TEGLUTIK 5 mg/ml oral suspension

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

riluzole

Available from:

ITALFARMACO S.A.

ATC code:

N07XX02

INN (International Name):

riluzole

Dosage:

5mg/ml

Pharmaceutical form:

Oral suspension

Administration route:

oral use

Units in package:

300 mL

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

ITALFARMACO S.A.

Therapeutic group:

other nervous system drugs

Therapeutic indications:

Clinical trials have demonstrated that riluzole 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 TEGLUTIK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. TEGLUTIK has not been shown to be effective in the late stages of ALS. Safety and efficacy of TEGLUTIK has only been studied in ALS. Therefore, TEGLUTIK should not be used in patients with any other form of motor neurone disease.

Authorization status:

Authorised

Authorization date:

2015-11-23

Patient Information leaflet

100MM MEASUREMENT VERIFICATION BAR
D03050
D03050     
3050-
C
PACKAGE LEAFLET: INFORMATION FOR THE USER
TEGLUTIK 5 MG/ML ORAL SUSPENSION
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
pharmacist. This includes 
any possible side effects not listed in this leaflet. 
211922/01
WHAT IS IN THIS LEAFLET:
1. What TEGLUTIK is and what it is
used for
2.  What you need to know before you 
take TEGLUTIK
3.  How to take TEGLUTIK
4.  Possible side effects
5.  How to store TEGLUTIK
6. Contents of the pack and other
information
1. WHAT TEGLUTIK IS AND WHAT IT 
IS USED FOR
WHAT TEGLUTIK IS
The active substance in TEGLUTIK is 
riluzole which acts on the nervous 
system. 
WHAT TEGLUTIK IS USED FOR
TEGLUTIK 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. TEGLUTIK 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 TEGLUTIK
DO NOT TAKE TEGLUTIK
- 
- 
-
if you are ALLERGIC to riluzole or 
any of the other ingredients of this 
medicine (listed in s

Summary of Product characteristics

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