Disipal

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Orphenadrine hydrochloride 50mg; Orphenadrine hydrochloride 50mg; Orphenadrine hydrochloride 50mg

Available from:

Seqirus (NZ) Ltd

INN (International Name):

Orphenadrine hydrochloride 50 mg

Dosage:

50 mg

Pharmaceutical form:

Coated tablet

Composition:

Active: Orphenadrine hydrochloride 50mg Excipient: Acacia Gelatin Lactose monohydrate Polyvinyl acetate Potato starch Purified talc   Shellac Stearic acid Sucrose   Titanium dioxide White beeswax Active: Orphenadrine hydrochloride 50mg Excipient: Acacia   Calcium carbonate Calcium phosphate Gelatin Opaseal P-17-0200 Opalux AS 3026 yellow - contains tartrazine Kaolin Lactose monohydrate Magnesium stearate Maize starch Opacode black S-1-27794 Opaglos white 6000 Purified talc Stearic acid Sucrose   Titanium dioxide Active: Orphenadrine hydrochloride 50mg Excipient: Acacia   Calcium carbonate Calcium phosphate Gelatin Opaseal P-17-0200 Opalux AS 3026 yellow - contains tartrazine Kaolin Lactose monohydrate Magnesium stearate Maize starch Opaglos white 6000 Purified talc Stearic acid Sucrose   Titanium dioxide

Units in package:

Bottle, plastic, White securitainer with a screw cap and foam insert, 250 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Procos SpA

Therapeutic indications:

Parkinson's disease, all forms of parkinsonism.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, White securitainer with a screw cap and foam insert - 250 tablets - 36 months from date of manufacture stored store at room temperature 15-25°

Authorization date:

1969-12-31

Patient Information leaflet

 
CONSUMER MEDICINE INFORMATION 
DISIPAL
50 MG ORPHENADRINE HYDROCHLORIDE 
®

TABLET 

_WHAT IS IN THIS LEAFLET _
This leaflet answers some common
questions about DISIPAL. 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 risks of you taking
this 
medicine against the expected benefits. 
Use DISIPAL
as instructed. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS
MEDICINE, ASK 
YOUR DOCTOR OR PHARMACIST. 
KEEP THIS LEAFLET. You may need to read it again. 
WHAT DISIPAL IS USED FOR 
This medicine is used to treat a type
of movement disorder caused by changes in the brain. 
This is called
Parkinson’s Syndrome and includes all forms of Parkinsonism. 
This medicine belongs to a group of medicines called
anticholinergics. 
This medicine works in the central nervous system (CNS). 
 It relaxes muscles affected by 
Parkinson’s Syndrome. Your doctor may have prescribed DISIPAL
for another reason.  Ask 
your doctor why this medicine has been prescribed for you. 
This medicine is available only with
a doctor’s prescription. 
BEFORE YOU TAKE DISIPAL 
_WHEN YOU MUST NOT TAKE DISIPAL_.  
DO NOT TAKE THIS MEDICINE IF YOU ARE ALLERGIC TO: 
•  ORPHENADRINE 
•  ANY OF THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET (see PRODUCT DESCRIPTION) 

Some of the symptoms of an allergic reaction may include
shortness of breath, wheezing or 
difficulty breathing; swelling of the face, lips, tongue
or other parts of the body; rash, itching or 
hives on the skin. 
DO NOT TAKE THIS MEDICINE IF YOU HAVE, OR HAVE HAD, ANY OF
THE FOLLOWING MEDICAL 
CONDITIONS: 
•  MYASTHENIA GRAVIS (a disease of the
muscles causing drooping eyelids, double vision, 
difficulty in speaking 

Summary of Product characteristics

- 1  

DISIPAL 
Orphenadrine hydrochloride 


PRESENTATION 
DISIPAL tablets are presented as yellow sugar-coated tablets each
containing 50mg orphenadrine 
hydrochloride.  

USES 

ACTIONS 
Orphenadrine is an anticholinergic with a
predominantly central effect and only a weak peripheral 
effect.  In addition, it has mild antihistaminic and
local anaesthetic properties. 
Parkinson’s syndrome is the consequence of a disturbed balance
between cholinergic and 
dopaminergic neurotransmission in the basal ganglia caused by a
decrease in dopamine.  
Orphenadrine restores the physiological equilibrium and has a
favourable effect on the rigidity and 
tremor of Parkinson’s disease and Parkinsonian syndromes.  The
effect is somewhat less on 
bradykinesia. 
Orphenadrine restores the motor disturbances induced
by neuroleptics, in particular the hyperkinesia.  
The dopamine deficiency in the striatum increases the stimulating
effects of the cholinergic system.  
This stimulation is counteracted by the
anticholinergic effect of orphenadrine.  It may have a
relaxing 
effect on skeletal muscle spasms and it has a mood elevating
effect. 

PHARMACOKINETICS 

Absorption 
Orphenadrine is almost completely absorbed in the
gastrointestinal tract. 

Distribution 
It is rapidly distributed in the tissues.  Protein binding
is approximately 95%. 

Biotransformation 
Biotransformation occurs mainly in the liver. 
Pharmacologically active metabolites are N-demethyl 
orphenadrine and N,N-didemethyl orphenadrine.  After a single dose
the half life value is 13-20 hours.  
After multiple doses this half life value may be increased. 

Elimination 
Within 3 days about 60% of the metabolites are excreted via the
urine and about 16% with the faeces.  
N-demethyl orphenadrine is for 8% and N,N-didemethyl orphenadrine
for 5% of the administered dose 
excreted in the urine.�