Orphenadrine 50mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Orphenadrine hydrochloride

Tilgængelig fra:

Part VIIID Drug Tariff Special Order

ATC-kode:

N04AB02

INN (International Name):

Orphenadrine hydrochloride

Dosering:

50mg

Lægemiddelform:

Oral tablet

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04090200

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
DISIPAL
® 50MG TABLETS
(orphenadrine hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms
are the same as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
The name of your medicine is Disipal
®
50mg Tablets but will
be referred to as Disipal Tablets throughout this leaflet.
IN THIS LEAFLET:
1.
What Disipal Tablets are and what they are used for
2.
Before you take Disipal Tablets
3.
How to take Disipal Tablets
4.
Possible side effects
5.
How to store Disipal Tablets
6.
Further information
1.
WHAT DISIPAL TABLETS ARE AND WHAT THEY ARE
USED FOR
The active ingredient in Disipal Tablets belongs to the group
of medicines called anticholinergic agents. Disipal Tablets
are used in the treatment of all forms of Parkinson’s disease,
a condition which can cause uncontrollable trembling of the
hands, and other difficulties of movement, for example in
standing or walking. Anticholinergic agents are also used
when other medicines have caused these problems.
2.
BEFORE YOU TAKE DISIPAL TABLETS
DO NOT TAKE DISIPAL TABLETS. TELL YOUR DOCTOR IF YOU:
are
ALLERGIC (HYPERSENSITIVE)
to orphenadrine or any of
the other ingredients of Disipal Tablets (see list in section
6 ‘Further information’)
have
INCREASED PRESSURE IN THE EYE
(glaucoma).
have an
ENLARGED PROSTATE.
are
UNABLE TO PASS WATER
for any reason.
have a
BLOCKAGE
in your
DIGESTIVE SYSTEM
or any
STOMACH DISORDERS.
suffer from
A RARE INHERITED DISEASE
where the
BREAKDOWN OF HAEMOGLOBIN
(a pigment in the red blood
cells) is affected (porphyria).
suffer from
INVOLUNTARY MOVEMENTS OF THE FACE OR BODY
(tardive dyskinesia). Your doctor will take this into
consideration before

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Orphenadrine Hydrochloride 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of orphenadrine hydrochloride.
Excipients with known effect
This product contains lactose, sucrose, and sunset yellow (E110)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Yellow, sugar-coated, round tablet with convex faces, coded 5X1 on one
side
and plain on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anticholinergic agent used to treat all forms of Parkinsonism
including drug-
induced (neuroleptic syndrome) extrapyramidal symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS and ELDERLY_: Initially 150mg per day in divided doses, if
necessary increasing by 50mg every two or three days until maximal
benefit is
obtained.
Optimal doses are usually as follows:
Idiopathic and post encephalitic Parkinsonism
- 250 to 300 mg daily in divided doses.
Neuroleptic syndrome
- 100 to 300 mg daily in divided doses.
Maximal dose is 400mg daily in divided doses.
The elderly may be more susceptible to side effect at doses which are
clinically optimal.
_Paediatric population _
A suitable dose has not been established.
Method of administration
To be taken orally.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Patients with glaucoma, prostatic hypertrophy and tardive dyskinesia.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with caution in patients with micturition difficulties, in
pregnancy, in the
presence of cardiovascular disease and hepatic or renal impairment. Do
not
discontinue treatment abruptly. It is potentially liable to abuse
because of its
mood altering effects e.g. euphoria.
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase
deficiency or glucose-galactose malabsorption should not take this
medicine.
Patients with rare hereditary problems of fructose intolerance or
sucrase-
isomaltase in