Kamiren XL Modified Release Tablet 4 mg

Nazione: Malesia

Lingua: inglese

Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Principio attivo:

DOXAZOSIN MESYLATE

Commercializzato da:

PAHANG PHARMACY SDN. BHD.

INN (Nome Internazionale):

DOXAZOSIN MESYLATE

Confezione:

90Tablet Tablets

Prodotto da:

KRKA

Foglio illustrativo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
KAMIREN XL MODIFIED RELEASE
TABLETS
Doxazosin (4 mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Kamiren XL is used for
2.
How Kamiren XL works
3.
Before you use Kamiren XL
4.
How to use Kamiren XL
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Kamiren
XL
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT KAMIREN XL IS USED FOR
Kamiren XL contains the active
substance doxazosin, which belongs to
a group of medicines called alpha-
adrenergic blocking agents (alpha-
blockers).
Kamiren XL is recommended for:
- for the treatment of increased blood
pressure (hypertension).
- the symptoms caused by enlargement
of the prostate gland in men.
HOW KAMIREN XL WORKS
Thanks to special technology, the
release of doxazosin in tablets is
gradual and continuous.
Therefore, with the regular use only a
slight variation in levels of doxazosin in
the blood was observed.
In patients with HIGH BLOOD PRESSURE
(HYPERTENSION) Kamiren XL relaxes
blood vessels so that blood passes
through them more easily. This helps to
lower blood pressure.
In patients with an ENLARGED PROSTATE
GLAND, Kamiren XL is taken to treat
poor and/or frequent passing of urine.
This is common in patients with an
enlarged prostate gland. Kamiren XL
works by relaxing muscle around the
bladder exit and prostate gland so urine
is passed more easily.
BEFORE YOU USE KAMIREN XL
-
_When you must not use it _
- if you are allergic (hypersensitive) to
doxazosin, other types of quinazolines
(e.g. prazosin or terazosin) or any of the
other ingredients of Kamiren XL.
- if you have a history of a condition
known as ‘orthostatic hypotension’
which is a form of low blood pressure
that causes you to feel dizzy or light-
headed when you stand up from sitting
or lying down
- if you have any form of obstruction of
the digestive tract
- if you have an enlarged prostate gland
with one of the following: any kind of
congestion or blockage in your urinary
tract, a longstanding

Scheda tecnica

1.3.1
Doxazosin mesylate
SPC, Labeling and Package Leaflet
MY
SmPCPIL129224_2
01.04.2019 – Updated:
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Kamiren XL modified-release tablets 4 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 4 mg doxazosin as doxazosin
mesylate.
The excipients are stated under item 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablets: white, round, slightly convex tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The drug is recommended for the treatment of hypertension. Kamiren XL
may be used alone or in
combination with other antihypertensive drugs, such as thiazide
diuretics, beta-antagonists, calcium
channel blockers or angiotensin-converting enzyme inhibitors.
The drug is recommended in benign prostatic hyperplasia to improve the
clinical symptoms and
increase the urine flow. It may be used in both hypertensive and
normotensive patients. In
hypertensive patients, it simultaneously reduces blood pressure. In
normotensive patients, the effect on
blood pressure is clinically insignificant.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Kamiren XL modified-release tablets should be ingested whole with some
liquid. They should not be
chewed, broken or crushed (see also Special warnings and special
precautions for use). Patients may
take the drug before, during or after a meal.
_Hypertension and benign prostatic hyperplasia _
The usual dose of Kamiren XL is 1 tablet (4 mg) daily. Its effect can
be seen already on the first day
but the full effect occurs after 4 weeks of treatment. A daily dose of
4 mg is effective in the majority
of patients. If the effect after 4 weeks of treatment is inadequate
and if the patient tolerates the drug
well, a higher dose of the drug may be administered. The maximum
recommended dose is 2 tablets (8
mg) once daily.
No dosage adjustments are required in elderly patients and patients
with renal impairment.
In patients with liver impairment, caution should be used (see also
Special war