TAPAZOLE 5 mg Tablets

Зміст інструкції

1. Tapazole 5 mg tablets
   1. What is Tapazole and what is it used for
   2. What you need to know before taking Tapazole
   3. How to take Tapazole
   4. Possible side effects
   5. How to store Tapazole
   6. Contents of the pack and other information

Tapazole 5 mg tablets

methimazole

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Tapazole is and what it is used for
• 2. What you need to know before you take Tapazole
• 3. How to take Tapazole
• 4. Possible side effects
• 5. How to store Tapazole
• 6. Contents of the pack and other information

1. What is Tapazole and what is it used for

Tapazole contains the active substance methimazole, a substance that is used to block the
production of thyroid hormones (antithyroid).
Tapazole is indicated to treat increased production of thyroid hormones (hyperthyroidism) and
long-term therapy can lead to the patient's recovery.
Tapazole is also used:

• to prepare the patient for partial surgical removal of the thyroid (thyroidectomy);
• to prepare the patient for therapy with radioactive iodine;
• when removal of the thyroid is contraindicated or not advisable.

2. What you need to know before taking Tapazole

DO NOT take Tapazole

• if you are allergic to methimazole or other antithyroid medicines or to any of the other ingredients of this medicine (listed in section 6),
• if you are breastfeeding (see section “Pregnancy and breastfeeding”),
• if you have had inflammation of the pancreas (acute pancreatitis) in the past following the administration of methimazole or carbimazole.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tapazole.
If you are being treated with Tapazole
Your doctor will monitor you closely. Tell them immediately if you experience any
symptom such as:

• sore throat,
• skin changes (skin rashes),
• fever,
• migraine (a particular type of headache characterized by severe pain localized to one side of the head),
• general malaise. In these cases, your doctor may ask you to undergo laboratory tests to rule out a reduction in the blood of a type of white blood cells known as granulocytes (agranulocytosis) and to perform a more accurate check if you are taking medicines that can cause agranulocytosis at the same time.

Contact your doctor immediately if you have a fever or abdominal pain, which may be
signs of inflammation of the pancreas (acute pancreatitis). It may be necessary to
stop using Tapazole.
Also, inform your doctor:

• if you have hepatitis,
• if you have skin inflammation with the formation of whitish scales (exfoliative dermatitis),
• if you have a reduction in the number of leukocytes (leukopenia) and platelets (thrombocytopenia),
• if you have a decrease in the number of white blood cells, red blood cells and platelets (aplastic anemia or pancytopenia).
• if you have had or have inflammation of blood vessels (vasculitis) In these cases, your doctor may decide to stop treatment with Tapazole.

Tapazole can cause liver problems, even serious ones, so you should report any
symptom that may be related to liver damage to your doctor, such as:

• marked loss of appetite,
• itching,
• pain in the right flank, etc. In this case, your doctor will ask you to undergo tests to assess liver function and may decide to stop treatment with Tapazole if your liver is not functioning properly.

Your doctor may ask you to undergo periodic tests to evaluate:

• thyroid function, because if the level of the hormone that stimulates the thyroid (TSH) is higher, your doctor may reduce the dose of Tapazole;
• blood coagulation function (prothrombin levels), especially before surgery, because Tapazole can cause a decrease in prothrombin levels (hypoprothrombinemia);
• hematopoietic function, i.e. your body's ability to produce blood cells.

Tapazole can harm the fetus. Use reliable contraceptive methods from the moment you start
treatment and throughout its duration if you could become pregnant.

Children and adolescents
Tapazole is not recommended in children under 2 years of age due to the lack of safety and efficacy data in this age group.
In early childhood, the drug should only be used when absolutely necessary and under the direct
control of a doctor.

Other medicines and Tapazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Pay particular attention if you are taking or might take the medicines listed below:

• oral anticoagulants (medicines used to thin the blood) because Tapazole can increase blood fluidity;
• beta-blockers (used to treat high blood pressure and heart problems) because their dose may need to be reduced;
• digitalis glycosides (used to treat heart problems) because their dose may need to be reduced;
• theophylline (used to treat breathing problems) because its dose may need to be reduced.

Interaction studies have not been conducted in pediatric age.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tapazole can harm the fetus.
Use reliable contraceptive methods from the moment you start treatment and throughout its
duration if you could become pregnant.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, tell your doctor
immediately. Treatment with Tapazole may need to be continued during
pregnancy if the potential benefits outweigh the potential risks to you and the fetus. The
medicine will only be prescribed in cases of actual need and under the direct control of
the doctor.
Tapazole crosses the placenta rapidly, so it can cause the fetus:

• an increase in the volume of the thyroid gland (goiter)
• a decrease in the secretion of thyroid hormones with consequent arrest of physical and mental development (cretinism).

In addition, newborns whose mothers had been treated with Tapazole during pregnancy have rarely
presented the following defects at birth:

• failure of skin development, especially of the scalp (aplasia cutis);
• incomplete development of the esophagus (esophageal atresia) with abnormal communication between the trachea and esophagus (tracheoesophageal fistula);
• incomplete development of one or both nasal cavities (choanal atresia) accompanied by failure or incomplete development of the nipples.

Your doctor will inform you of the potential risks to the fetus if you take Tapazole
during pregnancy or if conception occurs during treatment with this medicine.
The doctor may also replace methimazole with another medicine, such as
propylthiouracil, for which these congenital defects have not been observed in newborns of mothers
who had taken propylthiouracil during pregnancy. The doctor will always consider the risk that the fetus will develop goiter and hypothyroidism.
If you are taking Tapazole during pregnancy, your doctor may reduce the dose because
thyroid dysfunction may decrease as the months of
pregnancy progress. Your doctor may also stop Tapazole 2-3 weeks before delivery.
Breastfeeding
Tapazole should not be used during breastfeeding due to the passage of
the medicine into breast milk.

Driving and using machines
No effects of Tapazole on the ability to drive and operate machinery have been reported.

Tapazole contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.

3. How to take Tapazole

Take this medicine following strictly the instructions of the doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
Tapazole is taken orally (by mouth) generally in three equal doses at intervals of 8 hours.
Mild hyperthyroidism
The recommended dose is 15 mg per day.
Moderate hyperthyroidism
The recommended dose is 30-40 mg per day.
Severe hyperthyroidism
The recommended dose is 60 mg per day.
The recommended maintenance dose is 5-15 mg per day.

Use in children and adolescents
Tapazole is not recommended in children aged 2 years or less.
Children and adolescents (3-17 years)
The initial dose for the treatment of children over 3 years of age and adolescents must
be calculated in relation to body weight. Generally, the initial daily dose is
0.5/mg/kg divided into two or three equal doses.
For maintenance therapy, the daily dose may be reduced based on the patient's response to
treatment.
Additional treatment with levothyroxine may be necessary to avoid hypothyroidism. Do not
exceed a dose of 40 mg per day.
The score line is to facilitate breaking the tablet if you have difficulty swallowing it
whole.

If you take more Tapazole than you should
In case of accidental ingestion of an excessive dose of Tapazole, immediately notify your
doctor or go to the nearest hospital. For updated information, if you have taken an
excessive dose of Tapazole, contact the Regional Poison Control Center.
The signs and symptoms that may occur when an excessive dose is taken include:

• nausea;
• vomiting;
• stomach pain;
• headache;
• fever;
• joint pain;
• itching;
• fluid accumulation in the tissues (edema).

Within a few hours or days of taking an excessive dose of Tapazole, you may experience:

• a decrease in the number of white blood cells, red blood cells, and platelets (aplastic anemia);
• a decrease in the number of granulocytes (agranulocytosis). Although the mechanism that triggers agranulocytosis is not yet known, the phenomenon is generally associated with the intake of methimazole doses equal to or greater than 40 mg in patients over 40 years of age.

Less frequently, the following may occur:

• liver inflammation (hepatitis);
• alteration of kidney filtration with consequent loss of proteins in the urine (nephrotic syndrome);
• skin inflammation with the formation of whitish scales (exfoliative dermatitis);
• peripheral nervous system disorders (neuropathies);
• stimulation or reduction of central nervous system activity.

If you forget to take Tapazole
Do not take a double dose to make up for a missed dose.

If you stop taking Tapazole
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Very rare (may affect up to 1 in 10,000 people):

• inhibition of bone marrow function (agranulocytosis and thrombocytopenia);
• simultaneous decrease in the number of blood cells such as white blood cells, red blood cells and platelets (aplastic anemia);
• fever above 40°C (hyperpyrexia);
• joint pain (arthralgia);
• muscle pain (myalgia);
• syndrome with manifestation similar to an autoimmune disease called lupus;
• hepatitis and yellowing of the skin and mucous membranes, determined by the accumulation of a substance called bilirubin (jaundice) which may persist for many weeks after stopping the medicine;
• fluid accumulation in the tissues (edema);
• decrease in prothrombin levels in the blood (hypoprothrombinemia) with risk of bleeding;
• severe skin and mucous membrane reaction (Stevens-Johnson syndrome).
• increase in size and/or pain in the salivary glands (sialoadenopathy);
• generalized skin inflammation (dermatitis);
• itching, itchy rash (urticaria);
• hair loss;
• sensation of tingling and numbness (paresthesia)
• headache;
• drowsiness;
• inflammation of the nerves, cranial or peripheral (neuritis);
• loss of taste (ageusia);
• dizziness;
• pain in the upper part of the stomach (epigastralgia);
• nausea, vomiting;
• inflammation of the walls of blood vessels (vasculitis).

Frequency not known (the frequency cannot be estimated from available data):

• inhibition of bone marrow function (granulocytopenia);
• autoimmune syndrome towards insulin, which can cause coma due to decreased blood sugar (hypoglycemic coma);
• inflammation of the wall of an artery (periarteritis);
• inflammation of the pancreas (acute pancreatitis).
• increase in size and/or pain in the lymph glands (lymphadenopathy);
• skin discoloration;
• onset of fever in conjunction with taking the medicine (drug fever);
• inflammation of the kidney (nephritis).

Paediatric population
The frequency, type and severity of adverse reactions in children are comparable to those of
adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Tapazole

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging after Scad. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tapazole contains

• The active ingredient is methimazole. Each tablet contains 5 mg of methimazole.
• The other ingredients are lactose monohydrate, corn starch, magnesium stearate, talc.

Description of the appearance of Tapazole and contents of the pack
Each pack contains 100 divisible tablets of 5 mg in blisters.

Marketing Authorisation Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia