PATIENT INFORMATION LEAFLET

Tetrabenazine SUN 25 mg Tablets EFG

Read this 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. Do 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 SUN is and what it is used for

2.What you need to know before you start taking Tetrabenazine SUN

3.How to take Tetrabenazine SUN

4.Possible side effects

5.Storage of Tetrabenazine SUN

6.Contents of the pack and additional information

Tetrabenazina SUN belongs to a group of medications used for the treatment of nervous system disorders.

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

Do not take Tetrabenazina SUN

-if you are allergic (hypersensitive) to tetrabenazine or to any of the other components of this medication

-if you are taking reserpine (a medication for controlling high blood pressure and treating psychotic states)

-if you are taking monoamine oxidase inhibitors (a medication for treating depression)

-if you have parkinsonian symptoms

-if you have been diagnosed with depression and it has not been treated or has been difficult to treat

-if you have suicidal behavior (feelings of wanting to commit suicide)

-if you are breastfeeding

-if you have pheochromocytoma (a tumor of the adrenal gland)

-if you have tumors dependent on prolactin (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 in this case it may be possible that you will need to receive a different dose

-if you have moderate or severe liver insufficiency

-if you have a known heart condition called long QT syndrome or if you have or have had heart rhythm problems

-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 feel restless, agitated, or have difficulty sitting still

-if you experience dizziness or drowsiness when standing up

-if you have hyperprolactinemia (elevated levels of prolactin hormone in the blood - hormone responsible for lactation)

-if you have started to experience mental changes such as confusion or hallucinations, or note stiffness in the muscles and fever, as you may be developing a condition called Neuroleptic Malignant Syndrome. If you experience these symptoms, contact your doctor immediately.

Use of Tetrabenazina SUN with other medications

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

Use of other medications

Do not use Tetrabenazina SUN with reserpine.

The treatment with monoamine oxidase inhibitors must be suspended 14 days before starting treatment with Tetrabenazina SUN, and monoamine oxidase inhibitors should not be used until at least 14 days after the end of treatment with Tetrabenazina SUN.

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

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

Use of Tetrabenazina SUN with alcohol

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

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. 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 necessary, treatment with tetrabenazine must be interrupted.

Driving and operating machinery

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

Tetrabenazina SUN contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Tetrabenazina SUN contains sodium. This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free

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

Adults

The recommended starting dose is 12.5 mg taken one to three times a day. This can be increased by 12.5 mg every three or four days as needed based 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 7 days and your condition has not improved, it is unlikely that the medication will provide a benefit.

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

Older adults

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 for children.

Patients with liver disorders

Patients with mild to moderate liver insufficiency should start with 12.5 mg per day. Patients with severe liver insufficiency should have additional caution.

Patients with renal disorders

Tetrabenazine SUN is not recommended for use in this group of patients.

If you take more Tetrabenazine SUN than you should

If you take too many tablets or another person accidentally takes your medication,

consult your doctor or pharmacist immediately or visit the nearest hospital or call the Toxicological Information Service. Phone 915 620 420.

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

If you forgot to take Tetrabenazine SUN

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

If you interrupt treatment with Tetrabenazine SUN

Do not stop treatment with Tetrabenazine SUN unless your doctor tells you to. A malignant neuroleptic syndrome has been described after abrupt discontinuation of tetrabenazine administration (see section 4, Rare adverse effects).

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

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

More serious side effects

If you experience the following side 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 down or very sad, you may be starting to become depressed, and you should inform your doctor of this change.

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

-If you have had previous attempts at suicide

-If you have intentionally harmed yourself or have started thinking about intentionally harming yourself

• If you have a feeling of anger or aggression

Other side effects

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

-Drowsiness (with higher doses)

-Parkinsonian syndrome (uncontrollable movements of hands, arms, legs, andhead, with higher doses).

Common (may affect up to 1 in 10 people)

-Confusion

-Anxiety

-Insomnia

-Low blood pressure

-Difficulty swallowing

-Nausea

-Vomiting

-Diarrhea

-Constipation

-Autonomic dysfunction (sweating and fluctuations in blood pressure).

Rare (may affect up to 1 in 100 people)

-Mental changes such as confusion or hallucinations

-Muscle rigidity

-Fever.

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

-Neuroleptic Malignant Syndrome (NMS)

If you start to experience mental changes such as confusion or hallucinations, or feel muscle rigidity and fever, you may be developing a condition called Neuroleptic Malignant Syndrome (NMS). NMS has been described after a sudden discontinuation of tetrabenazine.

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

-Muscle damage.

Frequency not known (available data do not allow the incidence of the following side effects to be estimated)

-Disorientation

-Nervousness

-Coordination problems

-Uncontrollable and sometimes painful muscle spasms (dystonia)

-Feeling unable to sit or be still (akathisia)

-Dizziness

-Amnesia

-Bradycardia

-Stomach pain

-Dry mouth

-Increased appetite

-Weight gain.

Reporting of side effects

If you experience any type of side effect, consult your doctor, 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 Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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 label after the CAD initials. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tetrabenazine SUN

25 mg tablets:

-The active ingredient is tetrabenazine. Each tablet contains 25 mg of tetrabenazine.

-The other components are: anhydrous lactose, cornstarch, sodium starch glycolate, yellow iron oxide (E172), talc, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the container

Tetrabenazine SUN 25 mg tablets:

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

Holder of the marketing authorization and responsible for manufacturing

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

Phone: +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) with 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 12.5 mg/ 25 mg comprimidos EFG

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

Last review date of this leaflet: September 2022

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