DIPROSALIC LOTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BETAMETHASONE AS DIPROPIONATE; SALICYLIC ACID

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

D07XC

Pharmaceutical form:

LOTION

Composition:

SALICYLIC ACID 20 MG/G; BETAMETHASONE AS DIPROPIONATE 0.5 MG/G

Administration route:

DERMAL

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

CORTICOSTEROIDS, POTENT, OTHER COMBINATIONS

Therapeutic indications:

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

Authorization date:

2016-08-31

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
® LOTION
ACTIVE INGREDIENTS:
Each gram contains:
Betamethasone Dipropionate 0.64 mg (equivalent to 0.5 mg
Betamethasone)
Salicylic Acid 20 mg
For a list of inactive ingredients see section 6.1 "What DIPROSALIC
LOTION contains?".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about DIPROSALIC LOTION. 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 DIPROSALIC LOTION USED FOR?
DIPROSALIC LOTION provides anti inflammatory, antipruritic, anti
allergic and keratolytic activity in the topical
management of subacute dermatoses responsive to corticosteroid
therapy.
THERAPEUTIC GROUP: DIPROSALIC LOTION 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.
BEFORE USING THE MEDICINE
2.1 DO NOT USE DIPROSALIC LOTION:
−
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 conditions

Summary of Product characteristics

[Organon] Proprietary
1. NAME OF THE MEDICINAL PRODUCT
Diprosalic
®
Lotion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone Dipropionate 0.64 mg/g*
(* equivalent to 0.5 mg/g Betamethasone)
Salicylic Acid 20 mg/g
3. PHARMACEUTICAL FORM
Cutaneous solution
A colorless, translucent, viscous solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betamethasone Dipropionate is a synthetic fluorinated corticosteroid
.
Diprosalic Lotion 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
the affected areas twice
daily and massaged gently and thoroughly into the skin.
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 SPECIAL 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 conti