Vasran XL 10mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Alfuzosin hydrochloride

Inapatikana kutoka:

Sun Pharma UK Ltd

ATC kanuni:

G04CA01

INN (Jina la Kimataifa):

Alfuzosin hydrochloride

Kipimo:

10mg

Dawa fomu:

Modified-release tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 07040100; GTIN: 5015525222917

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VASRAN XL 10 MG PROLONGED-RELEASE TABLETS
Alfuzosin hydrochloride
WHAT IS IN THIS LEAFLET
:
1.
What Vasran XL 10 mg prolonged release tablets are and what they are
used
for
2.
What you need to know before you take Vasran XL 10 mg prolonged
release
tablets
3.
How to take Vasran XL 10 mg prolonged release tablets
4.
Possible side effects
5.
How to store Vasran XL 10 mg prolonged release tablets
6.
Contents of the pack and other information
1.
WHAT VASRAN XL 10 MG PROLONGED RELEASE TABLETS ARE AND WHAT THEY ARE
USED FOR
Alfuzosin belongs to a group of medicines called alpha- blockers.
Alfuzosin can be used to treat the symptoms of
BENIGN PROSTATE HYPERPLASIA
. This is
when the prostate gland enlarges (hyperplasia), but the growth is not
cancerous (it is
benign).
It can cause problems in passing water (urine). This happens mainly in
older
men.
-
The prostate gland lies underneath the bladder. It surrounds the
urethra. This is
the tube that takes your water to the outside of the body.
-
If the prostate gets bigger it presses on the urethra making it
smaller. This makes
it difficult to pass water.
-
Your tablets work by relaxing the prostate gland muscle. This allows
the urethra
to get bigger and so makes it easier to pass water.
In a few
patients with benign prostatic
hyperplasia,
the prostate gland gets so
big
that it stops the flow of urine completely.
This is called
ACUTE URINARY
RETENTION.
-
This is very painful and you may need a short stay in hospital.
-
A thin, flexible tube (catheter) is passed into the bladder. This
drains the water
and relieves the pain.
-
During this time, alfuzosin may be used to help the water to flow
again. This has
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

Tabia za bidhaa

OBJECT 1
VASRAN XL 10 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 21-Oct-2016 | Ranbaxy (UK)
Limited a Sun Pharmaceutical
Company
1. Name of the medicinal product
Vasran XL 10 mg prolonged-release tablets.
2. Qualitative and quantitative composition
Each tablet contains 10 mg alfuzosin hydrochloride.
Excipients with known effect: lactose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
White to off-white, round, uncoated, biconvex tablets with flattened
edges, debossed with 'RY 10' on one
side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of moderate to severe functional symptoms of benign prostate
hyperplasia (BPH).
As an adjunct therapy in connection with catheterisation in acute
urinary retention (AUR) related to BPH.
4.2 Posology and method of administration
Posology:
_Adults:_
BPH: The recommended dose is one 10 mg prolonged-release tablet daily.
AUR: One 10 mg prolonged-release tablet daily after a meal to be taken
from the first day of
catheterisation. Efficacy in the long-term treatment of AUR has not
been established.
_Older people (over the age of 65 years)_
The recommended dose is the same as that for adults. Pharmacokinetic
and clinical safety studies have
shown that dose adjustment is not necessary in the case of elderly
patients.
_Patients with renal impairment_
Based on pharmacokinetic and clinical safety data, patients with renal
insufficiency (creatinine clearance
≥30 ml/min) can be treated with the usual dose.
Alfuzosin 10 mg should not be given to patients with severely impaired
renal function (creatinine
clearance < 30 ml/min) as there are no clinical safety data available
for this patient group (see section
4.4).
_Hepatic insufficiency:_
Alfuzosin, given as 10 mg prolonged-release tablets are
contraindicated in patients with hepatic
insufficiency. Preparations containing a low dose of alfuzosin
hydrochloride might be used in patients
with mild to moderate hepatic insufficiency as instructed in the