TEGLUTIK riluzole 50 mg/10 mL oral liquid suspension bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

riluzole, Quantity: 0.5 g

Available from:

Seqirus Pty Ltd

Pharmaceutical form:

Oral Liquid, suspension

Composition:

Excipient Ingredients: sorbitol solution (70 per cent) (non-crystallising); aluminium magnesium silicate; xanthan gum; saccharin sodium; sodium lauryl sulfate; ceteareth-25; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; PEG-4 stearate

Administration route:

Oral

Units in package:

250 mL, 300 mL, 2 x 250 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RILUZOLE is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Product summary:

Visual Identification: Slightly brown, opaque homogeneous suspension after being manually shaken; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-08-21

Patient Information leaflet

TEGLUTIK

Consumer Medicine Information (CMI)
Page 1 of 4
TEGLUTIK

Oral Suspension
Riluzole
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS
MEDICINE.
This leaflet answers some common
questions about TEGLUTIK

oral
suspension.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using TEGLUTIK

oral
suspension against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT TEGLUTIK
 IS USED
FOR
The brand name of your medicine is
TEGLUTIK

. The active ingredient in
the medicine is called riluzole,
which acts on the nervous system.
TEGLUTIK

is used to treat people
with amyotrophic lateral sclerosis
(ALS),
a form of MOTOR NEURONE
DISEASE, which can cause muscle
degeneration leading to muscle
weakness.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
TEGLUTIK

oral suspension is
available only with a doctor's
prescription.
There is not enough information to
recommend the use of this
medicine for children under the age
of 18 years.
It is important to remember that
you may not feel any different when
you take TEGLUTIK

. The benefits
of using TEGLUTIK

may not be
noticeable to you. You should not
stop taking TEGLUTIK

without
speaking to your doctor first.
BEFORE YOU TAKE IT
When you must not use it
DO NOT USE TEGLUTIK
 IF YOU:
•
HAVE LIVER DISEASE
•
ARE PREGNANT OR INTEND TO
BECOME PREGNANT
•
ARE BREASTFEEDING OR INTEND
TO BREASTFEED
DO NOT USE THIS MEDICINE IF YOU
ARE ALLERGIC TO RILUZOLE OR ANY OF
THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include:
•
shortness

Summary of Product characteristics

Teglutik

Product Information
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION - TEGLUTIK
®
(RILUZOLE)
1.
NAME OF THE MEDICINE
Riluzole
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of oral suspension contains 5 mg of riluzole.
Riluzole is a white to slightly yellow powder. It is very slightly
soluble in water and
0.1N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid;
and very soluble
in methanol, acetone, acetonitrile, dichloromethane and dimethyl
sulfoxide.
1 mL of oral suspension contains 400 mg of sorbitol (equivalent to
571.43 mg of
sorbitol solution (70% w/w)). For the full list of excipients, see
Section 6 List of
excipients.
3.
PHARMACEUTICAL FORM
TEGLUTIK

is an oral suspension containing riluzole, a benzothiazole. Chemical
name:
6-(trifluoromethoxy)-2-benzothiazolamine
It
is
a
slightly
brown,
opaque
homogenous suspension after manually shaken.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Riluzole is indicated for the treatment of patients with amyotrophic
lateral
sclerosis (ALS).
4.2 DOSAGE AND ADMINISTRATION
DOSAGE
The recommended dose is 10 mL (equivalent to 50 mg riluzole) two times
a day. The
maximum recommended daily dose is 100 mg (50 mg every 12 hours). No
significant
increase in benefit can be expected from higher daily doses.
Due to the reduction in absorption observed when administered with
high fat meals,
riluzole should not be taken with a fat containing meal.
METHOD OF ADMINISTRATION
The suspension can be given per oral administration. Dilution with
liquids is not
necessary.
The suspension is administered by means of graduated dosing syringe
orally or via a
Percutaneous Endoscopic Gastrostomy (PEG).
Teglutik

Product Information
Page 2 of 16
The suspension must be manually gently shaken for at least 30 seconds
by rotating
the bottle by 180° and the homogeneity should be visually verified.
Open the bottle, connect the dosing syringe to the bottle
syringe-adapter, invert the
bottle and, by maintaining the bottle in the inverted position, slowly
withdraw the
s