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COLCHICINE Tablet (2022)

Αναφορές

Βιβλιογραφική αναφορά

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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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