COLCHICINE Tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Colchicine Tiofarma 500 microgram tablets
Qualitative and quantitative composition
Each Colchicine Tiofarma 500 microgram Tablet contains 500 micrograms of colchicine. Each Colchicine Tiofarma 500 microgram Tablet contains 83 mg of the excipient lactose monohydrate, equivalent to 78.6 ...
Pharmaceutical form
Tablet. Off-white, round, flat tablets with facet, ca. 6 mm diameter, ca. 3 mm thickness and with the inscription 0,5 on one side.
Therapeutic indications
<u>Adults:</u> Colchicine is indicated for the treatment of acute gout. Colchicine is indicated for the prophylaxis of a gout attack during initiation of urate-lowering therapy. <u>Adults and paediatric ...
Posology and method of administration
Posology Gout Acute gout attack 2 to 3 times daily 0.5 mg, possibly preceded by an initial dose of 1 mg. Treatment should end until the acute attack resolves, or earlier in the event of gastrointestinal ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with blood dyscrasias. Patients with severe renal impairment. Patients with severe hepatic impairment. ...
Special warnings and precautions for use
Colchicine is potentially toxic so it is important not to exceed the dose prescribed by a medical specialist with the necessary knowledge and experience. Colchicine has a narrow therapeutic window. The ...
Interaction with other medicinal products and other forms of interaction
Interactions with other drugs are not or scarcely documented. Given the nature of the side effects, caution is advised with concomitant administration of drugs that can affect the blood count or have a ...
Fertility, pregnancy and lactation
Fertility Animal research has shown that administration of colchicine may negatively influence spermatogenesis (see section 5.3). Rare cases of reversible oligospermia and azoospermia in men are known ...
Effects on ability to drive and use machines
No data are available regarding the influence of colchicine on the ability to drive and use machines. However, the possibility of drowsiness and dizziness should be taken into account.
Undesirable effects
The following adverse reactions have been observed. The frequencies are unknown, unless listed under one of the following classifications: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, ...
Overdose
Colchicine has a narrow therapeutic window and is extremely toxic in overdose. Patients at particular risk of toxicity are those with renal or hepatic impairment, gastro-intestinal or cardiac disease and ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> drugs for gout, with no effect on uric acid metabolism <b>ATC code:</b> M04AC01 Mechanism of action The mechanism of action of colchicine in the treatment of gout is not ...
Pharmacokinetic properties
Absorption Colchicine is rapidly and almost completely absorbed after oral administration. Maximum plasma concentrations are met usually after 30 to 120 minutes. Distribution Plasma protein binding of ...
Preclinical safety data
Colchicine causes DNA damage <em>in vitro</em> and chromosomal aberrations were observed <em>in vivo</em>. No toxicity data are available from own preclinical research. Studies in animals have shown that ...
List of excipients
Microcrystalline cellulose E460 Lactose monohydrate Sodium starch glycolate Magnesium stearate E572
Incompatibilities
Not applicable.
Shelf life
5 years. Shelf life after first opening of the tablet container is 6 months.
Special precautions for storage
Store below 25°C. Store in the original package in order to protect from light.
Nature and contents of container
Colchicine Tiofarma 500 microgram Tablets are available in: <u>Blisters:</u> 12 tablets in a PVC/Alu blister, with 12 tablets in a carton box 10 tablets in a PVC/Alu blister, with 30 or 100 tablets in ...
Special precautions for disposal
No special requirements.
Marketing authorization holder
Tiofarma B.V., Benjamin Franklinstraat 5-10, 3261 LW Oud-Beijerland, Netherlands
Marketing authorization number(s)
PA2200/001/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 29<sup>th</sup> September 2017 Date of last renewal: 15<sup>th</sup> August 2022
Date of revision of the text
August 2022
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