Tamzeltos 400 micrograms prolonged-release tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Tamsulosin hydrochloride

Предлага се от:

KRKA, d.d., Novo mesto

АТС код:

G04CA; G04CA02

INN (Международно Name):

Tamsulosin hydrochloride

дозиране:

400 microgram(s)

Лекарствена форма:

Prolonged-release tablet

Терапевтична област:

Alpha-adrenoreceptor antagonists; tamsulosin

Статус Оторизация:

Marketed

Дата Оторизация:

2019-11-29

Листовка

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
_ - blackU_
_PL. Tamzeltos 400mcg IE_ first page
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Tamzeltos 400 micrograms
prolonged-release tablets
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 Tamzeltos is and what it is used for
2. What you need to know before you take Tamzeltos
3. How to take Tamzeltos
4. Possible side effects
5. How to store Tamzeltos
6. Contents of the pack and other information
1. What Tamzeltos is and what it is used for
The active ingredient in Tamzeltos is tamsulosin. This is a
selective alpha
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.
Tamzeltos 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
Tamzeltos
DO NOT TAKE TAMZELTOS IF YOU:
• are ALLERGIC TO TAMSULOSIN OR ANY OF THE OTHER INGREDIENTS of
this me

Данни за продукта

Health Products Regulatory Authority
01 November 2023
CRN00DT45
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamzeltos 400 micrograms prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 400 micrograms tamsulosin
hydrochloride.
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
Posology
One tablet daily.
Tamsulosin can be taken independently of food.
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 Tamzeltos 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
Oral use.
The tablet must be swallowed whole and not be crunched or chewed as
this interferes with the prolonged release of the active
substance.
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.
Health Products Regulatory Authority
01 November 2023
CRN00DT45
Page 2 of 7
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other α
1
-adrenoceptor 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.
Bef