KETESSE Film-coated tablets (2021)
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Περιεχόμενα
1. Name of the medicinal product
Ketesse 25 mg film coated tablets.
2. Qualitative and quantitative composition
Each tablet contains: dexketoprofen 25 mg (as dexketoprofen trometamol). Sugar free. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablets. <u>Ketesse 25 mg:</u> White film coated tablets, scored on both sides, with convex sides. The tablets can be divided into equal doses.
4.1. Therapeutic indications
Symptomatic short term treatment of pain of mild to moderate intensity, such as musculoskeletal pain, dysmenorrhoea, dental pain.
4.2. Posology and method of administration
Posology Adults According to the nature and severity of pain, the recommended dosage is 12,5 mg every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg. Undesirable effects ...
4.3. Contraindications
Ketesse tablets must not be administered in the following cases: patients hypersensitive to the active substance, to any other NSAID, or to any of the excipients listed in section 6.1. patients in whom ...
4.4. Special warnings and precautions for use
Administer with caution in patients with a history of allergic conditions. Ketesse should not be used concomitantly with other NSAIDs including cyclooxygenase-2 (COX2) selective inhibitors. Undesirable ...
4.5. Interaction with other medicinal products and other forms of interaction
The following interactions apply to non-steroidal anti-inflammatory drugs (NSAIDs) in general: Inadvisable combinations Other NSAIDs (including cyclooxygenase-2 selective inhibitors) and high doses of ...
4.6. Fertility, pregnancy and lactation
Ketesse tablets are contraindicated during third trimester of pregnancy and lactation (see section 4.3). Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal ...
4.7. Effects on ability to drive and use machines
Ketesse tablets may cause undesirable effects such as dizziness, visual disturbances or drowsiness. The ability to react and the ability to take part actively in road traffic and to operate machines may ...
4.8. Undesirable effects
The adverse events reported in clinical trials, are tabulated below, classified by system organ class and ordered by frequency: SYSTEM ORGAN CLASS Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) ...
4.9. Overdose
The symptomatology following overdose is not known. Similar medicines have produced gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, vertigo, disorientation, headache) ...
5.1. Pharmacodynamic properties
<b>Category and class:</b> A 2.7 Antipyretic or antipyretic and anti-inflammatory analgesic <b>Pharmacotherapeutic group:</b> Propionic acid derivatives <b>ATC code:</b> M01AE17 Dexketoprofen trometamol ...
5.2. Pharmacokinetic properties
Absorption After oral administration of dexketoprofen trometamol to humans, the C<sub>max</sub> is reached at 30 min (range 15 to 60 min). When administered concomitantly with food, the AUC does not change, ...
6.1. List of excipients
Maize starch Microcrystalline cellulose Sodium starch glycollate Glycerol distearate Hypromellose Titanium dioxide Propylene glycol Macrogol 6000
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years. Store at or below 25°C.
6.4. Special precautions for storage
Keep the blister strips in the outer carton until required for use. Do not remove the tablets from the blister strips until required for use.
6.5. Nature and contents of container
Opaque white or transparent PVC/aluminium or aluminium/aluminium blister strips in an outer carton. <u>Pack sizes:</u> 4, 10, 20, 30, 50 or 500 film coated tablets. Not all pack sizes may be marketed. ...
6.6. Special precautions for disposal and other handling
Any unused medicine or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville, 7551
8. Marketing authorization number(s)
54/2.7/0536
9. Date of first authorization / renewal of the authorization
27 July 2021
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