Neo-Tomizol 5 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Neo-tomizol 5 mg tablets
Carbimazole
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Neo-tomizol is and what it is used for
- What you need to know before taking Neo-tomizol
- How to take Neo-tomizol
- Possible side effects
- How to store Neo-tomizol
- Contents of the pack and other information
1. What Neo-tomizol is and what it is used for
Neo-tomizol is a medication (antithyroid agent) that works by controlling the overproduction of thyroid hormones in the thyroid gland.
It is used in children and adolescents (3–17 years) and adults for the treatment of:
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Hyperthyroidism, that is, a condition in which the thyroid gland is more active than normal. Carbimazole reduces the production of thyroid hormones.
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Preparation for surgery of the thyroid gland.
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Treatment of other conditions, such as restoration of normal thyroid function after surgery involving partial removal of the thyroid gland.
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Sudden worsening of hyperthyroidism symptoms (thyrotoxic crisis or thyroid storm).
2. What you need to know before starting Neo-tomizol
Do not take Neo-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 counts such as leukocytes or neutrophils
- if you have liver disorders, elevated liver enzymes, or biliary flow obstruction not caused by hyperthyroidism
- if you have previously experienced bone marrow damage during treatment with other antithyroid drugs such as thiamazole
- if you have previously experienced acute pancreatitis (inflammation of the pancreas) after receiving carbimazole or thiamazole.
Warnings and precautions
Talk to your doctor or pharmacist before starting Neo-tomizol.
If your symptoms worsen or persist, consult your doctor.
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Inform your doctor of any illness that occurs, especially sore throat, bleeding, mouth ulcers, fever, or malaise, as these may represent early signs of blood disorders (agranulocytosis), which can have serious consequences in patients.
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If you are pregnant, think you may be pregnant, or are trying to become pregnant.
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Inform your doctor if symptoms such as abdominal pain, loss of appetite, or generalized itching occur, as they may be related to early signs of liver impairment.
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The administration of carbimazole should be temporarily discontinued if radioactive iodine is administered.
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If you have goiter (swelling in the front of the neck), treatment with Neo-tomizol must be carried out under strict medical supervision.
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Inform your doctor if symptoms such as mental confusion or memory loss occur.
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There is a risk of cross-allergy between carbimazole, its active metabolite thiamazole (methimazole), and propylthiouracil.
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Inform your doctor immediately if you develop fever or abdominal pain, as these may be signs of acute pancreatitis (inflammation of the pancreas). It may be necessary to discontinue Neo-tomizol.
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Neo-tomizol may harm the fetus. If you could become pregnant, use a reliable contraceptive method from the start of treatment and throughout its duration.
Your doctor may request blood tests during treatment to monitor your response.
Use of Neo-tomizol with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, you must inform your doctor if you are taking:
- Theophylline, used in the treatment of asthma or respiratory problems.
- Anticoagulants used to thin the blood, for example: warfarin.
- Medicines used for hypertension, heart failure (propranolol or other beta-blockers).
- Medicines that increase the force of heart contraction (digoxin).
- Erythromycin, used to treat infections.
Neo-tomizol may reduce the effects of oral anticoagulants.
Taking Neo-tomizol with food and drinks
Neo-tomizol may be taken with or without food.
Pregnancy and breastfeeding
Neo-tomizol may harm the fetus.
If you could become pregnant, use a reliable contraceptive method from the beginning of treatment and during treatment.
If you are pregnant or breastfeeding, think you might be pregnant, or plan 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 fetal harm:
- Your doctor will prescribe the lowest possible dose.
- Treatment may be discontinued 3 to 4 weeks before the expected delivery date.
- You must not breastfeed while taking carbimazole.
Driving and using machines
The effect of Neo-tomizol on the ability to drive and use machines is negligible or none.
Neo-tomizol contains lactose.
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Neo-tomizol
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Do not increase or decrease the dose. Consult your doctor or pharmacist if you have any doubts.
This medicine is administered orally. The tablets should be taken with a sufficient amount of liquid and may be taken with or without food.
Your doctor will decide when treatment should be discontinued. Blood tests may occasionally be requested to assess your response to treatment.
Radioactive iodine is another type of treatment for hyperthyroidism. If you are to be treated with radioactive iodine, your doctor will instruct you to temporarily discontinue carbimazole treatment.
If you think that the effect of Neo-tomizol is too strong or too weak, inform your doctor or pharmacist.
Recommended dose:
Adults: The usual starting dose is 20 to 60 mg of carbimazole per day orally (4 to 12 tablets of Neo-tomizol), depending on the degree of hyperthyroidism, divided into 2–3 daily doses. Initial treatment should be maintained until the patient's thyroid function normalizes.
Subsequent treatment may be administered in two different ways:
Maintenance regimen:
The maintenance dose is usually 5 to 15 mg of carbimazole (1 to 3 Neo-tomizol tablets) daily. Treatment should normally continue for 6 to 18 months.
It is recommended to perform periodic blood tests to monitor thyroid function and adjust the dose as necessary to maintain normal thyroid hormone levels.
Block and replace regimen:
The dose is maintained at the initial level of 20 to 60 mg of carbimazole per day orally (4 to 12 Neo-tomizol tablets). This is administered concomitantly with a daily dose of l-thyroxine 50–150 mg to prevent hypothyroidism. Treatment should continue for 6 to 18 months.
Children and Adolescents (3 to 17 years of age):
The usual starting dose is 0.75–1 mg/kg/day, divided into equal doses 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 of age.
If you take more Neo-tomizol than you should
Overdose causes hypothyroidism, with symptoms of reduced metabolism and activation of the adenohypophysis, leading to goiter growth. This effect can be prevented by reducing the dose once normal thyroid hormone levels are achieved, and, if necessary, by additional administration of levothyroxine (thyroid hormone).
If you or someone else takes more tablets than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. Bring the package and container to allow rapid identification of the product and dose.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Neo-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 taking Neo-tomizol
To maintain control of your thyroid gland, you may need to take carbimazole for several months. Do not stop treatment with Neo-tomizol without first consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
The most common adverse effects (may affect more than 1 in 10 people) are: skin rashes, itching, urticaria. These are considered mild and disappear during treatment with Neo-tomizol.
Frequent adverse effects (may affect up to 1 in 10 people) are: stomach discomfort, nausea, joint and muscle pain.
Uncommon adverse effects (may affect up to 1 in 100 people) but which can be serious are: agranulocytosis.
Rare adverse effects (may affect up to 1 in 1,000 people) are: headache, loss of taste, malaise, fever, and bruising.
Adverse effects with unknown frequency (cannot be estimated from the available data) are: inflammation of the pancreas (acute pancreatitis).
Very rare adverse effects (may affect up to 1 in 10,000 people) are: reduction in the number of certain blood cells (neutropenia, leucopenia, pancytopenia, thrombocytopenia), two types of anaemia (aplastic anaemia, haemolytic anaemia), bile or liver problems (hepatitis, cholestatic hepatitis, cholestatic jaundice), hair loss, bleeding disorders (haemorrhage), angioedema (a 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 (reduced urine output, fluid retention, and blood in urine).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse 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 stated on the packaging, after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Neo-tomizol
- The active substance is carbimazole. Each tablet contains 5 mg of carbimazole.
- The other components (excipients) are: lactose, corn starch, arabic gum (E-414), polyvinylpyrrolidone (E-1201), sodium croscarmellose, talc (E-553b) and magnesium stearate.
Appearance of the medicine and contents of the pack
Round, white tablets with a score line on one side. Packaged 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 the most recent review of this leaflet: January 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.