NITOMAN 25 mg TABLETS

2. BEFORE TAKING NITOMAN

Do not use Nitoman

• If you are allergic (hypersensitive) to tetrabenazina or any of the components of Nitoman.
• During pregnancy and breastfeeding.
• If you have ever been diagnosed with depression or if you have thought about or attempted suicide.
• If you have ever had depression.
• If you have liver failure (Child-Pugh score between 5 and 9).
• If you are taking any medicine that contains reserpine.
• If you have uncontrolled or inadequately treated depression.
• Tetrabenazina should not be administered in the two weeks following treatment with monoamine oxidase inhibitors (MAOIs) (see sections "Be careful with Nitoman", "Using other medicines", and "Possible side effects").
• If you are taking any medicine that contains levodopa or dopaminergic medicines (used to treat Parkinson's disease).
• If you have parkinsonism and rigid hypokinetic syndrome (parkinsonism).

• In children.

Be careful 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 pre-existing symptoms of the disease.
• If you are being treated with antidepressant medicines, or have a history of depression, as Nitoman may cause depression or worsen pre-existing depression. Cases of suicidal thoughts and behaviors have been reported in patients taking Nitoman. Consult your doctor before taking this medicine. Irritability and aggressive behavior may occur, or worsen existing conditions.
• If you have liver failure (see section "How to take Nitoman").
• If you have kidney failure (see section "How to take Nitoman").
• If you have any heart disease (patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy).

If you have hypotension (low blood pressure).

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

• When stopping treatment, as a malignant neuroleptic syndrome (rigid muscles, fever, and changes in consciousness) may appear. This syndrome may appear immediately after starting treatment, after increasing the dose, or in case of prolonged treatments.

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

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

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

• Levodopa and dopamine agonists (medicines used to treat Parkinson's disease)
• Reserpine (medicine used to treat hypertension) (see section "Do not use Nitoman").
• Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression). After stopping treatment with MAOIs, it is recommended to wait two weeks before starting treatment with Nitoman. Monoamine oxidase inhibitors (MAOIs) should not be used until at least two weeks after the last dose of tetrabenazina, to avoid potentially serious interactions between the medicines.
• Medicines that inhibit the Central Nervous System (CNS) increasing the sedative effects of tetrabenazina (neuroleptics, hypnotics, and opioids).
• Medicines used to treat epilepsy (such as phenytoin).
• Medicines that increase the QTc interval (such as tricyclic antidepressants, such as chlorpromazine, thioridazine), antibiotics (such as gatifloxacin, moxifloxacin), and antiarrhythmic class I and II medicines (such as quinidine, procainamide, amiodarone, sotalol). Antipsychotic medicines (such as haloperidol, chlorpromazine, thioridazine).
• Antihypertensive and beta-blocker medicines, may increase the risk of orthostatic hypotension (decrease in blood pressure when standing up).

Using Nitoman with food and drinks

No interactions with food are known.

This medicine may enhance the effects of alcohol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

You should tell your doctor if you are pregnant, or if you are planning to become pregnant. You should not take Nitoman during pregnancy.

You should not breastfeed while taking this medicine.

Driving and using machines

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

Important information about some of the ingredients of Nitoman

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 NITOMAN

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

Remember to take your medicine.

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

• Adults:

The normal 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 what dose is suitable for you.

• Patients with kidney failure:

It is recommended that the gradual increase in the dose of this medicine be slow. Additionally, a lower daily dose may be necessary.

• Patients with liver failure:

It is recommended that the gradual increase in the dose of this medicine be slow. Additionally, a lower daily dose may be necessary.

• Children

Nitoman is not recommended for use in children.

The tablets should be swallowed with a sufficient amount of liquid, either water or another non-alcoholic drink.

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 Toxicology Information Service. Telephone 915 620420.

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

If you forget to take Nitoman

Do not take a double dose to make up for forgotten doses. Continue taking your normal dose when it is due.

If you stop taking Nitoman

It is recommended to gradually stop treatment. Abrupt interruption of treatment may induce a malignant neuroleptic syndrome (a serious condition characterized by rigid muscles, high fever, and drowsiness).

4. POSSIBLE SIDE EFFECTS

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

Side effects are usually mild and reversible when treatment is stopped.

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

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

• Depression (feeling of sadness), which has been reported in association with suicidal thoughts and behaviors. If you feel down or very sad or may be starting to become depressed, you should inform your doctor about this change.
• Parkinsonism (may include symptoms such as muscle stiffness, tremors, and balance or walking 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 tried to harm yourself or have started thinking about harming yourself.
• Irritability or aggressive behavior
• Malignant neuroleptic syndrome (muscle stiffness, fever, and changes in consciousness)
• Pneumonia
• Oculogyric crisis (the eyes have an uncontrolled circular movement)

Frequency not known(cannot be estimated from the available data)

• Dizziness and orthostatic hypotension (dizziness or fainting when standing up quickly from a sitting position)
• Bradycardia (decrease in heart rate)
• Akathisia (feeling of restlessness in the body without reaching anxiety)
• Hypertensive crises (critical increase in blood pressure)

Other known side 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)

• Leukopenia (decrease in the number of white blood cells)
• Decreased appetite, dehydration (lack of water in the body), weight loss
• Light intolerance (photophobia)
• Rash, itching, or hives
• Falls

Frequency not known(cannot be estimated from the available data)

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's pharmacovigilance system: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. STORAGE OF NITOMAN

Keep out of the reach and sight of children.

Do not store above 30°C.

Do not use Nitoman after the expiry date stated on the packaging after EXP.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines.

This will help protect the environment.

6. FURTHER INFORMATION

Composition of Nitoman 25 mg tablets

The active ingredient is tetrabenazina.

The other ingredients are: lactose monohydrate, corn starch, talc, magnesium stearate, and yellow iron oxide (E172).

Appearance of the product and packaging contents

Beige-yellow tablets, cylindrical, biplanar, with a beveled edge, scored, and marked with "CL25".

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

Marketing authorization holder and manufacturer

Holder:

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3, Ireland.

Manufacturer:

Astrea Fontaine

Rue des Pres Potes – 21121

Fontaine Les Dijon - (France)

You can request more information about this medicine by contacting 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 on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This leaflet was approved in August 2022