ART Capsule
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Art 50 mg, capsule.
Qualitative and quantitative composition
Each capsule of ART 50 contains Diacerein 50 mg. For a full list of excipients, see section 6.1.
Pharmaceutical form
Capsule.
Therapeutic indications
Symptomatic treatment of functional symptoms and signs of osteoarthritis. Note: action onset is deferred: a period of 30 to 45 days precedes analgesic effect onset. Treatment may therefore have to be initiated ...
Posology and method of administration
ADULTS (aged over 15 years). Oral route. The capsules should be swallowed whole, without chewing, with a glass of water, preferably during a meal. The recommended dosage is 2 capsules daily, 1 in the morning, ...
Contraindications
This medicinal product is contraindicated in case of: Inflammatory organic bowel disease (ulcerative colitis, Crohns disease) Intestinal obstruction or partial obstruction Abdominal pain syndromes of indeterminate ...
Special warnings and precautions for use
ART 50 mg, capsule must not be administered to children under the age of 15 years. This medicinal product should not be taken during pregnancy or lactation. Taking into account frequency of diarrhoea, ...
Interaction with other medicinal products and other forms of interaction
Association involving precautions for use Antacids (aluminum, calcium, and magnesium salts, oxides or hydroxides): Decreased of digestive absorption of diacerein. Antacids should be taken separately from ...
Pregnancy and lactation
Pregnancy Animal studies have shown retarded foetal ossification due to a maternotoxic effect at high doses. In clinical practice, no sufficiently pertinent data are currently available for evaluation ...
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
<u>Gastrointestinal effects:</u> The most frequently reported adverse effects were diarrhoea, soft stools, abdominal pain. Pigmentation of the colorectal mucosa (colonic melanosis) has been rarely observed. ...
Overdose
Profuse diarrhoea may occur in the event of overdose. Symptomatic treatment should then be instituted and electrolyte disorders and dehydration corrected if necessary.
Pharmacodynamic properties
ANTI-ARTHROSIQUE (M: MUSCLE AND SKELETON) Diacerein is an anthraquinone derivative which has moderate anti-inflammatory activity. It is anti-inflammatory at high doses and devoid of any irritant effect ...
Pharmacokinetic properties
Orally administered diacerein undergoes a hepatic first-pass effect and is totally deacetylated to the sulphoconjugated metabolite, rhein. After a single 50 mg dose, plasma diacerein concentrations peak ...
Preclinical safety data
Not applicable.
List of excipients
Lactose monohydrate Magnesium stearate <U>Composition of empty capsule shell:</u> Titanium dioxide Indigotine Gelatin
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store at room temperature.
Nature and contents of container
30 capsules in heat-formed blister packs (PVC/aluminium).
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Rafa Laboratories Ltd, POB 405, Jerusalem 91003
Marketing authorization number(s)
Registration no: 1075328783
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