Prospect: information for the user

NITOMAN 25 mg tablets

Tetrabenazine

Read this prospect carefully before starting to take the medication.

1. What Nitoman is and for what it is used

2. Before taking Nitoman

3. How to take Nitoman

4. Possible adverse effects

5. Conservation of Nitoman

6. Additional information

NITOMAN belongs to a group of medications that act on the nervous system.

This medicationis indicated for the treatment of movement disorders associated with Huntington's chorea (an inherited disorder in which neurons in the brain degenerate and signs of dementia and abnormal movements appear).

No use Nitoman

- If you are allergic (hypersensitive) to tetrabenazine or any of the components of Nitoman.

- During pregnancy and lactation.

- If you have ever been diagnosed with depression or if you have thought or attempted to commit suicide.

• If you have ever had depression.
• If you have liver insufficiency (Child-Pugh scale between 5 and 9).
• If you are taking any medication that contains reserpine.
• If you have uncontrolled or inadequately treated depression.
• Tetrabenazine should not be administered in the two weeks following treatment with monoamine oxidase inhibitors (MAOIs) (see sections “Take special care with Nitoman”, “Use of other medications” and “Possible side effects”)
• If you are taking any medication that contains levodopa or dopaminergic medications (used for the treatment of Parkinson's disease).
• If you have parkinsonism and rigid-hypokinetic syndrome (parkinsonism).

- In children.

Take special care with Nitoman

- If you are a slow or intermediate metabolizer of an enzyme called CYP2D6, as you may need to receive a different dose.

- If you have Parkinson's disease, as Nitoman may cause parkinsonism and increase existing symptoms of the disease.

-If you are being treated with antidepressants, or have a history of depression, as Nitoman may cause depression or worsen existing depression. Cases of suicidal thoughts and behaviors have been reported in patients taking Nitoman. Consult your doctor before taking this medication. Aggressive and irritable behaviors may occur, or existing ones may worsen.

-If you have liver insufficiency (See section“How to take Nitoman”).

-If you have kidney insufficiency (See section“How to take Nitoman”)

-If you have any heart disease (patients with congenital long QT syndrome, congestive heart failure, hypertrophic cardiomyopathy).

If you have hypotension (low blood pressure).

• If you have low levels of potassium (hypokalemia) or magnesium (hypomagnesemia).

-When discontinuing treatment, as a malignant neuroleptic syndrome (MNS) may occur (muscle rigidity, fever, and altered consciousness). This syndrome may occur immediately after starting treatment, after increasing the dose, or during prolonged treatment.

Nitoman may elevate serum prolactin levels (hyperprolactinemia). The clinical significance of this is unknown

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

The following medications may interact with Nitoman. Inform your doctor if you are taking any of them:

• Levodopa and dopamine agonists (medications used in the treatment of Parkinson's disease)
• Reserpine (medication used to treat hypertension) (See section“Do not use Nitoman”).
• Monoamine oxidase inhibitors (MAOIs) (medications used in the treatment of depression). After discontinuing treatment with MAOIs, it is recommended to wait two weeks before starting treatment with Nitoman. MAOIs should not be used until at least two weeks after the last dose of tetrabenazine, to avoid potentially serious interactions between medications.
• Medications that increase the effects of the central nervous system (CNS) by increasing the sedative effects of tetrabenazine (neuroleptics, hypnotics, and opioids).
• Medications used in the treatment of epilepsy (such as phenytoin).
• Medications that increase the QTc interval (such as tricyclic antidepressants, chlorpromazine, thioridazine), antibiotics (such as gatifloxacin, moxifloxacin), and class I and II antiarrhythmic medications (such as quinidine, procainamide, amiodarone, sotalol). Antipsychotic medications (such as haloperidol, chlorpromazine, thioridazine).
• Antihypertensive and beta-blockers, may increase the risk of orthostatic hypotension (low blood pressure when standing up).

Use of Nitoman with food and beverages

No interactions with food are known.

This medication may potentiate the effects of alcohol.

Pregnancy and lactation.

Consult your doctor or pharmacist before using any medication.

You should inform your doctor if you are pregnant, or if you think or attempt to become pregnant. Do not take Nitoman during pregnancy.

Do not breastfeed while taking this medication.

Driving and operating machinery

Do not drive or operate tools or machines as Nitoman may cause drowsiness and therefore affect your ability to perform specific tasks.

Important information about some of the components of Nitoman

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

Follow exactly the administration instructions for Nitoman indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Nitoman.

- Adults:

The usual initial dose in adults is one tablet three times a day (a total of 75 mg). This dose is usually increased by one tablet every three or four days, up to a maximum of eight tablets a day (a total of 200 mg).

- Elderly patients:

Your doctor should decide on the appropriate dose.

- Patients with renal insufficiency:

A gradual increase in the dose of this medication is recommended. Additionally, a lower daily dose may be necessary.

- Patients with hepatic insufficiency:

A gradual increase in the dose of this medication is recommended. Additionally, a lower daily dose may be necessary.

- Children:

The use of Nitoman in children is not recommended.

Tablets should be swallowed with a sufficient amount of liquid, either water or another non-alcoholic beverage.

If you take more Nitoman than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicological Information Service. Phone 915 620420.

In case of overdose, the following symptoms may appear: acute dystonia (involuntary muscle contractions affecting the eyes, head, neck, and body), ocular crisis (eyes have an uncontrolled circular movement), excessive blinking, nausea, vomiting, diarrhea, sweating, drowsiness, dizziness, hypotension (decreased blood pressure), hypothermia (decreased body temperature), confusion, hallucination, sedation, redness/inflammation, and tremor.

If you forget to take Nitoman

Do not take a double dose to compensate for the missed doses. Continue taking your regular dose when it is due.

If you interrupt treatment with Nitoman

It is recommended to discontinue treatment gradually. Sudden interruption of treatment could induce a malignant neuroleptic syndrome (a serious condition characterized by muscle rigidity, high fever, and somnolence).

Like all medicines, Nitoman may cause side effects, although not everyone will experience them.

The side effects are generally mild and reversible upon discontinuing treatment.

The following adverse reactions are presented according to the MedDRA classification and by frequency:

Very common(may affect more than 1 in 10 people)

• Depression (feeling of sadness), which has been reported to be associated with suicidal thoughts and behaviors. If you feel down or very sad or may be starting to become depressed, inform your doctor about this change.
• Parkinsonism (may include symptoms such as muscle rigidity, tremors, and balance or gait problems).

• Common(may affect up to 1 in 10 people)Agitation
• Anxiety (restlessness)
• Confusion

Very rare(may affect up to 1 in 10,000 people)

• Suicidal thoughts
• If you have intentionally attempted to harm yourself or have started thinking about harming yourself.
• Irritability or aggressive behavior
• Malignant neuroleptic syndrome (muscle rigidity, fever, and altered consciousness)
• Pneumonia
• Ocular-gyric crisis (eyes have an uncontrolled circular movement)

Frequency not known(cannot be estimated from available data)

• Dizziness and postural hypotension (dizziness or even fainting that occurs when standing up quickly from a seated position)
• Bradycardia (decreased heart rate)
• Acatisia (sensation of bodily unease without reaching anxiety)
• Hypertensive crisis (critical increase in blood pressure)

Other known adverse effects are:

Very common(may affect more than 1 in 10 people)

• Drowsiness
• Tremors
• Excessive salivation

Common(may affect up to 1 in 10 people)

• Insomnia (difficulty sleeping)

Very rare(may affect up to 1 in 10,000 people)

• Leucopenia (decreased number of white blood cells)
• Decreased appetite, dehydration (lack of water in the body), weight loss
• Photophobia (intolerance to light)
• Rash, pruritus, or urticaria
• Falls

Frequency not known(cannot be estimated from available data)

• Disorientation, nervousness, discomfort, sleep disturbances
• Ataxia (uncoordinated movements), dystonia (involuntary muscle contractions)
• Memory loss
• Difficulty swallowing, nausea, vomiting, abdominal pain, diarrhea, constipation, dry mouth
• Increased appetite, weight gain
• Excessive sweating (hyperhidrosis)
• Irregular menstrual cycle
• Fatigue, weakness, hypothermia (reduced body temperature)

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines 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 out of reach and sight of children.

Do not store at a temperature above 86°F (30°C).

Do not use Nitoman after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines.In this way, you will help protect the environment.

Composition of Nitoman 25 mg tablets

The active ingredient is tetrabenazine.

The other components are: lactose monohydrate, cornstarch, talc, magnesium stearate, and yellow iron oxide (E172).

Appearance of the product and contents of the package

Beige-yellow, cylindrical, biplanar, beveled-edge, scored tablets with the mark “CL25”.

Child-resistant bottle and cap made of high-density white polyethylene, containing 112 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3, Ireland.

Responsible for manufacturing:

Astrea Fontaine

Rue des Pres Potes – 21121

Fontaine Les Dijon - (France)

For more information about this medication, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Paseo Club Deportivo 1, Edif 4.

Pozuelo de Alarcón 28223 – Madrid, Spain

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

This leaflet was approved in August 2022