THYROZOL Film-coated tablet Ref.[7828] Active ingredients: Thiamazole

Source: European Medicines Agency (EU)  Revision Year: 2019 

Product name and form

Thyrozol 5 mg film-coated tablets.

Thyrozol 10 mg film-coated tablets.

Thyrozol 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Thyrozol 5 mg: yellow, round, biconvex film-coated tablet of 9 mm with a dividing score on both sides.

Thyrozol 10 mg: grey-orange, round, biconvex film-coated tablet of 9 mm with a dividing score on both sides.

Thyrozol 20 mg: brown, round, biconvex film-coated tablet of 9 mm with a dividing score on both sides.

The tablet can be divided into equal halves.

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:

Contains 200 mg lactose monohydrate (Thyrozol 5 mg), see section 4.4.

Contains 195 mg lactose monohydrate (Thyrozol 10mg), see section 4.4.

Contains 185 mg lactose monohydrate (Thyrozol 20mg), see section 4.4

For a full list of excipients, see section 6.1.

Active Ingredient Description
Thiamazole

Thiamazole inhibits dose-dependently the incorporation of iodine into tyrosine and thereby the neosynthesis of thyroid hormones. This property permits symptomatic therapy of hyperthyroidism regardless of its cause.

List of Excipients

Tablet core:

Silica, colloidal anhydrous
Magnesium stearate
Hypromellose
Talc
Cellulose powered
Maize starch
Lactose monohydrate
Sodium starch glycollate

Coating:

Dimeticone 100
Macrogol 400
Hypromellose
Titanium dioxide (E171)
Iron oxide (E172)

Pack sizes and marketing

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 20 mg: 20, 30, 50 film-coated tablets.

Not all pack sizes may be marketed.

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