Tamsulosine HCL Sandoz retard capsule 0,4 mg, capsules met gereguleerde afgifte, hard

Nazione: Paesi Bassi

Lingua: olandese

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

Principio attivo:

TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk

Commercializzato da:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Codice ATC:

G04CA02

INN (Nome Internazionale):

TAMSULOSINEHYDROCHLORIDE 0,4 mg/stuk SAMENSTELLING overeenkomend met ; TAMSULOSINE 0,37 mg/stuk

Forma farmaceutica:

Capsule met gereguleerde afgifte, hard

Composizione:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) (E 1206) ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; NATRIUMLAURILSULFAAT (E 487) ; PATENTBLAUW V (E131) ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Via di somministrazione:

Oraal gebruik

Area terapeutica:

Tamsulosin

Dettagli prodotto:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); NATRIUMLAURILSULFAAT (E 487); PATENTBLAUW V (E131); POLYSORBAAT 80 (E 433); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Data dell'autorizzazione:

1900-01-01

Foglio illustrativo

Sandoz B.V.
Pagina 1
Tamsulosine HCL Sandoz retard capsule 0,4 mg, capsules met
gereguleerde afgifte, hard
RVG 33747
1313-V16
1.3.1.3 Bijsluiter
September 2019
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAMSULOSINE HCL SANDOZ RETARD CAPSULE 0,4 MG, CAPSULES MET
GEREGULEERDE AFGIFTE, HARD
tamsulosin 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 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 [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1 WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
The active substance of [Nationally completed name] is tamsulosin.
This is an alpha-1-receptor
blocker that reduces the ability to contract the muscles in the
prostate and urethra. As a result, the
urethra, which runs through the prostate, is less constricted so that
urinating is easier. In addition, it
diminishes sensations of urge.
[Nationally completed name] is used by men for the treatment of
complaints in the lower urinary tract
that occur in benign prostate enlargement. These complaints 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 [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
−
if you are allergic to tamsulosin or any of the other ingredients

Scheda tecnica

Sandoz B.V.
Pagina 1/9
Tamsulosine HCI retard 0,4 mg, capsules met gereguleerde afgifte, hard
RVG 33747
1311-V11
1.3.1.1 Samenvatting van de productkenmerken
September 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamsulosine HCl Sandoz retard capsule 0,4 mg, capsules met
gereguleerde afgifte, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard modified-release capsule contains 0.4 mg of tamsulosin
hydrochloride.
For the full list of excipients, see 6.1.
3
PHARMACEUTICAL FORM
Hard modified-release capsule.
Light green/yellow hard modified-release capsules filled with white to
slightly yellowish pellets.
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
One capsule a day after breakfast or the first meal of the day. The
capsule is swallowed whole with a
glass of water while standing or sitting (not lying down). The capsule
should not be broken or pulled
apart as this may have an effect on the release of the long-acting
active ingredient.
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
4.3
CONTRAINDICATIONS
Sandoz B.V.
Pagina 2/9
Tamsulosine HCI retard 0,4 mg, capsules met gereguleerde afgifte, hard
RVG 33747
1311-V11
1.3.1.1 Samenvatting van de productkenmerken
September 2019
Hypersensitivity to tamsulosin, including drug-induced angio-oedema,
or to any of the excipients
listed in section 6.1.
Orthostatic hypotension observed earlier (history of orthostatic
hypotension).
Severe hepatic insufficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other α1-blockers the use of tamsulosin may lower blood
pressure, which in rare cases may
cause fainting. If initial s