Tamfrex XL 400microgram capsules

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Tamsulosin hydrochloride

Tilgængelig fra:

Milpharm Ltd

ATC-kode:

G04CA02

INN (International Name):

Tamsulosin hydrochloride

Dosering:

400microgram

Lægemiddelform:

Modified-release capsule

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 07040100; GTIN: 8901175012978

Indlægsseddel

TAMFREX XL 400 MICROGRAM CAPSULES
Tamsulosin hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 TAMFREX XL is and what it is used for
2.
What you need to know before you take TAMFREX XL
3.
How to take TAMFREX XL
4.
Possible side effects
5.
How to store TAMFREX XL
6.
Contents of the pack and other information
1.
WHAT TAMFREX XL IS AND WHAT IT IS USED FOR
The active ingredient in TAMFREX XL is tamsulosin. This is a
selective alpha1A/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.
TAMFREX 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
TAMFREX XL
DO NOT TAKE TAMFREX XL
if you are allergic to tamsulosin hydrochloride or any of the
other ingredients in TAMFREX XL (listed in section 6).
Hypersensitivity may present as sudden local swelling of 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 fainting due to reduced blood pressure when
changing posture

Produktets egenskaber

OBJECT 1
TAMFREX XL 400 MICROGRAM CAPSULES
Summary of Product Characteristics Updated 09-Aug-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
TAMFREX XL 400 microgram capsules
2. Qualitative and quantitative composition
Each prolonged-release capsule, hard contains 0.4 mg of tamsulosin
hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release capsule, hard
Olive green opaque/ Orange opaque size '1EL' hard gelatin capsules
imprinted with 'D' on cap and '53' on
body with black edible ink filled with white to off-white beadlets.
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
For oral use.
Adults:
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.
Elderly persons:
Dose reduction is not necessary.
Patients with renal insufficiency:
In patients with creatinine clearance over 0.17 ml/sec. (10 ml/min)
there is no need of dosage
modification.
Patients with hepatic insufficiency:
In patients with mild to moderate liver dysfunction there is no need
of dosage modification (see also 4.3,
contraindications).
Paediatric population
The safety and efficacy of tamsulosine in children < 18 years have not
been established. Currently
available data are described in section 5.1.
4.3 Contraindications
• Hypersensitivity to tamsulosin hydrochloride, 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 r