What Thiamazole Uni-Pharma is and what it is used for
This medicine contains thiamazole. Thiamazole keeps the overproduction of thyroid hormone in the thyroid gland under control, regardless of the cause.
Thiamazole Uni-Pharma is used for increased hormone secretion from the thyroid gland ( hyperthyroidism ) in adults and children from the age of 3.
You must speak to a doctor if you do not feel better or if you feel worse.
Thiamazole contained in Thiamazole Uni-Pharma may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use 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 previously had severe allergic reactions to substances used to treat overproduction of thyroid hormones (eg carbimazole, propylthiouracil).
- if laboratory tests show that you have a reduction in the number of certain blood cells ( granulocytopenia ).
- if you have blocked bile flow before starting treatment with thiamazole.
- if you have had bone marrow damage after previous treatment with thiamazole or carbimazole.
- in combination with thyroid hormone during pregnancy.
- if you previously had inflammation of the pancreas ( acute pancreatitis ) after receiving thiamazole or carbimazole.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Thiamazole Uni-Pharma:
- if you have had mild allergic reactions in the past, such as allergic rashes or itching.
- if you have liver disease.
- if you have a large goiter (swelling in the front of the throat) that makes it difficult for you to breathe, the goiter may grow during treatment with Thiamazole Uni-Pharma.
- if the goiter grows during treatment with thiamazole or if the thyroid gland is underactive, your doctor may need to check the dose. However, such conditions may also arise due to the natural course of your disease. Similarly, a certain type of eye disease ( endocrine orbitopathy) may develop or worsen, but it is not related to the treatment with thiamazole.
You must stop the treatment and contact your doctor:
- if you have symptoms such as inflammation of the mucous membrane in the mouth, bleeding from the skin and mucous membranes, sore throat, fever, or other symptoms of infection. These may be due to a sharp reduction in the number of certain blood cells ( agranulocytosis ). It can develop especially during the first weeks of treatment and lead to serious consequences.
If you have a particularly severe form of overproduction of thyroid hormone, you may need to take very high doses of Thiamazole Uni-Pharma. In this case, the doctor will take blood samples from time to time, as the bone marrow may be affected. If this happens, your doctor may decide to stop treatment and, if necessary, give you another medicine.
When the elevated metabolism returns to normal, you may experience weight gain during treatment with Thiamazole Uni-Pharma. This is a normal reaction in the body and means that your metabolism is returning to normal. Thiamazole Uni-Pharma affects your thyroid hormones, which control your energy expenditure.
Thiamazole Uni-Pharma can cause harm to an unborn baby. If you can become pregnant, use reliable contraception from the time you start treatment and during treatment.
Tell your doctor immediately if you develop a fever or abdominal pain, which may be signs of inflammation of the pancreas ( acute pancreatitis ). The use of Thiamazole Uni-Pharma may need to be discontinued.
Children and young people
Thiamazol is not intended for use by children under 3 years of age.
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 intake affects how Thiamazole Uni-Pharma works. Talk to your doctor if you are being treated or have been treated with iodine in the last few years. The doctor determines the dose of Thiamazole Uni-Pharma according to your iodine supply and your thyroid function.
Please note that your illness can change the effect of other medicines. Talk to your doctor if you are taking anticoagulants (medicines used to prevent blood clots), as normalizing thyroid function with Thiamazole Uni-Pharma may affect their effectiveness. The same may apply to other drugs, so the dose of other drugs may need to be changed when thyroid function has normalized.
Thiamazole Uni-Pharma with food, drink, and alcohol
You can take Thiamazole Uni-Pharma with food, even if it is not necessary.
Pregnancy and breastfeeding
Thiamazole Uni-Pharma can cause harm to an unborn baby.
If you can become 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 right away. Your treatment with Thiamazole Uni-Pharma may need to be continued during pregnancy if the benefit of the treatment is greater than the possible risk to you and your unborn child.
Thiamazole passes into breast milk. Thiamazole should be used during breastfeeding only if your doctor considers this necessary. Ask your doctor for advice before taking this medicine.
Driving ability and use of machinery
Thiamazole Uni-Pharma does not affect the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
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 medicine.
How to use Thiamazole Uni-Pharma
Always use this medicine as directed by your doctor. Consult a doctor if you are unsure.
Recommended dose:
Depending on how serious your condition is, the doctor determines your dose. The following dose is usually recommended:
Use for adults
Serious cases :
Initial dose: 6 to 8 tablets (30-40 mg) daily divided into several doses. Follow the doctor’s instructions.
Mild cases :
Initial dose: 2 to 4 tablets (10-20 mg) daily divided into 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 if you have been treated with iodine, your doctor may prescribe very large doses at the beginning of treatment.
Your doctor may reduce the dose according to your individual needs.
Thiamazole Uni-Pharma can be used in combination with thyroid hormone to treat your condition.
You should take the tablets with a glass of water.
Use for children and adolescents
Children and young people (3 – 17 years) :
Does one depend on the child’s weight? The doctor determines the appropriate dose and how long the treatment should last.
Patients with liver problems
Tell your doctor if you have had liver problems or liver disease. In that case, your dose of Thiamazole Uni-Pharma must be reduced.
Patients with kidney problems
Tell your doctor if you have had kidney problems or kidney disease. In that case, your dose of Thiamazole Uni-Pharma must be reduced.
Treatment time
The treatment time may vary depending on the condition you are taking Thiamazole Uni-Pharma for. Your doctor will therefore discuss with you how long you should be treated.
How to take the tablets
Swallow the tablets with a little liquid, for example, half a glass of water, in the morning with or after breakfast. Do not chew the tablets.
If you take more than one tablet daily, you can also take them divided into several times at regular intervals throughout the day.
The tablet can be divided into two equal doses.
If you have taken too much Thiamazole Uni-Pharma
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Symptoms of overdose can be changes in the blood that can lead to fatigue, bleeding from the skin and mucous membranes as well as infection and fever. Possible fainting, cold sweats, hunger, confusion, unconsciousness due to low blood sugar, and effects on liver function. Overdose can also lead to reduced production of thyroid hormone, with symptoms such as the tendency to weight gain, sleepiness, and sometimes dry, waxy swelling with abnormal levels in the skin and other tissues of a substance called mucin ( myxedema ). Your doctor may need to adjust your dose of Thiamazole Uni-Pharma or give you additional thyroid hormones to avoid goiter growth.
If you forget to use Thiamazole Uni-Pharma
Do not take a double dose to make up for a forgotten tablet, but take the usual dose on the following day.
If you stop using Thiamazole Uni-Pharma
For the treatment to be successful, Thiamazole Uni-Pharma must be taken regularly in the doses prescribed by your doctor. You should not change, interrupt or end the treatment without discussing it with a doctor.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
While 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 users
- General malaise, the tendency to inflammation ( infection er), especially sore throat and fever due to changes in the blood (decrease in the number of white blood cells – granulocytes ). It could be serious. If you develop a fever, contact your doctor immediately.
Common: may affect up to 1 in 10 users
- Decrease in the number of white blood cells ( leukopenia ). It could be serious. If you develop a fever, contact your doctor immediately.
- Pain, heat, and swelling in one or more joints due to inflammation ( arthritis ), especially at the base of the thumb, may develop gradually and even occur several months after treatment.
- Allergic reactions and skin reactions of varying degrees (rash, itching, hives ). These usually have a mild course and often disappear with continued treatment.
- Fever.
Uncommon: may affect up to 1 in 100 users
- Severe reduction in the number of white blood cells which increases the risk of infection ( agranulocytosis ). Contact a doctor immediately.
- Bleeding from the skin and mucous membranes and bruising due to changes in the blood (low platelet count ). Contact a doctor immediately.
- Yellowing of the skin or the whites of the eyes. This may be a sign of jaundice or impaired liver function. It could be serious. If you have jaundice, see a doctor.
- Nausea or vomiting and stomach pain.
Rare: may affect up to 1 in 1,000 users
- Severe liver disease. Contact a doctor immediately.
- Severe reduction in blood cells, which can cause weakness, bruising, or increase the risk of infection ( aplastic anemia ). Contact a doctor.
- Swollen salivary glands.
- Swollen lymph nodes. Change in or loss of sense of taste, which may subside after treatment ends.
- Fever, redness of the eyes and lips and the inside of the mouth, gum disease, swollen glands in the throat, 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 a doctor immediately.
- Fever due to hypersensitivity to Thiamazole Uni-Pharma.
Very rare: may affect up to 1 in 10,000 users
- Fever, extreme tiredness, and general malaise due to inflammation of the blood vessels. It may or may not be serious. Contact a doctor.
- Severe reduction in blood cells, which can cause weakness, bruising, or increase the risk of infection (pancytopenia). Contact a doctor immediately.
- Pain and sensory disturbances due to nerve inflammation.
- Impaired feeling and paralysis mainly in the arms and legs, but breathing can also be affected. Contact a doctor immediately.
- Muscle pain.
Has been reported: occurring in an unknown number of users
- Disturbance of the hormones that regulate glucose in the blood with reduced blood sugar levels as a result. Contact a doctor.
- inflammation of the pancreas ( acute pancreatitis ).
How to store Thiamazole Uni-Pharma
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label after EXP.
The expiration date is the last day of the specified month.
No special temperature instructions. Store the blister in the outer carton. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is thiamazole. 1 tablet contains 5 mg of thiamazole.
- Other ingredients are lactose monohydrate, sodium starch glycolate, talc, and magnesium stearate.
Appearance and package sizes of the medicine
Thiamazole Uni-Pharma 5 mg tablets are white, divisible tablets with a flat surface and beveled edges.
Packages: 100, 105 or 125 tablets.
Not all pack sizes may be marketed.
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories SA
14 km National Road Athens-Lamia 1,
GR-145 64 Kifissia
Greece
Local Representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com
This medicine is approved in the European Economic Area under the names:
Denmark: Thiamazole Uni-Pharma
Sweden: Thiamazole Uni-Pharma
Iceland: Thiamazole Uni-Pharma
Finland: Thiamazole Uni-Pharma
France: Thiamazole Uni-Pharma