ARTANE 5mg trihexyphenidyl (benzhexol) hydrochloride 5mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

trihexyphenidyl (benzhexol) hydrochloride, Quantity: 5 mg

Available from:

Arrow Pharma Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; pregelatinised maize starch; calcium hydrogen phosphate dihydrate; maize starch

Administration route:

Oral

Units in package:

200 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

As an adjunct in the therapy of all forms of Parkinsonism (postencephalitis, artencephalitis, arteriosclerotic and idiopathic). It is useful in the prevention or control of extrapyramidal disorders due to CNS drugs such as phenothiazines.

Product summary:

Visual Identification: White, round, flat-faced, beveled edge tablet with break bar on one side and plain on the other; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-09

Patient Information leaflet

ARTANE- Consumer Medicine Information
Page 1 of 4
ARTANE

_Trihexyphenidyl (benzhexol) hydrochloride _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ARTANE. 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 risks and benefits.
Your doctor has weighed the risks of
you taking ARTANE against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ARTANE IS USED FOR
ARTANE is used along with other
medicines to help treat Parkinson’s
disease.
Parkinson’s disease is a brain disorder,
which affects movement. The symptoms
of Parkinson’s disease include
trembling, rigid posture, slow
movements and a shuffling unbalanced
walk.
ARTANE is also used after illnesses,
which have after-effects like
Parkinson’s disease.
ARTANE can also be used to help
prevent tremor or shaking, which have
been caused by tranquillisers such as
reserpine and phenothiazines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ARTANE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another purpose.
ARTANE belongs to a group of
medicines known as antidyskinetics. It
works by relaxing muscle tissue and by
acting on the nerves, which control the
working of muscles.
ARTANE is not habit forming.
This medicine is available only with a
doctor’s prescription.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ARTANE IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
trihexyphenidyl hydrochloride
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines
Some symptoms of an allergic reaction
include rash, itching or hives on the
skin, swelling of the face, lips, tongue or
other parts of the body, shortness of
breath, wheezing or troubled breathing.
DO NOT TAKE ARTANE IF

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION–
ARTANE (TRIHEXYPHENIDYL HYRDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Trihexyphenidyl (benzhexol) hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Artane is supplied in two tablet strengths containing 2 mg and 5 mg
Trihexyphenidyl hydrochloride
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Artane 2 mg: white, scored tablets
Artane 5mg: white scored tablets
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
As an adjunct in the therapy of all forms of Parkinsonism
(postencephalitis, arteriosclerotic and
idiopathic). It is useful in the prevention or control of
extrapyramidal disorders due to CNS drugs
such as phenothiazines.
4.2
D
OSE AND METHOD OF ADMINISTRATION
PARKINSONISM
Dosage should be individualised. The initial dose should be low and
then increased gradually,
especially in patients over 60. Whether Artane may best be given
before or after meals should be
determined by the way the patient reacts. Postencephalitic patients,
who are usually more prone to
excessive salivation, may prefer to take it after meals and may, in
addition, require small amounts of
atropine, which under such circumstances is sometimes an effective
adjuvant. If Artane tends to dry
the mouth excessively, it may be better to take it before meals,
unless it causes nausea. If taken
after meals, mints, chewing gum or water can allay the thirst
sometimes induced.
As initial therapy for Parkinsonism, 1 mg of Artane in tablet form may
be administered the first day.
The dose may then be increased by 2 mg increments at intervals of
three to five days, until a total of
6 to 10 mg is given daily. The total daily dose will depend upon what
is found to be the optimal level.
Many patients derive maximum benefit from a daily total of 6 to 10 mg.
A daily intake at this dosage
level is tolerated best if divided into 3 doses and taken at
mealtimes. Some patients, chiefly those in
the post-encephalitic group, may require a total daily dose of 12 to
15 mg. High doses