Leaflet: information for the user

Tetrabenazine Aristo 25 mg tablets EFG

tetrabenazine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Tetrabenazine Aristo is and for what it is used

2. What you need to know before starting to take Tetrabenazine Aristo

3. How to take Tetrabenazine Aristo

4. Possible side effects

5. Storage of Tetrabenazine Aristo

6. Contents of the pack and additional informationl

Tetrabenazina Aristo are oral tablets. The active substance in Tetrabenazina Aristo is tetrabenazine.

Tetrabenazine inhibits the storage of special neurotransmitters in the brain. This reduces the transmission of stimuli in nerve cells of certain brain regions that participate in the regulation of individual movement sequences. As a result, excessive and/or involuntary movements (hyperkinesia) can be better controlled. These excessive and/or involuntary movements may be of organic origin (physical) (such as Huntington's disease, for example). However, they can also be caused by medications, for example, after prolonged use of neuroleptics (medications for the treatment of mental disorders). In this case, the condition is called tardive dyskinesia (late movement disorder).

Tetrabenazine is used to treat the following diseases:

• Excessive and/or involuntary movements (hyperkinesia) in Huntington's disease.
• Moderate to severe tardive dyskinesia (late movement disorder); tetrabenazine can only be used for this movement disorder if other treatment options have failed.

Do not take Tetrabenazina Aristo

• If you are allergic to tetrabenazina or any of the other components of this medication (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 hormone-dependent tumors (e.g. pituitary tumor or breast cancer);
• If you have a pheochromocytoma (adrenal gland tumor);
• 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 the active ingredient;
• If you have Parkinson's disease or parkinsonism.

Warnings and precautions

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

• If you are a slow or intermediate metabolizer of an enzyme called CYP2D6, as it may be possible that you will need a different dose;

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

Treatment of tardive dyskinesia (delayed movement disorders)
Ask your doctor if you can be considered for treatment with tetrabenazina. He/she will advise you accordingly. However, tetrabenazina is a central-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 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 shown suicidal behavior.

If depression or suicidal thoughts are deep, consider interrupting treatment with tetrabenazina and starting treatment with antidepressants.

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

Irritability and aggressive behavior
In patients with depression or a history of other psychiatric disorders taking tetrabenazina, there is a potential risk of developing or worsening irritability and aggressive behavior.

Appearance of Parkinson's symptoms

Tetrabenazina may induce parkinsonism and worsen existing symptoms of Parkinson's disease. If this occurs, inform your doctor. He/she 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 esophageal motility) 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.

Neuroleptic Malignant Syndrome (NMS)

NMS may appear in some patients during treatment with tetrabenazina, in rare cases. This is a life-threatening condition in rare cases, in which high fever, sweating, blood pressure fluctuations, irregular or rapid heart rhythm, cardiac arrhythmias, muscle rigidity, and loss of consciousness occur.

If you experience one or more of these symptoms, inform your doctor or go to the nearest hospital immediately.

Patients with a history of tumors
If tetrabenazina is taken for a prolonged period, prolactin levels in the blood may increase. This higher concentration may, 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 QT interval

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

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

Restlessness and agitation

Inform your doctor if you have any difficulty staying seated or standing for prolonged periods (inability to remain still) or if you experience restlessness or increased restlessness. You may need to reduce your dose if you experience these side effects.

Sedation and somnolence

Tetrabenazina may cause sedation (calming effect) or somnolence (abnormal drowsiness). In this case, refrain from performing tasks that require special alertness (e.g., driving or operating hazardous machinery).

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

Binding to melanin in tissues

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

Laboratory tests

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

Other medications and Tetrabenazina Aristo

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

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

• Levodopa, a medication for Parkinson's disease.
• Medications with a sedative effect on the brain, e.g. neuroleptics, hypnotics, and opioids.
• Medications to treat high blood pressure (anti-hypertensives) 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 (gatifloxacine, moxifloxacine), certain antiarrhythmics (quinidine, procainamide, amiodarone, sotalol).
• MAO inhibitors (certain antidepressants): to avoid the risk of a serious interaction that may result in a hypertensive crisis, at least 14 days should elapse between the interruption of treatment with tetrabenazina and the start of treatment with an MAO inhibitor, as well as between stopping the MAO inhibitor and starting treatment with tetrabenazina.
• Medications analyzed through CYP2D6 (e.g. metoprolol, amitriptyline, imipramine, haloperidol, and risperidone): the effects of these medications may increase. The use of additional 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 and with a sufficient interval of several days.

Tetrabenazina Aristo and alcohol

If you take alcohol with tetrabenazina at the same time, it may potentiate the sedative effect.

Fertility, pregnancy, and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

There are insufficient data on the safety of tetrabenazina in pregnant women, therefore, tetrabenazina is not recommended during pregnancy unless your doctor considers it absolutely necessary.

It is not recommended to use tetrabenazina during pregnancy or in fertile women without adequate contraceptive measures.

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

Lactation

Do not breastfeed while taking this medication.

Fertility

Studies in animals with tetrabenazina have shown that there is no effect on pregnancy or intrauterine survival. Menstrual cycles were prolonged and a delay in fertility was observed.

Driving and operating machinery

Do not drive or operate tools or machinery as tetrabenazina may cause drowsiness and therefore 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 medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

During the initial prescription, your doctor will gradually increase the dose of tetrabenazine over several weeks until finding a dose 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 dose 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 uncontrollable movements caused by Huntington's chorea

Unless your doctor tells you otherwise, the usual initial dose is one tetrabenazine 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.

Do not exceed the maximum daily dose of 8 tetrabenazine tablets.

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 tetrabenazine Aristo treatment if:

• No improvement in clinical symptoms after increasing the dose;
• Severe side effects occur

Restarting 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 the concomitant use of other medications, your tetrabenazine therapy should be discontinued when restarting. Depending on your doctor, the dose should be initiated at 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 deterioration, 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

Older adults and pediatric age

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

Older adults generally receive the recommended adult dose.

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

Discuss with your doctor or pharmacist if you feel that the effect of tetrabenazine is too strong or too weak.

Patients with liver insufficiency, renal insufficiency
If you have liver or kidney problems, your doctor may prescribe a different dosage and/or a different dose.

Before starting to take tetrabenazine, consult your doctorif you are a slow or intermediate metabolizer of an enzyme called CYP2D6, as in this case it is possible that you will need to receive a different dose

Administration form
Tetrabenazine 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 breaking line and can be divided into equal doses. This allows taking half tablets.

If you take more Tetrabenazine Aristo than you should

If you take too many tablets or another person accidentally takes your medication, contact your doctor, pharmacist, or nearest hospital or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Tetrabenazine Aristo

Do not take a double dose to compensate for the missed doses. Continue taking your regular dose when it's time.

If you interrupt the treatment withTetrabenazine Aristo

Do not change the dose of tetrabenazine without consulting your doctor first. If you want to stop taking tetrabenazine, you should also consult your doctor before.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Important side effects or signs to be aware of and measures to take if affected

If you experience muscle stiffness or fever and altered consciousness (such as confusion or hallucinations), stop taking tetrabenazine Aristo. Consult your doctor or the nearest hospital as soon as possible (see also section 2 “warnings and precautions”).

Contact your doctor or hospital immediately or go to the hospital if you experience the following side effects:

• If you experience muscle stiffness, fever, or impaired consciousness (e.g., confusion or hallucinations), stop taking Tetrabenazine. 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): Tetrabenazine Aristo may cause depression, which in some people may lead to suicidal thoughts. If you feel depressed or very sad, you may be starting to feel 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 have intentionally harmed yourself or if you have started thinking about intentionally harming yourself.

Other possible side effects

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

• Depression (feeling sad), which has been associated with suicidal thoughts and behaviors. If you feel down or very sad or may be starting to feel depressed, you should inform your doctor about this change.

• drowsiness
• parkinsonian 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 (leucopenia)
• rapid and uncontrolled eye movements (oculogyric crisis)
• light intolerance (photophobia)
• dehydration
• aggression, anger
• suicidal thoughts, intention to harm oneself or thought of harming oneself.
• malignant neuroleptic syndrome (a condition in which high fever, sweating, fluctuations in blood pressure, muscle stiffness, and impaired consciousness occur), see section 2 "Warnings and Precautions"
• hives, pruritus, urticaria
• weight loss
• fall risk

Unknown frequency(cannot be estimated from available data)

• balance disorder and uncoordinated movements (ataxia)
• sensation of being unable to remain still (akathisia)
• involuntary muscle spasms (dystonia)
• memory loss
• dizziness
• disorientation
• nervousness
• restlessness
• sleep disorders
• slow heart rate (bradycardia)
• orthostatic hypotension (low blood pressure with dizziness when standing up)
• hypertensive crisis
• difficulty swallowing
• nausea (discomfort)
• vomiting
• abdominal pain
• diarrhea
• constipation
• dry mouth
• sweating
• irregular menstrual periods
• fatigue
• weakness
• low body temperature (hypothermia)
• increased appetite
• weight gain

To avoid the risk of a potentially serious intention that may lead to a hypertensive crisis, it is essential to ensure that at least 14 days pass between the discontinuation of tetrabenazine Aristo and the start of treatment with an MAO inhibitor, as well as between the discontinuation of the MAO inhibitor treatment and the start of treatment with tetrabenazine Aristo.

If you take Tetrabenazine for extended periods, the concentration of prolactin (a hormone produced by 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, male breast enlargement (gynecomastia), breast pain, breast enlargement, pituitary tumors (prolactinomas), orgasm disorders, and impotence may occur.

Reporting side effects

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

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.

Do not store above30º. Keep in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and themedicines that you do not need at the SIGREcollection point of the pharmacy. Ask your pharmacist howto dispose of the packaging and the medicines that you do not need.This way, you will help to protect the environment.

Composition of Tetrabenazine Aristo 25 mg tablets

The active ingredient is tetrabenazine.

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

Appearance of the product and content of the container

Yellowish clear tablets, round, with a breaking 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.

Holder of the marketing authorization and responsible for manufacturing

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 with 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

Last review date of this leaflet: December 2024

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