TAMSU 400 micrograms modified-release capsules, hard

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Tamsulosin hydrochloride

Beszerezhető a:

Rowex Ltd

ATC-kód:

G04CA; G04CA02

INN (nemzetközi neve):

Tamsulosin hydrochloride

Adagolás:

400 microgram(s)

Gyógyszerészeti forma:

Modified-release capsule, hard

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Alpha-adrenoreceptor antagonists; tamsulosin

Engedélyezési státusz:

Marketed

Engedély dátuma:

2005-12-02

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAMSU 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 Tamsu is and what it is used for
2. What you need to know before you take Tamsu
3. How to take Tamsu
4. Possible side effects
5. How to store Tamsu
6. Contents of the pack and other information
1. WHAT TAMSU IS AND WHAT IT IS USED FOR
Tamsu is used for the treatment of urination symptoms caused by benign
prostatic hyperplasia (BPH -
enlarged prostate).
These symptoms may include difficulty urinating (poor stream),
dribbling, urgency and having to
urinate frequently at night as well as during the day.
The active ingredient in the capsules is a so-called alpha
1A
-blocker that reduces muscle contraction in
the prostate and urethra. This facilitates the flow of urine through
the urethra and aids urination.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMSU
DO NOT TAKE TAMSU

If you are allergic to tamsulosin hydrochloride or any of the other
ingredients of this medicine
(listed in section 6). Allergy to tamsulosin hydrochloride can express
itself as sudden swelling of
hands or feet, difficulties in breathing and/or itch and rash
(angio-oedema).

If you have experienced dizziness or have fainted from lowered blood
pressure (e.g. when
suddenly sitting or standing up).

If you have been found to suffer from severe liver problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tamsu
●
If you have been f

Termékjellemzők

Health Products Regulatory Authority
14 January 2020
CRN009FZ5
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TAMSU 0.4 mg modified-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.4 mg of tamsulosin hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard modified-release capsule.
Orange/olive-green capsules filled with 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
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.
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.
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.).
4.3 CONTRAINDICATIONS
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 alpha 1-adrenoceptor antagonists, the use of tamsulosin
may lower blood pressure, which in rare cases may
cause fainting. If initial symptoms of orthostatic hypotension start
to appear (dizziness, weakness), then the patient should sit
or lie down until the symptoms have gone.
The patient should be examined before commencement of therapy with
tamsulosin to exclude the presence of other
conditions that can produce similar symptoms to those of BPH. The
prostate should be examined via