THYROZOL Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Thyrozol 5 mg film-coated tablets. Thyrozol 10 mg film-coated tablets. Thyrozol 20 mg film-coated tablets.
Qualitative and quantitative composition
Each Thyrozol 5 mg film-coated tablet contains 5 mg thiamazole. Each Thyrozol 10 mg film-coated tablet contains 10 mg thiamazole. Each Thyrozol 20 mg film-coated tablet contains 20 mg thiamazole. Excipients: ...
Pharmaceutical form
Film-coated tablet. <u>Thyrozol 5 mg:</u> yellow, round, biconvex film-coated tablet of 9 mm with a dividing score on both sides. <u>Thyrozol 10 mg:</u> grey-orange, round, biconvex film-coated tablet ...
Therapeutic indications
Treatment of hyperthyroidism, including: Conservative treatment of hyperthyroidism, especially in small or absent goitre, Preparation for surgery in all forms of hyperthyroidism, Preparation for radioiodine ...
Posology and method of administration
Thiamazole is the active metabolite of carbimazole, but 1mg of thiamazole is not equivalent to 1 mg of carbimazole.This should be kept in mind when starting therapy with thiamazole or in case of switch ...
Contraindications
Thyrozol must not be used in patients with: Hypersensitivity to thiamazole, other thionamide derivatives or to any of the excipients (see section 6.1), Moderate to severe blood count disturbances (granulocytopenia), ...
Special warnings and precautions for use
Thyrozol should not be used in patients with: History of mild hypersensitivity reactions (e.g. allergic rashes, pruritus). Thiamazole should only be used in short-term treatment and under careful monitoring ...
Interaction with other medicinal products and other forms of interaction
Iodine deficiency increases the response of the thyroid to thiamazole, whereas iodine excess lowers the response. Further direct interactions with other medicinal products are not known. However, it should ...
Pregnancy and lactation
In general, pregnancy has a positive effect on hyperthyroidism. Nevertheless, treatment of hyperthyroidism is often required especially in the first months of pregnancy. Untreated hyperthyroidism during ...
Effects on ability to drive and use machines
Thiamazole has no influence on the ability to drive and use machines.
Undesirable effects
The assessment of undesirable effects is based on the following definitions of frequencies: very common ≥1/10 common ≥1/100 to <1/10 uncommon ≥1/1,000 to <1/100 rare ≥1/10,000 to <1/1,000 very rare <1/10,000. ...
Overdose
Overdose leads to hypothyroidism with corresponding symptoms of a reduced metabolism and, through the feedback effect, to activation of the adenohypophysis with subsequent goitre growth. This can be avoided ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-thyroid preparation, sulfur-containing imidazole derivative. ATC Code: H03BB02 Thiamazole inhibits dose-dependently the incorporation of iodine into tyrosine and thereby ...
Pharmacokinetic properties
Thiamazole is absorbed rapidly and completely. After administration, maximum serum levels are reached within 0.4 to 1.2 hours. Protein binding is negligibly low. Thiamazole accumulates in the thyroid where ...
Preclinical safety data
Preclinical safety studies are limited. Single-dose toxicity data show that the acute toxic potential of thiamazole is low. In repeat-dose studies, bone marrow depression was seen at dose levels, which ...
List of excipients
<u>Tablet core:</u> Silica, colloidal anhydrous Magnesium stearate Hypromellose Talc Cellulose powered Maize starch Lactose monohydrate Sodium starch glycollate <u>Coating:</u> Dimeticone 100 Macrogol ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Blister consisting of a polyvinyl chloride film and an aluminium cover foil. Pack sizes: Thyrozol 5 mg: 20, 30, 50, 100 film-coated tablets. Thyrozol 10 mg: 20, 30, 50, 100 film-coated tablets. Thyrozol ...
Special precautions for disposal and other handling
No special requirements.
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