SUMMARY OF PRODUCT CHARACTERISTICS
1 1. NAME OF THE MEDICINAL PRODUCT
Thyrozol 5 mg film-coated tablets Thyrozol 10 mg film-coated tablets Thyrozol 20 mg film-coated tablets
2. 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.
3. 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
4. CLINICAL PARTICULARS
4.1 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 treatment particularly in patients with severe hyperthyroidism,
Intermediate therapy after treatment with radioiodine,
Prophylactic treatment in patients with sub-clinical hyperthyroidism, autonomous adenomas or a history of hyperthyroidism, in whom exposure to iodine is indispensable (e.g. examination with iodine-containing contrast media).
2 4.2 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 from carbimazole to thiamazole. The following doses recommendations should be followed.
General dosage recommendations
Dosage in adults
Depending on the severity of the disease and the iodine supply, treatment is usually initiated with daily thiamazole doses between 10 to 40 mg. In many cases, inhibition of thyroid hormone production can usually be achieved with initial doses of 20 to 30 mg thiamazole daily. In milder cases, a full blocking dose may not be required, thus, a lower initial dose 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 thyroid hormone status.
For maintenance therapy, one of the following treatment options is recommended: a) Daily maintenance dose of 5 to 20 mg thiamazole in combination with levothyroxine, in order to avoid hypothyroidism. b) Monotherapy with daily doses of 2.5 to 10 mg thiamazole.
Iodine-induced hyperthyroidism may require higher doses.
Dosage in children
The average initial dosage in children is 0.5 mg thiamazole/kg body weight per day. After normalisation of the thyroid function, the dose is stepwise reduced to a lower maintenance dose, which depends on the metabolic condition of the patient. Additional treatment with levothyroxine may be required to avoid hypothyroidism.
Conservative treatment of hyperthyroidism
The aim of therapy is to achieve a euthyroid metabolic condition and long-term remission after a limited duration of treatment. Depending on the selection of the treated patients, one-year remission can be achieved in 50% of cases at the most. The reported remission rates vary considerably without underlying reasons having been completely clarified. The type of hyperthyroidism (immunogenic or non-immunogenic), the duration of treatment, the thiamazole dose as well as dietary or iatrogenic iodine supply, are probably influencing factors.
In conservative treatment of hyperthyroidism therapy is usually continued over a period of 6 months to 2 years (1 year on average). Statistically, the probability of remission increases with the duration of therapy. In cases where remission of the disease cannot be achieved and definite therapeutic measures do not apply or are rejected, thiamazole may be used as long-term anti-thyroid therapy in as low a dosage as possible without addition or together with a small quantity of levothyroxine.
3 Patients with large goitres and constriction of the trachea should, if at all, only undergo short-term treatment with thiamazole since long-term administration can result in goitre growth. It may be necessary to monitor therapy particularly thoroughly (TSH level, tracheal lumen). The treatment is preferably combined with additional administration of levothyroxine.
Pre-operative therapy
Temporary pre-treatment (for 3 to 4 weeks or longer, in individual cases) may serve to achieve a euthyroid metabolic condition, thus reducing operative risks.
Surgery should be performed as soon as the patient is euthyroid. Otherwise, supplementary levothyroxine must be administered. Treatment may be terminated the day before surgery.
The thiamazole induced increased brittleness and bleeding risk of the thyroid tissue may be compensated by additional pre-operative administration of high dosed iodine in the last ten days before surgery (Plummer's iodine therapy).
Treatment prior to radioiodine therapy
Achievement of a euthyroid metabolism before initiation of radioiodine therapy is important particularly in severe cases of hyperthyroidism, as post-therapeutic thyrotoxic crisis has occurred in individual cases after such therapy without pre-treatment.
Note: Thionamide derivatives may reduce the radio-sensitivity of the thyroid tissue. In scheduled radioiodine therapy of autonomous adenomas activation of paranodular tissue by means of pre- treatment must be prevented.
Intermediate anti-thyroid therapy after treatment with radioiodine
The duration and dose of treatment must be adjusted individually depending on the severity of the clinical picture and the estimated period until radioiodine therapy starts to be effective (approx. 4 to 6 months).
Prophylactic treatment of patients at risk of developing hyperthyroidism as a result of administration of iodine-containing substances for diagnostic purposes
In general, daily doses of 10 to 20 mg thiamazole and/or 1 g perchlorate are administered for approx. 10 days (e.g. for renally excreted contrast media). The duration of treatment depends on the period of time for which the iodine-containing substance is retained in the body.
Special populations
In patients with hepatic impairment, the plasma clearance of thiamazole is reduced. Therefore, the dose should be kept as low as possible and patients should be closely monitored.
As there is a lack of data regarding pharmacokinetic behaviour of Thiamazol in patients with renal impairment, careful individual dose adjustment under close monitoring is recommended. The dose should be kept as low as possible.
Although no dose accumulation is expected in elderly patients, careful individual dose adjustment under close monitoring is recommended.
4 Method of administration
The tablets are swallowed whole with sufficient liquid.
During high-dose initial therapy of hyperthyroidism the above stated daily doses can be subdivided and taken at regular intervals over the day.
The maintenance dose can be taken at once in the morning during or after breakfast.
4.3 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), Pre-existing cholestasis not caused by hyperthyroidism, Previous damage to bone marrow after treatment with thiamazole or carbimazole.
Combination therapy with thiamazole and thyroid hormones is contraindicated during pregnancy (see section 4.6).
4.4 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 in patients with Large goitres with constriction of the trachea because of the risk of goitre growth.
Agranulocytosis has been reported to occur in about 0.3 to 0.6% of cases and the patient´s attention should be drawn to its symptoms (stomatitis, pharyngitis, fever) prior to the start of therapy. It usually occurs during the first weeks of treatment, but may still become manifest some months after the start of therapy and upon its reintroduction. A close monitoring of blood count is recommended before and after initiation of therapy especially in cases with pre-existing mild granulocytopenia. In the case that any of these symptoms are observed, especially during the first weeks of treatment, patients should be advised to contact their physician immediately for a blood count. If an agranulocytosis is confirmed, a discontinuation of the medicinal product is necessary.
Other myelotoxic adverse reactions are rare with the recommended doses. They have frequently been reported in connection with very high doses of thiamazole (about 120 mg per day). These dosages should be reserved for special indications (severe forms of disease, thyrotoxic crisis). Occurrence of bone marrow toxicity during treatment with thiamazole requires discontinuation of the medicinal product and, if necessary, switch to an anti-thyroid medicinal product of another substance group.
Excess dosage can lead to sub-clinical or clinical hypothyroidism and goitre growth due to TSH increase. Therefore, the dose of thiamazole should be reduced as soon as a euthyroid metabolic condition is achieved and, if necessary, levothyroxine should be given additionally. It is not useful to discontinue thiamazole altogether and to continue with levothyroxine only.
Goitre growth under therapy with thiamazole in spite of suppressed TSH is a result of the underlying disease and cannot be prevented by additional treatment with levothyroxine.
5
Achievement of normal TSH levels is crucial to minimise the risk of occurrence or deterioration of endocrine orbitopathy. However, this condition is frequently independent of the course taken by the thyroid disease. Such a complication is no reason to change the adequate treatment regimen and is not to be regarded as an adverse reaction to the correctly carried out therapy.
At a low percentage late hypothyroidism may occur after anti-thyroid therapy without any additional ablative measures. This is probably not an adverse reaction to the medicinal product, but to be regarded as inflammatory and destructive processes in the parenchyma of the thyroid due to the underlying disease.
The reduction in the pathologically increased energy consumption in hyperthyroidism can lead to a (generally desired) gain in body weight during treatment with thiamazole. Patients should be informed that improvement of the clinical picture indicates normalisation of their energy consumption.
Thyrozol contains lactose; therefore its use is not recommended in patients with rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
4.5 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 be taken into account that the metabolism and elimination of other medicinal products can be accelerated in hyperthyroidism. They normalise in correlation with increasing normalisation of thyroid function. The dosage must be adjusted where necessary.
Furthermore, there is evidence that correction of hyperthyroidism may normalise the enhanced activity of anticoagulants in hyperthyroid patients.
4.6 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 pregnancy may lead to serious complications such as premature birth and malformation. However, hypothyroidism caused by treatment with inappropriate thiamazole doses is also associated with a tendency to abortion.
Thiamazole passes the placental barrier and, in foetal blood, reaches concentrations equal to those found in maternal serum. At an inappropriate dosage, this may lead to goitre formation and hypothyroidism in the foetus as well as to reduced birth weight. There have been repeated reports of partial aplasia cutis on the head of neonates born to women treated with thiamazole. This defect healed spontaneously within a few weeks.
In addition, a certain pattern of diverse malformations has been associated with high-dose thiamazole therapy during the first weeks of pregnancy, e.g. choanalatresia, oesophageal atresia, hypoplastic nipples, delayed mental as well as motor development. In contrast, several case studies on prenatal thiamazole exposition have neither revealed any morphological development disorders nor affection of the thyroid or the physical and intellectual development of the children.
Since embryotoxic effects cannot be completely excluded, Thyrozol must only be administered during pregnancy after strict benefit risk evaluation and only at the lowest still effective dose level without additional administration of thyroid hormones.
6 Thiamazole passes into breast milk where it can reach concentrations corresponding to maternal serum levels, so that there is a risk of hypothyroidism developing in the infant.
Breast-feeding is possible during thiamazole treatment; however, only low doses up to 10 mg daily may be used without additional administration of thyroid hormones.
The function of the thyroid gland of the neonate has to be monitored regularly.
4.7 Effects on ability to drive and use machines
Thiamazole has no influence on the ability to drive and use machines.
4.8 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
Blood and lymphatic system disorders
Uncommon Agranulocytosis occurs in about 0.3 to 0.6% of cases. It may still become manifest weeks or months after the start of therapy and necessitates discontinuation of the medicinal product. Most cases recede spontaneously.
Very rare Thrombocytopenia. Pancytopenia. Generalised lymphadenopathy.
Endocrine disorders
Very rare Insulin autoimmune syndrome (with pronounced decline in blood glucose level).
Nervous system disorders
Rare Disturbances in the sense of taste (dysgeusia, ageusia) occur rarely; they can recede after discontinuation of therapy. A return to normal can take several weeks, however.
Very rare Neuritis. Polyneuropathia.
Gastrointestinal disorders
Very rare Acute salivary gland swelling.
7 Hepatobiliary disorders
Very rare Individual cases of cholestatic jaundice or toxic hepatitis have been described. The symptoms generally recede after discontinuation of the medicinal product. Clinically inconspicuous signs of cholestasis during treatment have to be differentiated from disturbances caused by hyperthyroidism, such as an increase in GGT (Gamma Glutamyl Transferase) and alkaline phosphatase or its bone specific isoenzyme.
Skin and subcutaneous tissue disorders
Very common Allergic skin reactions of varying degrees (pruritus, rash, urticaria). They mostly take a mild course and frequently recede during continued therapy.
Very rare Severe forms of allergic skin reactions including generalised dermatitis. Alopecia. Drug-induced lupus erythematosus.
Musculoskeletal and connective tissue disorders
Common Arthralgia may develop gradually and occur even after several months of therapy.
General disorders and administration site conditions
Rare Drug fever.
4.9 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 by dose reduction as soon as a euthyroid metabolic condition is achieved and, if necessary, by additional administration of levothyroxine (see section 4.2).
Negative consequences of accidental ingestion of high doses of thiamazole are not known.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Anti-thyroid preparation, sulfur-containing imidazole derivative.
ATC Code: H03BB02
8 Thiamazole inhibits dose-dependently the incorporation of iodine into tyrosine and thereby the neo- synthesis of thyroid hormones. This property permits symptomatic therapy of hyperthyroidism regardless of its cause. Whether thiamazole furthermore affects the 'natural course' taken by the immunologically induced type of hyperthyroidism (Graves' disease), i.e. whether it suppresses the underlying immunopathogenitic process, can presently not be decided with certainty. The release of previously synthesised thyroid hormones from the thyroid is not affected. This explains why the length of the latency period until normalisation of the serum concentrations of thyroxine and triiodothyronine, and thus to clinical improvement, differs in individual cases. Hyperthyroidism due to the release of hormones after destruction of thyroid cells, e.g. after radioiodine therapy or in thyroiditis, is also not affected.
5.2 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 it is metabolised only slowly. In spite of fluctuating serum levels, the accumulation of thiamazole in the thyroid gland still leads to a concentration plateau. This results in a duration of action of nearly 24 hours for the single dose. According to present knowledge, the kinetics of thiamazole is independent of thyroid function. The elimination half-life is about 3 to 6 hours and is prolonged in hepatic insufficiency). Thiamazole undergoes renal and biliary elimination; excretion with the faeces is slight, suggesting enterohepatic circulation. 70% of the substance are excreted by the kidneys within 24 hours. Only a small amount is excreted in unchanged form. At present, no experience is available on the pharmacological activity of the metabolites. Limited data of pharmacokinetics in patients with renal and hepatic impairment are available (see section 4.2). No data are available following repeated dose administration (see section 4.2).
5.3 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 were considerably higher than the therapeutic dose levels.
Genotoxicity studies did not reveal any evidence of mutagenic or clastogenic effects.
In a two-year chronic toxicity study in rats no relevant findings other than pharmacologically mediated effects on the thyroid were observed. In a chronic two-year study in mice a higher incidence of hepatomas, which did not reach the level of statistical significance, was seen when thiamazole was administered at a concentration of 500 mg/l in drinking water. The relevance of the latter finding is questionable and thiamazole is not classified as a carcinogen by IARC (International Agency for Research of Cancer) or NTP (National Toxicology Program) criteria.
9 6. PHARMACEUTICAL PARTICULARS
6.1 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 (E 171) Iron oxide (E 172)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
4 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 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 20 mg: 20, 30, 50 film-coated tablets
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7. MARKETING AUTHORISATION HOLDER
[To be completed nationally]>
10
{Name and address} <{tel}> <{fax}> <{e-mail}>
8. MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
[To be completed nationally]
{Date of first authorisation: DD/MM/YYYY} {Date of last renewal: DD/MM/YYYY}
10. DATE OF REVISION OF THE TEXT
[To be completed nationally]
{MM/YYYY}
(25 November 2011; date of end of procedure, DE/H/0521/001-003/R/001)
11
LABELLING AND PACKAGE LEAFLET
12
LABELLING
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1. NAME OF THE MEDICINAL PRODUCT
Thyrozol 5 mg film-coated tablets Thyrozol 10 mg film-coated tablets Thyrozol 20 mg film-coated tablets Thiamazole
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each film-coated tablet contains 5 mg thiamazole. Each film-coated tablet contains 10 mg thiamazole. Each film-coated tablet contains 20 mg thiamazole.
3. LIST OF EXCIPIENTS
Contains lactose, see package leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
20 tablets 30 tablets 50 tablets only for Thyrozol 5 and 10 mg: 100 tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
14 8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Do not store above 25° C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally]
{Name and Address}
12. MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
13. BATCH NUMBER
BN
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
[To be completed nationally]
15
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER
1. NAME OF THE MEDICINAL PRODUCT
Thyrozol 5 mg film-coated tablets Thyrozol 10 mg film-coated tablets Thyrozol 20 mg film-coated tablets Thiamazole
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally]
{Name}
3. EXPIRY DATE
EXP
4. BATCH NUMBER
BN
5. OTHER
(25 November 2011; MRP, end of procedure, DE/H/0521/001-003/R/001)
16
PACKAGE LEAFLET
17 PACKAGE LEAFLET: INFORMATION FOR THE USER
Thyrozol 5 mg film-coated tablets Thyrozol 10 mg film-coated tablets Thyrozol 20 mg film-coated tablets Thiamazole
Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet: 1. What Thyrozol is and what it is used for 2. Before you take Thyrozol 3. How to take Thyrozol 4. Possible side effects 5. How to store Thyrozol 6. Further information
1. WHAT THYROZOL IS AND WHAT IT IS USED FOR
This medicine contains thiamazole. It controls the overproduction of thyroid hormones in the thyroid gland regardless of the cause.
Thyrozol is used to treat overproduction of thyroid hormones, - if you need to take a medicine to treat overproducing thyroid glands, especially if you have a small goitre (swelling in the front neck) or no goitre, - if you are going to have surgery on your thyroid gland, - if you are going to have treatment using radio-iodine, especially in severe cases of thyroid hormone overproduction, - after radio-iodine treatment until the effect of radio-iodine has fully set in.
Thyrozol is also used to prevent overproduction of thyroid hormones, before you have to undergo iodine exposure, such as an examination with iodine-containing contrast media, - if you have slight overproduction of thyroid hormones without further symptoms, - if your thyroid gland has certain hormone producing areas (autonomous adenoma), - if you have had overproduction of thyroid hormones earlier in life.
18 2. BEFORE YOU TAKE THYROZOL
Do not take Thyrozol - if you are allergic (hypersensitive) to thiamazole, to any related substances (thionamide derivatives), or any of the other ingredients of Thyrozol (see section 6), - if laboratory tests show that you have a reduction in the number of certain blood cells (granulocytopenia), - if your bile flow is blocked before the start of the treatment with Thyrozol, - if you have had bone marrow damage after previous treatment with thiamazole or carbimazole.
Take special care with Thyrozol Speak to your doctor if you have had mild allergic reactions to thiamazole before, such as allergic rashes or itching. The doctor will decide whether you can take Thyrozol.
Speak to your doctor if you have a large goitre (swelling in the front neck) that makes it difficult for you to breathe, because the goitre may grow during treatment wih Thyrozol. Your doctor may decide to prescribe Thyrozol only for a limited period and will regularly check you during the treatment.
Contact your doctor immediately if you have symptoms such as inflammation of the mucous membrane of the mouth, sore throat, or fever. These may be because of a severe reduction in the number of certain blood cells (agranulocytosis). It may develop especially in the first weeks of treatment and may lead to serious consequences.
If you have a particularly severe form of thyroid hormone overproduction, you may have to take very high doses of Thyrozol (more than 120 mg daily). In this case your doctor will do blood checks from time to time, because it is possible that your bone marrow will be affected. If this happens, your doctor may decide to stop the treatment and, if necessary, will give you another medicine.
If your goitre grows under Thyrozol treatment or if your thyroid gland is underactive, your doctor may have to check your Thyrozol dose. However, such conditions may also occur due to the natural course of your disease. Similarly, a certain type of eye disease (endocrine orbitopathy) may develop or worsen, which is not related to Thyrozol treatment.
It is possible that you gain weight during the treatment with Thyrozol. This is a normal reaction of your body. Thyrozol affects your thyroid hormones, which control your energy consumption.
Taking other medicines Your iodine supply has an effect of how Thyrozol works. Your doctor will decide the dose of Thyrozol according to your individual iodine supply and your thyroid function.
Speak to your doctor, if you take anticoagulants (medicines used to prevent blood clotting), because normalization of the thyroid function by Thyrozol may influence their effect. The same may be true for other medicines. Therefore, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding In general, pregnancy has a positive effect on thyroid hormone production. In any case contact your doctor, because it may be necessary that you continue taking Thyrozol especially in the first months of pregnancy. Your doctor may decide to lower your Thyrozol dose, in order to avoid any harm for your baby. This is of particular importance if you have taken Thyrozol together with thyroid hormones, because such combination must not be used during pregnancy.
19 The same applies if you want to breast-feed. Doses of up to 10 mg normally do not harm your baby. Your doctor will regularly check how the thyroid gland of your newborn baby is working.
Driving and using machines Thyrozol has no influence on the ability to drive and use machines.
Important information about some of the ingredients of Thyrozol Tell your doctor, if you have an intolerance to certain sugars, because Thyrozol contains lactose.
3. HOW TO TAKE THYROZOL
Always take Thyrozol exactly as your doctor has told you. Check with your doctor, if you are not sure.
Usual dose Depending on how serious your condition is, your doctor will decide on your individual dose. The following doses are ususally recommended:
- Adults The initial dose is 10 – 40 mg Thyrozol daily (or higher for certain patients) until the thyroid function is working normally. The maintenance dose is either 5 – 20 mg Thyrozol daily in combination with thyroid hormones or 2.5 – 10 mg Thyrozol daily without thyroid hormones. * - Children In children, the initial dose is 0.5 mg Thyrozol per kg body weight daily. Your doctor will then decide whether a lower maintenance dose is sufficient and whether additional thyroid hormones are necessary. *
If you are at risk of developing an overproduction of thyroid hormones following a diagnostic test with an iodine-containing contrast media, your doctor may prescribe 10 – 20 mg Thyrozol daily with perchlorate for approximately 10 days (until the iodine-containing contrast media has left the body). *
* For low doses tablets with 5 mg are available.
Patients with liver problems Tell your doctor, if have had liver problems or liver diseases. In this case your dose of Thyrozol will have to be reduced.
Patients with kidney problems Tell your doctor, if have had kidney problems or kidney diseases. In this case your dose of Thyrozol will have to be reduced.
Duration of treatment Duration of treatment may vary depending on the condition for which you use Thyrozol. Your doctor will discuss with you how long you need to take it. Usually the duration of treatment is as follows:
- Treatment of thyroid hormone overproduction (without surgery): 6 months – 2 years. - Treatment before thyroid surgery: 3 - 4 weeks before surgery. - Treatment before radio-iodine therapy: until your thyroid function has normalized. - Treatment after radio-iodine therapy: 4 - 6 months, until the effect of radio-iodine therapy starts.
20 Administration Swallow the tablets with some liquid, such as half a glass of water, in the morning after breakfast. If you take more than one tablet daily, you may also take them in several portions at regular intervals over the day.
If you take more Thyrozol than you should If you have taken a higher dose than prescribed accidentially, there will be no problem. If you have taken higher doses than prescribed more often, contact your doctor as soon as you notice. Your doctor may need to adjust your Thyrozol dose or may give you thyroid hormones in addition to avoid goitre growth.
If you forget to take Thyrozol Do not take a double dose to make up for a forgotten tablet, but take the normal dose the following day.
If you have any further questions on the use of Thyrozol, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Thyrozol can cause side effects, although not everybody gets them. While you are taking Thyrozol, you may experience one or more of the following side effects, in some cases even after several months of treatment:
Very common (affecting more than 1 out of 10 people):
Skin reactions of varying degrees (rash, itching, itching wheals). They mostly take a mild course and disappear during the treatment with Thyrozol.
Common (affecting less than 1 out of 10 people):
Joint pain (arthralgia).
Uncommon (affecting less than 1 out of 100 people):
If you experience symptoms such as inflammation of the mucous membrane of the mouth, sore throat, or fever, contact your doctor immediately. Those may be signs for a severe reduction in the number of certain blood cells (agranulocytosis).
Rare (affecting less than 1 out of 1,000 people):
Disturbances in, or loss of, the sense of taste (dysgeusia, ageusia) Fever.
Very rare (affecting less than 1 out of 10,000 people):
Reduction in the number of blood platelets (thrombocytopenia), reduction in the number of all blood cells (pancytopenia), lymph node disease (generalised lymphadenopathy) Disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels (insulin autoimmune syndrome) Inflammation or irritation of the nerves (neuritis, polyneuropathia) Swelling of the saliva glands
21 Liver dysfunction or liver inflammation (cholestatic jaundice, toxic hepatitis). The symptoms generally disappear after stopping the treatment Severe allergic skin reactions possibly appearing on the entire body, hair loss, an inflammatory autoimmune disease of the skin and the connective tissue (lupus erythematosus).
If any of these side effects gets serious, immediately contact your doctor.
If you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. HOW TO STORE THYROZOL
Keep out of the reach and sight of children.
Do not use Thyrozol after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Thyrozol contains - The active substance is thiamazole. Each film-coated tablet contains 5 mg, 10 mg, or 20 mg thiamazole.
- The other ingredients are: 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 (E 171); iron oxide (E 172).
What Thyrozol looks like and contents of the pack Thyrozol 5 mg film-coated tablets are yellow, biconvex, round with a dividing score on both sides. Thyrozol 10 mg film-coated tablets are grey-orange, biconvex, round with a dividing score on both sides. Thyrozol 20 mg film-coated tablets are brown, biconvex, round with a dividing score on both sides.
Thyrozol 5 mg and 10 mg film-coated tablets are available in packs of 20, 30, 50, or 100 tablets. Thyrozol 20 mg film-coated tablets are available in packs of 20, 30, or 50 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder [To be completed nationally]
{Name and address} <{tel}>
22 <{fax}> <{e-mail}>
Manufacturer
Merck KGaA Frankfurter Str. 250 64293 Darmstadt, Germany
Merck KGaA & Co. Werk Spittal Hösslgasse 20 9800 Spittal/Drau Austria
This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgaria: Thyrozol Czech Republic: Thyrozol Estonia: Thyrozol France: Thyrozol Germany: Thyrozol Latvia: Thyrozol Lithuania: Thyrozol Poland: Thyrozol Romania: Thyrozol Slovakia: Thyrozol Spain: Tirozol
This leaflet was last approved in {MM/YYYY}.
[To be completed nationally]
(25 November 2011; MRP, end of procedure, DE/H/0521/001-003/R/001)
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