NEO-TOMIZOL 5 mg TABLETS

2. What you need to know before you take Neo-tomizol

Do not takeNeo-tomizol

• if you are allergic (hypersensitive) to carbimazole or any of the other ingredients of this medicine (listed in section 6)
• if you are breastfeeding
• if you have blood disorders, low blood cell count such as leukocytes or neutrophils
• if you have liver disorders, high liver enzyme values, or biliary flow obstruction not caused by hyperthyroidism
• if you have suffered bone marrow damage during previous treatments with other antithyroid drugs such as thiamazole
• if you have suffered from pancreatitis (acute pancreatitis) after administration of carbimazole or thiamazole in the past.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Neo-tomizol.

If your disease symptoms worsen or persist, consult your doctor.

• Tell your doctor about the onset of any disease, especially sore throat, bleeding, mouth ulcers, fever, or malaise, as they may represent initial symptoms of a blood disorder (agranulocytosis) that can have serious consequences in patients.

• If you are pregnant, think you may be pregnant, or are planning to become pregnant.

• Tell your doctor if you experience symptoms such as (abdominal pain, loss of appetite, generalized itching) as they may be related to symptoms of liver damage.

• Carbimazole administration should be temporarily discontinued if radioactive iodine is administered.

• If you have a goiter (swelling in the front of the neck), treatment with Neo-tomizol should be carried out under strict medical control.

• Tell your doctor if you experience symptoms of mental confusion or memory loss.

• There is a risk of cross-allergy between carbimazole, the active metabolite thiamazole (methimazole), and propylthiouracil.

• Tell your doctor immediately if you experience fever or abdominal pain, as they may be signs of pancreatitis (acute pancreatitis). It may be necessary to discontinue Neo-tomizol administration.

• Neo-tomizol may harm the fetus. If you can become pregnant, use a reliable contraceptive method from the start of treatment and during treatment.

Your doctor may ask for blood tests during treatment to determine how you are responding to it.

Using Neo-tomizol with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, you should inform your doctor if you are taking:

• Theophylline used in the treatment of asthma or respiratory problems.
• Anticoagulants used to thin the blood, such as warfarin.
  • Medicines used for hypertension, heart failure (propranolol or other beta-blockers).
  • Medicines that increase the heart's contractile force (digoxin).
  • Erythromycin used for the treatment of infections.

Neo-tomizol may decrease the effects of oral anticoagulants.

Taking Neo-tomizol with food and drinks

It can be used with or without food.

Pregnancy and breastfeeding

Neo-tomizol may harm the fetus.

If you can become pregnant, use a reliable contraceptive method from the start of treatment and during treatment.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, inform your doctor immediately. It may be necessary to continue treatment with Neo-tomizol during pregnancy if the potential benefit outweighs the potential risk to you and the fetus. In some cases, it may cause harm to the fetus. To reduce the possibility of any harm to the fetus:

• Your doctor will prescribe the lowest possible dose.
• Treatment may be suspended 3-4 weeks before the expected delivery date.
• You should not breastfeed your child if you are taking carbimazole.

Driving and using machines

Neo-tomizol has no or negligible influence on the ability to drive and use machines.

Neo-tomizol contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Neo-tomizol

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Do not increase or decrease the dose. Consult your doctor or pharmacist if you have doubts.

This medicine is administered orally. The tablets can be administered with a sufficient amount of liquid and can be used with or without food.

Your doctor will decide when to discontinue treatment. Occasionally, blood tests may be requested to determine how you are responding to treatment.

Radioactive iodine is another type of treatment for hyperthyroidism. If you are going to be treated with radioactive iodine, your doctor will tell you to temporarily discontinue carbimazole treatment.

If you think the effect of Neo-tomizol is too strong or too weak, inform your doctor or pharmacist.

Recommended dose:

Adults:The normal starting dose is 20-60 mg of carbimazole per day orally (4-12 Neo-tomizol tablets) depending on the degree of hyperthyroidism, divided into 2-3 doses per day. The initial treatment should be established until the patient's thyroid function normalizes.

Subsequent treatment can be administered in two different ways:

Maintenance regimen:

The maintenance dose is usually 5-15 mg of carbimazole (1-3 Neo-tomizol tablets) per day. Treatment should continue normally between 6 and 18 months.

It is recommended to perform analytical controls of thyroid function and adjust the dose if necessary to maintain normal thyroid hormone levels.

Block and replacement regimen:

The dose is maintained at the initial level of 20-60 mg of carbimazole per day orally (4-12 Neo-tomizol tablets). A dose of l-thyroxine 50-150 mg per day is administered concurrently to prevent hypothyroidism. Treatment should continue between 6 and 18 months.

Children and Adolescents (3-17 years old):

The normal starting dose is 0.75-1 mg/kg/day divided into equal doses and administered every 8 hours and adjusted according to thyroid hormone levels. The maintenance dose will be half (50%) of the initial dose (0.4-0.5 mg/kg/day).

Administration of Neo-tomizol is not recommended in children under 3 years old.

If you take moreNeo-tomizolthan you should

Overdose causes hypothyroidism, with symptoms of reduced metabolism and activation of the adenohipophysis with subsequent goiter growth. This effect can be avoided by reducing the dose when normal thyroid hormone levels are reached and, if necessary, by administering additional levothyroxine (thyroid hormone).

If you or someone else ingests more tablets than they should, contact your doctor or go to the nearest hospital emergency department immediately. Bring the box and bottle to quickly identify the product and dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takeNeo-tomizol

If you forget to take a dose, take it as soon as you remember.

Do not take a double dose to make up for forgotten doses.

If you stop takingNeo-tomizol

To maintain control of your thyroid gland, you may need to take carbimazole for several months. Do not stop taking Neo-tomizol without consulting your doctor first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common side effects (may affect more than 1 in 10 patients) are: skin rash, itching, urticaria. They are considered mild and disappear during treatment with Neo-tomizol.

Common side effects (may affect up to 1 in 10 patients) are: stomach upset, nausea, joint and muscle pain.

Uncommon side effects (may affect up to 1 in 100 patients) but can be serious are: agranulocytosis.

Rare side effects (may affect up to 1 in 1,000 patients) are: headache, loss of taste, malaise, fever, and bruising.

Side effects of unknown frequency (cannot be estimated from the available data) are: pancreatitis (acute pancreatitis).

Very rare side effects (may affect up to 1 in 10,000 patients) are: decrease in the number of some blood cells (neutropenia, leukopenia, pancytopenia, thrombocytopenia), two types of anemia (aplastic anemia, hemolytic anemia), liver or bile duct disorders (hepatitis, cholestatic hepatitis, cholestatic jaundice), hair loss, coagulation problems (bleeding), angioedema (severe allergic reaction with symptoms such as swelling of the tongue, lips, face, or throat), multisystem hypersensitivity reactions such as cutaneous vasculitis, respiratory problems with symptoms such as shortness of breath or cough, and kidney problems (decreased urine output, fluid retention, and blood in urine).

Reporting of side effects

If you experience 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 through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Neo-tomizol

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 carton after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

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 protect the environment.

6. Contents of the pack and further information

Composition of Neo-tomizol

• The active substance is carbimazole. Each tablet contains 5 mg of carbimazole.
• The other ingredients (excipients) are: lactose, cornstarch, gum arabic (E-414), polyvinylpyrrolidone (E-1201), sodium croscarmellose, talc (E-553b), and magnesium stearate.

Appearance of the product and pack contents

Round, white tablets with a score line on one face. They come in bottles containing 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès

Barcelona (Spain)

Date of last revision of this leaflet: January 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.