KETOZOL SHAMPOO

देश: इसराइल

भाषा: अंग्रेज़ी

स्रोत: Ministry of Health

सक्रिय संघटक:

KETOCONAZOLE

थमां उपलब्ध:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ए.टी.सी कोड:

D01AC08

फार्मास्यूटिकल फॉर्म:

SHAMPOO

रचना:

KETOCONAZOLE 20 MG/G

प्रशासन का मार्ग:

TOPICAL- SCALP

प्रिस्क्रिप्शन प्रकार:

Required

द्वारा बनाया गया:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

चिकित्सीय समूह:

KETOCONAZOLE

चिकित्सीय क्षेत्र:

KETOCONAZOLE

चिकित्सीय संकेत:

Topical treatment of seborrhoeic dermatitis including dandruff resulting from proven fungal infection including Pityriasis versicolor.

प्राधिकरण की तारीख:

2023-05-31

सूचना पत्रक

DO NOT EXCEED THE RECOMMENDED DOSE.
For external use only.
Do not swallow Ketozol Shampoo. If you
accidentally swallowed the preparation, refer
to a doctor.
IF YOU OR YOUR CHILD HAS ACCIDENTALLY
SWALLOWED THE MEDICINE, refer immediately
to a doctor or proceed to a hospital emergency
room and bring the package of the medicine
with you.
IF YOU FORGOT TO USE THIS PREPARATION AT THE
REQUIRED TIME, do not use a double dose. Use
the next dose at the usual time and consult a
doctor.
Adhere to the treatment regimen as
recommended by the doctor.
DO NOT TAKE MEDICINES IN THE DARK! CHECK
THE LABEL AND THE DOSE EACH TIME YOU TAKE
MEDICINE. WEAR GLASSES IF YOU NEED THEM.
IF YOU HAVE FURTHER QUESTIONS REGARDING
USE OF THE MEDICINE, CONSULT THE DOCTOR OR
PHARMACIST.
4.
SIDE EFFECTS
As with any medicine, use of Ketozol Shampoo
may cause side effects in some users. Do not
be alarmed when reading the list of side effects.
You may not suffer from any of them.
STOP USING KETOZOL SHAMPOO AND REFER TO A
DOCTOR IMMEDIATELY IF YOU NOTICE OR SUSPECT
ANY OF THE FOLLOWING EFFECTS. YOU MAY NEED
URGENT MEDICAL TREATMENT.
Effects that can occur in less than one user
in 1,000:
•
Allergic reaction, swelling of the face, lips,
mouth, tongue or neck, which may cause
difficulty in swallowing or breathing
•
Peeling of the skin or blisters
Effects that can occur in less than one user
in 100:
•
Severe irritation or redness of the skin where
the shampoo was used, or other signs of
allergy during the first days of the treatment
Effects that can occur in less than one user
in 1,000:
•
Peeling of the skin or blisters
Tell your doctor or pharmacist if you notice or
suspect any of the following side effects:
Uncommon side effects )occur in up to one in
100 users(:
•
Inflammation of the hair roots
•
Increased tear production
•
Unusual hair loss or thinning
•
Dry skin, rash, burning feeling
•
Changes in the way your hair feels
Rare side effects )occur in up to one user in
1,000(:
•
Impaired sense of taste
•
Eye irritation
•
Acne
•
S

उत्पाद विशेषताएं

Summary of Product Characteristics
1. Name of the medicinal product
Ketozol shampoo
2. Qualitative and quantitative composition
Ketoconazole 2% w/w (each gram contains 20 mg).
For a full list of excipients, see 6.1
3. Pharmaceutical form
Orange to red viscous shampoo.
4. Clinical particulars
4.1 Therapeutic indications
Topical treatment of seborrhoeic dermatitis including dandruff
resulting from proven
fungal infection including pityriasis versicolor.
4.2 Posology and method of administration
For topical use only.
Ketoconazole shampoo 2% is intended for use in adults and adolescents
The frequency of use depends on the infection type:
Wash affected areas and leave for 3-5 minutes before rinsing.
Seborrhoeic dermatitis and Dandruff:
Twice weekly for 2 to 4 weeks.
Pytriasis versicolor:
Once daily for 1-5 days.
4.3 Contraindications
Hypersensitivity to the active substance ketoconazole or any of the
excipients listed
in section 6.1.
4.4 Special warnings and precautions for use
In patients who have been on prolonged treatment with topical
corticosteroids, it is
recommended that the steroid therapy be gradually withdrawn over a
period of 2 to 3
weeks, while using Ketozol shampoo, to prevent any potential rebound
effect.
Keep out of the eyes. If the shampoo should get into the eyes, they
should be bathed
with water.
4.5 Interaction with other medicinal products and other forms of
interaction
No interaction studies have been performed
4.6 Fertility, pregnancy and lactation
There are no adequate and well-controlled studies in pregnant or
lactating women.
Data on a limited number of exposed pregnancies indicate no adverse
effects of
topical ketoconazole on pregnancy or on the health of the
foetus/newborn child.
Animal studies have shown reproductive toxicity at doses that are not
relevant to the
topical administration of ketoconazole No effects on the breastfed
newborn/infant are
anticipated. See Pharmacokinetic properties, section 5.2.
Plasma concentrations of ketoconazole were not detectable after
topical
administration