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TARDIBEN 25 MG TABLETS

Active substance(s): TETRABENAZINE

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Tardiben 25 mg 112 tablets
GB
package leaflet
14.06.2016 new (EB)
05.07.2016 changes acc. to MHRA (EB)




Art.Nr.: xxxxxxx/xx-xxxx
Pharma-Code: xx
Format: 148 x 420 mm
colors: black

Package leaflet: Information for the user

Tardiben 25 mg tablets
Tetrabenazine

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

1. What Tardiben is and what it is used for
Tardiben contains a substance called
tetrabenazine. This is a medicine belonging
to the group treat disorders of the nervous
system.
Tardiben is used for the treatment of diseases
causing jerky, irregular, uncontrollable
movements (hyperkinetic motor disorders
with Huntington’s chorea).
Tardiben is also indicated for the treatment of
moderate to severe Tardive Dyskinesia:
- Tardive
dyskinesia
is
a
condition
characterised by uncontrollable movements
such as facial spasm, grimacing, or peculiar
tongue movements.
- Some medicines used to treat certain mental
health conditions (antipsychotics) can cause
tardive dyskinesia.
- Tardiben should only be given to you for
the treatment of tardive dyskinesia when
symptoms are moderate to severe, disabling,
and/or embarrassing in social situations.
- Tardiben should only be given to you when
symptoms persist, even after your doctor
has stopped, changed, or reduced the dose
of your antipsychotic medication.

2. What you need to know before you
take Tardiben
Do not take Tardiben:
- if you are allergic (hypersensitive) to
tetrabenazine or any of the other ingredients
of Tardiben (listed in section 6).
- if you use reserpine (medicine to control
high blood pressure and to treat psychotic
states).
- if you use MAO inhibitors (medicine to treat
depression).
- if you suffer from Parkinson-like symptoms.
- if you have depression.
- if you have suicidal thoughts.
- if you are breast-feeding.
- if you suffer from pheochromocytoma
(tumour of the adrenal gland).
- if you suffer from prolactin-dependent tumours,
e.g. pituitary or breast cancer.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Tardiben.
- if you have liver problems.
- if you have ever had trembling in the hands
and jerky movements in the arms and legs,
known as parkinsonism.
- if you suffer from high blood concentrations
of prolactin (Hyperprolactinemia).
- if you are vulnerable to sudden drop in blood
pressure when standing up or stretching.
- if you know that you are a slow or intermediate
metaboliser of an enzyme called CYP2D6,
because a different dose may be applicable
for you.
- if you have a heart condition known as long
QT syndrome or if you have or have had
problems with your heart rhythm.
- if you start to have mental changes such
as confusion or hallucinations, or develop
stiffness in your muscles and a temperature,
you may be developing a condition called
Neuroleptic Malignant Syndrome. If you
have these symptoms please contact your
doctor straight away.
- if you start to have neurological disorders
such as muscular stiffness, unpleasent
sensations of inner restlessness or agitation,
a compelling need to be in constant motion,
disturbances in arbitrary movement or
involuntary movements. Contact your doctor
if you experience a worsening of your motor
abilities.
- please consider that tetrabenazine, the
active substance of Tardiben, binds to
melanin containing tissues (pigment of hairs,
skin and eye) resulting in the possibility to
cause toxicity in these tissues.

Children
Tardiben is not recommended in children.
Other medicines and Tardiben
Please tell your doctor or pharmacist if you
are taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription.
Take special care if you use Tardiben together
with:
- levodopa (a medicine used to treat
Parkinson’s disease).
- drugs known to prolong the QTc interval
including:
- some drugs used to treat mental health
conditions
(e.g. chlorpromazine, thioridazine).
- certain antibiotics (e.g. gatifloxacin,
moxifloxacin).
- some drugs used to treat problems with
heart rhythm conditions (e.g. quinidine,
procainamide, amiodarone, sotalol).
- opioids (pain killers).
- beta blockers and antihypertensive drugs
(medicines to treat high blood pressure).
- hypnotics and neuroleptics (drugs which
affect the brain and nervous system).
- antidepressants which belong to the group
of medicines called monoamine oxidase
inhibitors (MAOI). Treatment with MAOI
should be stopped 14 days before the
treatment with Tardiben starts.
Do not use Tardiben together with reserpine
(medicine used to treat high blood pressure
and psychotic symptoms).
Some medicines (e.g. fluoxetine, paroxetine,
terbinafine, moclobemide and quinidine) may
increase the level of tetrabenazine in the
blood, and thus should only be combined with
caution. A reduction of the tetrabenazine dose
may be necessary.
Tardiben with food and alcohol
Drinking alcohol while you are taking Tardiben
may cause you feel abnormally sleepy.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant
or are planning to have a baby, ask your
doctor for advice before taking Tardiben. Your
doctor will decide after taking all risks and
benefits into account, if you may use Tardiben
during pregnancy. Tardiben must not be taken
by breast feeding mothers.
When animals were tested, a delay in female
fertility was observed. The effect on fertility
in humans has not been tested. If you are
concerned, ask your doctor for advice.
Driving and using machines
Tardiben may cause somnolence and therefore
may modify your performance at driving and
using machines to a varying degree, depending
on the dose and individual susceptibility.
Tardiben contains lactose
These tablets contain lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking Tardiben.

3. How to take Tardiben
Always take Tardiben exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
Swallow the tablet(s) with water or another
non-alcoholic drink.
Adults
Huntington’s chorea
The recommended starting dose is half a
tablet (12.5 mg) one to three times a day. This
can be increased every three or four days by
half a tablet until the optimal effect is observed
or up to the occurrence of intolerance effects
(sedation, Parkinsonism, depression).

The maximum daily dose is 8 tablets (200 mg)
a day.
If you have taken the maximum dose for a
period of seven days and your condition has
not improved, it is unlikely that the medicinal
product will be of benefit to you.
Tardive Dyskinesia
The recommended starting dose for patients
with tardive dyskinesia is half a tablet (12.5
mg) a day, which can be increased as needed
depending on your response to treatment.
These tablets will be stopped if there is no
clear benefit or if the side-effects become too
much for you.
The elderly
The standard dosage has been administered
to elderly patients without apparent side
effects. However, Parkinson-like side effects
are common.
Use in children
The treatment is not recommended in children.
Patients with hepatic disorder
Patients with mild to moderate hepatic
disorders should start with half a tablet (12.5
mg) a day. For patients with severe hepatic
disorders, additional caution is necessary.
Patient with renal disorder
Tardiben is not recommended for use in this
patient group.
If you take more Tardiben than you should
If you take more Tardiben than you should
or someone else accidentally takes your
medicine, contact your doctor, pharmacist
or nearest hospital straight away. You may
develop somnolence, sweating, low blood
pressure, and extremely low body temperature
(hypothermia). Your doctor will treat the signs.
If you forget to take Tardiben
If you forget to take one dose, you should never
make up for the missing dose by doubling it
at the next time. Instead you should simply
continue with the next dose when it is due.
If you stop taking Tardiben
Do not stop taking Tardiben unless your doctor
tells you to. A neuroleptic malignant syndrome
has been described after abrupt withdrawal of
Tardiben.
If you have any further question on the use of
this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Tardiben can cause side
effects, although not everybody gets them.
The following undesirable effects are
ranked according to system organ class
and to their frequency:
very
common:
common:
uncommon:
rare:
very rare:
not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in
10,000
frequency cannot be estimated
from the available data

Very common:
Somnolence
(with
higher
dosages),
depression,
Parkinson-like
syndrome
(uncontrollable movements of the hands,
arms, legs and head, with higher dosages)

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme (Website: www.mhra.gov.uk/
yellowcard). By reporting side effects you can
help provide more information on the safety of
this medicine.

5. How to store Tardiben
Keep this medicine out of the sight and reach
of children.
Do not use Tardiben after the expiry date
which is stated on the bottle label and carton.
The expiry date refers to the last day of that
month.
Store in the original package in order to
protect from light.
This medicinal product does not require any
special temperature storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other
information
What Tardiben contains
- The active substance is tetrabenazine.
- Each tablet contains 25 mg tetrabenazine.
- The other ingredients are: pre-gelatinised
maize starch, lactose monohydrate, talc,
ferric oxide yellow E172, magnesium
stearate.
What Tardiben looks like and contents of
the pack
Yellow, round, tablets with one-side break
notch in white twist-off bottles available in two
different pack-sizes:
One pack-size containing 42 tablets, the other
pack-size containing 112 tablets.
Not all pack-sizes may be marketed.
Marketing Authorisation
Manufacturer

Holder

and

Marketing Authorisation Holder:
AOP Orphan Pharmaceuticals AG
Wilhelminenstrasse 91/II f
1160 Vienna
Austria
Manufacturer:
AOP Orphan Pharmaceuticals AG
Wilhelminenstrasse 91/II f
1160 Vienna
Austria
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria:
Bulgaria:
Finland:
Germany:
Norway:
Poland:
Romania:
Slovakia:
United Kingdom:

Dystardis 25 mg Tabletten
Dystardis 25 mg таблетки
Dystardis 25 mg tabletit
Dystardis 25 mg Tabletten
Tardiben 25 mg tabletter
Dystardis
Artesyd 25 mg comprimate
Dystardis 25 mg tablety
Tardiben 25 mg tablets

This leaflet was last revised in 04.07.2016

Common:
Confusion, anxiety, sleeplessness, low blood
pressure, dysphagia (difficulty in swallowing),
nausea, vomiting, diarrhoea, obstipation
Uncommon:
Mental changes such as confusion or
hallucinations, muscular rigidity, hypothermia,
autonomic dysfunction
Rare:
Neuroleptic Malignant
(neurological disorder)

Syndrome

(NMS)

Very rare:
Skeletal muscle damage
For the following side-effects, it is not possible
to estimate the incidence from available data:
disorientation, nervousness, ataxia and
dystonia (loss of control of movements),
akathisia (restlessness), dizziness, amnesia
(memory loss), bradycardia (slow heart beat),
epigastric pain (stomach pain), dry mouth,
irregular menstrual cycle, feeling dizzy if you
stand suddenly (especially when first getting
out of bed or you have been sitting for a long
time).
xxxxxxx/xx-xxxx

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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