BETAPAM 5 mg TABLET

Χώρα: Νότια Αφρική

Γλώσσα: Αγγλικά

Πηγή: South African Health Products Regulatory Authority (SAHPRA)

Διαθέσιμο από:

Ranbaxy Pharmaceutical (Pty) Ltd û Roodepoort

Δοσολογία:

See ingredients

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

EACH TABLET CONTAINS DIAZEPAM 5,0 mg

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1979-07-09

Φύλλο οδηγιών χρήσης

RANBAXY PHARMACEUTICALS (PTY) LTD
(DIAZEPAM)
BETAPAM (L/2.6/185) TABLET/ 5 MG
Page 1 of 10
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S5
BETAPAM 5 MG TABLET
DIAZEPAM
Contains sugar (lactose monohydrate): 145,7 mg per tablet
Contains: TARTRAZINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING BETAPAM
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
BETAPAM has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What BETAPAM is and what it is used for
2.
What you need to know before you take BETAPAM
3.
How to take BETAPAM
4.
Possible side effects
5.
How to store BETAPAM
6.
Contents of the pack and other information
1. WHAT BETAPAM IS AND WHAT IT IS USED FOR
Diazepam belongs to a group of medicines called benzodiazepines.
Diazepam helps in the
treatment of anxiety and muscle spasm (cramps) such as those caused by
cerebral spasticity.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAPAM
DO NOT TAKE BETAPAM:
RANBAXY PHARMACEUTICALS (PTY) LTD
(DIAZEPAM)
BETAPAM (L/2.6/185) TABLET/ 5 MG
Page 2 of 10
•
if you are hypersensitive (allergic) to diazepam or any of the other
ingredients of BETAPAM )
listed in section 6
•
if you have an allergy to BETAPAM or any other benzodiazepine medicine
(e.g. clonazepam,
flurazepam and temazepam)
•
if you have breathing or lung problems
•
if you have severe liver problems.
•
if you have a condition called “sleep apnoea syndrome” (where your
breathing stops when you
are asleep)
•
if you have a condition called “myasthenia gravis” (where your
muscles are weak and get tired
easily)
•
if you have problems with phobias (strong fears) or obsessions
(troublesome, unwanted and
repeated thoughts, ideas or feelings).
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH BETAPAM :
•
if you regularly drink alcohol and/or CNS dep

Αρχείο Π.Χ.Π.

RANBAXY PHARMACEUTICALS (PTY) LTD
(DIAZEPAM)
BETAPAM (L/2.6/185) TABLET/ 5 MG
Page 1 of 15
PROPOSED PROFESSIONAL INFORMATION
SCHEDULING STATUS
S5
1.
NAME OF THE MEDICINE
BETAPAM (TABLETS)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg diazepam.
Contains sugar (lactose monohydrate): 145,7 mg per tablet
Contains TARTRAZINE
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
Yellow, biconvex, scored tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BETAPAM is used in the treatment of anxiety in neurotic patients, and
for pre-operative medication.
It may be effective in relieving the acute symptoms of the alcohol
withdrawal syndrome.
BETAPAM is only indicated when the disorder is severe, disabling or
when the individual is subject to
extreme stress.
BETAPAM is indicated for the following conditions:
_Anxiety_: symptomatic relief of anxiety, tension and other somatic or
psychological complaints
associated with the anxiety syndrome. It can also be used as an
adjunct to the treatment of anxiety or
excitation associated with psychiatric disorders.
RANBAXY PHARMACEUTICALS (PTY) LTD
(DIAZEPAM)
BETAPAM (L/2.6/185) TABLET/ 5 MG
Page 2 of 15
_Muscle relaxation_: as an adjunct for the relief of reflex muscle
spasm due to local trauma (injury,
inflammation). It can also be used to combat spasticity arising from
damage to spinal and supraspinal
interneurons such as cerebral palsy and paraplegia, as well as
athetosis and stiff-man syndrome.
Treatment should be as short as possible. The patient should be
assessed regularly and the need for
continued treatment should be re-evaluated especially when the patient
is symptom-free. The overall
duration of treatment of anxiety should not be more than 8 to 12
weeks, including a tapering off process.
In certain cases extension beyond the maximum treatment period may be
necessary. If so, it should
not take place without re-evaluation of the patient's status.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DURATION OF TREATMENT
The duration