Package leaflet: Information for the user

Thiamazole Uni-Pharma 5 mg tablets Thiamazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet 1. What Thiamazole Uni-Pharma is and what it is used for 2. What you need to know before you take Thiamazole Uni-Pharma 3. How to take Thiamazole Uni-Pharma 4. Possible side effects 5. How to store Thiamazole Uni-Pharma 6. Contents of the pack and other information

1. What Thiamazole Uni-Pharma 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. Thiamazole Uni-Pharma is used for the treatment of hyperthyroidism in adults and children from the age of 3 years.

You must talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Thiamazole Uni-Pharma

Do not take Thiamazole Uni-Pharma  if you are allergic to thiamazole or any of the other ingredients of this medicine (listed in section 6),  if you have had severe allergic reactions before to any related substances used to treat overproduction of thyroid hormones (such as carbimazole, propylthiouracil),  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 thiamazole,  if you have had bone marrow damage after previous treatment with thiamazole or carbimazole,  in combination with thyroid hormones during pregnancy,  if you had inflammation of the pancreas (acute pancreatitis) after administration of thiamazole or carbimazole in the past.

Warnings and precautions Talk to your doctor or pharmacist before taking Thiamazole Uni-Pharma:  if you have had mild allergic reactions before, such as allergic rashes or itching  if you have liver disease  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 with Thiamazole Uni-Pharma

 if your goitre grows under thiamazole treatment or if your thyroid gland is underactive; your doctor may then have to check your 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 thiamazole treatment.

You must stop the treatment and contact your doctor:  if you have symptoms such as inflammation of the mucous membrane of the mouth, bleeding from the skin and mucous membranes, sore throat, fever or other symptoms of infection. 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 Thiamazole Uni-Pharma. 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.

Once your elevated metabolism becomes normal again, you may experience weight gain while being treated with Thiamazole Uni-Pharma. This is a normal reaction of your body and suggests that your metabolism is normalising. Thiamazole Uni-Pharma affects your thyroid hormones, which control your energy consumption.

Thiamazole Uni-Pharma can cause harm to an unborn baby. If you could get pregnant, use reliable contraception from the time you start treatment and during treatment.

Tell your doctor straight away if you develop fever or abdominal pain, which may be signs of inflammation of the pancreas (acute pancreatitis). Thiamazole Uni-Pharma may need to be discontinued.

Children and adolescents Thiamazole is not intended for use by children under the age of 3 years.

Other medicines and Thiamazole Uni-Pharma Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your iodine supply has an effect on how Thiamazole Uni-Pharma works. Talk with your doctor if you are being treated or have been treated with iodine in the last few years. Your doctor will decide the dose of Thiamazole Uni-Pharma according to your individual iodine supply and your thyroid function. Please note that your illness can alter the effect of other medicines. Speak to your doctor if you take anticoagulants (medicines used to prevent blood clotting), because normalization of the thyroid function by Thiamazole Uni-Pharma may influence their effect. The same may be true for other medicines, so the dosage of other medicines may need to be changed once the function of the thyroid gland has normalised.

Thiamazole Uni-Pharma with food and drink You can take Thiamazole Uni-Pharma with a meal, although it is not necessary.

Pregnancy and breast-feeding

Thiamazole Uni-Pharma can cause harm to an unborn baby.

If you could get pregnant, use reliable contraception from the time you start treatment and during treatment. If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor straight away. Your treatment with Thiamazole Uni-Pharma may need to be continued during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby.

Thiamazole passes into breast milk. Thiamazole should be used during breast feeding only if your doctor considers this clearly necessary. Ask your doctor for advice before taking this medicine.

Driving and using machines Thiamazole Uni-Pharma has no influence on the ability to drive and use machines.

Thiamazole Uni-Pharma contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Thiamazole Uni-Pharma

Always take this medicine exactly as your doctor has told you. Check with your doctor, if you are not sure.

The recommended dose: Depending on how serious your condition is, your doctor will decide on your individual dose. The following doses are usually recommended:

Use in adults Severe cases: Initial dose: 6 to 8 tablets (30-40 mg) daily administered in several doses. Follow the doctor’s instructions.

Mild cases: Initial dose: 2 to 4 tablets (10-20 mg) daily administered in two doses. Follow the doctor’s instructions.

Maintenance dose: 1 to 2 tablets (5-10 mg) daily.

If you have an enlarged thyroid gland, or you have been in treatment with iodine, your doctor may prescribe very large doses at the beginning of the treatment.

Your doctor may reduce your dose according to your individual needs. Thiamazole Uni-Pharma may be used in combination with thyroid hormones to control your condition.

You should take the tablets with a glass of water.

Use in children and adolescents Children and adolescents (3–17 years): The dose depends on the child’s weight. The doctor can tell you what the dose is and how long the treatment lasts.

Patients with liver problems

Tell your doctor if you have had liver problems or liver diseases. In this case your dose of Thiamazole Uni-Pharma will have to be reduced.

Patients with kidney problems Tell your doctor if you have had kidney problems or kidney diseases. In this case your dose of Thiamazole Uni-Pharma will have to be reduced.

Duration of treatment Duration of treatment may vary depending on the condition for which you take Thiamazole Uni- Pharma. Your doctor will therefore discuss with you how long you need to take it for.

How to take Swallow the tablets with some liquid, such as half a glass of water, in the morning during or after breakfast. Do not chew the tablets. If you take more than one tablet daily, you may also take them in several portions at regular intervals over the day.

The tablet can be divided into equal doses.

If you take more Thiamazole Uni-Pharma than you should Contact your doctor or pharmacist if you have taken more of thiamazole than stated in this leaflet or more than your doctor has prescribed (and you feel uncomfortable). Symptoms of overdose may be changes in the blood that can occur as fatigue, bleeding from the skin and mucous membranes as well as infections and fever. Possibly fainting, cold sweats, hunger, confusion, unconsciousness due to low blood glucose and effect on liver function. Overdose may also lead to diminished production of thyroid hormone, of which the symptoms are e.g. tendency to weight gain, somnolence and sometimes dry, waxy swelling with abnormal deposits of mucin in the skin and other tissues (myxoedema). Your doctor may need to adjust your Thiamazole Uni-Pharma dose or may give you thyroid hormones in addition to avoid goitre growth.

If you forget to take Thiamazole Uni-Pharma Do not take a double dose to make up for a forgotten tablet, but take the normal dose the following day.

If you stop taking Thiamazole Uni-Pharma For the treatment to be successful, Thiamazole Uni-Pharma must be taken regularly at the dose prescribed by your doctor. Do not change, interrupt or stop the treatment without consultation.

If you have any further questions on the use of Thiamazole Uni-Pharma, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. While you are taking Thiamazole Uni-Pharma you may experience one or more of the following side effects, in some cases even after several months of treatment:

Very common (may affect more than 1 in 10 people):  General malaise, tendency towards inflammation (infections), particularly sore throat and fever due to changes in the blood (decrease in the number of white blood cells - granulocytes). This may become serious. If you develop a fever, you should contact your doctor immediately.

Common (may affect up to 1 in 10 people):  Decrease in the number of white blood cells (leukopenia). This may become serious. If you develop a fever, you should contact your doctor immediately.  Pain, heat and swelling in one or more joints due to inflammation (arthritis), especially in the base of the thumb, can develop gradually and even occur several months after the treatment.  Allergic reactions and skin reactions of varying degrees (rash, itching, itching wheals). These regularly have a mild course and often disappear with continued treatment.  Fever.

Uncommon (may affect up to 1 in 100 people):  Severe reduction in number of white blood cells which makes infections more likely (agranulocytosis). Contact your doctor or the hospital emergency department immediately.  Bleeding from the skin and mucous membranes and bruises due to changes in the blood (low platelet count). Contact your doctor or the hospital emergency department immediately.  Yellowing of your skin or whites of your eyes. These could be signs of jaundice or liver dysfunction. This may be serious. If you have jaundice, contact your doctor.  Feeling sick or vomiting, and stomach pain.

Rare (may affect up to 1 in 1,000 people):  Severe liver disease. Contact your doctor or the hospital emergency department immediately.  Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (aplastic anaemia). Contact your doctor.  Swelling of the saliva glands.  Swollen lymph glands. Change in or loss of the sense of taste, which may recede after treatment discontinuation.  Fever, reddening of the eyes and lips and the inside of the mouth, gum disease, swollen glands in the neck and a rash that is raised and bright red (mucocutaneous syndrome).  Dizziness.  Pain over the lower back, fever, foamy or bloody urine due to kidney inflammation. Contact your doctor or the hospital emergency department immediately.  Fever due to hypersensitivity to Thiamazole Uni-Pharma.

Very rare (may affect up to 1 in 10,000 people):  Fever, fatigue, malaise due to inflammation in blood vessels. This may be or become serious. Contact your doctor.  Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (pancytopenia). Contact your doctor or the hospital emergency department immediately.  Pain and sensory disturbances due to nerve inflammation.  Sensory impairment and paralysis mainly in the arms and legs, although breathing can also be affected. Contact your doctor or the hospital emergency department immediately.  Muscle pain.

Unknown frequency (cannot be reliably estimated from the available data):  Disorder of the blood glucose regulating hormones with decreased blood sugar levels. Contact your doctor.  Inflammation of the pancreas (acute pancreatitis).

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Thiamazole Uni-Pharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions. Store in the blister in the carton box in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Thiamazole Uni-Pharma contains  The active substance is thiamazole. Each tablet contains 5 mg thiamazole.

 The other ingredients are: lactose monohydrate, sodium starch glycolate, talc and magnesium stearate.

What Thiamazole Uni-Pharma looks like and contents of the pack Thiamazole Uni-Pharma 5 mg tablets are white, flat-faced bevel-edged, bisect tablets. Thiamazole Uni-Pharma 5 mg tablets are available in packs of 100, 105 or 125 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark: Thiamazole Uni-Pharma 5 mg tablets Sweden: Thiamazole Uni-Pharma 5 mg tablets Iceland: Thiamazole Uni-Pharma 5 mg tablets France: Thiamazole Uni-Pharma 5 mg tablets Finland: Thiamazole Uni-Pharma 5 mg tablets

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