CARSEM XL 4 Milligram Tablet Prolonged Release

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DOXAZOSIN MESILATE

Available from:

Teva Pharma B.V.

ATC code:

C02CA04

INN (International Name):

DOXAZOSIN MESILATE

Dosage:

4 Milligram

Pharmaceutical form:

Tablet Prolonged Release

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Alpha-adrenoreceptor antagonists

Authorization status:

Authorised

Authorization date:

2009-04-17

Patient Information leaflet

Doxazosin, DK/H/1388/001, 24.10.2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARSEM XL 4 MG PROLONGED-RELEASE TABLETS
Doxazosin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT CARSEM XL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARSEM XL
3.
HOW TO TAKE CARSEM XL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CARSEM XL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CARSEM XL IS AND WHAT IT IS USED FOR
The name of your medicine is Carsem XL 4mg prolonged-release tablets.
It belongs to a class of
medicines called “alpha blockers.” It can be used to treat high
blood pressure or a condition called
“Benign Prostatic Hyperplasia” (enlargement of the prostate).
If you suffer from high blood pressure, this can increase your risk of
developing heart disease or
having a stroke. Carsem XL lowers your blood pressure by relaxing your
blood vessels which
makes it easier for your heart to pump blood through them.
If
you
suffer
from
“Benign
Prostatic
Hyperplasia”
(enlargement
of
the
prostate)
you
may
experience problems passing urine. In men the prostate gland is just
below the bladder. If enlarged,
it can make it more difficult for urine to flow out of your bladder.
Carsem XL works by relaxing
muscles around the bladder and prostate gland making it easier to pass
urine.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARSEM XL
DO NOT TAKE CARSEM XL:

If you are allergic to doxazosin or other similar medicines which are
in the same chemical class
(e.g. prazosin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carsem XL 4 mg Prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 4 mg doxazosin (as mesilate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White, round biconvex film-coated tablets with bossing "DL" on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension.
Doxazosin is not appropriate for first-line treatment.
It may be used as a monotherapy in
patients who have failed to respond to or have contraindications to
other agents.
Alternatively, use should be limited to
second or third line treatment in combination with other
antihypertensives.
Symptomatic treatment of benign prostatic hyperplasia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The maximum recommended dose is 8 mg doxazosin once daily.
Essential hypertension:
Adults: Usually 4 mg doxazosin once daily. If necessary, the dosage
may be increased to 8 mg doxazosin once daily.
Carsem XL can be used as a sole agent or in combination with another
medicinal product e.g. a thiazide diuretic, beta-
adrenoceptor blocking agent, calcium antagonist or an ACE-inhibitor.
Symptomatic treatment of prostatic hyperplasia:
Adults: Usually 4 mg doxazosin once daily. If necessary, the dosage
may be increased to 8 mg doxazosin once daily.
Carsem XL may be used in benign prostatic hyperplasia (BPH) patients
who are either hypertensive or normotensive,
as the blood pressure changes in normotensive patients are clinically
insignificant.
In hypertensive patients both
conditions are treated concomitantly.
As with any other
medication of
this type it
is prudent
medical
practice to
monitor the patient during the initial period of therapy.
Older people: Same dosage as for adults.
Patients with renal
impairment:
Since there is no significant
variation in pharmacokinetics in patients with impaired
renal function the usual adult dose of Carsem XL is recommended.
Carsem XL are