Tamsulosin 400 micrograms Modified-release Capsules, Hard

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Tamsulosin hydrochloride

Dostupné z:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC kód:

G04CA; G04CA02

INN (Medzinárodný Name):

Tamsulosin hydrochloride

Dávkovanie:

400 microgram(s)

Forma lieku:

Modified-release capsule, hard

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Alpha-adrenoreceptor antagonists; tamsulosin

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2006-03-24

Príbalový leták

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAMSULOSIN 400 MICROGRAMS MODIFIED-RELEASE CAPSULES, 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 Tamsulosin is and what it is used for
2.
What you need to know before you take Tamsulosin
3.
How to take Tamsulosin
4.
Possible side effects
5.
How to store Tamsulosin
6.
Contents of the pack and further information
1. WHAT TAMSULOSIN IS AND WHAT IT IS USED FOR
Tamsulosin contains the
active ingredient tamsulosin hydrochloride which belongs to a group of
medicines called alpha-adrenoreceptor antagonists (alpha 1A-blockers).
These medicines are used to
reduce muscle contraction in the prostate and urethra. This
facilitates the flow of urine through the
urethra and aids urination.
Tamsulosin is used for the treatment of lower urinary tract symptoms
caused by an enlarged prostate,
known as benign prostatic hyperplasia (BPH).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMSULOSIN
DO NOT TAKE TAMSULOSIN:
•
If you are allergic to tamsulosin or any of the other ingredients of
this medicine (listed in section
6). Allergy to tamsulosin can express itself as sudden swelling of
hands or feet, difficulties in
breathing and/or itch and rash swollen lips, tongue or throat,
(angioedema).
•
If you have experienced dizziness or have fainted due to lowered blood
pressure (e.g. when
suddenly sitting or standing up).
•
If you have severe liver problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist bef

Súhrn charakteristických

Health Products Regulatory Authority
09 March 2021
CRN009ZR1
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamsulosin 400 micrograms Modified-release Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 400 micrograms of tamsulosin hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release capsule, hard
Orange body/olive-green cap. The capsules contain white to off-white
spheres.
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 a day to be taken after breakfast or the first meal of the
day.
_Patients with renal impairment_
No dose adjustment is warranted in renal impairment.
_Patients with hepatic impairment_
No dose adjustment is warranted in patients with mild to moderate
hepatic insufficiency (see also section 4.3,
Contraindications).
_Paediatric population_
The safety and efficacyof tamsulosin in children < 18 years have not
been established. Currently available data are described in
section 5.1.
Method of administration
For oral use.
Thecapsulemust be swallowedwholeand must not be crunched or chewed as
this interferes with the modified release of
theactiveingredient.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance, 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
Health Products Regulatory Authority
09 March 2021
CRN009ZR1
Page 2 of 7
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.
Before therapy with tam