CADEX 4 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

DOXAZOSIN AS MESYLATE

Dostopno od:

DEXCEL LTD, ISRAEL

Koda artikla:

C02CA04

Farmacevtska oblika:

CAPLETS

Sestava:

DOXAZOSIN AS MESYLATE 4 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

DEXCEL LTD, ISRAEL

Terapevtska skupina:

DOXAZOSIN

Terapevtsko območje:

DOXAZOSIN

Terapevtske indikacije:

Antihypertensive agent. For the treatment of benign prostatic hyperthropy.

Datum dovoljenje:

2014-02-28

Navodilo za uporabo

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS
(PREPARATIONS) –
1986
This medicine can be sold with a physician’s prescription only
CADEX 1 MG, TABLETS / CADEX 2,4 MG, CAPLETS
Each CADEX 1 mg tablet contains doxazosin as mesylate 1 mg
Each CADEX 2 mg caplet contains doxazosin as mesylate 2 mg
Each CADEX 4 mg caplet contains doxazosin as mesylate 4 mg
Inactive ingredients and allergens in the medicine
–
see section 6 "Additional information"
and in section 2 "Important information about some of the ingredients
of this medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. This
leaflet contains
concise information about the medicine. If you have any further
questions, ask the doctor
or pharmacist. This medicine has been prescribed to treat your
illness. Do not pass it on
to others. It may harm them, even if you think that their medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of hypertension and the
treatment of benign
prostatic hyperplasia.
THERAPEUTIC GROUP: Selective alpha-1 adrenoreceptor blockers.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are hypersensitive (allergic) to the active
ingredient (doxazosin), to other types of
quinazolines (such as prazosin or terazosin), or to any of the other
ingredients this
medicine contains (see section 6). This can manifest in itching,
redness of the skin, or
breathing difficulties.
•
You suffer from benign prostatic hyperplasia and low blood pressure.
•
You have a history of orthostatic hypotension, a type of low blood
pressure that causes
a feeling of dizziness when you stand up from sitting or lying down.
•
You suffer from an enlarged prostate gland with one of the following
conditions: any
type of congestion or blockage of the urinary tract, a longstanding
urinary tract infection,
or bladder stones.
•
You suffer from a certain type of incontinence due to bladder overflow
(you do not feel
the urge to urinate) or failure of the kidneys to

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Cadex 1 mg, Cadex 2 mg, Cadex 4 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION CADEX 1MG: each tablet contains Doxazosin 1mg (as mesylate).
Excipient with known effect:
Each tablet contains approximately 38mg Lactose. CADEX 2MG: each caplet contains Doxazosin 2mg (as mesylate).
Excipient with known effect:
Each caplet contains approximately 77mg Lactose. CADEX 4MG: each caplet contains Doxazosin 4mg (as mesylate).
Excipient with known effect:
Each caplet contains approximately 154mg Lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
CADEX 1 MG: White to off-white, round, biconvex tablets, scored on one
side.
CADEX 2 MG: White to off-white, biconvex caplets, scored on one side.
CADEX 4 MG: White to off-white, biconvex caplets, scored on both sides
and marked "D4" on
one side.
The tablets/caplets can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antihypertensive agent.
For the treatment of benign prostatic hypertrophy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
CADEX may be administered in the morning or the evening.
_HYPERTENSION:_ CADEX is used in a once daily regimen: the initial
dose is 1mg, to minimise the
potential for postural hypotension and/or syncope (see section 4.4:
Special warnings and
precautions for use). Dosage may then be increased to 2mg after an
additional one or two weeks
of therapy and thereafter, if necessary to 4mg. The majority of
patients who respond to CADEX
will do so at a dose of 4mg or less. Dosage can be further increased
if necessary to 8mg or the
maximum recommended dose of 16mg.
_BENIGN PROSTATIC HYPERPLASIA:_ The recommended initial dosage of
CADEX is 1mg given once
daily to minimise the potential for postural hypotension and/or
syncope (see section 4.4).
Depending on the individual patient's urodynamics and BPH
symptomatology dosage may then
be increased to 2mg and thereafter to 4mg and up to the maximum
recommended dose of 8mg.
The recommen