Tamsulosin Hydrochloride 400 micrograms Modified-release Capsules, hard

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Tamsulosin hydrochloride

Доступна з:

Synthon BV

Код атс:

G04CA; G04CA02

ІПН (Міжнародна Ім'я):

Tamsulosin hydrochloride

Дозування:

400 microgram(s)

Фармацевтична форма:

Modified-release capsule, hard

Адміністрація маршрут:

Oral use

Одиниць в упаковці:

Pack containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200 modified-release capsules

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична група:

alfa
1-adrenoceptor antagonist

Терапевтична области:

Alpha-adrenoreceptor antagonists; tamsulosin

Терапевтичні свідчення:

Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

Статус Авторизація:

Not marketed

Дата Авторизація:

2006-01-20

інформаційний буклет

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M1.3.1_03.TSL.hcl.mrc.037.06.IE.1620.05
1.3.1
Package Leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS, MODIFIED-RELEASE CAPSULE,
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.
IN THIS LEAFLET
:
1.
What Tamsulosin hydrochloride 400 micrograms is and what it is used
for
2.
What you need to know before you take Tamsulosin hydrochloride 400
micrograms
3.
How to take Tamsulosin hydrochloride 400 micrograms
4.
Possible side effects
5.
How to store Tamsulosin hydrochloride 400 micrograms
6.
Contents of the pack and other information
1.
WHAT TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS IS AND WHAT IT IS USED
FOR
Tamsulosin is an alpha
1A
-adrenoreceptor blocker. It relaxes the muscles in the prostate and
urinary
tract.
Tamsulosin is prescribed to alleviate urinary symptoms caused by an
enlarged prostrate (benign
prostatic hyperplasia). By relaxing the muscle it enables a more
easily pass of urine and helps
urination.
2.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMSULOSIN HYDROCHLORIDE 400
MICROGRAMS
DO NOT TAKE TAMSULOSIN HYDROCHLORIDE 400 MICROGRAMS
IF YOU:

are
ALLERGIC
to tamsulosin or any of the other ingredients of this medicine (listed
in section 6)
(symptoms may include:
SWELLING OF YOUR FACE AND THROAT
(angio-oedema)).

have a history of a fall in blood pressure on standing up, which
causes
DIZZINESS, LIGHT-
HEADEDNESS OR FAINTING
.

have
SEVERE LIVER PROBLEMS
_ _
2/6
M1.3.1_03.TSL.hcl.mrc.037.06.IE.1620.05
WARNINGS AND PRECAUTIONSTAMSULO

Характеристики продукта

Health Products Regulatory Authority
27 January 2021
CRN00C0R7
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamsulosin hydrochloride 400 micrograms modified-release capsules,
hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains as active ingredient tamsulosin hydrochloride
400 micrograms.
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Modified-release capsule, hard
Orange/olive-green capsule (19.3 x 6.4 mm). The capsules contain white
to off-white 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
Oral use
Posology
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
One capsule daily, to be taken after breakfast or the first meal of
the day.
The capsule must be swallowed whole and must not be crunched or
chewed, as this interferes with the modified release of the
active ingredient.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, 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
Health Products Regulatory Authority
27 January 2021
CRN00C0R7
Page 2 of 7
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
di