TETRABENAZINA ARISTO 25 MG Tabletka

Treść ulotki

1. Tetrabenazina Aristo 25 mg tablets
   1. What is Tetrabenazina Aristo and what is it used for?
   2. What you need to know before taking Tetrabenazina Aristo
   3. How to take Tetrabenazina Aristo
   4. Possible side effects
   5. How to store Tetrabenazina Aristo
   6. Contents of the pack and other information

Tetrabenazina Aristo 25 mg tablets

tetrabenazina

Generic medicine

Read this leaflet carefully before you start 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.
• 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 Aristo is and what it is used for
• 2. What you need to know before you take Tetrabenazina Aristo
• 3. How to take Tetrabenazina Aristo
• 4. Possible side effects
• 5. How to store Tetrabenazina Aristo
• 6. Contents of the pack and other information

1. What is Tetrabenazina Aristo and what is it used for?

Tetrabenazina Aristo are oral tablets. The active ingredient in Tetrabenazina 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 regions of the brain 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 (such as in Huntington's disease). However,
they can also be caused by medications, e.g., after prolonged use of neuroleptics (medicines for
the treatment of mental disorders). In this case, the condition is defined as tardive dyskinesia
(tardive movement disorder).
Tetrabenazina Aristo is used for the treatment of the following disorders:

• Excessive and/or involuntary movements (hyperkinesia) in Huntington's disease.
• Moderate to severe tardive dyskinesia (tardive movement disorder); Tetrabenazina Aristo can only be taken for this form of movement if other treatment options have failed.

2. What you need to know before taking Tetrabenazina Aristo

Do not take Tetrabenazina 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 the symptoms persist despite antidepressant treatment;
• if you have a tumor that depends on the hormone prolactin, such as breast cancer or a pituitary gland tumor (prolactinoma);
• if you have a tumor of the adrenal medulla (pheochromocytoma);
• if you are breastfeeding;
• if you are taking a monoamine oxidase inhibitor (a medicine for depression), or have taken one in the last 14 days;
• if your liver function is impaired;
• if you are taking medicines containing reserpine as the active ingredient;
• if you suffer from Parkinson's disease or the symptoms of Parkinson's disease.

Warnings and precautions
Talk to your doctor before taking tetrabenazine,
if you know you are a slow or moderate metabolizer of an enzyme called CYP2D6. In this
case, a different dose may be required for you;
if you have been diagnosed with depression or if you have thought about suicide or attempted to
commit suicide;
if you have ever suffered from depression.
Treatment of tardive dyskinesia (delayed movement disorders)
Ask your doctor if you can be considered for treatment with Tetrabenazina Aristo.
They will advise you accordingly. However, tetrabenazine is a centrally acting substance, which
depletes the transmitter which, in humans, can also cause extrapyramidal symptoms and,
theoretically, tardive dyskinesia.
Onset of depression (depressed mood) / suicide (suicidal thoughts or behavior)
Tetrabenazine can cause depression or worsen pre-existing depression.
If depression occurs, it may be controlled by reducing the dose. Isolated cases have been reported in
which patients treated with tetrabenazine have thought about taking their own life (suicidal thoughts) or have
exhibited suicidal behavior.
If severe depression or suicidal thoughts occur, tetrabenazine must be stopped and antidepressant
therapy must be started.
If you experience depression while taking Tetrabenazina Aristo, tell your doctor.
They will take the necessary steps.
Anger and aggressive behavior
In patients with depression or with a history of other psychiatric illnesses who are taking tetrabenazine,
there is a potential risk of developing or worsening anger and aggressive behavior.
Onset of parkinsonism
Tetrabenazina Aristo can trigger the symptoms of Parkinson's disease and worsen pre-existing symptoms of
Parkinson's disease. If this happens to you, tell your doctor who 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 and dysphagia. Dysphagia may be
associated with aspiration pneumonia. If you notice difficulty swallowing, ask your doctor for advice.
Onset of neuroleptic malignant syndrome
During treatment with Tetrabenazina Aristo, so-called neuroleptic malignant syndrome (NMS) may occur in
rare cases.
This is a life-threatening condition in rare cases, in which high fever, sweating,
fluctuations in blood pressure, irregular or rapid pulse, heart rhythm disturbances, muscle rigidity
and impaired consciousness occur.
If you experience one or more of these symptoms, you must contact your doctor or
the nearest hospital immediately.
Patients with a history of tumors
If Tetrabenazina Aristo is taken for a prolonged period of time, the concentrations of
prolactin (a hormone) in the blood may increase. This increased concentration can, in rare cases,
promote the growth of cells in breast tumors. For this reason, tell your doctor before
taking Tetrabenazina Aristo if you have had tumors in the past.
Patients with prolonged QT interval
Tetrabenazine leads to a slight prolongation of the QT interval in the ECG. Therefore, caution is
recommended in patients with congenital long QT syndrome and with a history of
heart rhythm disturbances or in patients taking other medicines that can prolong
the QT interval.
Heart disease
Tell your doctor if you have recently had heart problems such as a myocardial infarction or unstable heart
disease.
Restlessness and agitation
Tell your doctor if you notice difficulty maintaining a sitting or standing position for prolonged periods of time
(inability to stand still), or suffer from restlessness or increased agitation. These adverse effects may require a dose reduction.
Sedation and drowsiness
Tetrabenazine can cause sedation or drowsiness (abnormal sleepiness or fatigue). In this
case, you should refrain from activities that require particular attention (e.g. driving or operating dangerous machinery).
Orthostatic hypotension
A drop in blood pressure with symptoms of dizziness when getting up and loss of consciousness
(syncope) may occur under certain conditions in patients treated with Tetrabenazina Aristo (e.g. when getting up from a lying position). Tell your doctor if you have been told you have low blood pressure (associated with symptoms such as dizziness, headache, rapid heartbeat, or collapse).
Binding to melanin-containing tissues
Tetrabenazine and its metabolites can bind to melanin-containing tissues, where they accumulate
over time. It is therefore possible that tetrabenazine may cause damage to these tissues if used for long
periods. Although there are no specific recommendations for regular eye examinations, prescribing physicians
must be aware of the possible effects of long-term tetrabenazine use
on the eyes.
Laboratory tests
No clinically significant changes in laboratory parameters have been reported in clinical studies with tetrabenazine. In controlled clinical studies, tetrabenazine caused a slight increase in
laboratory values of ALT and AST compared to placebo.

Other medicines and Tetrabenazina 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 Tetrabenazina Aristo:

• Levodopa, a medicine for Parkinson's disease
• Medicines with a sedative effect on the brain, such as neuroleptics, hypnotics and opioids
• Medicines for high blood pressure (antihypertensives) and beta-blockers (medicines that reduce heart rate and blood pressure)
• Some medicines that slow down the degradation of tetrabenazine, such as fluoxetine, paroxetine, quinidine, duloxetine, terbinafine, amiodarone, sertraline
• Medicines that prolong the QT interval in the ECG, such as neuroleptics, some antibiotics (gatifloxacin, moxifloxacin), some antiarrhythmics (quinidine, procainamide, amiodarone, sotalol)
• MAO inhibitors (some antidepressants): to avoid the risk of a potential serious interaction with resulting hypertensive crisis, care must be taken to ensure that there is an interval of at least 14 days between discontinuation of Tetrabenazina Aristo and initiation of treatment with an MAO inhibitor, as well as between discontinuation of the MAO inhibitor and initiation of treatment with Tetrabenazina Aristo.
• Medicines metabolized by CYP2D6 (e.g. metoprolol, amitriptyline, imipramine, haloperidol and risperidone): the effects of these medicines may be potentiated. Additional use of medicines that inhibit CYP2D6 (e.g. fluoxetine, paroxetine, quinidine, duloxetine, terbinafine, amiodarone or sertraline) may further increase this effect.
• Reserpine: tetrabenazine should not be taken at the same time as reserpine. If treatment with reserpine needs to be switched to tetrabenazine, this must be done with caution and with a sufficient interval of several days.

Tetrabenazina Aristo with alcohol
The sedative effect of Tetrabenazina Aristo may be enhanced if alcohol is consumed at the same
time.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, 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,
Tetrabenazina Aristo is not recommended for use during pregnancy unless your
doctor considers it strictly necessary.
The use of tetrabenazine is not recommended during pregnancy or in women of childbearing potential
who are not using adequate contraception.
It is therefore essential that you tell your doctor if you are pregnant, suspect you are pregnant or wish to become
pregnant. Your doctor will decide whether you can still take Tetrabenazina Aristo.
Breastfeeding
You should not breastfeed during treatment with Tetrabenazina Aristo.
Fertility
Studies conducted on animals with tetrabenazine have not shown any effect on pregnancy or survival
in the uterus. An increase in the length of menstrual cycles and a delay
in the fertile phase have been observed.

Driving and using machines
Tetrabenazina Aristo can cause drowsiness. This may affect your ability to drive or operate
machinery. You should talk to your doctor about the effects of Tetrabenazina Aristo on your ability
to drive, as the degree of impairment can vary greatly between individuals.

Tetrabenazina Aristo contains lactose
Each tablet of Tetrabenazina Aristo contains 63.4 mg of lactose (as lactose monohydrate).
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking
this medicine.

3. How to take Tetrabenazina Aristo

Take this medicine following exactly the instructions given to you by your doctor. If you have any doubts, ask your doctor or pharmacist.
During initial prescription, your doctor will gradually increase the dose of tetrabenazina over several weeks to find a chronic dose that reduces symptoms and is well tolerated.

Notes
Dosage depends on the clinical picture and the reaction/response to treatment. The required dose may vary from patient to patient. The following dosage recommendations should therefore be understood only as a guide. Always follow your doctor's instructions on dosage. Your doctor will review the dosage at regular intervals.
If you have liver or kidney problems, your doctor may prescribe a different dosage.

Dosage for excessive and/or involuntary movements (hyperkinesia) in Huntington's disease
Unless otherwise prescribed by your doctor, the usual initial dose is one Tetrabenazina Aristo tablet three times a day.
This dose may be increased by one tablet per day every three or four days until optimal efficacy is achieved.
The maximum daily dose of 8 Tetrabenazina Aristo tablets must not be exceeded.

Dosage for tardive dyskinesia (late-onset movement disorder)
Adults
Unless otherwise prescribed by your doctor, the usual initial dose is half a tablet per day.
If you respond favorably to treatment, your doctor will gradually increase the dose. Your doctor may discontinue treatment with Tetrabenazina Aristo if:

• no improvement in the clinical picture is observed after increasing the dose;
• serious adverse reactions occur.

Resumption of treatment
If treatment has been interrupted for more than 5 days or a treatment interruption was necessary due to a medical condition or due to the concomitant use of other medicines, therapy with tetrabenazina must be titrated again after resumption. Depending on your doctor's instructions, the dose should be started at 12.5 mg twice a day. This low dose will be maintained for 7 days and after that your dose will be increased in increments of 12.5 mg per day.
If you notice adverse reactions such as inability to stand still (akathisia), restlessness, parkinsonism such as impaired balance, tremors or increased salivation, depression, insomnia, anxiety or intolerable sedation, contact your doctor.
The doctor will decide whether to interrupt the titration and reduce the dose.
Special populations

Elderly patients and children
Specific studies have not been conducted in any of these new age groups. The doctor will decide the appropriate dose.
Elderly patients usually receive the recommended dose for adults.
Children usually start with about half the daily dose of an adult. This dose can then be slowly and carefully adjusted, depending on tolerability and individual response.
Talk to your doctor or pharmacist if you feel that the effect of Tetrabenazina Aristo is too strong or too weak.
Patients with hepatic insufficiency, renal insufficiency
If you have liver or kidney problems, your doctor may prescribe a different dosage regimen and/or a different dose.
Talk to your doctor before taking tetrabenazina if you know you are a slow or intermediate metabolizer of an enzyme called CYP2D6. In this case, a different dose may be necessary.
How to administer
Tetrabenazina 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 allows you to take half tablets.

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

If you forget to take Tetrabenazina Aristo
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 Aristo
Under no circumstances should you change the dosage of Tetrabenazina Aristo without first consulting your doctor.
If you no longer wish to take Tetrabenazina Aristo, you must discuss this with your doctor first.
If you have any questions about using 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 watch out for and actions to take if you are affected
If you experience muscle stiffness or fever and changes in consciousness (such as confusion or
hallucinations), stop taking Tetrabenazina Aristo. Consult your doctor or the nearest hospital
as soon as possible (see also section 2 "Warnings and precautions").
Seek immediate advice or go to the nearest hospital if you experience the following side
effects:

• If you experience muscle rigidity, fever or disturbances of consciousness (e.g. confusion or hallucinations), stop taking Tetrabenazina Aristo. Consult your doctor or the nearest hospital as soon as possible (see also section 2 "Warnings and precautions").
• Very common (may affect more than 1 in 10 people): Tetrabenazina Aristo can cause depression which can lead to suicidal thoughts in some people. If you feel down or very sad you may become depressed and should inform your doctor of this change.
• Very rare (may affect up to 1 in 10,000 people): if you have attempted suicide or if you have intentionally harmed yourself or if you have thought about harming yourself intentionally.

Other possible side effects

Very common:may affect more than 1 in 10 people:

• Tetrabenazina Aristo can cause depression, which can lead to suicidal thoughts in some people. If you feel down or very sad, you may start to feel depressed and should inform your doctor of this change;
• drowsiness
• symptoms of Parkinson's disease such as impaired balance, tremors or increased salivation

Common:may affect up to 1 in 10 people:

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

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

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

Not known: frequency cannot be estimated based on available data:

• disorder of balance and coordination of movement (ataxia)
• inability to stay still (akathisia)
• movement disorder with involuntary spasms and abnormal postures (dystonia)
• memory loss
• dizziness
• disorientation
• nervousness
• restlessness
• sleep disorders
• slow heartbeat (bradycardia)
• lowering of blood pressure with dizziness when getting up (orthostatic hypotension)
• hypertensive crisis
• difficulty swallowing
• nausea (feeling sick)
• vomiting
• pain in the upper abdomen
• diarrhea
• constipation
• dry mouth
• sweating
• irregular menstrual cycle
• fatigue
• weakness
• lowering of body temperature (hypothermia)
• increased appetite
• weight gain

To avoid the risk of a potentially serious interaction, which may lead to a hypertensive crisis,
it is necessary to ensure that at least 14 days pass between stopping Tetrabenazina Aristo and
starting treatment with an MAO inhibitor, as well as between stopping the MAO inhibitor and
starting treatment with Tetrabenazina Aristo.
If Tetrabenazina Aristo is taken for prolonged periods, the concentration of prolactin (a hormone
secreted by the pituitary gland) in the blood may increase. This returns to normal levels after
stopping treatment. Consequently, abnormal breast milk secretion (galactorrhea), absent or irregular menstrual cycles, enlargement of the male breast
(gynecomastia), breast pain, breast enlargement, pituitary tumors (prolactinomas), disorders
of orgasm and impotence may occur.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://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 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 pack and label after
"Exp.". The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C. Store in the original packaging to protect
from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tetrabenazina Aristo contains

• The active ingredient is tetrabenazine.
• The excipients are: lactose monohydrate (see section 2 "What you need to know before you take Tetrabenazina Aristo"), corn starch, microcrystalline cellulose, talc, magnesium stearate (Ph.Eur.), yellow iron oxide (E172).

Description of the appearance of Tetrabenazina Aristo and contents of the pack
Tetrabenazina Aristo 25 mg tablets are pale yellow and round with a score line
on one side and with a diameter of approximately 7.00 mm ± 0.2 mm.
The tablet can be divided into equal doses.
Tetrabenazina Aristo is available in bottles of 112 tablets.

Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Distributor
Aristo Pharma Italy S.r.l.
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany: Tetrabenazin Aristo 25 mg Tabletten
Austria: Tetrabenazin Aristo 25 mg Tabletten
Italy: Tetrabenazina Aristo
Portugal: Tetrabenazina Aristo
Spain: Tetrabenazina Aristo 25 mg comprimidos
United Kingdom: Tetrabenazine Aristo 25 mg tablets