Stronazon 400microgram MR capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tamsulosin hydrochloride

Available from:

Actavis UK Ltd

ATC code:

G04CA02

INN (International Name):

Tamsulosin hydrochloride

Dosage:

400microgram

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040100; GTIN: 5012617015310

Patient Information leaflet

Tamsulosin (Stronazon) 0.4mg Capsules 30pk PIL - UK
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min pt size:
TECHNICAL APPROVAL
AAAE3366
5
17.12.12
DR
02.01.13
DR
Synthon Spain
170x240
8pts
24.09.12
01.10.12
STRONAZON 400MICROGRAMS
MR 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
your 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
WHAT IS IN THIS LEAFLET:
1
WHAT STRONAZON IS AND WHAT IT
IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
STRONAZON
3
HOW TO TAKE STRONAZON
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE STRONAZON
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT STRONAZON IS AND WHAT IT IS USED FOR
Stronazon modified-release capsules are used to treat
symptoms caused by an enlarged prostate gland (benign
prostatic hyperplasia BPH).
The prostate gland surrounds the urethra (the tube with
which urine passes from the bladder). When the prostate
gland is enlarged it presses on the urethra causing it to
narrow, so that it is difficult to pass urine.
Stronazon modified-release capsules relax the muscles in
the prostate gland, making the urethra wider and easing
the passing of urine.
Before starting treatment with Stronazon, your doctor may
w

Summary of Product characteristics

OBJECT 1
STRONAZON 400 MICROGRAMS MR CAPSULES
Summary of Product Characteristics Updated 17-Jan-2013 | Accord-UK Ltd
1. Name of the medicinal product
Stronazon 400 micrograms MR Capsules
2. Qualitative and quantitative composition
One capsule contains 0.4 mg of tamsulosin hydrochloride.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Modified-release capsule, hard
Orange/olive-green capsule, with the black printed mark TSL 0.4 and
with a black stripe at both ends.
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
Posology
One capsule a day after breakfast or the first meal of the day.
Method of administration
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
4.3 Contraindications
Hypersensitivity to the active substance 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
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 the rectum and, if necessary, the prostate specific
antigen PSA count determined prior to
commencement of treatmen