THYROZOL TABLET 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

THIAMAZOLE

Available from:

MERCK PTE. LTD.

ATC code:

H03BB02

Dosage:

5 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

THIAMAZOLE 5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

MERCK HEALTHCARE KGAA

Authorization status:

ACTIVE

Authorization date:

1997-12-22

Patient Information leaflet

 
THYROZOL
®

5mg film-coated tablets 
10mg film-coated tablets 
20mg film-coated tablets 
Active ingredient: Thiamazole (methimazole) 

COMPOSITION 
Medicinally active ingredients: 
Each Thyrozol 5mg film-coated tablet contains 5 mg thiamazole. 
Each Thyrozol 10mg film-coated tablet
contains 10 mg thiamazole 
Each Thyrozol 20mg film-coated tablet
contains 20 mg thiamazole 
Excipients: Lactose monohydrate (see
Special warnings and precautions for use), corn starch, cellulose 
powder, talc, methylhydroxypropyl cellulose, magnesium stearate, poly(O-carboxymethyl) starch sodium 
salt, silicon dioxide, Macrogol 400, dimethicone 100, colourings E 171
and E 172. 

INDICATIONS 
•  Drug treatment of hyperthyroidism , especially in slight
or absent thyroid enlargement (goitre) as well 
as in younger patients. 
•  Preparation for surgery in all forms of hyperthyroidism. 
•  Preparation of patients with hyperthyroidism for radioiodine treatment. 
•  Intermittent treatment after radioiodine therapy. 
•  In exceptional cases, for long-term
therapy of hyperthyroidism where definite therapeutic
measures are 
not applicable due to the patient’s general condition, due to
personal reasons or because they are 
rejected, and where Thyrozol (at the lowest
possible dose) is well tolerated. 
•  Prophylactic treatment
in patients with a history of hyperthyroidism and autonomous adenomas in 
whom iodine exposure is indispensable (e.g. examination with
iodine-containing contrast media)  

POSOLOGY AND METHOD OF ADMINISTRATION 
General dosage recommendations_ _

_Dosage in adults _
 Inhibition of thyroid
hormone production can usually be achieved with daily doses of 25
to 40 mg  
thiamazole.  For mild cases, an initial dose
of 20 mg thiamazole daily may be considere

Summary of Product characteristics

THYROZOL
®
5mg film-coated tablets
10mg film-coated tablets
Active ingredient: Thiamazole (methimazole)
COMPOSITION
Medicinally active ingredients:
Each Thyrozol 5mg film-coated tablet contains 5 mg thiamazole.
Each Thyrozol 10mg film-coated tablet contains 10 mg thiamazole
Excipients: Lactose monohydrate (see Special warnings and precautions
for use), corn starch, cellulose
powder, talc, methylhydroxypropyl cellulose, magnesium stearate,
poly(O-carboxymethyl) starch sodium
salt, silicon dioxide, Macrogol 400, dimethicone 100, colourings E 171
and E 172.
INDICATIONS
•
Drug treatment of hyperthyroidism, especially in slight or absent
thyroid enlargement (goitre) as well
as in younger patients.
•
Preparation for surgery in all forms of hyperthyroidism.
•
Preparation of patients with hyperthyroidism for radioiodine
treatment.
•
Intermittent treatment after radioiodine therapy.
•
In exceptional cases, for long-term therapy of hyperthyroidism where
definite therapeutic measures are
not applicable due to the patient’s general condition, due to
personal reasons or because they are
rejected, and where Thyrozol (at the lowest possible dose) is well
tolerated.
•
Prophylactic treatment in patients with a history of hyperthyroidism
and autonomous adenomas in
whom iodine exposure is indispensable (e.g. examination with
iodine-containing contrast media)
POSOLOGY AND METHOD OF ADMINISTRATION
General dosage recommendations
_ _
_Dosage in adults _
Inhibition of thyroid hormone production can usually be achieved with
daily doses of 25 to 40 mg
thiamazole. For mild cases, an initial dose of 20 mg thiamazole daily
may be considered. In severe cases
of hyperthyroidism an initial dose of 40 mg thiamazole may be required
The dose is individually adjusted depending on the metabolic condition
of the patient, as indicated by the
development of the thyroid hormone status.
For maintenance therapy, one of the following treatment options is
recommended:
a) Daily maintenance dose of 5-20 mg thiamazole in combination with
levothy