Tetrabenazine Sun 25 mg tablets EFG

Package Leaflet: Information for the User

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tetrabenazine SUN 25 mg tablets EFG

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

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

Leaflet contents:

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

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

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

Tetrabenazine SUN is used to treat conditions that cause spasmodic, irregular, and uncontrollable movements (hyperkinetic movement disorders associated with Huntington's chorea).

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

Do not take Tetrabenazine SUN

• if you are allergic (hypersensitive) to tetrabenazine or to any of the other ingredients of this medicine
• if you are taking reserpine (a medicine used to control high blood pressure and treat psychotic states)
• if you are taking monoamine oxidase inhibitors (medicines used to treat depression)
• if you have been diagnosed with parkinsonism and hypokinetic-rigid syndrome. Signs of parkinsonism include hand tremors or spasmodic movements in the arms and legs
• if you have been diagnosed with depression that has not been treated or has been difficult to treat
• if you have suicidal behaviour (feel like harming yourself)
• if you are breastfeeding
• if you have liver problems
• if you have pheochromocytoma (a tumour of the adrenal gland)
• if you have prolactin-dependent tumours (e.g. pituitary tumour or breast cancer).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tetrabenazine SUN.

• if you are a poor or intermediate metabolizer of an enzyme called CYP2D6, as you may require 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 had chest pain or heart disease
• if you have ever had hand tremors and spasmodic movements in the arms and legs, known as parkinsonism. If you begin 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, contact your doctor immediately.
• if you have been diagnosed with depression, or have developed suicidal thoughts or exhibited suicidal behaviour
• if you have a history of depression
• if you begin to display angry or aggressive behaviour
• 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 tetrabenazine, a drop in blood pressure may occur under certain circumstances (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 fainting).

• if you have hyperprolactinaemia (higher than normal blood levels of the hormone prolactin – the hormone responsible for lactation)
• if you start having difficulty swallowing
• if you develop movements resembling worms wriggling on the tongue or other uncontrollable movements of the mouth, tongue, cheeks or jaw, which may progress to the arms and legs (tardive dyskinesia)
• if you begin 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 difficulty digesting certain sugars, such as galactose.

Tetrabenazine and its metabolites may bind to melanin-containing tissues, where they accumulate over time. Therefore, tetrabenazine may cause damage to these tissues with long-term use. Although there are no specific recommendations for regular eye examinations, physicians prescribing this medicine should be aware of the potential effects of long-term tetrabenazine use on the eyes.

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

Taking Tetrabenazine SUN with other medicines

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

Taking other medicines

Do not take Tetrabenazine SUN together with reserpine.

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

Tell your doctor or pharmacist before starting to take Tetrabenazine SUN together 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 together with tetrabenazine may cause an increase in plasma concentrations of the active metabolite dihydrotetrabenazine; therefore, they should always be combined with caution. In these cases, it may be necessary to reduce the dose of tetrabenazine.
• medicines that prolong the QTc interval on the ECG, including some medicines used for mental disorders (neuroleptics), as well as certain antibiotics (gatifloxacin, moxifloxacin), and some medicines used to treat heart rhythm problems (quinidine, procainamide, amiodarone, sotalol).

Drinking alcohol while taking Tetrabenazine SUN

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. After evaluating all risks and benefits, your doctor will decide whether you can use Tetrabenazine SUN during pregnancy.

Tetrabenazine SUN is contraindicated in breastfeeding mothers. If treatment with tetrabenazine is necessary, breastfeeding must be discontinued.

Animal studies with tetrabenazine have not shown effects on pregnancy or intrauterine survival. Prolongation of the oestrous cycles and a delay in fertility phase were observed in female animals.

Driving and using machines

Tetrabenazine SUN may cause drowsiness, and depending on how you respond to this treatment, your ability to drive or operate machinery may be affected.

Tetrabenazine SUN contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

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

3. How to take Tetrabenazine SUN

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

The recommended starting dose is 12.5 mg one to three times daily. This may be increased by 12.5 mg every three or four days as required, 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 benefit.

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

Elderly patients

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

However, parkinsonian-type adverse effects are common.

Use in children

Treatment is not recommended in children.

Patients with hepatic impairment

Patients with mild to moderate hepatic impairment should start at 12.5 mg daily. Patients with severe hepatic impairment should be treated with additional caution.

Patients with renal impairment

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

If you take more Tetrabenazine SUN than you should

If you take too many tablets or if someone else accidentally takes your medicine,
contact your doctor, pharmacist, or nearest hospital immediately or call the Toxicology Information Service. Telephone number: 915 620 420.

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

If you forget to take Tetrabenazine SUN

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

If you stop taking Tetrabenazine SUN

Do not stop treatment with Tetrabenazine SUN unless instructed by your doctor. A neuroleptic malignant syndrome has been reported after abrupt discontinuation of tetrabenazine (see section 4, Rare adverse reactions).

If you have any further questions about 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 everyone experiences them.

Serious adverse effects

If you experience any of the following adverse effects, consult your doctor or nearest hospital as soon as possible:

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

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

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

• If you begin experiencing mental changes such as confusion or hallucinations, or develop muscle stiffness and fever, you may be developing neuroleptic malignant syndrome. If you have these symptoms, contact 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 thinking about intentionally harming yourself

Frequency not known (cannot be estimated from available data)

• if you have a severe increase in blood pressure (hypertensive crisis)
• if you feel restless and unable to stay still, you may have akathisia. If you feel this way, consult your doctor.

Other adverse effects

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

• somnolence (with higher doses)
• tremor
• 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
• leucopenia
• anger
• aggression
• dehydration
• uncontrolled muscle spasms affecting the eyes
• light sensitivity
• rash
• burning sensation
• urticaria
• weight loss
• falls

Frequency not known (available data do not allow estimation of incidence of the following adverse effects)

• disorientation
• nervousness
• nervous restlessness
• sleep disorders
• clumsiness and lack of coordination affecting balance, gait, limb, eye movements, and/or speech (ataxia)
• uncontrolled and sometimes painful muscle spasms (dystonia)
• dizziness
• memory loss
• decreased heart rate (bradycardia)
• decreased blood pressure
• dizziness and sudden fainting upon standing (postural hypotension)
• dysphagia (difficulty swallowing)
• 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 adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tetrabenazine SUN

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

Do not use this medicine after the expiry date stated on the label after the letters CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tetrabenazine SUN

Tablets 25 mg:

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

Nature of the product and contents of the pack

Tetrabenazine SUN 25 mg tablets:

Uncoated tablet, yellow in colour, round, flat-faced, bevelled edge, marked with “179” on one side and scored on the other side.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

This medicinal product is authorised 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

The 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 the most recent revision of this leaflet: April 2025

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