RAZIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PHENTERMINE AS RESINATE

Available from:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC code:

A08AA01

Pharmaceutical form:

CAPSULES

Composition:

PHENTERMINE AS RESINATE 15 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

PHENTERMINE

Therapeutic area:

PHENTERMINE

Therapeutic indications:

For the treatment of severe obesity that has not responded to an appropriate diet - a minimal body mass index of 30 kg/m2 is required.

Authorization date:

2022-08-31

Patient Information leaflet

LFL 206 12/21
PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor's
prescription only
RAZIN CAPSULES
Each capsule contains:
Phentermine (as resinate) 15 mg
Inactive ingredients and allergens in the
preparation – see the section “Important
information about some of the ingredients
of the medicine” and section 6 “Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE
USING THE MEDICINE. This leaflet contains
concise information about the medicine. If
you have any other questions, refer to the
doctor or the pharmacist.
This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them even if it seems to you that
their medical condition is similar.
This medicine is not intended for children
and adolescents under the age of 16.
This medicine is usually not intended for
adults over the age of 65.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Razin is intended for the treatment of
severe obesity that does not respond
to appropriate dietary treatment – a
minimum body mass index of 30 kg/m
2
is
required.
The treatment should be undertaken
under medical supervision and should be
based, among other things, on changes
in lifestyle, exercise, controlled diet,
behavioral support, etc.
THERAPEUTIC CLASS: a group of
preparations for weight loss that work via
the central nervous system.
The medicine directly affects the area in
the brain that is responsible for appetite
and reduces the feeling of hunger.
2. BEFORE USING RAZIN
DO NOT USE THIS MEDICINE IF ANY OF THE
FOLLOWING CONDITIONS APPLIES:
·
Sensitivity (allergy) to the active
ingredient or to any of the additional
ingredients the medicine contains,
or to similar medicines used for
weight loss. The symptoms of an
allergic reaction may be: shortness
of breath, wheezing or breathing
difficulties, swelling of the face, lips,
tongue or other areas in the body,
rash, itch, hives.
·
In combination with other medicines
for weight loss
·
Very high blood pressure
·
P

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Razin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phentermine (as resinate) 15 mg/cap
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of severe obesity that has not responded to an
appropriate diet- a minimal
body mass index of 30 kg/m
2
is required.
Razin is indicated as an adjunct in a medically monitored
comprehensive regimen of weight
reduction based on exercise, diet (caloric restriction) and behaviour
modification
.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children aged over 16 years:
One capsules daily at breakfast, swallowed whole. Evening dosing
should be avoided as this
agent may induce insomnia. It is recommended that treatment should be
initiated under the care
of medical practitioners experienced in the treatment of obesity.
Razin capsules may be used for a period of up to 3 months of
treatment.
Children:
Razin is not recommended for children under the age of 16.
Elderly:
Razin is not recommended for the elderly
4.3
CONTRAINDICATIONS
The use of Razin is contraindicated in cases of:

hypersensitivity to phentermine, Sympathomimetic drugs or to any of
the excipients listed in
section 6.1

Pulmonary artery hypertension

Existing heart valve abnormalities or heart murmurs

Moderate to severe arterial hypertension

Cerebrovascular disease

Severe cardiac disease including arrhythmias, Advanced
arteriosclerosis

Hyperthyroidism

Agitated states or a history of psychiatric illness including anorexia
nervosa and depression.

Glaucoma

History of drug/alcohol abuse or dependence.

Concomitant treatment with monoamine oxidase (MAO) inhibitors or
within 14 days following
their administration.

Co-administration of drug products for weight loss.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Razin capsules may be used for a period of up to 3 months of
treatment. Razin capsules are
indicated only as