Rilutek
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-01-2024
Charakterystyka produktu
(SPC)
26-01-2024
Sprawozdanie z oceny publicznego
(PAR)
24-05-2016
Składnik aktywny:
Riluzole
Dostępny od:
Sanofi Winthrop Industrie
Kod ATC:
N07XX02
INN (International Nazwa):
riluzole
Grupa terapeutyczna:
Other nervous system drugs
Dziedzina terapeutyczna:
Amyotrophic Lateral Sclerosis
Wskazania:
Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).Clinical trials have demonstrated that Rilutek extends survival for patients with ALS.Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.Rilutek has not been shown to be effective in the late stages of ALS.Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor-neurone disease.
Podsumowanie produktu:
Revision: 32
Status autoryzacji:
Authorised
Data autoryzacji:
1996-06-10
Ulotka dla pacjenta
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET: INFORMATION FOR THE USER
RILUTEK 50 MG FILM-COATED TABLETS
Riluzole
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 RILUTEK is and what it is used for
2.
What you need to know before you take RILUTEK
3.
How to take RILUTEK
4.
Possible side effects
5.
How to store RILUTEK
6.
Contents of the pack and other information
1.
WHAT RILUTEK IS AND WHAT IT IS USED FOR
WHAT RILUTEK IS
The active substance in RILUTEK is riluzole which acts on the nervous
system.
WHAT RILUTEK IS USED FOR
RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS).
ALS is a form of motor neurone disease where attacks of the nerve
cells responsible for sending
instructions to the muscles lead to weakness, muscle waste and
paralysis.
The destruction of nerve cells in motor neurone disease may be caused
by too much glutamate (a
chemical messenger) in the brain and spinal cord. RILUTEK stops the
release of glutamate and this
may help in preventing the nerve cells being damaged.
Please consult your doctor for more information about ALS and the
reason why this medicine has been
prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RILUTEK
DO NOT TAKE RILUTEK
-
if you are
ALLERGIC
to riluzole or any of the other ingredients of this medicine (listed
in section
6),
-
if you have any
LIVER DISEASE
or increased blood levels of some enzymes of the liver
(transaminases),
-
if you are
PREGNANT OR BREAST-FEEDING
.
19
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking RILUTEK:
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
RILUTEK 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of riluzole
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
The tablets are capsule-shaped, white and engraved with “RPR 202”
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RILUTEK is indicated to extend life or the time to mechanical
ventilation for patients with
amyotrophic lateral sclerosis (ALS).
Clinical trials have demonstrated that RILUTEK extends survival for
patients with ALS (see section
5.1). Survival was defined as patients who were alive, not intubated
for mechanical ventilation and
tracheotomy-free.
There is no evidence that RILUTEK exerts a therapeutic effect on motor
function, lung function,
fasciculations, muscle strength and motor symptoms. RILUTEK has not
been shown to be effective in
the late stages of ALS.
Safety and efficacy of RILUTEK has only been studied in ALS.
Therefore, RILUTEK should not be
used in patients with any other form of motor neurone disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with RILUTEK should only be initiated by specialist
physicians with experience in the
management of motor neurone diseases.
Posology
The recommended daily dose in adults or older people is 100 mg (50 mg
every 12 hours).
No significant increased benefit can be expected from higher daily
doses.
Special populations
_Impaired renal function _
RILUTEK is not recommended for use in patients with impaired renal
function, as studies at repeated
doses have not been conducted in this population (see section 4.4).
_Older people _
Based on pharmacokinetic data, there are no special instructions for
the use of RILUTEK in this
population.
_Impaired hepatic function_
See sections 4.3, 4.4 and 5.2.
_ _
3
_Paediatric population _
RILUTEK is not recommended for use in paediatric population, due to a
lack of data on the safety and
efficacy of ril
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