Tamsuda 0,4 mg, tabletten met verlengde afgifte

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,367 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

G04CA02

INN (Algemene Internationale Benaming):

TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,367 mg/stuk

farmaceutische vorm:

Tablet met verlengde afgifte

Samenstelling:

CARBOMEER 71G-NF ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tamsulosin

Product samenvatting:

Hulpstoffen: CARBOMEER 71G-NF; CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); IJZEROXIDE ROOD (E 172); MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551);

Autorisatie datum:

2011-02-15

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAMSUDA 0,4 MG, TABLETTEN MET VERLENGDE AFGIFTE
Tamsulosine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any of the side effects, talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
Tamsulosin relaxes the muscles in the prostate and urinary tract. By
relaxing the muscle
tamsulosin enables a more easily pass of urine and helps urination. In
addition, it diminishes
sensations of urge.
Tamsulosin is prescribed in men to alleviate urinary symptoms caused
by an enlarged
prostrate (benign prostatic hyperplasia). These symptoms may include
difficulty urinating
(poor stream), dribbling, urgency and having to urinate frequently at
night as well as during
the day.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE IF YOU:

Are ALLERGIC TO TAMSULOSIN OR ANY OF THE OTHER INGREDIENTS of this
medicine (listed in
section 6). Hypersensitivity may present a sudden local swelling of
the soft tissues of the
body (e.g. the throat or tongue), difficult breathing and/or itching
and rash (angioedema).

Have a history of a fall in blood pressure on standing up, which
causes DI

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Tamsuda 0,4 mg, tabletten met verlengde afgifte
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 0.400 mg 400 microgram
tamsulosin hydrochloride,
equivalent to 0.367 mg 367 microgram tamsulosin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Prolonged-release tablet.
White, unscored, round tablets with a diameter of 9 mm, debossed on
one side with "T9SL”
and “0.4” on the other side
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lower urinary tract symptoms (LUTS) associated with benign prostatic
hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
One tablet daily.
Tamsulosin can be taken independently of food.
The tablet must be swallowed whole and not be crunched or chewed as
this interferes with
the prolonged release of the active substance.
No dose adjustment is warranted in renal impairment.
No dose adjustment is warranted in patients with mild to moderate
hepatic insufficiency (see
also 4.3, Contraindications).
_Paediatric population _
The safety and efficacy of tamsulosin in children < 18 years have not
been established.
Currently available data are described in section 5.1.
There is no relevant indication for use of tamsulosin in children.
4.3 CONTRAINDICATIONS

Hypersensitivity to tamsulosin hydrochloride, including drug-induced
angioedema or to
any of the excipients listed in section 6.1.

A history of orthostatic hypotension.

Severe hepatic insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other α
1
-adrenoceptors antagonists, a reduction in blood pressure can occur in
individual cases during treatment with tamsulosin, as a result of
which, rarely, syncope can
occur. At the first signs of orthostatic hypotension (dizziness,
weakness), the patient should
sit or lie down until the symptoms have disappeared.
Before therapy with tamsulosin is initiated, the patient should be
examined in order to
exclude the presence of othe