Contiflo XL 400microgram capsules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Tamsulosin hydrochloride

Prieinama:

Sun Pharma UK Ltd

ATC kodas:

G04CA02

INN (Tarptautinis Pavadinimas):

Tamsulosin hydrochloride

Dozė:

400microgram

Vaisto forma:

Modified-release capsule

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 07040100; GTIN: 5015525030512

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
CONTIFLO XL 400 MICROGRAMS PROLONGED 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 Contiflo XL is and what it is used for
2.
What you need to know before you take Contiflo XL
3.
How to take Contiflo XL
4.
Possible side effects
5.
How to store Contiflo XL
6.
Contents of the pack and other information
1.
WHAT CONTIFLO XL_ _IS AND WHAT IT IS USED FOR
The active ingredient in Contiflo XL is tamsulosin. This is a
selective

1A/1D
-adrenoceptor
antagonist. It reduces tension of the smooth muscles in the prostate
and the urethra, enabling
urine to pass more readily through the urethra and facilitating
urination. In addition, it diminishes
sensations of urge.
Contiflo XL is used in men for the treatment of the complaints of the
lower urinary tract
associated with an enlarged prostatic gland (benign prostatic
hyperplasia) These complaints may
include difficulty urinating (poor stream), dribbling, urgency and
having to urinate frequently at
night as well as during the day.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CONTIFLO XL_ _
_ _
DO NOT TAKE CONTIFLO XL:
-
if you are allergic to tamsulosin hydrochloride or to any of the other
ingredients of this
medicine (listed in section 6). Hypersensitivity may present as sudden
local swelling of
the soft tissues of the body (e.g. the throat or tongue), difficult
breathing and/or itching
and rash (angioedema).
-
if you suffer from severe liver problems.
-
if you suffer from fain

Prekės savybės

OBJECT 1
CONTIFLO XL 400 MICROGRAMS PROLONGED RELEASE
CAPSULES
Summary of Product Characteristics Updated 18-Apr-2017 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Contiflo XL 400 micrograms capsules
2. Qualitative and quantitative composition
Each prolonged release capsule contains as active ingredient 400
micrograms of tamsulosin
hydrochloride.
Excipients with known effect:
One prolonged release capsule contains 0.0353 mg of sunset yellow,
0.0013 mg of Ponceau 4R, 0.0008
mg of brilliant blue and 0.0019 mg of azorubine
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release capsule
Brown /Orange size “2”capsules imprinted with 'R' on cap and
´TSN400' on body in black. The capsules
contain white to off-white granules.
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
Oral use.
One capsule daily, to be taken after breakfast or the first meal of
the day.
The capsule must be swallowed whole and should not be crunched or
chewed as this interferes with the
modified release of the active ingredient.
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 this medicine product in
children.
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
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
As with other α 1-adrenoceptors antagonists, a reduction in blood
pressure can occur in individual cases
during treatment with tamsulos