Tabphyn MR 400microgram capsules

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Tamsulosin hydrochloride

可用日期:

Genus Pharmaceuticals Ltd

ATC代码:

G04CA02

INN（国际名称）:

Tamsulosin hydrochloride

剂量:

400microgram

药物剂型:

Modified-release capsule

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 07040100; GTIN: 5030451003263

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TABPHYN
TM
MR 400 MICROGRAM 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 Tabphyn
TM
MR 400 microgram Capsules are
and what they are used for
2.
What you need to know before you take Tabphyn
TM
MR 400 microgram Capsules
3.
How to take Tabphyn
TM
MR 400 microgram
Capsules
4.
Possible side-effects
5.
How to store Tabphyn
TM
MR 400 microgram
Capsules
6.
Contents of the pack and other information
1.WHAT TABPHYN
TM
MR 400
MICROGRAM CAPSULES ARE AND
WHAT THEY ARE USED FOR
Tamsulosin is an α
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 urine to be passed more easily and helps
urination.
2.WHAT YOU NEED TO KNOW BEFORE
YOU TAKE TABPHYN
TM
MR 400
MICROGRAM CAPSULES
DO NOT TAKE TABPHYN
TM
MR 400
MICROGRAM CAPSULES 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.
TABPHYN
TM
MR 400 MICROGRAM CAPSULES
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Tabphyn
TM
MR 400 microgram Capsules if you:
•
experience d

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tabphyn MR 400 microgram 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. 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
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.
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
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 disappeared.
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 PSA count determined prior to
commencement
of treatment and again later at regular intervals.
The treatment of severely renally impaired patients (creatinine
clearance of <
10 ml/m