CLOTAM RAPID Tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Clotam Rapid. Tolfenamic Acid 200mg Tablets.
Qualitative and quantitative composition
Tolfenamic acid 200 mg.
Pharmaceutical form
Tablets.
Therapeutic indications
Acute migraine.
Posology and method of administration
Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see 4.4 Special warnings and precautions for use). Adults <u>Migraine ...
Contraindications
Hypersensitivity to tolfenamic acid or to any of the excipients. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). NSAIDs are contraindicated ...
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 4.2 Posology and administration, and GI and cardiovascular ...
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 4.4 Special ...
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 ...
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
Tolfenamic acid is well tolerated at the recommended dosage. <b>The following side effects have been observed:</b> <u>Gastrointestinal:</u> The most commonly-observed adverse events are gastrointestinal ...
Overdose
Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products ATC code: M01AG02 NSAID with anti-inflammatory, analgesic, and antipyretic effects. Tolfenamic acid is a prostaglandin synthesis inhibitor ...
Pharmacokinetic properties
Tolfenamic acid is absorbed quickly and almost completely after oral administration. Hepatic first pass metabolism is as low as 15% (bioavailability 85%). Maximum plasma concentrations are reached after ...
Preclinical safety data
The therapeutic index for tolfenamic acid is high, and gastrointestinal ulceration and kidney changes have only been seen with oral doses approximately 6-10 times the maximum therapeutic dose recommended ...
List of excipients
Maize starch Sodium starch glycollate (Type A) Macrogol 6000 Alginic acid Cellulose, microcrystalline Croscarmellose sodium Silica, colloidal anhydrous Sodium stearyl fumarate
Incompatibilities
None known.
Shelf life
Five years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
<u>Blister card:</u> Cover foil: 20 μm Al foil. Form foil: 250 μm PVC foil. HDPE tablet container with LDPE closure. <u>Pack sizes:</u> 3, 10 and 30 tablets.
Special precautions for disposal and other handling
None.
Marketing authorization holder
A/S GEA Farmaceutisk Fabrik, Edvard Thomsens Vej 14, 2300, Copenhagen S, Denmark
Marketing authorization number(s)
PL 04012/0043
Date of first authorization / renewal of the authorization
25 April 1997
Date of revision of the text
24 September 2018
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