Tetrabenazine Aristo 25 mg tablets – patient leaflet, side effects, dosage

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

Tetrabenazine Aristo are oral tablets.

The active substance in Tetrabenazine

Aristo is tetrabenazine.

Tetrabenazine inhibits the storage of

special messenger substances in the

brain. This reduces the transmission

of stimuli in the nerve cells of certain

brain regions that are involved 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 can

be of organic (physical) origin (as in

Huntington`s disease). However, they

can also be caused by medication, e.g.

after prolonged use of neuroleptics

(medication for the treatment of mental

disorders). In this case, the condition

is referred to as ‘tardive dyskinesia’

(tardive movement disorders).

Tetrabenazine Aristo is used for the

treatment of the following diseases:

• Excessive and/or involuntary

  movements (hyperkinesia) in

  Huntington`s disease.

• Moderate to severe tardive dyskinesia

  (tardive movement disorders);

  Tetrabenazine Aristo may only be used

  for this form of movement disorder if

  other treatment options have failed.

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

Do not take Tetrabenazine Aristo

• if you are allergic to tetrabenazine 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 a prolactin (a hormone)-

  dependent tumour, such as breast

  cancer or a tumour of the pituitary

  gland (pituitary prolactinoma);

• if you have a tumour of the adrenal

  medulla (phaeochromocytoma);

  • if you are breast-feeding;
  • if you are taking a monoamine oxidase inhibitor (a medicine for depression), or have taken one within the last 14 days;
  • if your liver function is impaired;
  • if you are taking medicines containing reserpine as active substance;
  • if you are suffering from Parkinson’s disease or Parkinson’s symptoms. Warnings and precautions

Talk to your doctor before taking tetrabenazine

• if you know that you are a slow or moderate metaboliser of an enzyme called CYP2D6. In this case, you may require a different dose;
• if you have been diagnosed with depression or have thought about or tried to commit suicide;
• if you have ever had depression. Treatment of tardive dyskinesia (delayed movement disorders)

Ask your doctor whether you can be considered for treatment with Tetrabenazine Aristo. He/she will advise you accordingly. However, tetrabenazine is a centrally-acting, transmitter-depleting substance which, in humans, may also cause extrapyramidal symptoms and, theoretically, tardive dyskinesia.

Onset of depression (morbidly depressed mood) / suicidal thoughts or behaviour Tetrabenazine can cause depression or worsen pre-existing depression. If depression occurs, it may possibly be controlled by dose reduction. There have been isolated cases where patients taking tetrabenazine have developed thoughts of taking their own lives (suicidal thoughts) or have shown suicidal behaviour.

If marked depression or suicidal thoughts occur, tetrabenazine should be discontinued and antidepressant therapy started. If you experience depression during treatment with this medicine, please tell your doctor. He/she will take the necessary steps.

Anger and aggressive behaviour In patients taking tetrabenazine with depression or a history of other psychiatric illnesses, there is a potential risk of developing or worsening anger and aggressive behaviour.

Onset of Parkinson’s symptoms Tetrabenazine Aristo can trigger Parkinson’s symptoms and worsen pre-existing symptoms of Parkinson’s disease. If this happens to you, please inform your doctor. He/she will take the necessary steps. Dysphagia

Dysphagia is a component of Huntington’s disease. However, medicines 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 kind of pneumonia caused by aspiration of foreign bodies or liquids). If you notice difficulties in swallowing ask your doctor for advice. Onset of neuroleptic malignant syndrome During treatment with this medicine, so-called neuroleptic malignant syndrome (NMS) may occur in rare cases. This is a condition that is life-threatening in rare cases, in which high fever, sweating, blood pressure fluctuations, irregular or rapid pulse, heart rhythm disorders, muscle stiffness and impaired consciousness occur.

If you experience one or more of these symptoms, you must contact your doctor or nearest hospital immediately. Patients with a history of tumours If this medicine is taken over a prolonged period of time, concentrations of prolactin (a hormone) in the blood may increase. This higher concentration can, in rare cases, promote the growth of cells in breast tumours. For this reason, please tell your doctor before taking this medicine if you have a history of any tumours.

Patients with prolonged QT interval Tetrabenazine leads to a slight

prolongation of the QT interval in the ECG. Caution must therefore be exercised in patients with congenital long QT syndrome and with a history of heart rhythm disorders, or in patients taking other medicines that can prolong the QT interval. Cardiac disease

Tell your doctor if you recently had heart problems as myocardial infarction or unstable cardiac disease.

Restlessness and agitation

Tell your doctor if you notice any difficulties in maintaining a sitting or standing position for prolonged periods of time (inability to sit still), or suffer from restlessness or increased fidgeting. These side effects may make it necessary to reduce your dose.

Sedation and somnolence

Tetrabenazine may cause sedation or somnolence (drowsiness or abnormal tiredness). In this case, you should refrain from activities that require special alertness (e.g. driving or operating hazardous machinery).

Orthostatic hypotension

A drop in blood pressure with symptoms of dizziness when standing up and fainting (syncope) may occur under certain conditions in patients treated with Tetrabenazine Aristo (e.g. when getting up from lying down). Tell your doctor if you have been told you have low blood pressure (associated with symptoms such as dizziness, headache, racing heart or collapse).

Binding to melanin-containing tissues Tetrabenazine and its metabolites may bind to melanin-containing tissues, where they accumulate over time. It is therefore possible that tetrabenazine may cause damage to these tissues with long-term use. Although there are no specific recommendations for regular eye tests, prescribing doctors should be aware of the possible effects of long-term use of tetrabenazine on the eyes. Laboratory tests

In clinical studies with tetrabenazine, no clinically significant changes in laboratory parameters were reported. In controlled clinical studies, tetrabenazine caused a slight increase in ALT and AST laboratory values compared to placebo.

Other medicines and Tetrabenazine Aristo

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. If taken at the same time, the following medicines may interact with Tetrabenazine Aristo:

• Levodopa, a medicine for Parkinson’s disease
• Medicines with a sedative effect in the brain, e.g. neuroleptics, hypnotics and opioids
• Medicines for high blood pressure (antihypertensives) and beta-blockers (medicines that reduce heart rate and blood pressure)
• Certain medicines that slow the breakdown of tetrabenazine, e.g. fluoxetine, paroxetine, quinidine, duloxetine, terbinafine, amiodarone, sertraline
• Medicines 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 potential serious interaction resulting in hypertensive crisis, care must be taken to ensure that there is an interval of at least 14 days between stopping this medicine and starting treatment with a MAO inhibitor, as well as between stopping the MAO inhibitor and starting treatment with Tetrabenazine Aristo.

• Medicines broken down via CYP2D6 (e.g. metoprolol, amitriptyline, imipramine, haloperidol and risperidone): the effects of these medicines may be enhanced. Additional use of medicines that inhibit CYP2D6 (e.g. fluoxetine, paroxetine, quinidine, duloxetine, terbinafine, amiodarone or sertraline) may additionally increase this effect.
• Reserpine: tetrabenazine must not be taken at the same time as reserpine. If treatment with reserpine is to be switched to tetrabenazine, this must be done carefully and with a sufficient interval of several days.

Tetrabenazine Aristo with alcohol

The sedative effect of this medicine may be enhanced if alcohol is consumed at the same time.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy

There are no adequate data on the safety of tetrabenazine in pregnant women. Therefore, Tetrabenazine Aristo is not recommended for use during pregnancy unless your doctor deems it absolutely necessary.

It is not recommended to use tetrabenazine during pregnancy or in women of childbearing age without adequate contraceptive measures. It is therefore essential that you inform your doctor if you are pregnant, think you might be pregnant or are planning to have a baby. Your doctor will decide whether or not you can still take this medicine. Breast-feeding

You must not breastfeed during treatment with this medicine.

Fertility

Animal studies with tetrabenazine have shown no effect on pregnancy or intrauterine survival. Female menstrual cycles were prolonged and a delayed fertility phase was observed.

Package leaflet: Information for the patient

Tetrabenazine Aristo 25 mg tablets Tetrabenazine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. Driving and using machines

This medicine may cause drowsiness. This may affect your ability to drive or use machines. You should talk to your doctor about the effects of this medicine on your ability to drive, as the degree of impairment may differ greatly between individuals.

Tetrabenazine Aristo contains lactose

Each tablet contains 63.4 mg lactose (as lactose monohydrate).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Tetrabenazine Aristo

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

When starting treatment, your doctor will slowly increase your dose over several weeks to find a dose for chronic use that reduces your symptoms and is well-tolerated.

Your dose will depend on your symptoms and your response to treatment. The required dose may vary from patient to patient. The following dose recommendations are therefore only a guide. Always follow your doctor`s dosage instructions. Your doctor will check the dosage at regular intervals.

If you have problems with your liver or kidneys, your doctor may prescribe a different dosage.

Dosage for excessive and/or involuntary movements (hyperkinesia) in Huntington`s disease

Adults

Unless otherwise prescribed by your doctor, the usual starting dose is one tablet three times a day.

This dose can be increased by one tablet per day every three or four days until optimum effect is achieved. The maximum daily dose of 8 tablets should not be exceeded.

Dosage for tardive dyskinesia (tardive movement disorders)

Adults

Unless otherwise prescribed by your doctor, the usual starting dose is ½ tablet daily. If you respond favourably to treatment, your doctor will gradually increase the dose. Your doctor may discontinue treatment if:

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

Resumption of treatment

If your treatment was interrupted for more than 5 days or interruption of your treatment was necessary due to a medical condition or due to concomitant use of other medicines, your tetrabenazine therapy should be retitrated when resumed. Depending on your doctors instruction, your dose should be started at 12.5mg twice a day. wait 7 days and then titrate up to 12.5mg per day.

If you notice adverse reactions such as inability to sit still (akathisia), restlessness, parkinson’s symptoms such as impaired balance, tremors or increased salivation, depression, insomnia, anxiety or an intolerable sedation occurs, contact your doctor. Your doctor will decide whether your titration should be stopped and the dose should be reduced.

Special populations

Elderly patients and children

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

Elderly patients usually receive the dose recommended for adults.

Children are usually started on about half the daily dose for an adult. This dose may then be slowly and carefully modified, depending on tolerability and individual response.

Talk to your doctor or pharmacist if you have the impression that the effect of Tetrabenazine Aristo is too strong or too weak.

Patients with liver or kidney impairment If you have problems with your liver or kidneys, your doctor may prescribe a different dosing schedule and/or a different dose.

Talk to your doctor before taking tetrabenazine if you know you are a slow or medium-fast metaboliser of an enzyme called CYP2D6. In this case, you may require a different dose.

Children

No specific studies have been conducted. The treatment is not recommended in children.

Method of administration

Tetrabenazine Aristo 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 score line and can be divided into equal doses. This makes it possible to take half tablets.

If you take more Tetrabenazine Aristo than you should

If you take too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

Symptoms of overdose include uncontrollable muscle spasms

affecting the eyes, head, neck and body, uncontrolled rolling of the eyes, excessive eye blinking, nausea, vomiting, diarrhoea, sweating, dizziness, feeling cold, confusion, hallucinations, drowsiness, redness/inflammation and tremor.

If you forget to take Tetrabenazine Aristo

Do not take a double dose to make up for a forgotten dose. Continue treatment with the next dose as normal.

If you stop taking Tetrabenazine Aristo

Do not change the dosage of this medicine without first consulting your doctor. If you no longer wish to take the medicine, you must also discuss this with your doctor beforehand.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Significant side effects or signs to look out for and action to take if you are affected.

If you experience stiffening of

the muscles or fever and impaired 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”).

Please seek advice immediately or go to your emergency department if you experience the following side effects:

• If you experience muscle stiffness, fever or impaired consciousness (e.g. confusion or hallucinations), stop taking the tablets. Consult your doctor or 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 can cause depression, which can, in some people, lead to thoughts of committing suicide. If you feel down or very sad you may be starting to become depressed and you should tell your doctor about this change.
• Very rare (may affect up to 1 in 10,000 people): if you have tried to commit suicide or if you have intentionally hurt yourself or if you have started to think about intentionally hurting yourself.

Other possible side effects:

Very common: may affect more than 1 in 10 people

• depression, which can lead to suicidal thoughts in some people. If you feel down or very sad, you may be starting to feel depressed and you should tell your doctor about this change
• drowsiness
• Parkinson’s symptoms such as impaired balance, tremors or increased salivation

Common: may affect up to 1 in 10 people

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

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

• pneumonia
• reduction in the number of white blood cells (leukopenia)
• involuntary rolling of the eyes (oculogyric crisis)
• aversion to light (photophobia)
• dehydration
• aggression, anger
• suicidal thoughts, deliberate self-harm or thoughts of deliberately harming oneself
• neuroleptic malignant syndrome (a condition where high fever, sweating, blood pressure fluctuations, muscle stiffness and impaired consciousness occur), see section 2 “Warnings and precautions”
• rash, itching, hives
• weight loss
• increased risk of falling

Not known: frequency cannot be estimated from the available data

• disturbance of balance regulation and movement coordination (ataxia)
• inability to sit still (akathisia)
• movement disorder with involuntary spasms and abnormal postures (dystonia)
• impaired memory performance
• dizziness
• disorientation
• nervousness
• restlessness
• sleep disturbances
• slow heart beat (bradycardia)

• drop in blood pressure with

  dizziness on standing up (orthostatic hypotension)

• hypertensive crisis
• swallowing difficulties
• nausea (feeling sick)
• vomiting
• pain in the upper abdomen
• diarrhoea
• constipation

• dry mouth

  • sweating
  • irregular monthly periods
  • tiredness
  • weakness

  • reduced body temperature

    (hypothermia)

  • increased appetite
  • weight increase

To avoid the risk of a potentially serious interaction resulting in a hypertensive crisis, you must ensure that at least 14 days elapse between discontinuation of this medicine and the start of treatment with a MAO inhibitor, as well as between discontinuation of the MAO inhibitor and the start of treatment with this medicine. If Tetrabenazine Aristo is taken for prolonged periods, the concentration of prolactin (a pituitary gland hormone) in your blood may increase. This returns to normal after treatment is stopped. As a result, abnormal breast milk discharge (galactorrhoea), absent or irregular monthly periods, male breast enlargement (gynaecomastia), breast pain, breast enlargement, pituitary tumours (prolactinomas), orgasmic disorders and impotence may occur.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tetrabenazine Aristo

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

Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tetrabenazine Aristo contains

• The active substance is tetrabenazine.
• The other ingredients are: lactose monohydrate (see section 2 “What you need to know before you take Tetrabenazine Aristo”), maize starch, microcrystalline cellulose, talc, magnesium stearate, yellow iron oxide (E172). What Tetrabenazine Aristo looks like and contents of the pack

Tetrabenazine Aristo 25 mg tablets are pale yellow and round with a score line on one side and with an approximate diameter of 7.00 mm ± 0.2 mm.

The tablet can be divided into equal doses. Tetrabenazine Aristo is available in bottles of 112 tablets.

Marketing Authorisation Holder and Manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

This leaflet was last revised in 12/2024.

GI899000-04/UK/1224 50006562/2