DIBENYLINE

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

PHENOXYBENZAMINE HYDROCHLORIDE

Dostopno od:

RAFA LABORATORIES LTD

Koda artikla:

C04AX02

Farmacevtska oblika:

CAPSULES

Sestava:

PHENOXYBENZAMINE HYDROCHLORIDE 10 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

DALES PHARMACEUTICALS LTD, UK

Terapevtska skupina:

PHENOXYBENZAMINE

Terapevtsko območje:

PHENOXYBENZAMINE

Terapevtske indikacije:

Pheochromocytoma, benign prostatic hypertrophy.

Datum dovoljenje:

2012-06-30

Navodilo za uporabo

Patient Leaflet According to the Pharmacists’ Regulations
(Preparations) - 1986
This medicine requires a doctor’s prescription
Please read the entire leaflet carefully before using this
medicine
DIBENYLINE
CAPSULES
COMPOSITION:
Active ingredient
Each capsule contains:
Phenoxybenzamine Hydrochloride 10 mg
Inactive ingredients
Lactose, talc, titanium dioxide, indigotine,
erythrosine, edible grey ink, gelatin.
Each capsule contains about 180 mg of lactose.
THERAPEUTIC GROUP:
Peripheral vasodilator.
THERAPEUTIC ACTIVITY:
Treatment of the prostate gland, Treatment of
pheochromocytoma.
WHEN SHOULD THIS MEDICINE NOT BE USED?
Do not use this medicine if you are hypersensitive to any
of its ingredients, or to any other medicine that is used to
lower blood pressure.
Do not use this medicine if you had a stroke.
Do not use this medicine if you had a heart attack
(coronary thrombosis) within the last month.
DO NOT TAKE THIS MEDICINE WITHOUT CONSULTING A
DOCTOR BEFORE STARTING TREATMENT, IN THE FOLLOWING
CASES:
If
you
are
pregnant,
planning
to
get
pregnant
or
breastfeeding.
If you suffer or have suffered in the past from impaired
function of the: heart and/or vascular system, kidney/urinary
tract, atherosclerosis (including in the brain), or if you suffer
or have suffered in the past from extremity edema. If you
are being treated for shock or your blood pressure is lower
than normal.
HOW MIGHT THIS MEDICINE AFFECT YOUR DAILY LIFE?
Use of this drug may cause you to feel dizzy and
therefore caution should be exercised when driving a
vehicle, operating dangerous machinery, or performing
any other activity that requires special vigilance.
WARNINGS:
If you are sensitive to any type of food or medicine, inform
your doctor before starting treatment with this medication.
This medicine contains lactose. If you are sensitive to
lactose, inform your doctor before taking this medication.
During treatment with this medicine you should be under
medical
observation
by
your
doctor,
furthermore
it
is
recommended to take blood pressure rea

Lastnosti izdelka

Dibenyline-DL-Feb2012-01
דומע
1
ךותמ
3
PRODUCT INFORMATION
DIBENYLINE CAPSULES
1.
NAME OF THE MEDICINAL PRODUCT
Dibenyline Capsules 10mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg Phenoxybenzamine hydrochloride.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of hypertensive episodes associated with phaeochromocytoma
and
treatment of benign prostatic hypertrophy.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Method of Administration: Oral
Posology
Adults: The usual starting dose is 10 mg daily. This may be increased
by 10 mg daily until control of hypertensive
episodes is achieved, or postural hypotension occurs.
Usually the dosage required is 1-2 mg/kg body weight split into 2
doses. Concomitant beta-adrenergic blockade
may be necessary to control tachycardia and arrythmias notably when
tumours are secreting an appreciable
amount of adrenaline as well as noradrenaline.
Elderly: Use with caution, 10 mg daily dose should be sufficient (see
Contra-Indications and Cautions below).
Children: There is little experience in children but, doses of 1 to 2
mg/kg daily have been used successfully.
4.3. CONTRAINDICATIONS
Phenoxybenzamine should not be used in patients who have had a
cerebrovascular accident; or in the recovery
period (usually 3-4 weeks) after acute myocardial infarction.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Phenoxybenzamine should be used with great caution in patients in whom
a fall in blood pressure and/or
tachycardia may be undesirable, such as the elderly or those with
severe heart disease, congestive heart failure,
cerebrovascular disease or renal damage. The mode of action should be
borne in mind, if used concurrently with α-
sympatho-mimetics or myocardial depressants.
Phenoxybenzamine is carcinogenic in the rat and has shown mutagenic
activity in the bacterial Ames test and
mouse lymphoma assay. It should only be used after very careful
consideration of the risks, i