TAMSULOSIN 0,4 BIOTECH CAPSULES

Pays: Afrique du Sud

Langue: anglais

Source: South African Health Products Regulatory Authority (SAHPRA)

Disponible depuis:

Biotech Laboratories (Pty) Ltd

Dosage:

See ingredients

forme pharmaceutique:

CAPSULES

Composition:

EACH CAPSULE CONTAINS TAMSULOSIN HYDROCHLORIDE 0,4 mg

Statut de autorisation:

Registered

Date de l'autorisation:

2009-04-12

Notice patient

Biotech Laboratories (Pty) Ltd.
Module 1.3.2 Patient Information Leaflet
TAMSULOSIN 0,4 BIOTECH
(Each capsule contains 0,4 mg tamsulosin hydrochloride
42/18.10/0478-– registered)
Page
1
of
9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
TAMSULOSIN 0,4 BIOTECH, 0,4 MG SUSTAINED RELEASE CAPSULES
TAMSULOSIN HYDROCHLORIDE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TAMSULOSIN
0,4 BIOTECH:
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare provider.
•
TAMSULOSIN 0,4 BIOTECH 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.
•
If side effects get serious or you notice side effects not listed,
please tell your doctor.
WHAT IS IN THIS LEAFLET
1. What TAMSULOSIN 0,4 BIOTECH is and what it is used for
2. What you need to know before you take TAMSULOSIN 0,4 BIOTECH
3. How to take TAMSULOSIN 0,4 BIOTECH
4. Possible side effects
5. How to store TAMSULOSIN 0,4 BIOTECH
6. Contents of the pack and other information
1. WHAT TAMSULOSIN 0,4 BIOTECH IS AND WHAT IT IS USED FOR
Biotech Laboratories (Pty) Ltd.
Module 1.3.2 Patient Information Leaflet
TAMSULOSIN 0,4 BIOTECH
(Each capsule contains 0,4 mg tamsulosin hydrochloride
42/18.10/0478-– registered)
Page
2
of
9
Your medicine is in the form of a modified release hard capsule. This
means that the capsule releases the drug
slowly into the body.
TAMSULOSIN 0,4 BIOTECH capsules contain tamsulosin hydrochloride,
which belongs to a group of medicine
called alpha-blockers.
It reduces tension of the smooth muscles in the prostate and the
urethra, enabling urine to pass more readily
through the urethra and facilitating urination. In addition, it
diminishes sensations of urge.
TAMSULOSIN 0,4 BIOTECH can be given to men suffering from an enlarged
prostate gland (benign prostatic
hyperplasia), because it relaxes the muscles allowing urine to be
passe

Résumé des caractéristiques du produit

Biotech Laboratories (Pty) Ltd.
Module 1.3.1.1 Professional Information
TAMSULOSIN 0,4 BIOTECH
(Each capsule contains 0,4 mg tamsulosin hydrochloride
42/18.10/0478-– registered)
_ _
_ _
Page
1
of
13
SCHEDULING STATUS
S4
1 NAME OF THE MEDICINE
TAMSULOSIN 0,4 BIOTECH,
sustained release, capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TAMSULOSIN 0,4 BIOTECH capsule contains: 0,4 mg tamsulosin
hydrochloride.
Sugar free.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Sustained release capsules
TAMSULOSIN 0,4 BIOTECH capsules are yellow (body) and light-green
(cap) in colour. The mark ‘TML
0,4’ is printed on the capsule in black. The capsules contain white
to slightly yellowish pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TAMSULOSIN 0,4 BIOTECH is indicated for the treatment of functional
symptoms of benign prostatic
hyperplasia (BPH) in adult males.
Efficacy in children with neurogenic bladder has not been
demonstrated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Biotech Laboratories (Pty) Ltd.
Module 1.3.1.1 Professional Information
TAMSULOSIN 0,4 BIOTECH
(Each capsule contains 0,4 mg tamsulosin hydrochloride
42/18.10/0478-– registered)
_ _
_ _
Page
2
of
13
POSOLOGY
One TAMSULOSIN 0,4 BIOTECH sustained release capsule to be taken daily
after breakfast.
METHOD OF ADMINISTRATION
Oral administration
TAMSULOSIN 0,4 BIOTECH should be swallowed whole with water (about 150
ml) in the standing or sitting
position.
TAMSULOSIN 0,4 BIOTECH should not be crunched or chewed, as this will
interfere with the sustained
release property of the active ingredient.
4.3 CONTRAINDICATIONS
TAMSULOSIN 0,4 BIOTECH is contra-indicated in the following
conditions:
•
In patients hypersensitive to tamsulosin hydrochloride or to any of
the excipients of TAMSULOSIN 0,4
BIOTECH, listed in section 6.1.
•
A history of orthostatic hypotension.
•
Hepatic insufficiency.
•
TAMSULOSIN 0,4 BIOTECH should not be used in combination with strong
inhibitors of CYP3A4, e.g.,
ketoconazole (see section 4.5