BELASIC 0.5 mg/g, 30 mg/g Ointment

Зміст інструкції

1. BELASIC 0.5 mg/g + 30 mg/g ointment
   1. What is BELASIC and what is it used for
   2. What you need to know before using BELASIC
   3. How to use BELASIC
   4. Possible side effects
   5. How to store BELASIC
   6. Contents of the pack and other information

BELASIC 0.5 mg/g + 30 mg/g ointment

betamethasone, salicylic acid
Equivalent medicinal product

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BELASIC is and what it is used for
• 2. What you need to know before you use BELASIC
• 3. How to use BELASIC
• 4. Possible side effects
• 5. How to store BELASIC
• 6. Contents of the pack and other information

1. What is BELASIC and what is it used for

BELASIC ointment is a combination of a corticosteroid and a keratolytic agent (exfoliating agent) to be
applied to the skin.
BELASIC ointment is used for the treatment of dermatoses characterized by non-acute or chronic dry skin
that respond to treatment with a highly effective topical corticosteroid, such as:
Psoriasis (Psoriasis vulgaris)
Chronic eczema.

2. What you need to know before using BELASIC

Do not use BELASIC

• if you are allergic to betamethasone dipropionate, salicylic acid or any of the other ingredients of this medicine (listed in section 6).
• in case of viral infections (e.g. chickenpox)
• in case of bacterial skin infections (e.g. cutaneous tuberculosis, erysipelas or syphilitic skin diseases),
• in case of fungal skin infections (dermatomycoses)
• in case of rosacea, perioral dermatitis (rosacea-like dermatitis)
• in case of acne
• in case of reactions to vaccines.

BELASIC ointment should not be used in infants and young children and in patients with
renal insufficiency.
Due to the content of glucocorticoids and salicylic acid, long-term treatment (more than 3 weeks) and/or
treatment of extensive areas of skin (more than 10% of the body surface) should not be carried out. This
applies particularly to children and patients with liver dysfunction.

Warnings and precautions
Consult your doctor or pharmacist before using BELASIC ointment.
Adverse effects, such as adrenal suppression, which have been reported following systemic administration
of corticosteroids, can also occur with topical use, especially in children and adolescents.
Systemic absorption of corticosteroids or salicylic acid applied locally can occur if
extensive areas of skin are treated or if therapy is carried out with occlusive dressings. Under these
conditions, or when long-term treatment is planned, especially in children and adolescents, specific
precautions must be taken.
BELASIC ointment is not intended for use on mucous membranes.
If used on the face, BELASIC ointment should be used with caution, and in no case should it be
applied around the eyes.
Furthermore, BELASIC ointment should not be used with occlusive dressings (bandages, etc.).
In exceptional cases, patients with renal insufficiency may be treated on skin areas less than
10 cm for a maximum period of 3 days.
If you experience blurred vision or other visual disturbances, contact your doctor.

Children
In general, treatment with BELASIC ointment in children requires greater caution because,
compared to adults, a child's skin may absorb larger amounts of glucocorticoids and salicylic acid due to
the nature of the skin and the greater skin surface in relation to body weight.

Other medicines and BELASIC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Interactions with laboratory tests are currently unknown.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
If you are pregnant, the use of BELASIC ointment should be avoided as much as possible.
If absolutely necessary, it should be applied for the shortest possible time and on the smallest possible
surfaces. Because growth disorders and fetal damage cannot be ruled out in the case of long-term
administration of glucocorticoids during pregnancy, inform your doctor if you become pregnant, are already
pregnant or suspect you are pregnant.
Breastfeeding
It is not known whether systemic absorption occurs in the case of topical application of corticosteroids to a
sufficient extent to determine detectable levels in breast milk. Salicylic acid passes into breast milk.
No cases of harm to the infant have been reported so far.
However, you should only apply BELASIC ointment during breastfeeding if absolutely necessary. Please
consult your doctor. If application during breastfeeding is necessary, BELASIC ointment should not be
applied to the breast area. Contact of the infant with the treated areas of the body should be avoided.

Driving and operating machinery
Not applicable.

BELASIC ointment contains paraffin
If BELASIC ointment is applied to the genital or anal area, the resistance to breakage of
latex condoms may be reduced due to the presence of the excipient paraffin, and
therefore the safety of condoms will be compromised.

3. How to use BELASIC

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Please follow the rules of application because otherwise BELASIC ointment will not be effective!
The recommended dosage is as follows:
Apply a thin layer of BELASIC to the affected area twice a day, in the morning and in the evening,
and massage gently.
In some cases, application once a day is sufficient. The frequency of application can be
reduced in parallel with the improvement of symptoms.
The duration of application should not exceed 3 weeks.
The maximum daily dose for adults is 2 g of salicylic acid. It should not be applied for more
than 1 week.
In case of infection, the need for further antibiotic treatment should be evaluated.
Consult your doctor or pharmacist if you feel that the effect of BELASIC ointment is too strong
or too weak.

Use in children
If used in children, the daily dose of BELASIC ointment should not exceed 0.2 g of acid
salicylic. In children, the treated body surface area should not exceed 10%.
Children should not be treated with BELASIC ointment for more than 1 week.

If you use more BELASIC than you should
Excessive and prolonged application of locally applied corticosteroids (chronic overdose or
abuse) can lead to suppression of pituitary-adrenal function with resulting secondary adrenal
insufficiency and symptoms of hypercortisolism, such as Cushing's syndrome.
Appropriate symptomatic treatment should be initiated. Acute symptoms of hypercortisolism (e.g.
moon face) are largely reversible. If necessary, changes in electrolyte balance should be treated.
If chronic toxic damage has occurred, corticosteroids should be discontinued gradually.
However, no such cases have yet occurred.
Excessive and prolonged application of locally applied preparations containing salicylic acid can
cause symptoms of salicylic poisoning (ringing in the ears with deafness, nosebleeds,
nausea, vomiting, irritability, dryness of the mucous membranes). In this case, treatment is symptomatic. It
is necessary to take measures for rapid excretion of salicylates, e.g. oral administration of sodium
hydrogen carbonate for alkalinization of the urine and increased diuresis.

If you forget to use BELASIC
Do not use a double dose of the ointment if you have forgotten the previous application.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
BELASIC ointment is generally well tolerated.
The following frequency scale has been established for the evaluation of side effects:
Very common: more than 1 in 10 patients
Common: 1 to 10 patients in 100
Uncommon: 1 to 10 patients in 1,000
Rare: 1 to 10 patients in 10,000
Very rare: less than 1 in 10,000
Not known: the frequency cannot be estimated from the available data

Undesirable effects or serious symptoms to watch out for and measures to take if they occur:
If you experience any of the following side effects, stop using BELASIC ointment and consult your
doctor as soon as possible.
BELASIC ointment is generally well tolerated. In rare cases, hypersensitivity reactions to one of the
components may occur.
In case of skin irritation or side effects such as rosacea-like dermatitis (perioral), thinning of the skin,
stretch marks, blisters, steroid acne, hypopigmentation, dilation and thickening of skin vessels,
burning sensation, itching, dry skin, inflammation of hair follicles and altered hair growth, or if
sensitization develops during the application of BELASIC ointment, treatment should be discontinued.
Perioral and allergic contact dermatitis have also been observed in the context of topical corticosteroid
application.
The following adverse effects may occur more commonly if the application occurs under occlusive
dressings: skin maceration, secondary infections, thinning of the skin, stretch marks and blisters.
In case of external application of salicylic acid, dry skin, skin irritation and unwanted skin scaling may
occur. Glucocorticoids may delay wound healing.
When using BELASIC ointment, systemic absorption of the active ingredient betamethasone dipropionate
cannot be ruled out and therefore the risk of systemic effects such as suppression of the hypothalamus-pituitary-adrenal axis and Cushing's syndrome.
Blurred vision has been reported during the use of glucocorticoids (frequency: not known).

Additional side effects in children
Suppression of the hypothalamus-pituitary-adrenal axis, Cushing's syndrome, growth retardation, reduced
weight gain and increased intracranial pressure (intracranial hypertension) have been observed in children
to whom corticosteroids have been applied for external use.
Suppression of the hypothalamus-pituitary-adrenal axis manifests in children with a low level of cortisol in
the plasma and a failure to respond to ACTH stimulation.
Increased intracranial pressure manifests as a bulging fontanelle, headache and bilateral swelling of the
optic nerve (bilateral papilledema).
Due to the higher ratio between skin surface area and body weight, children are more susceptible than
adult patients to the suppressive effects of glucocorticoids on the hypothalamus-pituitary-adrenal axis and
to the effects of exogenous corticosteroids.

What measures should be taken in case of side effects?
If side effects such as rosacea-like dermatitis (perioral), thinning of the skin, stretch marks, blisters,
steroid acne, hypopigmentation or dilation and thickening of skin vessels occur, the medicine should be
discontinued. The same applies in case of a burning sensation, itching, dry skin, inflammation of hair
follicles and altered hair growth.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can
also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BELASIC

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
After first opening, this medicine can be used for 6 months if stored at a temperature
below 25  C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BELASIC contains

• The active ingredients are betamethasone dipropionate and salicylic acid. 1 gram of ointment contains 0.5 mg of betamethasone (corresponding to 0.64 mg of betamethasone dipropionate) and 30 mg of salicylic acid.
• The other ingredients are: liquid paraffin; white petrolatum.

Description of the appearance of BELASIC and contents of the pack
BELASIC is a homogeneous, white, semi-transparent ointment packaged in an aluminum tube with
internal protective coating (epoxy-phenol coating) and protective membrane and a screw cap made of HDPE with
a piercing tip, in a cardboard box.
Tube of 30 g.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Laboratoires Medgen SAS
24 rue Erlanger, 75016 Paris – France
Manufacturer:
BELUPO lijekovi i kozmetika d.d.
Ulica Danica 5, 48000-Koprivnica, Croatia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
CROATIABelasic 0.5 mg/g + 30 mg/g cream

ITALYBELASIC