CATAFLAM Sugar coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
CATAFLAM Sugar Coated Tablets 50mg.
2. Qualitative and quantitative composition
Each tablet contains 50 mg of diclofenac potassium. Chemical name: Potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate <u>Excipient(s) with known effect:</u> Sodium starch glycolate. For the full ...
3. Pharmaceutical form
Sugar 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). For oral administration. The tablets should be swallowed ...
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients. Active gastric or intestinal ulcer, bleeding or perforation. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct ...
4.4. Special warnings and precautions for use
Warnings 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 ...
4.5. Interaction with other medicinal products and other forms of interaction
The following interactions include those observed with Cataflam sugar coated tablets and/or other pharmaceutical forms of diclofenac. <u>CYP2C9 inhibitors:</u> Caution is recommended when co-prescribing ...
4.6. Pregnancy and lactation
Pregnancy Some epidemiological studies suggest an increased risk of miscarriage after use of a prostaglandin synthesis inhibitor (such as NSAIDs) in early pregnancy, however the overall data are inconclusive. ...
4.7. Effects on ability to drive and use machines
Patients who experience dizziness, drowsiness, fatigue or visual disturbances, while taking NSAIDs should refrain from driving or operating machinery.
4.8. Undesirable effects
Adverse drug reactions from clinical trials and/or spontaneous or literature reports (Table 7-1) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ...
4.9. Overdose
Symptoms There is no typical clinical picture resulting from diclofenac overdosage. Overdosage can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Nonsteroidal anti-inflammatory drug (NSAID) <b>ATC code:</b> M01AB05 Cataflam tablets contain the potassium salt of diclofenac, a nonsteroidal compound with pronounced ...
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
Preclinical data from acute and repeated dose toxicity studies, as well as from genotoxicity, mutagenicity, and carcinogenicity studies with diclofenac revealed no specific hazard for humans at the intended ...
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
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 20 tablets. (PVC 190-275 micron, PE20-40 micron, PVDC 32-59 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 Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland <u>Marketing License Holder Representative in Cyprus:</u> Novartis Pharma Services Inc., Methonis Tower, 73 Arch. Makarios ...
8. Marketing authorization number(s)
18492
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 08 March 1991 Date of latest renewal: 26 September 2011
10. Date of revision of the text
5/3/2020
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