Alfuzosin 2.5mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Alfuzosin hydrochloride

Fáanlegur frá:

Mawdsley-Brooks & Company Ltd

ATC númer:

G04CA01

INN (Alþjóðlegt nafn):

Alfuzosin hydrochloride

Skammtar:

2.5mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 07040100

Upplýsingar fylgiseðill

PATIENT INFORMATION LEAFLET
ALFUZOSIN HYDROCHLORIDE
2.5MG TABLETS
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
symptoms 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).
IN THIS LEAFLET:
1. What alfuzosin is and what it is used for
2.
What you need to know befor
e you take alfuzosin
3. How to take alfuzosin
4.
Possible side effects
5. How to store alfuzosin
6. Contents of the pack and other information
1. WHAT ALFUZOSIN IS AND WHAT IT IS USED FOR
WHAT ALFUZOSIN IS
The name of your medicine is Alfuzosin Hydrochloride
2.5mg Tablets (called alfuzosin throughout this leaflet). This belongs
to a
group of medicines alpha-blockers.
HOW ALFUZOSIN WORKS
Alfuzosin can be used to treat the symptoms of BENIGN PROSTATIC
HYPERTROPHY. 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 blad

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alfuzosin Hydrochloride 2.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg alfuzosin hydrochloride.
Excipients:
Each tablet contains 61 mg lactose anhydrous.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets.
White round, film coated tablet for oral administration marked Xatral
2.5 on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of the functional symptoms of benign prostatic hypertrophy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Alfuzosin Hydrochloride 2.5mg Tablets should be swallowed whole. The
first
dose should be given just before bedtime.
Adults
The usual dose is one tablet three times daily. The dose may be
increased to a
maximum of 4 tablets (10mg) per day depending on the clinical
response.
Elderly and treated hypertensive patients
As a routine precaution when prescribing alfuzosin to elderly patients
(aged
over 65 years) and the treated hypertensive patient, the initial dose
should be 1
tablet in the morning and 1 tablet in the evening.
Renal insufficiency
In patients with renal insufficiency, as a precaution, it is
recommended that the
dosing
be
started
at
Alfuzosin
Hydrochloride
2.5mg
Tablets
twice
daily
adjusted according to clinical response.
Hepatic insufficiency
In patients with mild to moderate hepatic insufficiency, it is
recommended that
therapy should commence with a single dose of Alfuzosin Hydrochloride
2.5mg Tablets/day to be increased to Alfuzosin Hydrochloride 2.5mg
Tablets
twice daily according to clinical response.
Paediatric population
Efficacy of alfuzosin has not been demonstrated in children aged 2 to
16 years
(see section 5.1). Therefore, alfuzosin is not indicated for use in
the paediatric
population.
Lactose
Patients with rare hereditary problems of galactose intolerance, the
Lapp
lactase deficiency or glucose-galactose malabsorption should not take
this
medicine.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the acti