TANYZ 400 micrograms hard modified-release capsules

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Tamsulosin hydrochloride

Доступно од:

KRKA, d.d., Novo mesto

АТЦ код:

G04CA; G04CA02

INN (Међународно име):

Tamsulosin hydrochloride

Дозирање:

400 microgram(s)

Фармацеутски облик:

Modified-release capsule, hard

Терапеутска област:

Alpha-adrenoreceptor antagonists; tamsulosin

Статус ауторизације:

Marketed

Датум одобрења:

2019-08-13

Информативни летак

direction on fibre
direction of reading PhC
70 mm ± 0,5 mm
70 mm ± 0,5 mm
direction of reading PhC
Leaflet folded on middle with visibly first side (title);
PhC that comes out of the middle of leaflet must be visible!/
148 mm ± 0,5 mm
420 mm ± 0,8 mm
_ - PMS-433U-KRKA_
_XX PL. TANYZ IE_ first page
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TANYZ 400 micrograms
hard modified-release capsules
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 TANYZ is and what it is used for
2. What you need to know before you take TANYZ
3. How to take TANYZ
4. Possible side effects
5. How to store TANYZ
6. Contents of the pack and other information
1. What TANYZ is and what it is used for
WHAT IS TANYZ
The active ingredient in TANYZ is tamsulosin hydrochloride. This
is a selective α
1A/1D
-adrenoceptor antagonist. 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.
TANYZ is used in men for the treatment of the complaints of the
lower urinary tract associated with an enlarged prostatic gland
(benign prostatic hyperplasia). 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
TANYZ
DO NOT TAKE TANYZ
• if you are ALLERGIC TO TAMSULOSIN OR ANY OF THE OTHER
INGREDIENTS OF THIS MEDICINE (list

Карактеристике производа

Health Products Regulatory Authority
01 November 2023
CRN00DT43
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TANYZ 400 micrograms hard modified-release capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard modified-release capsule contains 400 micrograms tamsulosin
hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard modified-release capsule
Orange/olive-green capsule. The capsules contain white to off-white
pellets. Capsule dimensions: 19.3 mm x 6.4 mm.
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
_Posology_
One capsule daily, to be taken after breakfast or the first meal of
the day.
_ _
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_
There is no relevant indication for use of tamsulosin in children.
The safety and efficacy of tamsulosine in children <18 years have not
been established. Currently available data are described
in section 5.1
Method of administration
For oral use.
The capsule should not be broken or pulled apart as this may have an
effect on the release of the long-acting active ingredient.
4.3 CONTRAINDICATIONS
Hypersensitivity to tamsulosin hydrochloride, including drug-induced
angio-oedema, 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.
Health Products Regulatory Authority
01 November 2023
CRN00