DERALIN 40 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PROPRANOLOL HYDROCHLORIDE

Available from:

ABIC LTD.

ATC code:

C07AA05

Pharmaceutical form:

TABLETS

Composition:

PROPRANOLOL HYDROCHLORIDE 40 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

PROPRANOLOL

Therapeutic area:

PROPRANOLOL

Therapeutic indications:

1. Management of angina pectoris. 2. Control of essential and renal hypertension essential tremor most forms of cardiac dysrhythmias. 3. As and adjunct in the management of tachycardias and arrhythmias due to thyrotoxicosis and thyrotoxic crises hypertrophic obstructive cardiomyopathy pheochromocytoma (with an alpha blocker). 4. Deralin is also indicated for long term prophylaxis following recovery from acute myocardial infarction (treatment to be initiated by a hospital physician) . 5. Migraine prophylaxis.

Authorization date:

2012-04-30

Patient Information leaflet

Deralin-07-05-12-AH/JO
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Propranolol HCl 10 mg
Propranolol HCl 40 mg
Lactose monohydrate, magnesium stearate, gelatin, carmine powder.
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Propranolol HCl 80 mg
Propranolol HCl 160 mg
In a sustained release form
In a sustained release form
Microcrystalline cellulose, ethylcellulose, hypromellose, erythrosine,
black iron oxide, red iron oxide, titanium
dioxide, water, gelatin.
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Summary of Product characteristics

DERALIN tablets 3 4. 2012 , RH
"
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
."
רשואמ ןולע
:
לירפא
2012
.
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been checked and
approved.” Date of approval: April 2012.
PHYSICIANS’ PRESCIBING INFORMATION
DERALIN
® TABLETS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
`DERALIN'
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propranolol Hydrochloride 10mg, or 40mg.
3.
PHARMACEUTICAL FORM
Pink round flat tablet bisected on one side and plain on the other
side.
Pink round flat tablet bisected on one side and plain on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Management of angina pectoris.
2.
Control of essential and renal hypertension, essential tremor, most
forms of cardiac
dysrhythmias.
3.
As
an
adjunct
in
the
management
of
tachycardias
and
arrhythmias
due
to
thyrotoxicosis
and
thyrotoxic
crises,
hypertrophic
obstructive
cardiomyopathy,
pheochromocytoma (with an alpha--blocker).
4.
Deralin Tablets are also indicated for long-term prophylaxis following
recovery from
acute myocardial infarction (treatment to be initiated by a hospital
physician).
5.
Migraine prophylaxis.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Since
the
half-life
may
be
increased
in
patients
with
significant
hepatic
or
renal
impairment, caution must be exercised when starting treatment and
selecting the initial
dose.
As with any other potent beta-blocking agent, the optimum dosage of
Deralin has to be
determined individually for each patient.
Food
may
slow
the
hepatic
metabolism
of
propranolol
therapy,
enhancing
its
bioavailability. In order to standardize conditions, it is recommended
that Deralin should
be taken with meals.
DERALIN tablets 3 4. 2012 , RH Page 2 of 10
2
As a guide for the correct dosage, bradycardia (usually less than 45
beats/minute) is
indicative that dosage should not be further increased.
When discontinuation of chronic administration of Deralin is