Xatral 2.5mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Alfuzosin hydrochloride

Disponibil de la:

DE Pharmaceuticals

Codul ATC:

G04CA01

INN (nume internaţional):

Alfuzosin hydrochloride

Dozare:

2.5mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 07040100

Prospect

PATIENT INFORMATION LEAFLET
XATRAL
® 2.5MG FILM-COATED 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.
The name of your medicine is Xatral 2.5mg Film-coated Tablets,
but will be referred to as Xatral throughout the remainder of the
leaflet.
IN THIS LEAFLET:
1. What Xatral is and what it is used for
2. Before you take Xatral
3. How to take Xatral
4. Possible side effects
5. How to store Xatral
6. Further information
1. WHAT XATRAL XL IS AND WHAT IT IS USED FOR
The name of your tablets is Xatral. This belongs to a group of
medicines called alpha-blockers.
Xatral can be used to treat the symptoms of BENIGN PROSTATIC
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.
2. BEFORE YOU TAKE XATRAL
DO NOT TAKE XATRAL IF:
•
You are allergic (hypersensitive) to alfuzosin or any of the
other ingredients of Xatral (see Section 6). Signs of an
allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, throat, or tongue.
•
You are taking another alpha-blocker. See section below on
‘Taking

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Xatral 2.5 mg film coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg alfuzosin hydrochloride.
Excipient: Lactose
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film coated tablet
White round tablet 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
Xatral 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 Xatral 2.5mg 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 Xatral 2.5mg/day to be
increased to Xatral 2.5mg 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.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or any of the excipients (see
Section 6.1
List of excipients);
•
history of orthostatic hypotension;
•
combination with other alpha-1 receptor blockers;
•
severe hepatic insufficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As
with
all
alpha-1-blockers,
in
some
subjects,
in
particular
patients
receiving
antihypertensive
med