketing authorization number(s)
PL 00101/0482
9. Date of first authorization / renewal of the authorization
17 February 1998
10. Date of revision of the text
4 December 2019
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