TEVAX 10 MG, PROLONGED RELEASE TABLETS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ALFUZOSIN HYDROCHLORIDE

Available from:

Teva Pharma B.V.

ATC code:

G04CA01

INN (International Name):

ALFUZOSIN HYDROCHLORIDE

Dosage:

10 Milligram

Pharmaceutical form:

Tablet Prolonged Release

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

alfuzosin

Authorization status:

Not marketed

Authorization date:

2007-08-10

Patient Information leaflet

common-pl-10 mg / CCSI und QRD – September 2014
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEVAX 10 mg, prolonged release tablets
Alfuzosin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What TEVAX 10 mg is and what it is used for
2.
What you need to know before you take TEVAX 10 mg
3.
How to take TEVAX 10 mg
4.
Possible side effects
5.
How to store TEVAX 10 mg
6.
Contents of pack and other information
1.
WHAT TEVAX 10 MG IS AND WHAT IT IS USED FOR
This drug belongs to the group of medicines called alpha-blockers.
It is used to treat moderate to severe symptoms caused by an enlarged
prostate gland, a condition that
is also called benign prostatic hyperplasia. Enlarged prostate glands
can cause urinary problems such
as frequent and difficult urination.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEVAX 10 MG
DO NOT TAKE TEVAX 10 MG, PROLONGED RELEASE TABLETS:
-
if you are allergic to alfuzosin, other quinazoline (e.g. terazosin,
doxazosin) or any of the other
ingredients of this medicine (listed in section 6).
-
if you suffer from conditions that cause a marked drop in blood
pressure when standing up;
-
if you have hepatic impairment (liver function disorder);
-
if you are taking other medicines belonging to the group called
alpha1-blockers (e.g.
tamsulosin).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking TEVAX 10 mg,
-
if you have severe kidney problems.
-
if you take other medicines to treat high blood pressure. In this case
your doctor will check your
blood pressure regularly, especially at the beginning o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TEVAX 10 mg, 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
_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)
Tevax 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_
Tevax 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.
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