BENIPROSIN SR CAPSULES

Maa: Etelä-Afrikka

Kieli: englanti

Lähde: South African Health Products Regulatory Authority (SAHPRA)

Saatavilla:

Ranbaxy Pharmaceutical (Pty) Ltd û Roodepoort

Annos:

See ingredients

Lääkemuoto:

CAPSULES

Koostumus:

EACH CAPSULE CONTAINS TAMSULOSIN HYDROCHLORIDE 0,4 mg

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2008-09-12

Pakkausseloste

Page 1 of 8
SCHEDULING STATUS:
S4
1. NAME OF THE MEDICINE
BENIPROSIN SR
Tamsulosin hydrochloride 0,4 mg (capsules)
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING BENIPROSIN
SR

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or pharmacist,
nurse or other health
care provider.

BENIPROSIN SR 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 BENIPROSIN SR is and what it is used for
2.
What you need to know before you take BENIPROSIN SR
3.
How to use BENIPROSIN SR
4.
Possible side effects
5.
How to store BENIPROSIN SR
6.
Contents of the pack and other information
1.WHAT BENIPROSIN SR IS AND WHAT IT IS USED FOR
BENIPROSIN SR capsules contains tamsulosin hydrochloride 0,4 mg
Page 2 of 8
BENIPROSIN SR capsules are indicated for the treatment of functional
symptoms of benign
prostatic hyperplasia (BPH).
2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENIPROSIN SR
DO NOT TAKE BENIPROSIN SR :

If you are hypersensitive (allergic) to tamsulosin
hydrochloride or any of the other ingredients of BENIPROSIN SR.
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue.

If you suffer from dizziness when you want to sit up or stand up from
the lying position

If you suffer from serious infection of the liver.

If you have a history of fainting while urinating or right after
urinating

If you are using in combination with ketoconazole (a strong CYP3A4
inhibitor) used to
treat fungal infections
Do not take BENIPROSIN SR if any of the above applies to you.
If you are not sure, talk to your doctor or pharmacist before
receiving BENIPROSIN SR. Do this
even if they have applied in the past
WARNINGS AND PRECAUTIONS
BENIPROSIN SR capsules are intended for male patients only
TAKE SPECIAL CARE WITH BENIPROSIN SR :

If you have a de

Valmisteyhteenveto

Page 1 of 11
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
BENIPROSIN SR ( Capsule 0,4 mg)
2. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BENIPROSIN SR
Each capsule contains tamsulosin hydrochloride 0,4 mg
Sugar free.
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule
Brown, opaque cap/ orange opaque body, of size '2' imprinted with 'R'
on cap and 'TSN400' on body in
black edible ink, containing white to off-white granular beads.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
BENIPROSIN SR capsules are indicated for the treatment of functional
symptoms of benign prostatic
hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
One 0,4 mg of BENIPROSIN SR capsule to be taken daily after breakfast
or after first daily meal
BENIPROSIN SR capsules should be swallowed whole with water (about 150
ml) in the standing or
sitting position.
BENIPROSIN SR capsules should not be crushed or chewed, as this will
interfere with the sustained
release property of this active ingredient
.
Page 2 of 11
4.3 CONTRAINDICATIONS:
BENIPROSIN SR capsules are contra-indicated in the following
conditions:

In patients hypersensitive to tamsulosin hydrochioride or any other
components of the product.

A history of orthostatic hypotension.

Hepatic insufficiency.

Micturition syncope history

Should not be used in combinations with strong inhibitors of CYP3A4 eg
ketoconazole (See
section 4.5)
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A
decrease in blood pressure with orthostatic hypotension and syncope
may occur during treatment with
BENIPROSIN SR. At the first signs of orthostatic hypotension
(dizziness, weakness), the patient should
sit or lie down until the symptoms have disappeared.
Before therapy with BENIPROSIN SR is initiated, the patient should be
examined in order to exclude the
presence of other conditions, which can cause the same symptoms as
benign prostatic hyperplasia.
Digital rectal
examination, and when necessary, determination of prostate specific
ant