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TEGLUTIK 5 MG/ML ORAL SUSPENSION

Active substance(s): RILUZOLE

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Anverso / Front

158 mm

210 mm

- numbness or tingling of the mouth
- vomiting
- sleepiness
- increase in heart beat
- diarrhoea
- headache
- abdominal pain
- pain
Uncommon side effects (affecting
between 1 in 100 and 1 in 1000 patients)
- 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.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.

Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.

5. How to store TEGLUTIK

Marketing Authorisation Holder
ITALFARMACO S.A.
San Rafael, 3 - 28108 Alcobendas
(Madrid) Spain

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
After the first opening: 15 days, without
any special storage conditions.
Do not throw away any medicines via
wastewater or household waste.

6. Contents of the pack and other
information
What TEGLUTIK contains
- The active substance is riluzole. -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 300
ml with a plastic graduated oral dosing
syringe. The syringe barrel is graduated
in milliliters up to 10 ml.

Manufacturer
ITALFARMACO S.A.
San Rafael, 3 - 28108 Alcobendas
(Madrid) Spain
This leaflet was last revised in
06/2015

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.
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

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.

1. What TEGLUTIK is and what it is
used for

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.

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

2. What you need to know before
you take TEGLUTIK

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;

Reverso / Back
210 mm

- 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;
- 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.
If any of the above applies to you,
or if you are not sure, tell your
doctor who will decide what to do.

158 mm

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 are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, 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.

3A

3B

3C

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

4A

4B

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

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).

for a forgotten dose.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

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

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 (affecting
more than 1 in 10 patients)
- tiredness
- feeling sick
- increased blood levels of some
enzymes of the liver (transaminases).
Common side effects (affecting
between 1 in 10 and 1 in 100 patients):
- dizziness

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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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