Fuzatal XL 10mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Alfuzosin hydrochloride

Dostopno od:

Teva UK Ltd

Koda artikla:

G04CA01

INN (mednarodno ime):

Alfuzosin hydrochloride

Odmerek:

10mg

Farmacevtska oblika:

Modified-release tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 07040100; GTIN: 5017007314158

Navodilo za uporabo

Top of page cut-off to middle of registration mark: 44 mm.
PAGE 1: FRONT FACE (INSIDE OF REEL)
Pharma code 891
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
pressure. You should discuss with your
doctor whether to continue or stop your
treatment with Fuzatal
®
XL, especially
when the chest pain recurs or worsens
- if you have an abnormal heart rhythm
called QTc prolongation (long QT) or you
are taking medicines likely to increase the
risk of QTc prolongation. Tell your doctor if
you suffer from this condition or are
taking any other medicines.
- if you are over 65. This is due to the
increased risk of developing low blood
pressure (hypotension) and related side
effects in elderly patients.
- if you are undergoing eye surgery
because of cataract (cloudiness of the
lens) please inform your eye specialist
before the operation that you are using or
have previously used Fuzatal
®
XL. This is
because Fuzatal
®
XL may cause
complications during the surgery which
can be managed if your specialist is
prepared in advance.
OTHER MEDICINES AND FUZATAL
® XL
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicine, including medicines
obtained without a prescription.
Fuzatal
®
XL and some medicines may
interfere with each other. These include:
- other medicines that belong to the group
of alpha-blockers: you must not take such
medicines at the same time as Fuzatal
®
XL
(see “Do not take Fuzatal
®
XL” above)
- ketoconazole and itraconazole (medicines
used to treat fungal infections) and
ritonavir (medicine used to treat HIV
- certain antibiotic drugs (clarithromycin,
erythromycin)
- medicines you receive before an
operation (general anaesthetics). Your
blood pressure can drop markedly. If you
have to undergo an operation, please tell
the doctor that you are taking Fuzatal
®
XL.
FUZATAL
® XL WITH FOOD AND DRINK
The tablet should be taken immediately
after the same meal each day.
PREGNANCY AND BREAST-FEEDING
Fuzatal
®
XL is only intended for men.
DRIVING AND USING MACHINE

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fuzatal
®
XL 10mg prolonged release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged release tablet contains 10 mg of alfuzosin hydrochloride
Excipient with known effect: Each tablet contains 8 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Prolonged release tablet.
White, round, bevelled-edges tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe functional symptoms of benign
prostatic hyperplasia
(BPH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults :
The recommended dose is one 10 mg tablet daily
Elderly (over 65 years)
As adults. Pharmacokinetic and clinical safety data demonstrate that
dose
reduction is usually not necessary to elderly patients.
Renal impairment
Mild to moderate renal insufficiency (creatinine clearance > 30
ml/min)
Dose reduction is usually not necessary (see section 5.2).
Severe renal insufficiency (creatinine clearance < 30 ml/min)
Alfuzosin 10 mg prolonged-release tablets should not be given to
patients with
severely impaired renal function 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. After careful medical
consideration, a
preparation containing a lower dose of alfuzosin hydrochloride might
be
considered appropriate. Refer to the corresponding product information
for
dosing instructions.
_Paediatric population _
Efficacy of alfuzosin has not been demonstrated in children aged 2 to
16 years
(see section 5.1).Therefore, alfuzosin 10 mg prolonged release tablets
is not
indicated for use in paediatric population.There is no relevant
indication for
use of Alfuzosine 10 mg prolonged release tablets in children.
Method of administration
Oral use.
The prolonged-release tablet should be swallowed whole with a
sufficient
amount of fluid (e.g.