Riluzole 50mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Riluzole

Հասանելի է:

Sun Pharmaceutical Industries Europe B.V.

ATC կոդը:

N07XX02

INN (Միջազգային անվանումը):

Riluzole

Դոզան:

50mg

Դեղագործական ձեւ:

Tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 04090300; GTIN: 8718309122546

Տեղեկատվական թերթիկ

V011
1
PACKAGE LEAFLET
V011
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PACKAGE LEAFLET: INFORMATION FOR THE USER
RILUZOLE 50 MG FILM-COATED TABLETS
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 Riluzole is and what it is used for
2.
What you need to know before you take Riluzole
3.
How to take Riluzole
4.
Possible side effects
5.
How to store Riluzole
6.
Contents of the pack and other information
1.
WHAT RILUZOLE IS AND WHAT IT IS USED FOR
WHAT RILUZOLE IS
The active substance in Riluzole 50 mg film-coated tablets is riluzole
which acts on the nervous system.
WHAT RILUZOLE IS USED FOR
Riluzole is used in patients with amyotrophic lateral sclerosis (ALS).
ALS is a form of motor neurone disease where damage to the nerve cells
responsible for sending
instructions to the muscles lead to weakness, muscle wastage 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. Riluzole 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 RILUZOLE
DO NOT TAKE RILUZOLE
-
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
.
WARNINGS AND PRECAUTIONS
Talk to you

Ապրանքի հատկությունները

OBJECT 1
RILUZOLE 50 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 21-Mar-2018 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Riluzole SUN 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 white to off white coloured, round shape, biconvex,
film coated tablets debossed with '538'
on one side and plain on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Riluzole SUN is indicated to extend life or the time to mechanical
ventilation for patients with
amyotrophic lateral sclerosis (ALS).
Clinical trials have demonstrated that Riluzole SUN 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 Riluzole SUN exerts a therapeutic effect on
motor function, lung function,
fasciculations, muscle strength and motor symptoms. Riluzole SUN has
not been shown to be effective in
the late stages of ALS.
Safety and efficacy of Riluzole SUN has only been studied in ALS.
Therefore, Riluzole SUN should not
be used in patients with any other form of motor neurone disease.
4.2 Posology and method of administration
Treatment with Riluzole SUN should only be initiated by specialist
physicians with experience in the
management of motor neurone diseases.
Posology
The recommended daily dose in adults or elderly is 100 mg (50 mg every
12 hours).
No significant increased benefit can be expected from higher daily
doses.
Special populations
_Paediatric population_
Riluzole SUN is not recommended for use in children, due to a lack of
data on the safety and efficacy of
riluzole in any neurodegenerative diseases occurring in children or
adolescents.
_Patients with impaired renal function_
Riluzole SUN is not recommended for use in patients with impaired
r