BEPROSALIC OINTMENT

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
14-02-2023

ingredients actius:

SALICYLIC ACID/2-HYDROXYBENZOIC ACID; BETAMETHASONE DIPROPIONATE

Disponible des:

HOE PHARMACEUTICALS SDN. BHD.

Designació comuna internacional (DCI):

SALICYLIC ACID/2-HYDROXYBENZOIC ACID; BETAMETHASONE DIPROPIONATE

Unidades en paquete:

15 gm; 450 gm

Fabricat per:

HOE PHARMACEUTICALS SDN. BHD.

Informació per a l'usuari

                                _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
BEPROSALIC OINTMENT
Betamethasone Dipropionate / Salicylic Acid (0.05%w/w / 3%w/w)
1
WHAT IS IN THIS LEAFLET
1.
What BEPROSALIC
OINTMENT is used for
2.
How BEPROSALIC
OINTMENT works
3.
Before you use BEPROSALIC
OINTMENT
4.
How to use BEPROSALIC
OINTMENT
5.
While you are using
BEPROSALIC OINTMENT
6.
Side effects
7.
Storage and Disposal of
BEPROSALIC OINTMENT
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
This leaflet answers some common
questions
about
BEPROSALIC
OINTMENT. It does not contain all
the available information. It does not
take
the
place
of
talking
to
your
pharmacist or doctor.
All
medicines
have
risks
and
benefits. Your pharmacist or doctor
has weighed the risks of you taking
BEPROSALIC OINTMENT against
the benefits they expect it will have
for you.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT BEPROSALIC
OINTMENT IS USED FOR
BEPROSALIC OINTMENT is
indicated
for
relief
from
inflammatory
manifestations
of
hyperkeratotic and dry corticosteroid
responsive
dermatoses.
This
includes:
•
Psoriasis (skin condition that
causes red, flaky, crusty patches
of skin covered with silvery
scales).
•
Chronic Atopic Dermatitis
(condition that makes the skin
red and itchy).
•
Neurodermatitis (skin condition
that begins with an itch).
•
Lichen planus (non-infectious,
itchy rash that can affect many
areas of the body).
•
Eczema (term for a group of
medical conditions that cause the
skin to become inflamed or
irritated).
•
Dyshidrosis (is a skin condition
in which blisters develop on the
soles of feet and/or the palms of
hands).
•
Seborrheic dermatitis of the
scalp (common, inflammatory
skin condition that causes flaky,
white to yellowish scales to form
on oily areas such as the scalp. It
can occur with or without
reddened skin).
•
Ichthyosis vulgaris (skin
condition that causes dry, dead
skin cells to accumulate in
patches on the surface of the
skin).
•
Other ichthyotic (a conge
                                
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Fitxa tècnica

                                BEPROSALIC OINTMENT
Est. 1979
NAME
AND
STRENGTH
OF
ACTIVE
SUBSTANCES
:
Betamethasone
dipropionate
0.064% w/w (equiv. to Betamethasone 0.05% w/w) and Salicylic acid 3%
w/w.
PRODUCT DESCRIPTION : A white ointment.
Other ingredients: White soft paraffin and Liquid paraffin.
PHARMACODYNAMICS
:
Betamethasone
dipropionate
is
a
topically
active
fluorinated
corticosteroid which has anti-inflammatory, anti-pruritic and
vasoconstrictive actions. Salicylic
acid has keratolytic properties, as well as bacteriostatic and
fungicidal actions.
PHARMACOKINETICS : When administered topically , particularly under
occlusive dressing or
when the skin is broken, sufficient corticosteroid may be absorbed to
give systemic effects.
Corticosteroids are extensively bound to plasma proteins. Only unbound
corticosteroid has
pharmacological effects or is metabolized. They are metabolized mainly
in the liver, also in the
kidney and are excreted in the urine. When salicylic acid is
administered topically to large areas
of the body, it may cause symptoms of acute systemic salicylate
poisoning.
INDICATIONS : For the relief of the inflammatory manifestations of
hyperkeratotic and dry
corticosteroid-responsive dermatoses such as : psoriasis, chronic
atopic dermatitis, neuroder-
matitis (lichen simplex chronicus), lichen planus, eczema (including
nummular eczema, hand
eczema, eczematous dermatitis), dyshidrosis (pompholyx), seborrheic
dermatitis of the scalp,
ichthyosis vulgaris and other ichthyotic conditions.
CONTRAINDICATIONS : Hypersensitivity to Betamethasone dipropionate,
other corticoster-
oids, Salicylic acid, or other salicylates, or any component in the
base. Topical corticosteroids are
contraindicated in most viral infections of the skin and also
tuberculosis and acne rosacea.
DRUG INTERACTIONS : Not known.
SIDE EFFECTS/ADVERSE REACTIONS : Reported local adverse reactions
associated with
corticosteroids are burning, itching, irritation, dryness,
folliculitis, hypertrichosis, acneiform
eruptions, hypopigmentation, maceration of the skin, se
                                
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