HYCOMYCIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HYDROCORTISONE; NEOMYCIN AS SULFATE

Available from:

TEVA ISRAEL LTD

ATC code:

D07CA01

Pharmaceutical form:

OINTMENT

Composition:

NEOMYCIN AS SULFATE 0.5 %; HYDROCORTISONE 2.5 %

Administration route:

DERMAL

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

HYDROCORTISONE AND ANTIBIOTICS

Therapeutic area:

HYDROCORTISONE AND ANTIBIOTICS

Therapeutic indications:

Allergic dermatoses and other corticosteroid responsive inflammatory skin diseases including atopic dermatitis, contact dermatitis, seborrheic dermatitis, anogenital pruritus, infantile eczema and external otitis.

Authorization date:

2021-01-31

Patient Information leaflet

1
Hycomycin FW Notification 03-2023
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
HYCOMYCIN
Skin ointment
COMPOSITION
Hydrocortisone 2.5%
Neomycin sulfate 0.5%
For information about inactive ingredients and allergens 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.
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?
Used to treat of inflammatory skin infections.
THERAPEUTIC GROUP
Hydrocortisone: corticosteroid
Neomycin sulfate: an aminoglycoside antibiotic
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to hydrocortisone, neomycin sulfate,
other aminoglycoside
medicines or to any of the other ingredients that this medicine
contains, which are listed in
section 6.
•
You have viral infections, such as cold sores, herpes or chicken pox
•
You have fungal infections, such as athlete
’
s foot, ringworm, or thrush
•
You have skin blisters or sores that are caused by a bacterial
infection, such as impetigo,
tuberculosis of the skin
•
Like all medicinal products for external use that contain neomycin, do
not use this medicine
for inflammation of the outer ear if the eardrum is perforated.
If any of the above conditions apply to you, consult your doctor or
pharmacist.
_ _
Special warnings regarding use of this medicine
Do not use this medicine on large areas of skin or on open sores
unless your doctor tells you
to.
Do not allow this medicine to come into contact with your eyes. In
case of contact, rinse with
water immediately

Summary of Product characteristics

Hycomycin SPC Notification FW 03-2023
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Hycomycin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active Ingredients _
Hydrocortisone 2.5%
Neomycin sulfate 0.5%
_ _
For the full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Dermal Ointment.
While-yellowish homogenous ointment
.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Allergic dermatoses and other corticosteroid-responsive inflammatory
skin diseases
including atopic dermatitis, contact dermatitis, seborrheic
dermatitis, anogenital
pruritus, infantile eczema and external otitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Directions for Use:
Apply to the affected area 3-4 times daily.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances, to other aminoglycoside
antibiotics or to
any of the excipients listed in section 6.1.
Skin lesions, caused by infection with viruses (e.g. herpes simplex,
chicken pox),
fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo).
Use is not indicated in treatment of primary or secondary infections
due to yeast; or
secondary infections due to
_Pseudomonas _
or
_Proteus _
species.
Due to the known ototoxic and nephrotoxic potential of neomycin
sulfate, the use of
this medicine in large quantities or on large areas for prolonged
periods of time is not
recommended in circumstances where significant systemic absorption may
occur.
The ointment should not be applied in the external auditory canal of
patients with
perforated eardrum.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hycomycin SPC Notification FW 03-2023
Long term continuous or inappropriate use of topical steroids can
result in the
development of rebound flares after stopping treatment (topical
steroid withdrawal
syndrome). A severe form of rebound flare can develop which takes the
form of a
dermatitis with intense redness, stinging and burning that can spread
beyond the
initial treatment area. It is more likely to occur when delicate skin
sites such as the
face and flexures are tre