Xatral XL Tablet Prolonged Release 10mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALFUZOSIN HYDROCHLORIDE

Available from:

Sanofi Malta Limited

ATC code:

G04CA01

INN (International Name):

ALFUZOSIN HYDROCHLORIDE

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

ALFUZOSIN HYDROCHLORIDE 10 milligram(s)

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Authorised

Authorization date:

2006-05-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
XATRAL XL 10 MG
PROLONGED RELEASE TABLETS
_alfuzosin hydrochloride _
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the
same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What Xatral XL is and what it is used for
2. Before you take Xatral XL
3. How to take Xatral XL
4. Possible side effects
5. How to store Xatral XL
6. Further information
1. WHAT XATRAL XL IS AND WHAT IT IS USED FOR
Xatral contains alfuzosin. This medicine belongs to a group of
medicines called alpha-blockers. It has an effect on the bladder,
the tube which takes urine outside of the body (the urethra) and the
prostate.
Xatral is used when your prostate increases in size (benign prostatic
hyperplasia):
• to make it easier to urinate,
• or in addition to the urine being drained using a catheter in your
bladder, when it is impossible to urinate. This medicine is
for use in men only.
2. BEFORE YOU TAKE XATRAL XL
DO NOT TAKE XATRAL XL IF:
• if you are allergic to the active ingredient, alfuzosin, or any of
the other ingredients of Xatral. See Section 6 for a list of
ingredients.
• if you have postural hypotension (drop in blood pressure when
standing up, possibly with dizziness and/or fainting);
• if you have a serious liver disease (liver failure) or a serious
kidney disease (severe kidney failure);
• if you are taking certain other medicines to treat HIV (e.g.
protease inhibitor in combination with ritonavir or cobicistat), or
used to treat hepatitis C (e.g. telaprevir or boceprevir), or used to
treat certain fungal infections (e.g. ketoconazole,
itraconazole, posaconazole), or used to treat certai

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xatral® XL 10 mg, prolonged-release tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alfuzosin hydrochloride
.........................................................................................................
10 mg
for _one prolonged-release tablet. _
_For a full list of excipients see section 6.1 _
_ _
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Treatment of functional symptoms of benign prostatic hypertrophy
(BPH).
-
Adjuvant treatment to a catheter in acute urinary retention AUR)
related to benign
prostatic hypertrophy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route.
Tablet should be swallowed whole with a glass of water (see 4.4
Special warnings and
precautions for use).
BPH: The recommended dose is one 10 mg tablet per day, to be taken
immediately after the
evening meal.
Adjuvant treatment to a catheter in acute urinary retention related to
benign prostatic
hypertrophy.
The recommended dose is one 10 mg tablet per day, to be taken after a
meal, starting on the
day of insertion of the urethral catheter.
Treatment is administered for 3 to 4 days, with 2 to 3 days during
catheterization and 1 day
following its removal.
_ _
_Paediatric population: _
Efficacy of Xatral XL has not been demonstrated in children aged 2 to
16 years (see section
5.1). Therefore, Xatral XL is not indicated for use in paediatric
population.
4.3
CONTRAINDICATIONS
This medicinal product must not be given in the following situations:
-
Hypersensitivity to alfuzosin and/or to any of the other components,
-
postural hypotension,
-
Liver failure,
-
Severe kidney failure (creatinine clearance < 30 ml/min),
-
in combination with potent CYP3A4 inhibitors (SEE SECTION 4.5).
Page 2 of 7
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
WARNINGS
This medicinal product must be used with caution in patients treated
with antihypertensives
or nitrate derivatives.
Coadministration of this medicinal produc