Galebon 400microgram modified-release capsules

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Tamsulosin hydrochloride

Доступно од:

Consilient Health Ltd

АТЦ код:

G04CA02

INN (Међународно име):

Tamsulosin hydrochloride

Дозирање:

400microgram

Фармацеутски облик:

Modified-release capsule

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 07040100; GTIN: 5391512450533

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
GALEBON 0.4 MG 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 Galebon is and what it is used for
2. What you need to know before you take Galebon
3. How to take Galebon
4. Possible side effects
5. How to store Galebon
6. Contents of the pack and other information
1. WHAT GALEBON IS AND WHAT IT IS USED FOR
The name of this medicine is Galebon 0.4 mg prolonged-release
capsules, hard (referred to as Galebon through the remainder of this
leaflet). Galebon is used to treat the
symptoms of an enlarged prostate - a condition technically known as
benign prostatic hyperplasia or BPH. If the gland becomes enlarged, it
can squeeze the urethra, interfering
with the flow of urine. This can cause difficulty in starting
urination, a weak flow of urine, and the need to urinate urgently or
more frequently. Galebon does not shrink the
prostate. Instead, it relaxes the muscle around it, freeing the flow
of urine and decreasing urinary symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALEBON
DO NOT TAKE GALEBON:
•
If you are allergic to tamsulosin hydrochloride or any of the other
ingredients of this medicine (listed in section 6).
•
If you have severe liver insufficiency.
•
If you feel dizzy when you stand up.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Galebon if you are
suffering from any other disease, particularly from kidney and liver
disorders, heart and circulatory syste

Карактеристике производа

OBJECT 1
GALEBON 0.4 MG PROLONGED-RELEASE CAPSULES
Summary of Product Characteristics Updated 14-Jan-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Galebon 0.4 mg prolonged-release capsules, hard
2. Qualitative and quantitative composition
Each prolonged-release capsule, hard contains 0.4 mg tamsulosin
hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release capsule, hard.
330 mg white or off-white film-coated pellets are filled in the size
No. 2 capsules which upper part is
brown opaque, lower part is buff opaque.
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 daily, to be taken after breakfast or the first meal of
the day.
_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.
_Use in renal impairment_
No dose adjustment is warranted in renal impairment.
_Use in hepatic impairment_
No dose adjustment is warranted in patients with mild to moderate
hepatic insufficiency (see also section
4.3 Contraindications).
Method of administration
For oral use. The capsule must be swallowed whole and must not be
crunched or chewed as this interferes
with the prolonged release of the active substance.
4.3 Contraindications
- Hypersensitivity to the active substance, including drug-induced
angioedema, or to any of the excipients
listed in section 6.1.
- History of orthostatic hypotension.
- Severe hepatic insufficiency.
4.4 Special warnings and precautions for use
As with other α
1
-adrenoceptor 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.
Before therapy