Orfenal 50mg coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ORPHENADRINE HYDROCHLORIDE

Available from:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC code:

N04AB02

INN (International Name):

ORPHENADRINE HYDROCHLORIDE 50 mg

Pharmaceutical form:

COATED TABLET

Composition:

ORPHENADRINE HYDROCHLORIDE 50 mg

Prescription type:

POM

Therapeutic area:

ANTI-PARKINSON DRUGS

Authorization status:

Withdrawn

Authorization date:

2007-02-15

Patient Information leaflet

_____________________________________________________________________________________________________
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ORFENAL 50 MG COATED TABLETS
Orphenadrine hydrochloride
READ
ALL
OF
THIS
LEAFLET
BEFORE
YOU
START
TAKING
THIS
MEDICINE
BECAUSE
IT
CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Orfenal is and what it is used for
2.
What you need to know before you take Orfenal
3.
How to use Orfenal
4.
Possible side effects
5.
How to store Orfenal
6.
Contents of the pack and other information
1.
WHAT ORFENAL IS AND WHAT IT IS USED FOR
Orfenal contains the active substance orphenadrine hydrochloride.
Orphenadrine belongs to a
group of drugs called antimuscarinic agents.
Orfenal is used to:
•
help in the control of Parkinsonism (symptoms of tremor, stiffness and
shuffling).
•
treat related Parkinson-like side effects of other drugs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORFENAL
DO NOT TAKE ORFENAL
•
if you are allergic to orphenadrine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6).
•
if you have glaucoma (loss of vision due to abnormally high pressure
in the eye).
•
if you have an enlarged prostate causing difficulty passing urine.
•
if you have tardive dyskinesia (uncontrollable movements of mouth,
tongue and
limbs).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Orfenal
•
if you have difficulties passing urine.
•
if you have heart, blood vessel or blood circulation problems.
•
if you have liver or kidney problems.
____

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Orfenal 50 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 50 mg orphenadrine hydrochloride.
Excipient(s) with known effect
Each coated tablet contains 26,5 mg lactose monohydrate.
Each coated tablet contains 62,505 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet.
Yellow, round, coated tablets.
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
Posology
Adults and the elderly: Initially 150 mg per day in divided doses, if
necessary increasing by
50 mg every 2 or 3 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 400 mg daily in divided doses.
The elderly may be more susceptible to side effect at doses which are
clinically optimal.
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Paediatric population
A suitable dose has not been established.
Method of administration
Oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Patients with tardive dyskinesia, glaucoma or prostatic hypertrophy.
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.
THIS MEDICINE CONTAINS SODIUM.
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to say essentially
‘sodium-free’.
THIS MEDICINE CONTAINS L