Kemadrin

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Procyclidine hydrochloride 5mg

Tilgjengelig fra:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Procyclidine hydrochloride 5 mg

Dosering :

5 mg

Legemiddelform:

Tablet

Sammensetning:

Active: Procyclidine hydrochloride 5mg Excipient: Lactose monohydrate Magnesium stearate Povidone Sodium starch glycolate

Enheter i pakken:

Bottle, 1x100, 100 tablets

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Trifarma SpA

Indikasjoner:

KEMADRIN is indicated for the treatment of all forms of Parkinson's disease: idiopathic (paralysis agitans), postencephalitic and arteriosclerotic. KEMADRIN is efficacious in the relief of parkinsonian symptoms. It is particularly effective in the alleviation of rigidity. Tremor, akinesia, speech and writing difficulties, gait, sialorrhoea and drooling, sweating, oculogyric crises and depressed mood are also beneficially influenced.

Produkt oppsummering:

Package - Contents - Shelf Life: Bottle, - 100 tablets - 60 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

1969-12-31

Informasjon til brukeren

1
KEMADRIN™
Procyclidine hydrochloride tablets 5mg
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
KEMADRIN tablets.
This leaflet answers some common
questions about KEMADRIN
tablets. It does not contain all 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 expected benefits of you taking
KEMADRIN against the risks this
medicine could have for you.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep this leaflet with your
medicine. You may need to read it
again.
WHAT KEMADRIN IS
USED FOR
KEMADRIN contains the active
ingredient procyclidine.
KEMADRIN is used to treat and
relieve the symptoms of
Parkinson’s disease. KEMADRIN
is also used to manage the side
effects of neuroleptic medicines
(used to treat serious mental
illnesses). These side effects are
quite similar to the symptoms of
Parkinson’s disease.
Common parkinsonian symptoms
include shaking of the head and
limbs, muscle stiffness, an
expressionless face and being
unable to start and control muscle
movements properly. These
symptoms are caused by an
imbalance between the chemicals
dopamine and acetylcholine in the
brain. These two chemicals
normally work in a balanced way,
transmitting nerve signals in the
part of the brain controlling
movement. In Parkinson’s disease,
the amount of dopamine in this
part of the brain is reduced, so the
effects of acetylcholine are
stronger, and coordination of
muscle movement is lost.
Dopamine levels in the brain are
abnormally high in people with
some mental illnesses, e.g.
schizophrenia. Treatment with
neuroleptic medication reduces
these high levels, sometimes to
below normal. If this happens, the
balance between acetylcholine and
dopamine in the brain gets out of
balance causing parkinsonian-like
symptoms.
KEMADRIN belongs to a group of
medicines called anticholinergics.
KEMADRIN works by stopping
brai

Preparatomtale

1
NEW ZEALAND DATA SHEET
1. KEMADRIN Tablets (procyclidine hydrochloride 5 mg tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: procyclidine hydrochloride 5mg
White, round, biconvex tablets, one face with a break line and coded
KT above the
break line and 05 below the break line, with a score line on the other
face.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
KEMADRIN is indicated for the treatment of all forms of Parkinson's
disease:
idiopathic (paralysis agitans), postencephalitic and arteriosclerotic.
KEMADRIN is efficacious in the relief of parkinsonian symptoms. It is
particularly
effective in the alleviation of rigidity. Tremor, akinesia, speech and
writing difficulties,
gait, sialorrhoea and drooling, sweating, oculogyric crises and
depressed mood are
also beneficially influenced.
KEMADRIN is also indicated for the control of extrapyramidal symptoms
induced by
neuroleptic drugs including pseudo-parkinsonism, acute dystonic
reactions and
akathisia.
4.2 Dose and method of administration
The variation in optimum dosage from one patient to another should be
taken into
consideration by the physician.
Dosage in adults
Parkinson's disease
Treatment is usually started at 2.5mg procyclidine three times per
day, increasing by
2.5 to 5mg per day at intervals of two or three days until the optimum
clinical response
is achieved.
The usual maintenance dose to achieve optimal response is 15 to 30mg
procyclidine
per day. Addition of a fourth dose before retiring has been seen to be
beneficial in
some patients. Doses up to 60mg procyclidine have been well tolerated,
and at the
discretion of the attending physician dosing to this level may be
appropriate.
In general younger patients or those with postencephalitic
parkinsonism may require
higher doses for a therapeutic response than older patients and those
with
arteriosclerotic parkinsonism.
2
KEMADRIN may be combined with levodopa or amantadine in patients who