TRAMAZAC 50 CAPSULES

Land: Sydafrika

Sprog: engelsk

Kilde: South African Health Products Regulatory Authority (SAHPRA)

Tilgængelig fra:

Zydus Healthcare (Pty) Ltd

Dosering:

See ingredients

Lægemiddelform:

CAPSULES

Sammensætning:

EACH CAPSULE CONTAINS TRAMADOL HYDROCHLORIDE 50,0 mg

Autorisation status:

Registered

Autorisation dato:

2007-05-02

Indlægsseddel

Zydus Healthcare SA (Pty) Ltd
TRAMAZAC 50
Tramadol hydrochloride 50 mg
Capsules
Page 1 of 14
PATIENT INFORMATION LEAFLET FOR TRAMAZAC 50
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
TRAMAZAC 50, CAPSULES
TRAMADOL HYDROCHLORIDE
SUGAR FREE._ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TRAMAZAC 50
•
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.
•
TRAMAZAC 50 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 TRAMAZAC 50 is and what it is used for
2.
What you need to know before you take TRAMAZAC 50
3.
How to take TRAMAZAC 50
4.
Possible side effects
5.
How to store TRAMAZAC 50
6.
Contents of the pack and other information.
1.
WHAT TRAMAZAC 50 IS AND WHAT IT IS USED FOR
Tramadol, the active substance in TRAMAZAC 50, is a painkiller
belonging to a class of medicines
called opioids, that acts on the central nervous system. TRAMAZAC 50
is used for the
management of moderate to moderately severe pain.
S5
Zydus Healthcare SA (Pty) Ltd
TRAMAZAC 50
Tramadol hydrochloride 50 mg
Capsules
Page 2 of 14
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMAZAC 50
DO NOT TAKE TRAMAZAC 50
•
If you are hypersensitive (allergic) to tramadol hydrochloride, other
opioid pain-relieving
medicines or any of the other ingredients of TRAMAZAC 50 (listed in
section 6).
•
If you have drunk enough alcohol to make you feel woozy or drunk or if
you have taken more
than the prescribed dose of your sleeping tablets, other painkillers
or psychotropic medicines
(medicines that affect your mood and emotions), which can slow down
your breathing and
reactions.
•
If you are taking monoamine oxidase (MAO) inhibitors (medicine used to
treat depression) or
have taken them in the last 14 days before treatment with TRAMAZAC 50
(see OTHER
MEDICINES AND TRAMAZAC 50).
•
If you have proble

Produktets egenskaber

Zydus Healthcare SA (Pty) Ltd
TRAMAZAC 50
Tramadol hydrochloride 50 mg
Capsules
Page 1 of 17
PROFESSIONAL INFORMATION FOR TRAMAZAC 50
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
TRAMAZAC 50, capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg tramadol (as tramadol hydrochloride).
Sugar free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules.
Size 2 locked hard gelatine capsule with a green cap and green body,
containing white to off-white
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of moderate to moderately severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage should be adjusted to the intensity of pain and the
sensitivity of the individual patient.
In principle, the lowest pain-relieving dose should be selected. In
general, a total oral daily dose of
400 mg of tramadol (equivalent to 8 TRAMAZAC 50 capsules) should not
be exceeded. The
S5
Zydus Healthcare SA (Pty) Ltd
TRAMAZAC 50
Tramadol hydrochloride 50 mg
Capsules
Page 2 of 17
recommended dosages are guidelines.
TRAMAZAC 50 should be taken as follows:
_ADULTS AND CHILDREN OVER_ _12 YEARS_
_Moderate pain:_
Initial dose of 50 mg of tramadol (one TRAMAZAC 50 capsule), followed
by 50 mg or 100 mg 4 – 6
hourly.
_ _
_Severe pain:_
Initial dose of 100 mg followed by 50 mg or 100 mg 4 – 6 hourly.
SPECIAL POPULATIONS
_ELDERLY PATIENTS_
A downward adjustment of the dose and/or prolongation of the interval
between doses are
recommended in the elderly over 75 years.
_PATIENTS WITH RENAL INSUFFICIENCY/DIALYSIS_
In patients with renal insufficiency, the elimination of tramadol
hydrochloride is delayed. In these
patients prolongation of the dosage intervals should be carefully
considered according to the
patient’s requirements. In cases of severe renal insufficiency
TRAMAZAC 50 is not recommended.
_PATIENTS WITH HEPATIC IMPAIRMENT_
In patients with hepatic insufficiency the elimination of tramadol
hydrochloride is delayed. In these
patients prolongation of the dos