UROTAL CAPSULES

País: Sudáfrica

Idioma: inglés

Fuente: South African Health Products Regulatory Authority (SAHPRA)

Disponible desde:

ALKEM LABORATORIES (PTY) LTD

Dosis:

0,4 mg

formulario farmacéutico:

CAPSULES

Composición:

TAMSULOSIN HYDROCHLORIDE

Estado de Autorización:

Registered

Información para el usuario

PROPRIETARY NAME:
UROTAL
DOSAGE FORM:
Capsules
ACTIVE INGREDIENT:
Tamsulosin hydrochloride
STRENGTH PER DOSAGE UNIT:
0,4 mg per capsule
Version: 23 February 2023
Page 1 of 9
1.3.2
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
UROTAL 0,4 mg (capsules)
Sugar free
PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING UROTAL.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or your
pharmacist.
•
UROTAL 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 UROTAL is and what it is used for
2.
What you need to know before you take UROTAL
3.
How to take UROTAL
4.
Possible side effects
5.
How to store UROTAL
6.
Contents of the pack and other information
PROPRIETARY NAME:
UROTAL
DOSAGE FORM:
Capsules
ACTIVE INGREDIENT:
Tamsulosin hydrochloride
STRENGTH PER DOSAGE UNIT:
0,4 mg per capsule
Version: 23 February 2023
Page 2 of 9
1.
WHAT UROTAL IS AND WHAT IT IS USED FOR
UROTAL acts by relaxing the muscles in the prostate and urethra (the
tube that carries urine to the
outside), and lets urine pass more readily through the urethra and
assist with urination.
In the prostate gland, bladder, and urethra there are specialised
cells containing alpha
1A
-receptors
that cause the muscles in the urethra to tighten. UROTAL is an alpha
1A
-adrenoceptor blocker, which
reduces the action of these specialised cells and relaxes the muscles
making it easier to pass
water.
UROTAL is used in men to treat the symptoms associated with benign
prostatic hyperplasia (BPH)
which is enlargement of the prostate. These symptoms include
difficulty in starting to pass water,
frequent trips to the toilet to pass water, a feeling of not
completely emptying the bladder and
having to get up several times in the night to pass water.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE UROTAL:
DO NOT TAKE UROTAL IF:
•

Ficha técnica

PROPRIETARY NAME:
UROTAL
DOSAGE FORM:
Capsules
ACTIVE INGREDIENT:
Tamsulosin hydrochloride
STRENGTH PER DOSAGE UNIT:
0,4 mg per capsule
Version: 23 February 2023
Page 1 of 15
1.3.1.1
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1
NAME OF THE MEDICINE
UROTAL 0,4 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0,4 mg of tamsulosin hydrochloride.
Excipients with known effect:
Sugar-free.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White to off white pellets filled in hard gelatin capsule size "1"
Olive green opaque cap &
orange opaque body imprinted with "TAM" on cap and "0.4 mg" on body in
black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
UROTAL is indicated for the treatment of functional symptoms of benign
prostatic hyperplasia
(BPH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
One capsule daily to be taken after breakfast or the first meal of the
day.
PROPRIETARY NAME:
UROTAL
DOSAGE FORM:
Capsules
ACTIVE INGREDIENT:
Tamsulosin hydrochloride
STRENGTH PER DOSAGE UNIT:
0,4 mg per capsule
Version: 23 February 2023
Page 2 of 15
_SPECIAL POPULATIONS _
_Renal Impairment: _
No dose adjustment is warranted in renal impairment.
_Hepatic impairment: _
No dose adjustment is warranted in patients with mild to moderate
hepatic insufficiency (see
section 4.3).
METHOD OF ADMINISTRATION:
For oral use.
The capsule should be swallowed whole and should not be crunched or
chewed, as this will
interfere with the sustained release property of the active
ingredient.
4.3
CONTRAINDICATIONS
UROTAL is contraindicated in:
•
known hypersensitivity to tamsulosin hydrochloride, or to any of the
excipients listed
in section 6.1.
•
a history of orthostatic hypotension.
•
severe hepatic insufficiency.
•
combination with strong inhibitors of CYP3A4, e.g. ketoconazole (see
section 4.5)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Orthostatis: _
A reduction in blood pressure can occur during treatment with UROTAL,
as a result of which,
orthostatic hypotension and sy