AGISPOR SHAMPOO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BIFONAZOLE

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

D01AC10

Pharmaceutical form:

SHAMPOO

Composition:

BIFONAZOLE 1 %

Administration route:

TOPICAL- SCALP

Prescription type:

Required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

BIFONAZOLE

Therapeutic area:

BIFONAZOLE

Therapeutic indications:

Pityriorisis versicolor and sebarrrhoeic dermatitis of the scalp caused by pityrosporum.

Authorization date:

2022-02-28

Patient Information leaflet

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH
THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed
with a doctor’s
prescription only.
AGISPOR
SHAMPOO
EACH BOTTLE CONTAINS:
BIFONAZOLE 1%
Inactive ingredients and
allergens in the preparation –
see Section 6.
READ THIS LEAFLET CAREFULLY
IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet
contains concise information
about the medicine. If you
have further questions,
refer
to
the
doctor
or
pharmacist.
This medicine has been
prescribed to treat you. Do
not pass it on to others. It
may harm them, even if
it seems to you that their
medical condition is similar.
THE
MEDICINE
IS
NOT
INTENDED FOR INFANTS BELOW
THE AGE OF ONE MONTH.
1. W H AT
I S
T H E
MEDICINE INTENDED
FOR?
For the treatment of mycotic
diseases of the scalp, such
as pityriasis versicolor and
seborrheic dermatitis.
THERAPEUTIC GROUP
An antifungal belonging to
the family of imidazoles.
2. BEFORE USING THE
MEDICINE DO
NOT
USE
THE
MEDICINE:
• If you are sensitive
(allergic) to the active
ingredient or to any of
the other ingredients
found in the medicine.
S P E C I A L
W A R N I N G S
REGARDING USE OF THE
MEDICINE
• Do not use the medicine
frequently, or for a long
period, without consulting
the doctor.
associated with the use
of Bifonazole:
• Reactions on the skin
and
subcutaneous
tissue:
Contact
dermatitis,
a l
l
e r g i
c
s k i
n
inflammation, reddening,
itching, rash, urticaria,
blistering, peeling of the
skin, eczema, dry skin,
skin irritation, softening
of the skin, and burning
sensation.
• Pain and/or edema in
the treated area.
These
side
effects
disappear after cessation
of treatment, however if
these effects persist and/
or are bothersome, refer
to the doctor.
If any of the side effects
worsen, or if you suffer
from a side effect that
is not mentioned in the
leaflet, consult with the
doctor.
5. H O W
S H O U L D
THE MEDICINE BE
STORED?
• Avoid poisoning! This
medicine,
and
any
If a child or anyone
else has accidentally
swallowed the medicine,
proceed immediate

Summary of Product characteristics

PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
AGISPOR SHAMPOO
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1.
PREPARATIONS
QUALITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT(S) (INN):
Bifonazole
QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT(S) PER
DOSAGE FORM
_ _
_ _
1 g shampoo contains 10 mg bifonazole
_ _
3. PHARMACEUTICAL FORM
3.1.
PREPARATIONS
Pharmaceutical formulation in accordance with standardized
terminology:
Shampoo
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Pityriorisis versicolor and Seborrhoeic dermatitis of the scalp caused
by pityrosporum.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
INDICATION
DURATION OF TREATMENT
Pityriorisis versicolor
Seborrhoeic
dermatitis of the scalp
caused by
pityrosporum
4 weeks
Method of administration:
Patients should be instructed to shake the bottle well and apply
Agispor shampoo to the
hair or affected areas of the skin.
The recommended dose is one scalp wash three times a week, with two
applications of
the shampoo each time. The shampoo should be left on the scalp for 5
minutes before
rinsing. Sufficient shampoo should be used to ensure a good lathering
of the scalp.
USE IN CHILDREN
No in-depth studies have been performed in children. From a survey of
the clinical data
reported there is no indication that harmful effects should be
anticipated in children.
However, in infants and toddlers, the medicinal product should only be
used under medical
supervision.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If unsure of diagnosis, the patient should seek the advice of a doctor
or
pharmacist before using this product.
Patients with a history of hypersensitivity reactions to other
imidazole
antifungal agents (e.g. econazole, clotrimazole, miconazole) must take
bifonazole-containing products with caution.
This medicine contains 338 mg Sodium lauryl sulfate in each gram .
Sodium lauryl
sulfate may cause local s