XATRAL SR 5 MG

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

ALFUZOSIN HYDROCHLORIDE

Saatavilla:

SANOFI ISRAEL LTD

ATC-koodi:

G04CA01

Lääkemuoto:

TABLETS SUSTAINED RELEASE

Koostumus:

ALFUZOSIN HYDROCHLORIDE 5 MG

Antoreitti:

PER OS

Prescription tyyppi:

Required

Valmistaja:

SANOFI WINTHROP INDUSTRIE, FRANCE

Terapeuttinen ryhmä:

ALFUZOSIN

Terapeuttinen alue:

ALFUZOSIN

Käyttöaiheet:

Treatment of certain functional symptoms of benign prostatic hypertrophy, particularly if surgery has to be delayed for some reason

Valtuutus päivämäärä:

2023-03-31

Pakkausseloste

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) -1986
The medicine is dispensed by doctor’s prescription only
XATRAL SR 5 MG
SUSTAINED-RELEASE TABLETS
Each Xatral SR 5 mg tablet contains: alfuzosin HCl 5 mg.
Inactive ingredients and allergens: see Section 6 ‘Additional
information’.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE.
This leaflet contains concise information about the medicine. If
you have further questions, refer to the doctor or pharmacist.
This medicine was prescribed for you. Do not pass it on to
others. It can harm them even if it seems to you that their medical
condition is similar to yours. The medicine is intended for men.
This medicine is not intended for treating children and adolescents
under 16 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
Xatral SR is used to treat symptoms of benign growth of the
prostate, particularly if surgery is delayed.
THERAPEUTIC GROUP:
Xatral belongs to a group of medicines called alpha blockers, and
it is a selective blocker of the α1 (alpha one) receptor.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
•
if you are sensitive (allergic) to alfuzosin or to any of the
ingredients of the medicine (see Section 6)
•
if you have or have had orthostatic hypotension (sudden drop
in blood pressure that occurs when suddenly getting up from
a sitting or lying position)
•
in combination with other α1-blockers
•
if you have reduced liver function
SPECIAL WARNINGS RELATING TO USE OF THE MEDICINE
TALK TO YOUR DOCTOR BEFORE TAKING THIS MEDICINE:
•
if
you
show
symptoms
of
orthostatic
hypotension
(sudden
drop in blood pressure when changing position). Orthostatic
hypotension may occur in the first few hours after taking this
medicine.
This
is
especially
common
at
the
beginning
of
treatment and when you are also being treated for increased
blood pressure or have a cardiac disorder. It may be associated
with the following symptoms: dizziness, fatigue, and sweating. In
this case, you should

Valmisteyhteenveto

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Xatral SR 5 mg sustained-release tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is alfuzosin. Each tablet contains 5 mg alfuzosin
hydrochloride.
Excipient with known effect: each tablet contains 19.6 mg hydrogenated
castor oil.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Pale yellow biconvex film coated sustained release tablet for oral
administration.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of certain functional symptoms of benign prostatic
hypertrophy, particularly if surgery has
to be delayed for some reason
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_ORAL USE _
_ _Xatral SR 5mg tablet must be swallowed whole with a glass of water.
The first dose of Xatral SR 5mg tablet should be given just before
bedtime.
_Adults: _
The usual dose is one Xatral SR 5 mg tablet morning and evening
_Elderly patients (over 65 years) or patients treated for
hypertension:_
As a systematic precaution, it is recommended that treatment be
started with one Xatral SR 5 mg
tablet in the evening and that the dosage then be increased on the
basis of the patient individual
response, without exceeding the maximum dosage of one Xatral SR 5mg
tablet morning and
evening.
Some patients should receive a lower dose of XATRAL, in particular the
following patient groups:
-
Renal insufficiency
-
Hepatic insufficiency
If lower dose is not optional, the physician should consider
alternative therapies for these patients.
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_Paediatric population _
The efficacy of Xatral in children aged 2 to 16 years has not been
established (see section 5.1).
Therefore Xatral is not indicated for use in paediatric patients.
4.3. CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
- Antecedents of orthostatic hypotension.
- Combination with other alpha-blockers.
- Hepatic insufficiency.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Warnings
As with all
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