PITREX

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

TOLNAFTATE

זמין מ:

TEVA ISRAEL LTD

קוד ATC:

D01AE

טופס פרצבטיות:

CREAM

הרכב:

TOLNAFTATE 1 %

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

Not required

תוצרת:

TEVA ISRAEL LTD, ISRAEL

קבוצה תרפויטית:

OTHER ANTIFUNGALS FOR TOPICAL USE

סממני תרפויטית:

Topical treatment of superficial dermatomycoses.

תאריך אישור:

2021-11-30

עלון מידע

PITR CRE PL SH 200220
PITR CRE PL SH 200220
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed without a doctor’s prescription
Pitrex
®
Cream
Composition:
Tolnaftate 1% w/w
For information on the inactive and allergenic ingredients,
see section 2 – “Important information about some of the
ingredients of the medicine” and section 6 – “Further
Information”.
Read the 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.
Use this preparation according to the instructions in the
dosage section of this leaflet. Consult a pharmacist if you
need further information.
Refer to a doctor if the symptoms of the disease are not
improving after 10 days.
1. WHAT IS THE MEDICINE INTENDED fOR?
Cream for topical treatment of superficial fungal skin
diseases.
Therapeutic group: Topical antifungal.
2. BEfORE USING THE MEDICINE
Do not use the medicine:
• If you are sensitive )allergic( to the active ingredient
or to any of the additional ingredients contained in the
medicine. See section 6 “Further Information”.
• To treat nail or scalp infections.
Drug interactions
If you are taking, or have recently taken, other
medicines, including non-prescription medicines
and nutritional supplements, tell the doctor or
pharmacist.
Important information about some of the ingredients
of the medicine
The preparation contains butylated hydroxytoluene
)E 321(, which may cause a localized skin reaction
)e.g., contact dermatitis( or irritation of the eyes or mucous
membranes.
3. HOW SHOULD YOU USE THE MEDICINE?
Check with the doctor or pharmacist if you are uncertain
about the dosage and treatment regimen of the
preparation.
The usual dosage is generally:
Apply a thin layer on the affected area 2-3 times a day.
Do not exceed the recommended dose.
This medicine is not generally intended for children
and infants under two years

מאפייני מוצר

Pitrex Cream SZ/LC 12/2021 Notification
SUMMARY OF PRODUCT CHARACTERISTICS
PITREX
®
1. NAME OF THE MEDICINAL PRODUCT
Pitrex
®
Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolnaftate 1.0% w/w
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream
Pure white, smooth homogeneous cream, free from specks and the like.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of superficial dermatomycoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply a thin layer on the affected area 2-3 times daily.
Do not exceed the recommended dosage.
This medicine is not usually intended for administration to children
and infants under
2 years of age.
If there is no improvement in the condition within 10 days, the
patient should refer to
the doctor.
4.3 CONTRAINDICATIONS
Contraindicated in nail or scalp infections.
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Keep out of eyes.
If symptoms do not improve within 10 days, discontinue use and consult
your doctor.
Keep out of the reach and sight of children.
The product contains butylated hydroxytoluene (E 321) which may cause
local skin
reactions (e.g. contact dermatitis), or irritation to the eyes and
mucous membranes.
If irritation or rash occurs, use of the product should be
discontinued and medical
advice should be sought.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Not relevant to topical use
Pitrex Cream SZ/LC 12/2021 Notification
4.6 PREGNANCY AND LACTATION
No known restrictions.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated.
4.8 UNDESIRABLE EFFECTS
Adverse reactions have been ranked under headings of frequency using
the
following convention:
Very common
≥ 1/10
Common
≥ 1/100 to ≥ 1/10
Uncommon
≥ 1/1,000 to < 1/100
Rare
≥ 1/10,000 to < 1/1,000
Very rare
<1/10,000
Not known
(cannot be estimated from the available data)
Within each frequency grouping, undesirable ef