DIPROSALIC OINTMENT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BETAMETHASONE AS DIPROPIONATE; SALICYLIC ACID

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

D07XC01

Pharmaceutical form:

OINTMENT

Composition:

SALICYLIC ACID 30 MG/G; BETAMETHASONE AS DIPROPIONATE 0.5 MG/G

Administration route:

DERMAL

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

BETAMETHASONE

Therapeutic area:

BETAMETHASONE

Therapeutic indications:

Provides anti inflammatory, antipruritic, anti allergic and chronic hyperkeratotic and dry keratolytic activity in the topical management of subacute dermatoses responsive to corticosteroid therapy.

Authorization date:

2021-09-30

Patient Information leaflet

[Organon] Proprietary
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
DIPROSALIC
® OINTMENT
ACTIVE INGREDIENTS:
Each gram contains:
Betamethasone Dipropionate 0.64 mg (equivalent to 0.5 mg
Betamethasone)
Salicylic Acid 30 mg
For a list of inactive ingredients see section 6.1 "What DIPROSALIC
OINTMENT contains?"
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about DIPROSALIC OINTMENT.
If you have any further questions,
ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
ailment seems similar to yours.
1. WHAT IS THE MEDICINE USED FOR?
DIPROSALIC OINTMENT provides anti inflammatory, antipruritic, anti
allergic and keratolytic activity in the topical
management of subacute dermatoses responsive to corticosteroid
therapy.
THERAPEUTIC GROUP: DIPROSALIC OINTMENT contains two active
ingredients, betamethasone dipropionate
and salicylic acid.
Betamethasone dipropionate is one of a group of medicines called
topical corticosteroids. It is classified as a
“potent corticosteroid”. These medicines are put on the surface of
the skin to reduce the redness and itchiness
caused by certain skin problems. Salicylic acid softens the top layer
of scales on the surface of the skin, which
are caused by your skin problem. This allows the betamethasone
dipropionate to reach the diseased skin
underneath to help heal it.
2. BEF
ORE USING THE MEDICINE
2.1 DO NOT USE DIPROSALIC OINTMENT:
−
if you are sensitive (allergic) to betamethasone dipropionate,
salicylic acid or any of the other
ingredients in this medicine (listed in section 6).
−
if you have any other skin problem as it could make it worse
especially rosacea (a skin condition
affecting the face), acne, dermatitis (skin inflammation) around the
mouth, genital itching, nappy
rash, cold sores, chickenpox or other skin con

Summary of Product characteristics

[Organon] Proprietary
1. NAME OF THE MEDICINAL PRODUCT
Diprosalic
®
Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone Dipropionate 0.64 mg/g*
(* equivalent to 0.5 mg/g Betamethasone)
Salicylic Acid 30 mg/g
3. PHARMACEUTICAL FORM
Ointment
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betamethasone Dipropionate is a synthetic fluorinated corticosteroid.
Diprosalic Ointment provides anti inflammatory, antipruritic, anti
allergic and chronic
hyperkeratotic and dry keratolytic activity in the topical management
of subacute
dermatoses responsive to corticosteroid therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Once to twice daily. In most cases a thin film should be applied to
cover the affected
area twice daily.
For some patients adequate maintenance therapy may be achieved with
less
frequent application.
It is recommended that Diprosalic preparations are prescribed for two
weeks, and that
treatment is reviewed at that time. The maximum weekly dose should not
exceed 60 g.
Children:
Dosage in children should be limited to 5 days.
4.3 CONTRAINDICATIONS
Rosacea, acne, perioral dermatitis, perianal and genital pruritus.
Hypersensitivity to
any of the ingredients of the Diprosalic presentations
contra-indicates their use as
does tuberculous and most viral lesions of the skin, particularly
herpes simplex,
vacinia, varicella. Diprosalic should not be used in napkin eruptions,
fungal or
bacterial skin infections without suitable concomitant anti-infective
therapy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Occlusion must not be used, since under these circumstances the
keratolytic action
of salicylic acid may lead to enhanced absorption of the steroid.
Local and systemic toxicity is common, especially following long
continuous use on
large areas of damaged skin, in flexures or with polythene occlusion.
If used in
children or on the face courses should be limited to 5 days. Long term
continuous
therapy should be avoided in all patients irrespective of age.
Topical corticosteroids may be haz