Pimafucort

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hydrocortisone 1%{relative} (1% overage added); Natamycin 1%{relative};  ; Neomycin sulfate 0.5%{relative} (10% overage added)

Available from:

LEO Pharma Limited

INN (International Name):

Hydrocortisone 1% w/w (1% overage added)

Pharmaceutical form:

Topical cream

Composition:

Active: Hydrocortisone 1%{relative} (1% overage added) Natamycin 1%{relative}   Neomycin sulfate 0.5%{relative} (10% overage added) Excipient: Cetyl esters wax Decyl oleate Emulgade F Macrogol stearates Methyl hydroxybenzoate Propyl hydroxybenzoate Purified water Sodium citrate Sorbitan stearate

Units in package:

Tube, 15 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pharmacia & Upjohn Company LLC

Product summary:

Package - Contents - Shelf Life: Tube, - 15 g - 36 months from date of manufacture stored at or below 25°C - Tube, - 30 g - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

1
CONSUMER MEDICINE INFORMATION
PIMAFUCORT
®
1% HYDROCORTISONE, 1% NATAMYCIN AND 0.35% NEOMYCIN
CREAM AND OINTMENT
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Pimafucort
®
Cream and Ointment_. _It does not
contain all the available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using this medicine
against the expected benefits.
Use Pimafucort
®
as instructed. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT PIMAFUCORT
® IS USED FOR
Pimafucort
®
is used on the skin to relieve the itching and discomfort of many skin
problems where
these also have an added bacterial and/or candidal (fungal) infection.
Pimafucort
®
contains the medicines:
•
hydrocortisone: a corticosteroid which relieves inflammation of the
skin
•
neomycin: an antibiotic which is active against bacterial infections
and
•
natamycin: an antifungal which is active against yeast infections,
particularly Candida infections.
Your doctor may have prescribed Pimafucort
®
for another reason. Ask your doctor why this medicine
has been prescribed for you.
This medicine is available only with a doctor’s prescription.
BEFORE YOU USE PIMAFUCORT
®
_WHEN YOU MUST NOT USE PIMAFUCORT_
_®_
DO NOT USE THIS MEDICINE IF YOU HAVE:
1.
AN ALLERGY TO:
•
ANY MEDICINE CONTAINING HYDROCORTISONE, NATAMYCIN OR NEOMYCIN SULPHATE
(or related
antibiotics belonging to the aminoglycoside group, such as kanamycin,
framycetin,
paromomycin and gentamicin).
•
any of the ingredients listed at the end of this leaflet (see Product
Description).
Some of the symptoms of an allergic reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the
skin.
2.
A SKIN DISORDER _CAUSED _IN THE FIRST INSTANCE BY A:
•
BACTERIAL INFECTION
•
VIRAL INFE

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PIMAFUCORT
®
Cream
Ointment
Hydrocortisone, natamycin and neomycin sulphate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CREAM
per gram: 10mg hydrocortisone, 10mg natamycin and 3.5mg neomycin (as
neomycin
sulphate).
OINTMENT
per gram: 10mg hydrocortisone, 10mg natamycin and to 3.5mg neomycin
(as neomycin
sulphate).
Excipients with known effect:
Pimafucort
®
cream: methyl hydroxybenzoate, propyl hydroxybenzoate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
CREAM
Description of the medicinal product: white to lightly yellowish cream
OINTMENT
Description of the medicinal product: whitish ointment.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term treatment of superficial dermatoses which are sensitive to
corticosteroids, but not primarily
caused by micro-organisms, if these are complicated by secondary
bacterial and candidal infections
sensitive to neomycin or natamycin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Pimafucort
®
should be applied sparingly to the affected area 2-4 times daily.
Treatment should not be
continued for longer than 14 days.
For treatment of acute and subacute skin disorders and for treatment
of disorders of hirsute areas and
those in the skin folds, Pimafucort
®
cream should preferably be used, whereas in the treatment of
chronic disorders of the skin with scaly, dry or fissured skin
lesions, and for seborrhoea in particular,
Pimafucort
®
ointment should be applied.
.
eDoc-000775370 - Version 1.0
2
4.3 CONTRAINDICATIONS
Because Pimafucort
®
contains the weak corticosteroid hydrocortisone the following
contraindications
apply:
•
Skin disorders caused by:
−
primary bacterial infections
−
viral infections
−
primary fungal and yeast infections
−
parasitic infections
•
Ulcerous skin disorders, wounds, ulcera cruris, burn wounds.
•
Side-effects caused by corticosteroids (dermatitis perioralis, striae
atrophicae).
•
Ichthyosis, juvenile dermatosis plantaris, acne vulgaris, acne
rosacea, fragility of skin vessels