TETRABENAZINE SUN 25 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tetrabenazina SUN 25 mg tablets EFG

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.

Contents of the pack and other information:

1. What is Tetrabenazina SUN and what is it used for
2. What you need to know before you take Tetrabenazina SUN
3. How to take Tetrabenazina SUN
4. Possible side effects
5. Storing Tetrabenazina SUN
6. Contents of the pack and other information

1. What is Tetrabenazina SUN and what is it used for

Tetrabenazina SUN belongs to a group of medicines used to treat disorders of the nervous system.

Tetrabenazina SUN is used to treat diseases that cause spasmodic, irregular, and uncontrollable movements (hyperkinetic motor disorders associated with Huntington's Chorea).

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

Do not take Tetrabenazina SUN

• if you are allergic (hypersensitive) to tetrabenazina or any of the other ingredients of this medicine
• if you are using reserpine (a medicine to control high blood pressure and treat psychotic states)
• if you are using monoamine oxidase inhibitors (a medicine to treat depression)
• if you have been diagnosed with parkinsonism and hypokinetic-rigid syndrome. The signs of parkinsonism are tremors in the hands or spasmodic movements in arms and legs
• if you have been diagnosed with depression and it has not been treated or has been difficult to treat
• if you have suicidal behavior (feel like committing suicide)
• if you are breastfeeding
  • if you have liver problems

• if you have pheochromocytoma (a tumor of the adrenal gland)
• if you have prolactin-dependent tumors (e.g., pituitary tumor or breast cancer).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tetrabenazina SUN.

• 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 a known heart condition called long QT syndrome or if you have or have had heart rhythm problems
• if you have recently experienced chest pain or heart disease
• if you have ever had tremors in your hands and spasmodic movements in your arms and legs, known as parkinsonism. If you start to experience mental changes such as confusion or hallucinations, or develop muscle stiffness and fever, you may be developing a condition called neuroleptic malignant syndrome. If you experience these symptoms, consult your doctor immediately.
• if you have been diagnosed with depression, or have developed suicidal thoughts or have shown suicidal behavior
• if you have a history of depression
• if you start to experience angry or aggressive behavior
• if you feel restless, agitated, or have difficulty sitting still
• if you experience drowsiness
• if you experience dizziness or lightheadedness when standing up

In patients treated with tetrabenazina, a drop in blood pressure may occur in certain circumstances (e.g., when standing up after being in bed). Inform your doctor if you have been told that you have low blood pressure (associated with symptoms such as dizziness, headache, tachycardia, or collapse).

• if you have hyperprolactinemia (higher than normal blood levels of the hormone prolactin - hormone responsible for lactation)
• if you start to have difficulty swallowing
• if you have a reaction with worm-like movements in the tongue or other uncontrolled movements of the mouth, tongue, cheeks, or jaws, which can progress to the arms and legs (tardive dyskinesia)
• if you have started to experience mental changes such as confusion or hallucinations, or notice muscle stiffness and fever, as you may be developing a condition called neuroleptic malignant syndrome. If you experience these symptoms, contact your doctor immediately.
• if you have problems digesting certain sugars, such as galactose.

Tetrabenazina and its metabolites may bind to melanin-containing tissues, where they accumulate over time. Therefore, it is possible that tetrabenazina may cause damage to these tissues with long-term use. Although there are no specific recommendations for regular eye exams, doctors who prescribe the medicine should be aware of the potential effects of long-term use of tetrabenazina on the eyes.

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

Using Tetrabenazina SUN with other medicines

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

Taking other medicines

Do not use Tetrabenazina SUN with reserpine.

Treatment with monoamine oxidase inhibitors should be stopped 14 days before starting treatment with Tetrabenazina SUN, and monoamine oxidase inhibitors should not be used until at least 14 days after stopping treatment with Tetrabenazina SUN.

Tell your doctor or pharmacist before starting to use Tetrabenazina SUN with

• levodopa (a medicine used to treat Parkinson's disease)
• certain types of antidepressants, opioids, beta-blockers, antihypertensive drugs (medicines to treat high blood pressure), hypnotics, and neuroleptics (medicines to treat psychotic disorders)
• CYP2D6 inhibitors (such as fluoxetine, paroxetine, duloxetine, terbinafine, moclobemide, quinidine, amiodarone, or sertraline). Their use with tetrabenazina may cause an increase in the plasma concentrations of the active metabolite dihydrotetrabenazina; therefore, they should always be combined with caution. In these cases, it may be necessary to reduce the dose of tetrabenazina.
• drugs that prolong the QTc interval in the ECG, including some medicines for mental disorders (neuroleptics), as well as certain antibiotics (gatifloxacin, moxifloxacin) and some drugs used to treat heart rhythm problems (quinidine, procainamide, amiodarone, sotalol).

Using Tetrabenazina SUN with alcohol

Drinking alcohol while taking Tetrabenazina SUN may make you feel unusually drowsy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. After evaluating all the risks and benefits, your doctor will decide if you can use Tetrabenazina SUN during pregnancy.

Tetrabenazina SUN is contraindicated for breastfeeding mothers. If treatment with tetrabenazina is necessary, breastfeeding should be discontinued.

Animal studies with tetrabenazina have not shown effects on pregnancy or intrauterine survival. A prolongation of menstrual cycles was observed in females and a delay in the fertility phase.

Driving and using machines

Tetrabenazina SUN may cause drowsiness and, depending on how you respond to this treatment, your ability to drive or use machines may be affected.

Tetrabenazina SUN contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Tetrabenazina SUN contains sodium. This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially “sodium-free”

3. How to take Tetrabenazina SUN

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

Adults

The recommended starting dose is 12.5 mg one to three times a day. This can be increased by 12.5 mg every three or four days as needed, depending on your response to treatment.

The maximum daily dose is 8 tablets of 25 mg or 16 tablets of 12.5 mg (a total of 200 mg).

If you have taken the maximum dose for a period of 7 days and your condition has not improved, it is unlikely that the medicine will provide a benefit.

Take the tablet(s) with water or another non-alcoholic drink.

Elderly

The standard dose has been administered to elderly patients without apparent adverse effects.

However, parkinsonian-like adverse effects are common.

Use in children

Treatment is not recommended in children.

Patients with hepatic disorders

Patients with mild to moderate hepatic insufficiency should start with 12.5 mg per day. Patients with severe hepatic insufficiency should be treated with caution.

Patients with renal disorders

Tetrabenazina SUN is not recommended for use in this patient group.

If you take more Tetrabenazina SUN than you should

If you take too many tablets or someone else takes your medicine by mistake,

contact your doctor or pharmacist immediately or go to the nearest hospital or call the Toxicology Information Service. Telephone 915 620 420.

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

If you forget to take Tetrabenazina SUN

If you forget to take a dose, do not take a double dose to make up for forgotten doses. Instead, continue with the next dose as usual.

If you stop taking Tetrabenazina SUN

Do not stop taking Tetrabenazina SUN unless your doctor tells you to. A neuroleptic malignant syndrome has been described after abrupt interruption of tetrabenazina administration (see section 4, Rare side effects).

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.

More serious side effects

If you experience the following side effects, consult your doctor or go to the nearest hospital as soon as possible:

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

• Tetrabenazina SUN may cause depression, which has been reported in some people associated with suicidal thoughts and behavior. If you feel low or very sad, you may be starting to get depressed, and you should inform your doctor of this change.
• If you experience tremors or uncontrollable movements in your hands, arms, legs, and head, drooling, difficulty swallowing, or balance problems, you may have parkinsonism. If you experience any of these problems, consult your doctor.

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

• If you start to experience mental changes such as confusion or hallucinations, or develop muscle stiffness and fever, you may be developing neuroleptic malignant syndrome. If you experience these symptoms, consult your doctor immediately.

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

• if you have previous suicide attempts
• if you have intentionally harmed yourself or have started to think about harming yourself

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

• if you have a severe increase in blood pressure (hypertensive crisis)
• if you feel restless and cannot stay still, you may have akathisia. If you feel this way, consult your doctor.

Other side effects

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

• drowsiness (with higher doses)
• tremors
• excessive salivation.

Common (may affect up to 1 in 10 people)

• confusion
• anxiety
• insomnia
• agitation
• decreased appetite

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

• pneumonia
• leukopenia
• anger
• aggressiveness
• dehydration
• uncontrollable muscle spasms that affect the eyes
• light sensitivity
• rash
• itching
• urticaria
• weight loss
• falls

Frequency not known (the available data do not allow an estimate of the incidence of the following side effects)

• disorientation
• nervousness
• restlessness
• sleep disorders
• clumsiness and lack of coordination, affecting balance and gait, limb movements, or eyes and/or speech (ataxia)
• uncontrollable and sometimes painful muscle spasms (dystonia)
• dizziness
• memory loss
• decreased heart rate (bradycardia)
• decreased blood pressure
• dizziness and fainting when standing up (postural hypotension)
• difficulty swallowing (dysphagia)
• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• dry mouth
• excessive sweating (hyperhidrosis)
• irregular menstrual cycle
• fatigue
• weakness
• decreased body temperature (hypothermia)
• increased appetite
• weight gain.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tetrabenazina SUN

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 label after the abbreviation EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tetrabenazina SUN

25 mg tablets:

• The active substance is tetrabenazina. Each tablet contains 25 mg of tetrabenazina.
• The other ingredients are: anhydrous lactose, cornstarch, sodium starch glycolate, yellow iron oxide (E172), talc, colloidal anhydrous silica, and magnesium stearate.

Appearance of the product and pack contents

Tetrabenazina SUN 25 mg tablets:

Uncoated tablet, yellow, round, flat face, beveled edge, marked with “179” on one face and scored on the other face.

Marketing authorization holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Tetrabenazin-neuraxpharm 12.5 mg/ 25 mg Tabletten

Italy: Tetrabenazina SUN 12.5 mg/ 25 mg compresse

Netherlands: Tetrabenazine SUN 12.5 mg/ 25 mg tabletten

Spain: Tetrabenazina SUN 25 mg comprimidos EFG

United Kingdom (Northern Ireland): Tetrabenazine 12.5 mg/ 25 mg tablets

Date of last revision of this leaflet: April 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/