SYMMETREL 100 amantadine hydrochloride 100mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amantadine hydrochloride, Quantity: 100 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: titanium dioxide; glycerol; lecithin; sodium propyl hydroxybenzoate; yellow beeswax; partially hydrogenated soya oil; iron oxide red; Gelatin; sodium ethyl hydroxybenzoate; hydrogenated soya oil; Rape Seed Oil; maize starch; sorbitol; mannitol; ethyl acetate; butan-1-ol; Shellac; industrial methylated spirit

Administration route:

Oral

Units in package:

100

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PARKINSON'S DISEASE: Idiopathic Parkinson's disease; post encephalitic parkinsonism; symptomatic parkinsonism (e.g. following CNS injury from carbon monoxide poisoning); arteriosclerotic parkinsonism; drug-induced extrapyramidal reactions. Symmetrel can be given alone for initial therapy or combined with anticholinergic drugs or L-dopa (see "Dosage and Administration"). Note: Symmetrel is not indicated for the treatment of tardive dyskinesia. TYPE A VIRUS INFLUENZA: Prophylaxis of respiratory tract illness caused by Influenza Type A. Prophylaxis in non-immunized individuals (including children) for whom influenza may have serious consequences (e.g. persons with chronic respiratory disease of diabetes mellitus).

Product summary:

Visual Identification: Reddish-brown, opaque, shiny, oblong capsule. One side branded "GEIGY", the other "GB", in white.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

SYMMETREL
®
_amantadine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Symmetrel.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. Some more recent
information on the medicine may be
available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SYMMETREL IS
USED FOR
Symmetrel capsule has two very
different uses:
1.
to treat the symptoms of
Parkinson's disease
2.
to prevent a type of influenza
("the flu") caused by Type A
influenza virus.
PARKINSON'S DISEASE
This is caused by a disturbance in the
balance of two substances, dopamine
and acetylcholine, that the brain uses
to send signals to other parts of the
body.
Symmetrel helps to fix the imbalance
of too little dopamine and/or too
much acetylcholine; and to relieve
the symptoms, such as shaking of the
limbs, stiffness and slowness of
movement which make it difficult to
perform usual tasks.
Symmetrel can be used alone or with
other medicines to treat this
condition.
TYPE A INFLUENZA VIRUS
Symmetrel is usually used for people
who could become very ill if they get
the flu infections (for example,
people who have a serious illness
such as lung disease or diabetes).
Usually these people will have been
vaccinated (had a flu shot). But if, for
some reason, they have not been
vaccinated, Symmetrel ca

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – SYMMETREL (AMANTADINE
HYDROCHLORIDE) CAPSULES
1
NAME OF THE MEDICINE
Amantadine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains amantadine hydrochloride 100 mg.
Excipients with known effect: contains hydroxybenzoates and sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
100 mg capsules: brown, soft gelatin, marked "GEIGY" on one side and
"GB" on reverse.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PARKINSON'S DISEASE
Idiopathic Parkinson's disease; post-encephalitic parkinsonism;
symptomatic parkinsonism (e.g.
following CNS injury from carbon monoxide poisoning); arteriosclerotic
parkinsonism; drug-induced
extrapyramidal reactions.
Symmetrel can be given alone for initial therapy or combined with
anticholinergic drugs or L-dopa
(see section 4.2 Dose and method of administration).
Note: Symmetrel is not indicated for the treatment of tardive
dyskinesia.
TYPE A VIRUS INFLUENZA
Prophylaxis of respiratory tract illness caused by Influenza Type A.
Prophylaxis in non-immunised individuals (including children) for whom
influenza may have serious
consequences (e.g. persons with chronic respiratory disease or
diabetes mellitus).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Before use in elderly patients or those with impaired liver or kidney
function, refer to section 4.4
Special warnings and precautions for use and section 5.2
Pharmacokinetics properties. In patients
over 65 years of age, both age and renal function should be taken into
consideration. By age 65,
renal function will typically have declined to a level at which
reduced doses of Symmetrel or
increased dosing interval are appropriate. Specific dosage schedules
for patients over 65 years of
age and those with impaired renal function are shown below.
2
RECOMMENDED DOSAGES
PARKINSON’S DISEASE
_Adults to 65 years _
When used alone, 100 mg daily for the first week of treatment,
increasing in the second week to 100
mg twice daily. The dose can