KERAL Film-coated tablet (2023)
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Περιεχόμενα
Name of the medicinal product
Keral 25 mg film-coated tablets.
Qualitative and quantitative composition
<u>Each tablet contains:</u> dexketoprofen 25 mg as dexketoprofen trometamol. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film coated tablet. White, round, scored film-coated tablet, with convex sides. The tablets can be divided into equal doses.
Therapeutic indications
Symptomatic treatment of pain of mild to moderate intensity, such as musculo-skeletal pain, dysmenorrhoea, dental pain.
Posology and method of administration
Posology Adults According to the nature and severity of pain, the recommended dosage is generally 12.5 mg (half a tablet) every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed ...
Contraindications
Dexketoprofen 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 substances ...
Special warnings and precautions for use
Administer with caution in patients with a history of allergic conditions. The use of dexketoprofen with concomitant other NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided. Undesirable ...
Interaction with other medicinal products and other forms of interaction
The following interactions apply to non-steroidal antiinflammatory drugs (NSAIDs) in general: <u>Inadvisable combinations:</u> Other NSAIDs (including cyclooxygenase-2 selectve inhibitors) and high doses ...
Fertility, pregnancy and lactation
Dexketoprofen is 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 ...
Effects on ability to drive and use machines
Dexketoprofen 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 ...
Undesirable effects
The adverse events reported as at least possibly related with dexketoprofen in clinical trials, as well as the adverse reactions reported after the marketing of dexketoprofen tablets are tabulated below, ...
Overdose
The symptomatology following overdose is not known. Similar medicinal products have produced gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, vertigo, disorientation, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> propionic acid derivatives <b>ATC code:</b> M01AE17 Dexketoprofen trometamol is the tromethamine salt of S-(+)-2 - (3-benzoylphenyl)propionic acid, an analgesic, anti-inflammatory ...
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, ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and immunopharmacology. The chronic toxicity studies carried out in mice and monkeys ...
List of excipients
<u>Tablet core:</u> Maize starch Microcrystalline cellulose Sodium starch glycollate Glycerol distearate <u>Film-coating:</u> Dry laquer composed of: Hypromellose Titanium dioxide Macrogol 6000 Propylene ...
Incompatibilities
Not applicable.
Shelf life
<u>PVC-aluminium blister:</u> 2 years. <u>Aclar-aluminium blister and aluminium-aluminium blister:</u> 3 years.
Special precautions for storage
<u>PVC-aluminium blister:</u> do not store above 30ºC; keep the blister packs in the outer carton in order to protect from light. <u>Aclar-aluminium blister and aluminium-aluminium blister:</u> this medicinal ...
Nature and contents of container
Tablets are provided in blister packs (PVC-aluminium blister or Aclar-aluminium blister or aluminium-aluminium blister). Keral 25 mg tablets 4, 10 or 20 film-coated tablets/pack. Keral 25 mg tablets ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg
Marketing authorization number(s)
Keral 25 mg tablets, 10 or 20 film-coated tablets MA204/00107 Keral 25 mg tablets, 30, 50 or 500 film-coated tablets MA204/00101
Date of first authorization / renewal of the authorization
<u>MA204/00101:</u> Date of first authorisation: 21st March 2006 Date of latest renewal: 29th July 2006 <u>MA204/00107:</u> Date of first authorisation: 27th September 2013
Date of revision of the text
08/2023
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