TETRABENAZINA 12.5 mg Tabletka

Treść ulotki

1. Tetrabenazina SUN 12.5 mg tablets, 25 mg tablets
   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. How to store Tetrabenazina SUN
   6. Package contents and other information

Tetrabenazina SUN 12.5 mg tablets, 25 mg tablets

Tetrabenazina

Generic medicine (for the 25 mg dosage only)

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

• Keep this leaflet. 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Tetrabenazina SUN is and what it is used for
• 2. What you need to know before you take Tetrabenazina SUN
• 3. How to take Tetrabenazina SUN
• 4. Possible side effects 5 How to store 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 in the treatment of disorders of the nervous system.
Tetrabenazina SUN is used in the treatment of disorders that cause uncontrollable, spasmodic,
irregular 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 tetrabenazine or any of the other ingredients of this medicine (listed in section 6);
• if you are taking reserpine (medicine used to control high blood pressure and for the treatment of psychotic states);
• if you are using MAO inhibitors (medicines for the treatment of depression);
• if you suffer from Parkinson-like symptoms;
• if you have been diagnosed with depression and it has not been treated or has been difficult to treat;
• if you have suicidal thoughts (tendency to suicide);
• if you are breastfeeding;
• if you suffer from pheochromocytoma (tumor of the adrenal gland);
• if you suffer from prolactin-dependent tumors, such as breast cancer or pituitary cancer.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tetrabenazina SUN:

• if you know you have reduced or intermediate activity of an enzyme called CYP2D6 because the doctor

may prescribe you a different dose;

• if you suffer from mild to severe liver problems;
• if you suffer from a heart condition called congenital long QT syndrome or if you have, or have had heart rhythm problems;
• if you have been diagnosed with depression or have contemplated or attempted suicide;
• if you have ever suffered from depression:
• if you start to experience mental changes such as confusion or hallucinations, or develop rigidity in your muscles and fever, you may develop a condition called Neuroleptic Malignant Syndrome. If you have these symptoms, please contact your doctor immediately.

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

Taking other medicines
Do not take Tetrabenazina SUN with reserpine.
Treatment with MAO inhibitors must be stopped 14 days before starting treatment
with Tetrabenazina SUN, and MAO inhibitors must not be used for 14 days after
stopping treatment with Tetrabenazina SUN.
Talk to your doctor or pharmacist before taking Tetrabenazina SUN together with:

• levodopa (a medicine used to treat Parkinson's disease);
• some antidepressants, opioids, beta-blockers, antihypertensive drugs (medicines used to treat high blood pressure), hypnotics and antipsychotics (medicines for the treatment of psychotic disorders);
• CYP2D6 inhibitors (e.g. fluoxetine, paroxetine, terbinafine, moclobemide and quinidine). The use of these with tetrabenazine may cause increased plasma concentrations of the active metabolite dihydrotetrabenazine; for this reason they must be combined with caution. A reduction in the dose of tetrabenazine may be necessary;
• drugs known to prolong the QTc interval in the ECG, including some drugs used to treat mental health conditions (antipsychotics), some antibiotics (e.g. gatifloxacin, moxifloxacin) and some drugs used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, sotalol).

Tetrabenazina SUN with alcohol
Drinking alcohol while taking Tetrabenazina SUN may result in abnormal sedative effects.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine.
The doctor will decide after evaluating all the risks and benefits, whether you can take Tetrabenazina SUN
during pregnancy.
Tetrabenazina SUN should not be taken during breastfeeding. If treatment with
tetrabenazine is necessary, breastfeeding must be stopped.

Driving and using machines
Tetrabenazina SUN may impair the ability to drive or operate machinery, as it may cause
drowsiness.

Tetrabenazina SUN contains lactose
Tetrabenazina SUN tablets contain lactose. If you have been diagnosed with intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Tetrabenazina SUN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

Adults
The recommended starting dose is 12.5 mg one to three times a day. This may be increased by
12.5 mg every three or four days depending on the response to treatment.
The maximum daily dose is eight 25 mg tablets or sixteen 12.5 mg tablets (for a total of
200 mg).
If you have taken the maximum dose for a period of seven days and your condition has not improved, it is
unlikely that the medicine will be of benefit to you.
Take the tablets with water or another non-alcoholic beverage.

Use in elderly patients
The standard dosage has been administered to elderly patients without apparent adverse effects. Parkinson-like
adverse reactions are quite common in these patients.

Use in children
Treatment is not recommended in children.

Patients with liver disorders
Patients with mild or moderate hepatic impairment should start therapy with 12.5 mg per day. In patients
with severe hepatic impairment, further caution is necessary.

Patients with kidney disorders
The use of Tetrabenazina SUN is not recommended in this group of patients.

If you take more Tetrabenazina SUN than you should
If you take too many tablets or someone else accidentally takes your medicine, contact
immediately your doctor, pharmacist or the nearest hospital. Symptoms of overdose include
uncontrollable muscle spasms affecting eyes, head, neck and body, involuntary rotation of the
eyes, excessive blinking, nausea, vomiting, diarrhea, sweating, dizziness, feeling cold,
confusion, hallucinations and drowsiness, flushing/inflammation and tremor.

If you forget to take Tetrabenazina SUN
Do not take a double dose to make up for a missed dose. Continue treatment with the next
dose as normal.

If you stop taking Tetrabenazina SUN
Do not stop taking Tetrabenazina SUN without consulting your doctor first. After sudden discontinuation
of tetrabenazine, Neuroleptic Malignant Syndrome (NMS) has been reported (see section 4,
Possible undesirable effects “Rare”).
If you have any doubts about 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.
manifest.

Serious side effects
Seek immediate medical attention or go to the nearest hospital emergency room if you experience any of the
side effects listed below:

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

• Tetrabenazina SUN may cause depression, which in some people can lead to suicidal thoughts. If you feel down or very sad, you may start to become depressed and should tell your doctor about this change.

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

• if you have attempted suicide
• if you have intentionally harmed yourself or if you have started to think about harming yourself intentionally.

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

• drowsiness (with high doses)
• Parkinson's-like syndrome (uncontrolled movements of hands, arms, legs and head, with high doses).

Common (may affect up to 1 in 10 people)

• confusion
• anxiety
• insomnia
• low blood pressure
• dysphagia (difficulty swallowing)
• nausea
• vomiting
• diarrhea
• constipation
• autonomic nervous system dysfunction (sweating and blood pressure fluctuations).

Uncommon (may affect up to 1 in 100 people)

• mental changes such as confusion or hallucinations
• muscle rigidity
• fever.

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

• a condition called Neuroleptic Malignant Syndrome (NMS). If you start to have mental changes such as confusion or hallucinations, or muscle rigidity and fever, you may have developed a condition called Neuroleptic Malignant Syndrome (NMS). NMS has been reported after the abrupt discontinuation of tetrabenazina.

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

• muscle damage.

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

• disorientation
• nervousness
• problems with coordination
• uncontrollable and sometimes painful muscle spasms (dystonia)
• feeling unable to sit or stay still (akathisia)
• dizziness
• memory loss
• slowed heart rate
• stomach pain
• dry mouth
• increased appetite
• weight gain.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store 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 Scad. The expiry date
refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tetrabenazina SUN contains

Tetrabenazina SUN 12.5 mg tablets

• The active ingredient is tetrabenazine. Each tablet contains 12.5 mg of tetrabenazine.
• The other ingredients are: anhydrous lactose, corn starch, sodium starch glycolate, talc, anhydrous colloidal silica and magnesium stearate.

Tetrabenazina SUN 25 mg tablets

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

Description of the appearance of Tetrabenazina SUN and package contents
Tetrabenazina SUN 12.5 mg tablets: this medicine presents as tablets of colour from white
to off-white, round, flat and with bevelled edge, uncoated with engraved “1” on one side and smooth on the other side.

Tetrabenazina SUN 25 mg tablets:this medicine presents as tablets of colour yellow,
round, flat and with bevelled edge, uncoated with engraved "179" on one side and with score line on the other
side. The tablet can be divided into equal parts.
Tetrabenazina SUN is available in plastic container containing 112 tablets.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH - Hoofddorp
Netherlands

Legal Representative for Italy:
Sun Pharma Italia Srl
Viale Giulio Richard, 1
20143 Milano

This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) with the following denominations:
Germany: Tetrabenazin-neuraxpharm 12.5 mg/ 25 mg Tablets
Italy: Tetrabenazina SUN 12.5 mg/ 25 mg tablets
Netherlands: Tetrabenazine SUN 12.5 mg/ 25 mg tablets
Spain: Tetrabenazina SUN 25 mg comprimidos EFG
United Kingdom (Northern Ireland): Tetrabenazine 12.5 mg/ 25 mg tablets