Package Insert: Information for the Patient

Neo-tomizol5 mg Tablets

Carbimazol

Read this package insert carefully before starting to take the medication, as it contains important information for you.

-Keep this package insert, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Neo-tomizol is a medication (thyroid hormone inhibitor) that acts by controlling the overproduction of thyroid hormones in the thyroid gland.

It is used in children and adolescents (3 – 17 years) and in adults for the treatment of:

• Hyperthyroidism, that is a situation in which the thyroid gland is more active than normal. Carbimazole reduces the formation of thyroid hormones.

•If undergoing thyroid gland surgery.

•Treatment of other situations such as for example the restoration of normal thyroid function after a surgical intervention in which a part of the thyroid gland was removed.

•Sudden worsening of hyperthyroidism symptoms (thyrotoxic crisis or thyroid storm)

Do not takeNeo-tomizol

-if you are allergic (hypersensitive) to carbimazol or any of the other components of this medication (listed in section 6)

-if you are breastfeeding

-if you have blood disorders, low white blood cell count or neutrophil count

-if you have liver disorders, high liver enzyme values or bile duct blockage not caused by hyperthyroidism

-if you have suffered bone marrow damage during previous treatments with other antithyroid medications such as thiamazol

-if you have suffered acute pancreatitis after administration of carbimazol or thiamazol in the past.

Warnings and precautions

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

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

-Inform your doctor of theappearance of any disease that may occur, especially sore throat, bleeding, mouth ulcers, fever or discomfort, as they may represent initial symptoms of a blood disorder (agranulocytosis) that can have serious consequences for patients.

-If you are pregnant, think you may be pregnant or are trying to become pregnant.

-Inform your doctor if symptoms such as(abdominal pain, loss of appetite, generalized itching) occur, as they may be related to symptoms of liver involvement.

-The administration of carbimazol should be temporarily interrupted if radioactive iodine is administered.

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

-Inform your doctor if symptoms of mental confusion or memory loss appear.

-There is a risk of cross-allergy between carbimazol, the active metabolite thiamazol (metimazol) and propylthiouracil.

-Inform your doctor immediately if you present fever or abdominal pain, as they may be signs of acute pancreatitis. It may be necessary to interrupt the administration of Neo-tomizol.

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

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

Use of Neo-tomizol with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Especially, 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.

• Medications used for hypertension, heart failure (propanolol or other beta-blockers).
• Medications that increase the contraction force of the heart (digoxin).
• erythromycin used for the treatment of infections.

Neo-tomizol may reduce the effects of oral anticoagulants.

Taking Neo-tomizol with food and drinks

It can be used indistinctly with or without food.

Pregnancy and breastfeeding

Neo-tomizol may cause damage to the fetus.

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

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, inform your doctor immediately. It may be necessary to continue treatment with Neo-tomizol during pregnancyif the potential benefit outweighs the potential risk for you and the fetus.On occasion, it may cause damage to the fetus. To reduce the possibility of any damage to the fetus:

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

Driving and operating machines

The influence of Neo-tomizol on the ability to drive and operate machines is negligible or insignificant.

Neo-tomizol contains lactose.

This medication contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as 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 any doubts.

This medication 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 suspend treatment. Blood tests may be requested occasionally 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 suspend treatment with carbimazol.

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

Recommended dose:

Adults:The initial normal dose is20 to 60 mg of carbimazol per day orally (4 to 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.

The subsequent treatment can be administered in two different ways:

Maintenance regimen:

The maintenance dose is usually5 to 15 mg of carbimazol (1 to 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 as necessary to maintain normal levels of thyroid hormones.

Block and replacement regimen:

The dose is maintained at the initial level of 20 to 60 mg of carbimazol per day orally (4 to 12 Neo-tomizol tablets). 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 to 17 years old):

The initial normal dose is0.75 – 1 mg/kg/day divided into two 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).

Neo-tomizol administration 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 adenohypophysis with subsequent growth of the goiter. This effect can be avoided by reducing the dose when normal levels of thyroid hormones are reached and if necessary by additional administration of levotiroxine (thyroid hormone).

If you or another person ingests more tablets than you should, contact your doctor immediately or go to the nearest hospital emergency room. 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 medication and the amount ingested.

If you forgot to takeNeo-tomizol

If you forgot to take a dose, take it immediately when you remember.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withNeo-tomizol

To maintain control of your thyroid gland, you may need to take carbimazol for several months. Do not interrupt treatment with Neo-tomizol without consulting your doctor first.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

The frequent adverse effects (may affect up to 1 in 10 patients) are: stomach discomfort, nausea, joint and muscle pain.

The infrequent adverse effects (may affect up to 1 in 100 patients) but can be severe are: agranulocytosis.

The rare adverse effects (may affect up to 1 in 1000 patients) are: headache, loss of taste, discomfort, fever, and hematomas.

The adverse effects of unknown frequency (cannot be estimated from available data) are: inflammation of the pancreas (acute pancreatitis).

The very rare adverse effects (may affect up to 1 in 10,000 patients) are: decrease in the number of some blood cells (neutropenia, leucopenia, pancitopenia, thrombocytopenia), two types of anemia (aplastic anemia, hemolytic anemia), liver or bile duct damage (hepatitis, cholestatic hepatitis, cholestatic icterus), hair loss, coagulation problems (hemorrhage), angioedema (severe allergic reaction with symptoms such as tongue, lip, face, or throat swelling), 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 and blood retention in urine).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Neo-tomizol

-The active ingredient is carbimazol. Each tablet contains 5 mg of carbimazol.

-The other components (excipients) are: lactose, cornstarch, gum arabic (E-414), polyvinylpyrrolidone (E-1201), sodium croscarmellose, talc (E-553b) and magnesium stearate.

Appearance of the product and contents of the packaging

Round tablets, white in color with a notch on one of the faces. They are presented in bottles containing 50 tablets.

Holder of the marketing authorization and manufacturer responsible

Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer responsible

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès

Barcelona (Spain)

Last review date of this leaflet: January 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.