NEO-MEDROL ACNE LOTION

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

ALUMINIUM CHLOROHYDROXIDE COMPLEX SOLUTION; METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE; SULFUR

Fáanlegur frá:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC númer:

D10AA02

Lyfjaform:

LOTION

Samsetning:

METHYLPREDNISOLONE ACETATE 2.5 MG/ML; NEOMYCIN SULFATE 2.5 MG/ML; SULFUR 50 MG/ML; ALUMINIUM CHLOROHYDROXIDE COMPLEX SOLUTION 200 MG/ML

Stjórnsýsluleið:

DERMAL

Gerð lyfseðils:

Required

Framleitt af:

PATHEON INC. WHITBY OPERATIONS, CANADA

Meðferðarhópur:

METHYLPREDNISOLONE

Lækningarsvæði:

METHYLPREDNISOLONE

Ábendingar:

Acne.

Leyfisdagur:

2014-01-31

Upplýsingar fylgiseðill

Pfleet 2020-0061264
2
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
NEO-MEDROL ACNE LOTION
®
ACTIVE INGREDIENTS
Each ml contains:
methylprednisolone acetate 2.5 mg
neomycin sulphate 2.5 mg
sulfidal (sulfur) 50.0 mg
aluminum chlorhydroxide complex solution 200 mg
For a list of inactive ingredients and allergens in this preparation,
see section 6 "Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information
about this medicine. If you have any further questions, consult your
doctor or 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 to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
For treating acne.
THERAPEUTIC GROUP:
Methylprednisolone acetate – synthetic glucocorticoid.
Neomycin sulphate – antibiotic from the aminoglycoside group.
Sulfur – mineral (sulfur).
Aluminum chlorohydrate - mineral.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredients or any of the
additional ingredients contained
in the medicine (listed in section 6).
•
you suffer from herpes simplex, cowpox, chicken pox, tuberculosis of
the skin or any other skin
infection which does not respond to neomycin.
DO NOT USE THE MEDICINE WITHOUT CONSULTING A DOCTOR BEFORE STARTING
TREATMENT:
•
If you are pregnant.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
•
If sensitivity or irritation develop, stop using the preparation.
•
Do not use the preparation on broad skin areas, unless recommended by
the attending doctor.
•
If previously non-existent local inflammation develops during use of
the preparation, stop using the
preparation.
•
Do not allow the preparation to come into contact with the eyes or
ears. In the event of contact,
wash immediately with water.
•
Special caution is required when

Vara einkenni

Neo-Medrol Acne Lotion CC LPD 210620
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Pfleet 2020-0061264
PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
NEO-MEDROL
® ACNE LOTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
NEO-MEDROL Acne Lotion contains Aluminum Chlorhydroxide Complex
Solution 200 mg/ml,
Sulfidal (Sulfur) 50.0 mg/ml, Methylprednisolone Acetate 2.5 mg/ml,
Neomycin Sulfate 2.5 mg/ml
EXCIPIENTS WITH KNOWN EFFECT:
butyl hydroxybenzoate 0.3% and methyl hydroxybenzoate 0.2%.
PHARMACEUTICAL FORM
Lotion
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
NEO-MEDROL Acne Lotion is used for the treatment of acne.
CONTRAINDICATIONS
In tuberculosis of the skin, herpes simplex, vaccinia, varicella and
in other cutaneous infections
which do not respond to neomycin.
Hypersensitivity to the active substance or to any of the excipients
listed in section
"PHARMACEUTICAL PARTICULARS"
PRECAUTIONS
Avoid contact with eyes. If signs of irritation or sensitivity
develop, application should be
discontinued. As with any antibiotic containing product, overgrowth by
resistant organisms may
occur, particularly monilia. If this occurs, discontinue treatment and
institute appropriate
measures. Articles in current medical literature indicate an increase
in the incidence of patients
allergic to neomycin. The possibility of such a reaction should be
borne in mind.
Neo-Medrol Acne Lotion CC LPD 210620
Pfleet 2020-0061264
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If extensive areas are treated or if the occlusion technique is used,
the possibility exists of
increased absorption of the corticosteroid and suitable precautions
should be taken. The
prolonged use of antibiotic-containing preparations may result in
overgrowth of nonsusceptible
organisms, particularly fungi. If new infections appear during
treatment, appropriate therapy
should be instituted.
Convulsions have been reported with concurrent use of
methylprednisolone and cyclosporine.
Since concurrent administration of these agents results in a mutual
inhibition of metabolism, it is
possible that convulsions and other adverse events associated with the
individual