ZEDRAST CAPSULES

Pajjiż: Afrika t’Isfel

Lingwa: Ingliż

Sors: South African Health Products Regulatory Authority (SAHPRA)

Disponibbli minn:

Zydus Healthcare (Pty) Ltd

Dożaġġ:

See ingredients

Għamla farmaċewtika:

CAPSULES

Kompożizzjoni:

EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg

L-istatus ta 'awtorizzazzjoni:

Registered

Fuljett ta 'informazzjoni

Zydus Healthcare SA (Pty) Ltd
ZEDRAST
0,5 mg soft capsules
Page 1 of 10
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
ZEDRAST 0,5 MG SOFT CAPSULES
DUTASTERIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ZEDRAST.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or
pharmacist.
•
ZEDRAST 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 ZEDRAST IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEDRAST
3.
HOW TO TAKE ZEDRAST
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ZEDRAST
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
Zydus Healthcare SA (Pty) Ltd
ZEDRAST
0,5 mg soft capsules
Page 2 of 10
1.
WHAT ZEDRAST IS AND WHAT IT IS USED FOR
ZEDRAST contains the active substance dutasteride that belongs to a
group of medicines
called 5 alpha-reductase inhibitors. ZEDRAST is used in men to treat
prostate enlargement,
also referred to as benign prostatic hyperplasia (BPH). BPH is an
increased growth of the
prostate gland and is caused by your body producing too much of a
hormone called
dihydrotestosterone.
ZEDRAST decreases your body’s production of dihydrotestosterone,
thereby reducing the
size of your enlarged prostate and relieving accompanying symptoms,
such as difficulty
passing urine and an urge to urinate more often than usual. By doing
this, ZEDRAST lowers
the need for surgery in men with enlarged prostates.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEDRAST
DO NOT TAKE ZEDRAST
•
If you are hypersensitive (allergic) to dutasteride or any of the
other ingredients of
ZEDRAST listed in section 6 of this leaflet.
•
If you are a women.
•
If you are a child or adolescent younger than 18 years old.
•
If you have severe liver disease.
WARNINGS AND PRECAUTIONS
_TAKE SPECIAL CARE WITH ZEDRAST: _
•
Before you start and while you are taking ZEDRAST, your doctor may
examine and
eva

Karatteristiċi tal-prodott

Zydus Healthcare SA (Pty) Ltd
ZEDRAST
0,5 mg soft capsules
Page 1 of 18
PROFESSIONAL INFORMATION FOR ZEDRAST
SCHEDULING STATUS
S4
1.
NAME OF THE MEDICINE
ZEDRAST 0,5 mg soft capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0,5 mg dutasteride.
Preservatives: 0,2 % _m/m_ methyl hydroxybenzoate and 0,03 % _m/m_
propyl
hydroxybenzoate.
Sugar free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, soft.
Opaque, yellow, oblong shaped soft gelatine capsules containing a
clear, colourless to
slightly yellowish oily liquid.
Zydus Healthcare SA (Pty) Ltd
ZEDRAST
0,5 mg soft capsules
Page 2 of 18
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZEDRAST is indicated for the treatment of benign prostatic hyperplasia
(BPH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULT MALES (INCLUDING ELDERLY) _
The recommended dose of ZEDRAST_ _is one capsule (0,5 mg) taken orally
once a day. The
capsules should be swallowed whole.
ZEDRAST may be taken with or without food.
Although an improvement may be observed at an early stage, treatment
for at least six
months may be necessary in order to assess objectively whether a
satisfactory response to
the treatment can be achieved.
_RENAL IMPAIRMENT _
The effect of renal impairment on dutasteride pharmacokinetics has not
been studied.
However, no adjustment in dosage is anticipated for patients with
renal impairment (see
section 5.2).
_HEPATIC IMPAIRMENT _
The effect of hepatic impairment on dutasteride pharmacokinetics has
not been studied (see
sections 4.4 and 5.2).
Zydus Healthcare SA (Pty) Ltd
ZEDRAST
0,5 mg soft capsules
Page 3 of 18
4.3
CONTRAINDICATIONS
ZEDRAST is contraindicated in:
•
Patients with hypersensitivity to dutasteride, other 5α-reductase
inhibitors or to any of the
excipients of ZEDRAST.
•
Women (see section 4.6).
•
Children and adolescents younger than 18 years (see section 4.4).
•
Patients with severe hepatic impairment.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Careful benefit risk assessment is r