TETRABENAZINE ARISTO 25 mg TABLETS

2. What you need to know before you take Tetrabenazina Aristo

Do not take Tetrabenazina Aristo

• if you are allergic to tetrabenazina or any of the other ingredients of this medicine (listed in section 6)
• if you have thoughts of self-harm or suicide;
• if you suffer from depression or if your symptoms persist despite antidepressant treatment;
• if you have prolactin-dependent tumors (e.g. pituitary tumor or breast cancer);
• if you have a tumor of the adrenal medulla (pheochromocytoma);
• if you are breastfeeding;
• if you are taking a monoamine oxidase inhibitor (a type of antidepressant) or have taken one in the last 14 days;
• if your liver function is impaired;
• if you are taking medications that contain reserpine as an active ingredient;
• if you suffer from Parkinson's disease or have parkinsonism.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• 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 been diagnosed with depression or have thought about or attempted suicide;
• if you have ever had depression.

Treatment of tardive dyskinesia (late movement disorders) Ask your doctor if you can be considered for treatment with tetrabenazina. He/she will advise you accordingly. However, tetrabenazina is a centrally acting substance, which can cause extrapyramidal symptoms and theoretically cause tardive dyskinesia in humans.

Onset of depression (depressive mood)/suicidal tendencies (suicidal thoughts or behaviors) Tetrabenazina may cause depression or worsen pre-existing depression. If you suffer from depression, it may be controlled by reducing the dose. Cases have been reported in which patients taking tetrabenazina have developed suicidal thoughts or have shown suicidal behavior.

If depression or suicidal thoughts are deep, it should be considered to discontinue treatment with tetrabenazina and start treatment with antidepressants.

If you notice depression during treatment with tetrabenazina, inform your doctor. He will take the necessary measures.

Anger and aggressive behavior In patients with depression or a history of other psychiatric disorders who take tetrabenazina, there is a potential risk of developing or worsening anger and aggressive behavior.

Appearance of Parkinson's symptoms

Tetrabenazina may induce parkinsonism and worsen pre-existing symptoms of Parkinson's disease. If this happens to you, inform your doctor. He will take the necessary measures.

Dysphagia

Dysphagia is a component of Huntington's disease. However, medications that reduce dopaminergic transmission have been associated with esophageal dysmotility (a disorder of motility in the esophagus) and dysphagia (swallowing disorder). Dysphagia may be associated with aspiration pneumonia (a type of pneumonia caused by aspiration of foreign bodies or liquids). If you have difficulty swallowing, consult your doctor.

Appearance of Neuroleptic Malignant Syndrome

In some patients, the so-called Neuroleptic Malignant Syndrome (NMS) may appear during treatment with tetrabenazina, in rare cases. This is a life-threatening condition in rare cases, in which high fever, sweating, fluctuations in blood pressure, irregular or rapid pulse, cardiac arrhythmias, muscle rigidity, and loss of consciousness occur. If you experience one or more of these symptoms, you should inform your doctor or go to the nearest hospital immediately.

Patients with a history of tumors. If tetrabenazina is taken over a prolonged period, prolactin concentrations (a hormone) in the blood may increase. This increased concentration can, in rare cases, promote the growth of cells in breast tumors. For this reason, inform your doctor before taking tetrabenazina if you have a history of any tumor.

Patients with prolonged QTc interval

Tetrabenazina causes a slight prolongation of the QT interval in the ECG. Therefore, caution should be exercised in patients with congenital long QT syndrome and with a history of cardiac arrhythmias, or in patients who take other medications that can prolong the QT interval.

Cardiac disease Inform your doctor if you have recently had heart problems such as myocardial infarction or unstable cardiac disease.

Agitation and restlessness

Inform your doctor if you have difficulty staying in a sitting or standing position for extended periods (inability to stay still) or if you suffer from restlessness or increased restlessness. It may be necessary to reduce your dose if you experience these side effects.

Sedation and somnolence

Tetrabenazina may cause sedation (calming effect) or somnolence (abnormal drowsiness or fatigue). In this case, you should avoid activities that require a special state of alertness (e.g. driving or operating hazardous machinery).

Orthostatic hypotension A drop in blood pressure can occur, with symptoms of dizziness when standing up or loss of consciousness (syncope) under certain conditions in patients treated with tetrabenazina (e.g. when standing up after lying down). Inform your doctor if you have been told that you have low blood pressure (associated with symptoms such as dizziness, headache, rapid heart rate, or collapse).

Binding to melanin in tissues

Tetrabenazina and its metabolites can bind to melanin-containing tissues and accumulate in these tissues for a long time. Therefore, it is possible that tetrabenazina can cause damage to these tissues with prolonged use. While there are no specific recommendations for regular eye exams, doctors should consider the potential effects of long-term use of tetrabenazina on the eyes.

Laboratory tests

No clinically significant changes in laboratory parameters have been reported in tetrabenazina trials. In controlled trials, tetrabenazina caused a small average increase in laboratory values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) compared to placebo.

Other medicines and Tetrabenazina Aristo

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

If taken at the same time, the following medicines may interact with tetrabenazina:

• Levodopa, a medication for Parkinson's disease.
• Medications with a sedating effect on the brain, e.g. neuroleptics, hypnotics, and opioids.
• Medications for treating high blood pressure (antihypertensives) and beta blockers (medications that reduce heart rate and blood pressure).
• Certain medications that slow down the breakdown of tetrabenazina, e.g. fluoxetine, paroxetine, quinidine, duloxetine, terbinafine, amiodarone, sertraline.
• Medications that prolong the QT interval in the ECG, e.g. neuroleptics, certain antibiotics (gatifloxacin, moxifloxacin), certain antiarrhythmics (quinidine, procainamide, amiodarone, sotalol).
• MAO inhibitors (certain antidepressants): to avoid the risk of a serious interaction that results in a hypertensive crisis, at least 14 days should elapse between discontinuation of tetrabenazina treatment and initiation of MAO treatment, as well as between stopping the MAO inhibitor and starting tetrabenazina treatment.
• Medications analyzed through CYP2D6 (e.g. metoprolol, amitriptyline, imipramine, haloperidol, and risperidone): the effects of these medications may increase. The additional use of medications that inhibit CYP2D6 (e.g. fluoxetine, paroxetine, quinidine, duloxetine, terbinafine, amiodarone, or sertraline) may also increase this effect.
• Reserpine: tetrabenazina should not be taken at the same time as reserpine. Caution should be exercised when switching a patient from reserpine to tetrabenazina, with a sufficient interval of several days.

Tetrabenazina Aristo and alcohol

If you take alcohol with tetrabenazina at the same time, it may enhance the sedating effect.

Fertility, pregnancy, and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There are no sufficient data on the safety of tetrabenazina in pregnant women; therefore, the use of tetrabenazina during pregnancy is not recommended unless your doctor considers it absolutely necessary.

The use of tetrabenazina during pregnancy or in women of childbearing age without adequate contraceptive measures is not recommended.

It is essential to inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will decide whether you can or cannot take Tetrabenazina Aristo.

Breastfeeding

You should not breastfeed while taking this medicine.

Fertility

Animal studies with tetrabenazina have shown that there is no effect on pregnancy or intrauterine survival. Female menstrual cycles were prolonged, and a delay in the fertility phase was observed.

Driving and using machines

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

Tetrabenazina Aristo contains lactose.

Each tablet contains 63.4 mg of lactose (as monohydrate). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Tetrabenazina Aristo

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

During the initial prescription, your doctor will gradually increase the dose of tetrabenazina over several weeks until a dose is found that reduces your symptoms and is well tolerated.

Note

The dose will depend on the symptoms of the disease and the reaction/response to treatment.

The required dose may vary from one patient to another. Therefore, the following dosage recommendations are only a guide. Always follow your doctor's orders regarding the dose. Your doctor will review the dose at regular intervals.

If you have liver or kidney problems, your doctor may prescribe a different dose.

Dose for uncontrolled movements caused by Huntington's Chorea

Unless your doctor tells you otherwise, the usual initial dose is one tetrabenazina tablet three times a day.

This dose can be increased by one tablet per day every three or four days until optimal efficacy is achieved.

The maximum daily dose of 8 tetrabenazina tablets should not be exceeded.

Dose for tardive dyskinesia (late movement disorders)

Adults

Unless your doctor tells you otherwise, the usual initial dose is half a tablet per day.

If you respond favorably to treatment, your doctor will gradually increase the dose. Your doctor may discontinue treatment with Tetrabenazina Aristo if:

• There is no improvement in clinical symptoms after increasing the dose;
• Severe side effects occur

Resumption of treatment If your treatment was interrupted for more than 5 days or the interruption of your treatment was necessary due to a medical condition or due to concomitant use of other medications, your therapy with tetrabenazina should be withdrawn when resumed. Depending on your doctor, the dose should be started with 12.5 mg twice a day, wait 7 days, and then increase to 12.5 mg per day.

If you notice adverse effects such as inability to sit (akathisia), restlessness, parkinsonism, balance disturbance, tremors, increased salivation, depression, insomnia, anxiety, or intolerable sedation, contact your doctor.

Your doctor will decide whether to discontinue your medication or reduce the dose.

Special populations

Elderly and pediatric patients

No specific studies have been conducted in either of these age groups. Your doctor will decide the appropriate dose.

Elderly patients usually receive the recommended dose for adults.

Children usually start with half the daily dose of an adult. This dose can then be modified slowly and carefully, depending on the tolerance and response of each individual.

Talk to your doctor or pharmacist if you think the effect of tetrabenazina is too strong or too weak.

Patients with hepatic or renal impairmentIf you have liver or kidney problems, your doctor may prescribe a different dosage and/or a different dose. Before starting to take tetrabenazina, consult your doctor if you are a slow or intermediate metabolizer of an enzyme called CYP2D6, as you may need to receive a different dose.

Method of administrationTetrabenazina is for oral use. Take the tablets with sufficient liquid (water or other non-alcoholic beverages. Do not take the tablets with alcohol) and do not chew them. The tablets have a break line and can be divided into equal doses. This allows taking half tablets.

If you take more Tetrabenazina Aristo than you should

If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist, or nearest hospital or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

The symptoms of overdose include uncontrolled muscle spasms that affect the eyes, head, neck, and body, rapid uncontrolled eye movements, excessive blinking, nausea, vomiting, diarrhea, sweating, dizziness, feeling of cold, confusion, hallucinations, somnolence, redness/inflammation, and tremor.

If you forget to take Tetrabenazina Aristo

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 Tetrabenazina Aristo

Do not change the dose of tetrabenazina without consulting your doctor first. If you want to stop taking tetrabenazina, you should also consult your doctor first. If you have any further questions on 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 all people suffer from them.

Important Side Effects or Signs to Watch Out for and Measures to Take if Affected

If you experience muscle stiffness or fever and altered consciousness (such as confusion or hallucinations), stop taking tetrabenazina Aristo. Consult your doctor or the nearest hospital as soon as possible (see also section 2 "Warnings and Precautions").

Contact immediately or go to the hospital if you experience the following adverse effects:

• If you experience muscle stiffness, fever, or deterioration of consciousness (e.g., confusion or hallucinations), stop taking Tetrabenazina. Consult your doctor or the nearest hospital as soon as possible (see also section 2 "Warnings and Precautions").
• Very common (may affect more than 1 in 10 people): Tetrabenazina Aristo may cause depression that, in some people, can lead to suicidal thoughts. If you feel depressed or very sad, you may be starting to become depressed and should inform your doctor about this change.
• Very rare (may affect up to 1 in 10,000 people): if you have attempted suicide or if you have intentionally self-harmed or if you have started thinking about intentionally self-harming.

Other Possible Adverse Effects

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, you may be starting to become depressed and should inform your doctor about this change.

• drowsiness
• Parkinson's symptoms such as loss of balance, tremors, or increased salivation

Common(may affect up to 1 in 10 people)

• agitation
• confusion
• feeling of anxiety
• insomnia
• decreased appetite

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

• pneumonia
• reduction in the number of white blood cells (leukopenia)
• rapid, uncontrollable eye movements (oculogyric crisis)
• light intolerance (photophobia)
• dehydration
• aggression, anger
• suicidal thoughts, intention to harm oneself, or thoughts of harming oneself.
• neuroleptic malignant syndrome (a condition in which high fever, sweating, fluctuations in blood pressure, muscle stiffness, and altered consciousness occur), see section 2 "Warnings and Precautions"
• rash, itching, hives
• weight loss
• risk of falls

Frequency Not Known(cannot be estimated from the available data)

• alteration of balance and uncoordinated movements (ataxia)
• feeling that you cannot stay still (akathisia)
• uncontrollable muscle spasms (dystonia)
• memory loss
• dizziness
• disorientation
• nervousness
• restlessness
• sleep disorders
• slow heart rate (bradycardia)
• drop in blood pressure with dizziness when standing up (orthostatic hypotension)
• hypertensive crisis
• difficulty swallowing
• nausea (discomfort)
• vomiting
• stomach pain
• diarrhea
• constipation
• dry mouth
• sweating
• irregular menstrual periods
• fatigue
• weakness
• reduced body temperature (hypothermia)
• increased appetite
• weight gain

To avoid the risk of a potentially serious intention that leads to a hypertensive crisis, it should be ensured that at least 14 days pass between the interruption of tetrabenazina Aristo and the start of treatment with an MAO inhibitor, as well as between the interruption of MAO inhibitor treatment and the start of treatment with tetrabenazina Aristo.

If you take Tetrabenazina for prolonged periods, the concentration of prolactin (a hormone of the pituitary gland) in the blood may increase. This returns to normal after stopping treatment. As a result, abnormal milk secretion (galactorrhea), absent or irregular menstrual periods, enlargement of male breasts (gynecomastia), breast pain, breast enlargement, pituitary tumors (prolactinomas), orgasmic disorders, and impotence may occur.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tetrabenazina Aristo

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

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

Do not store at a temperature above 30º. Keep in the original packaging to protect it from light.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Content of the Packaging and Additional Information

Composition of Tetrabenazina Aristo 25 mg Tablets

The active ingredient is tetrabenazina.

The other components are: lactose monohydrate (see section 2, "What you need to know before taking Tetrabenazina Aristo"), cornstarch, microcrystalline cellulose, talc, magnesium stearate, and yellow iron oxide (E172).

Appearance of the Product and Content of the Packaging

Light yellow, round tablets with a break line on one face and an approximate diameter of 7 mm ± 0.2 mm.

The tablets can be divided into equal doses.

This medicine is available in bottles with 112 tablets.

Marketing Authorization Holder and Manufacturer

Aristo Pharma GmbH

Wallenroder Str. 8-10,

13435 Berlin, Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Tetrabenazin Aristo 25 mg Tabletten

Austria: Tetrabenazin Aristo 25 mg Tabletten

Spain: Tetrabenazina Aristo 25 mg comprimidos EFG

Italy: Tetrabenazina Aristo 25 mg compresse

Portugal: Tetrabenazina Aristo 25 mg comprimidos

United Kingdom: Tetrabenazine Aristo 25 mg tablets

Date of the Last Revision of this Prospectus: December 2024

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/