SEBOSEL

Pajjiż: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

SELENIUM SULFIDE

Disponibbli minn:

TARO PHARMACEUTICAL INDUSTRIES LTD

Kodiċi ATC:

D01AE13

Għamla farmaċewtika:

SUSPENSION

Kompożizzjoni:

SELENIUM SULFIDE 25 MG/ML

Rotta amministrattiva:

TOPICAL- SCALP

Tip ta 'preskrizzjoni:

Not required

Manifatturat minn:

TARO PHARMACEUTICAL INDUSTRIES LTD

Grupp terapewtiku:

SELENIUM SULFIDE

Żona terapewtika:

SELENIUM SULFIDE

Indikazzjonijiet terapewtiċi:

For the treatment of dandruff, seborrheic dermatitis of the scalp and tinea versicolor.

Data ta 'l-awtorizzazzjoni:

2021-08-31

Fuljett ta 'informazzjoni

Sebosel PIL
_–_
Notification - 11.2023
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS)
– 1986
This medicine is dispensed without a doctor's prescription
SEBOSEL_ _
SUSPENSION
NAME AND CONCENTRATION OF THE ACTIVE INGREDIENT:
Each 1 ml contains:
selenium sulfide 25 mg
Inactive ingredients and allergens in this medicine:
see section 2 under ‘Important information
about some of this
medicine’s ingredients’, and section 6 ‘Additional
information’
.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
Use this medicine according to the instructions in the section about
dose in this leaflet. Consult a
pharmacist if you need further information.
Consult your doctor if your condition does not improve or gets worse
following or during the
recommended treatment.
1.
WHAT IS THIS MEDICINE INTENDED FOR?_ _
To treat dandruff, seborrheic dermatitis on the scalp, and tinea
versicolor.
THERAPEUTIC GROUP: antifungal.
This product works against dandruff in two ways:
•
by reducing greasiness of the scalp
•
by slowing down growth of the layer of skin cells on the scalp that
cause dandruff.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (selenium
sulfide) or to any of the other
ingredients in this medicine (see Section 6).
•
You have cracked, infected, or severely inflamed skin in the affected
area, as this may
cause absorption of selenium sulfide into your blood.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
•
Avoid contact of the medicine with the eyes. If the medicine
accidentally gets in your eyes,
rinse immediately with a lot of cold water.
•
Sebosel is meant for external use only. Sebosel is not to be swallowed
or eaten.
•
Do not leave the medicine in contact with your hair or skin for longer
than the
recommended time. This can cause irritation, a burning sen

Karatteristiċi tal-prodott

~ 1 ~
Sebosel SmPC
–
Notification November 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sebosel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of suspension contains 25 mg of selenium sulfide.
Excipients with known effect: methyl paraben and propyl paraben.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orange suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of dandruff, seborrheic dermatitis of the scalp and
tinea versicolor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply topically; scalp.
_Adults and the elderly: _
_ _
•
FOR TINEA VERSICOLOR
Apply to affected areas and lather with a small amount of water. Allow
product to remain on skin for 10 minutes, then rinse thoroughly.
Repeat
procedure once a day for seven days.
•
FOR SEBORRHEIC DERMATITIS AND DANDRUFF
Generally 2 applications each week for 2 weeks will control symptoms.
Subsequently, Sebosel may be used less frequently
–
weekly, every 2 weeks,
every 3 to 4 weeks.
Should not be applied more frequently than necessary to maintain
control.
_Pediatric Use:_
_ _
Safety and effectiveness in children have not been established.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance (selenium sulfide) or to any
of the
excipients listed in section 6.1.
-
Do not allow contact with broken or severely inflamed skin.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
~ 2 ~
Sebosel SmPC
–
Notification November 2023
This suspension is an irritant to the eyes. It should therefore be
kept away from the eyes.
If the suspension comes in contact with the eyes, they should rinse
thoroughly with cold
water. Exposure of Sebosel to eyes may result in ocular injuries such
as corneal abrasion
(see section 4.8).
Do not leave the suspension in contact with the hair or skin for more
than the
recommended duration as irritation, burning sensation or blistering
may occur and do
not use more often than recommended (see Section 4.2).
Sebosel is not to be inges