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TEGLUTIK 5 MG/ML ORAL SUSPENSION

Active substance(s): RILUZOLE / RILUZOLE / RILUZOLE

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Anverso / Front
210 mm

158 mm

anaemia
allergic reactions
inflammation of the pancreas
(pancreatitis).
As riluzole oral suspension is
more rapidly absorbed than
riluzole tablets, a slight increase in
tiredness, dizziness, diarrhoea and
transaminases cannot be excluded.
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 Yellow Card Scheme
at 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 TEGLUTIK
Keep out of the sight and reach of
children.
Do not use TEGLUTIK after the expiry
date which is stated on the carton
and the bottle, after EXP. The expiry
date refers to the last day of that
month.
This medicinal product does
not require any special storage
conditions.
Once opened, use within 15 days.
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 TEGLUTIK contains
The active substance is riluzole.
211922A/03

Código de Barras Sentido de Lectura
Barcode Read Direction

81

1 ml of oral suspension contains
5 mg of riluzole.
The other ingredients are: Liquid
Sorbitol (E420), Aluminum
magnesium Silicate, Xanthan
Gum, Saccharin Sodium,
Simethicone emulsion 30%,
Sodium Laurilsulphate, Macrogol
Cetostearyl Ether, Purified Water.
What TEGLUTIK looks like and
content of the pack
This medicine is presented
as a slightly brown, opaque
homogeneous oral suspension after
being manually gently shaken.
TEGLUTIK is available in a bottle
of 250 and 300 ml with a plastic
graduated oral dosing syringe. Pack
sizes are:
- carton box containing one or two
bottle of 250 ml of Riluzole 5 mg/
ml Oral Suspension.
- Carton box containing one bottle
of 300 ml of Riluzole 5 mg/ml Oral
Suspension.
The syringe barrel is graduated in
milliliters up to 10 ml.
Marketing Authorisation Holder
ITALFARMACO S.A.
San Rafael, 3
28108 Alcobendas (Madrid) Spain
Manufacturer
ITALFARMACO S.A.
San Rafael, 3
28108 Alcobendas (Madrid) Spain
This leaflet was last revised in
07/2016

PACKAGE LEAFLET: INFORMATION FOR THE USER

D03050

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.
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 section 6),
- if you have any liver disease
or increased blood levels of
some enzymes of the liver
(transaminases),
- if you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist
before taking TEGLUTIK:
- if you have any liver problems:
yellowing of your skin or the white
of your eyes (jaundice), itching all
over, feeling sick, being sick;
- if your kidneys are not working
very well;
- if you have any fever: it may be due
to a low number of white blood
cells which can cause an increased
risk of infection; Continued overleaf

Reverso / Back

158 mm

210 mm

D03050

If any of the above applies to you,
or if you are not sure, tell your
doctor who will decide what to do.
Children and Adolescents
If you are less than 18 years of
age, the use of TEGLUTIK is not
recommended in children because
there is no information available in this
population.
Other medicines and TEGLUTIK
Tell your doctor if you are taking or
have recently taken or might take any
other medicines, including medicines
obtained without a prescription.
Pregnancy, breast-feeding and
fertility
You must not take TEGLUTIK if you
are pregnant, think you may be
pregnant, or if you are breast feeding.
If you think you may pregnant or if
you intend to breast-feed, ask your
doctor for advice before taking this
medicine.
Driving and using machines
You can drive or use any tools or
machines, unless you feel dizzy or light
headed after taking this medicine.
TEGLUTIK contains liquid sorbitol
(E420).
If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before
taking this medicinal product.
3. How to take TEGLUTIK
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are
not sure.
The recommended dose is 100 mg a
day (50 mg every 12 hours).
10 ml of the oral suspension,
containing 50 mg of riluzole, should
be taken by mouth every 12 hours,
at the same time of the day each

day (for example, in the morning
and evening). The suspension is
administered by means of graduated
dosing syringe.
The oral suspension must be
manually gently shaken for at least
30 seconds by rotating the bottle by
180° and the homogeneity should be
visually verified.
Method of administration:
Instructions for use:
Open the bottle: press the cap and
turn it anticlockwise (figure 1)
1

Take the syringe, remove the tip and
insert the syringe in the adaptor
opening (figure 2). Turn the bottle
upside down (figure 3).
2

Turn the bottle the right way up
(figure 4A). Remove the syringe from
the adaptor (figure 4B).
4A

4B

Administer orally the whole
content of the syringe. Dilution in
water is not necessary.
Close the bottle with the plastic
screw cap.
Wash the syringe with water only
and re-assemble it with its tip cap
once dried (figure 5).
5

3

Fill the syringe with a small amount
of suspension by pulling the plunger
down (figure 3A), then push the
piston upward in order to remove
any possible bubble (figure 3B). Pull
the piston down to the graduation
mark corresponding to the quantity
in milliliters (ml) prescribed by your
doctor (figure 3C).
3A
3B
3C

If you take more TEGLUTIK than
you should
If you take too much suspension,
contact your doctor or the nearest
hospital emergency department
immediately.
If you forget to take TEGLUTIK
If you forget to take your dose, leave
out that dose completely and take the
next dose at the usual time.
Do not take a double dose to make
up for a forgotten dose.
If you have any further questions on
the use of this medicine, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, TEGLUTIK can
cause side effects, although not
everybody gets them.

Important
Tell your doctor immediately
if you experience any fever
(increase in temperature) because
TEGLUTIK may cause a decrease in
the number of white blood cells.
Your doctor may want to take a
blood sample to check the number
of white blood cells, which are
important in fighting infections.
if you experience any of the
following symptoms: yellowing of
your skin or the white of your eyes
(jaundice), itching all over, feeling
sick, being sick, as these may be
signs of liver disease (hepatitis).
Your doctor may do regular
blood tests while you are taking
TEGLUTIK to make sure that this
does not occur.
if you experience cough or
difficulties in breathing, as this may
be a sign of lung disease (called
interstitial lung disease).
Other side effects
Very common side effects
(may affect more than 1 in 10 people)
tiredness
feeling sick
increased blood levels of
some enzymes of the liver
(transaminases).
Common side effects
(may affect up to 1 in 10 people):
dizziness
numbness or tingling of the mouth
vomiting
sleepiness
increase in heart beat
diarrhoea
headache
abdominal pain
pain
Uncommon side effects
(may affect up to 1 in 100 people)

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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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