Xatral SR Sustained release Tablet, film coated 5mg

Ülke: Malta

Dil: İngilizce

Kaynak: Malta Medicines Authority

Aktif bileşen:

ALFUZOSIN HYDROCHLORIDE

Mevcut itibaren:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC kodu:

G04CA01

INN (International Adı):

ALFUZOSIN HYDROCHLORIDE 5 mg

Farmasötik formu:

MODIFIED-RELEASE TABLET

Kompozisyon:

ALFUZOSIN HYDROCHLORIDE 5 mg

Reçete türü:

POM

Terapötik alanı:

UROLOGICALS

Yetkilendirme durumu:

Withdrawn

Yetkilendirme tarihi:

2006-05-26

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
XATRAL SR 5 MG
SUSTAINED 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 SR is and what it is used for
2.
Before you take Xatral SR
3.
How to take Xatral SR
4.
Possible side effects
5.
How to store Xatral SR
6.
Further information
1.
WHAT XATRAL SR 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
SR DO NOT TAKE XATRAL SR 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 certain bac

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xatral® SR 5 mg, sustained release film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg alfuzosin hydrochloride.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Sustained release film coated tablets
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of functional symptoms of benign prostatic hypertrophy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults:_
One Xatral® SR 5 mg tablet in the morning and evening.
_Elderly patients or patients treated for hypertension:_
As a systematic precaution, it is recommended that treatment be
started with one Xatral LP 5
mg tablet in the evening and that the dosage then be increased on the
basis of the patient's
individual response, without exceeding the maximum dosage of one
Xatral LP 5 mg tablet
morning and evening
_Patients with liver failure:_
It is recommended that treatment be started with one Xatral LP 5 mg
tablet per day and that
the dosage then be increased on the basis of the patient's individual
response, without
exceeding the maximum dosage of one Xatral LP 5 mg tablet twice daily.
_Paediatric population:_
Since the efficacy of alfuzosin has not been demonstrated in children
aged between 2 and 16
years (see Section 5.1), it should not be used in pediatric patients.
METHOD OF ADMINISTRATION
Oral use.
The tablet must be swallowed whole with a glass of water (see Section
4.4).
4.3
CONTRAINDICATIONS
This medicinal product must not be administered in the following
situations:
-
Hypersensitivity to alfuzosin and/or to any of the other excipients
mentioned in Section
6.1;
1 of 7
-
Postural hypotension;
-
Severe liver failure (class C in the CHILD-PUGH);
-
Severe kidney failure (creatinine clearance < 30 ml/min);
-
in combination with potent CYP3A4 inhibitors (see Section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SPECIAL WARNINGS
This medicinal product must be used with caution in patients treated
with antihypertensive