Belasic

Patient Information Leaflet: Information for the User

BELASIC 0.5 mg/g + 30 mg/g ointment

betamethasone, salicylic acid
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 using 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 BELASIC is and what it is used for

BELASIC ointment is a combination of a corticosteroid and a keratolytic agent (exfoliating agent) for topical application to the skin.
BELASIC ointment is used to treat dry, non-acute or chronic dermatoses that respond to treatment with a highly potent topical corticosteroid, such as:
Psoriasis (vulgaris psoriasis)
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, rosacea-like dermatitis (perioral)
• in case of acne
• in case of reactions to vaccines.

BELASIC ointment must not be used in infants, young children, or in patients with renal insufficiency.
Due to its content of glucocorticoids and salicylic acid, long-term treatment (more than 3 weeks) and/or treatment of extensive skin areas (more than 10% of body surface area) must be avoided. This is particularly important for children and patients with liver dysfunction.

Warnings and precautions
Talk to your doctor or pharmacist before using BELASIC ointment.
Undesirable effects such as adrenal suppression, which have been reported following systemic administration of corticosteroids, may also occur with topical use, especially in children and adolescents.
Systemic absorption of locally applied corticosteroids or salicylic acid may occur when large skin areas are treated or when occlusive dressings are used. Under these conditions, or when long-term treatment is anticipated—particularly 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 must be used with caution and must in no case be applied around the eyes.
Furthermore, BELASIC ointment must not be used with occlusive dressings (e.g. plasters, etc.).
In exceptional cases, patients with renal insufficiency may be treated on skin areas smaller than 10 cm² for a maximum 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, as children’s skin may absorb higher amounts of glucocorticoids and salicylic acid compared to adults, due to the nature of their skin and their larger skin surface area relative to body weight.

Other medicines and BELASIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Interactions with laboratory tests are currently not known.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
If you are pregnant, use of BELASIC ointment should be avoided as much as possible.
If use is absolutely necessary, it should be applied for the shortest possible duration and over the smallest possible surface area. Since long-term administration of glucocorticoids during pregnancy may potentially lead to growth disturbances and fetal harm, inform your doctor if you become pregnant, are already pregnant, or suspect you may be pregnant.

Breastfeeding
It is not known whether topical application of corticosteroids results in sufficient systemic absorption to produce measurable levels in breast milk. Salicylic acid passes into breast milk.
To date, no cases of harm to the breastfed infant have been reported.
However, you should use BELASIC ointment during breastfeeding only if absolutely necessary. Please consult your doctor. If application is required during breastfeeding, BELASIC ointment must not be applied to the breast area. Contact between the infant and treated skin areas must be avoided.

Driving and using machines
Not applicable.

BELASIC ointment contains paraffin
If BELASIC ointment is applied to the genital or anal area, the strength of latex condoms may be reduced due to the presence of the excipient paraffin, thus compromising the effectiveness of the condoms.

3. How to use BELASIC

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Please follow the application instructions carefully, as otherwise BELASIC ointment will not be effective!
The recommended dosage is as follows:
Apply a thin layer of BELASIC to the affected area twice daily, in the morning and evening,
and massage gently.
In some cases, once-daily application may be sufficient. The frequency of application may be
reduced as symptoms improve.
The duration of treatment must not exceed 3 weeks.
The maximum daily dose for adults is 2 g of salicylic acid. It must not be applied for longer than
1 week.
If infection occurs, consider whether additional antibiotic treatment is necessary.
Consult your doctor or pharmacist if you feel that the effect of BELASIC ointment is too strong
or too weak.

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

If you use more BELASIC than you should
Excessive and prolonged application of locally applied corticosteroids (chronic overdosage or
abuse) may lead to suppression of the hypothalamic-pituitary-adrenal function, resulting in
secondary adrenal insufficiency and symptoms of hypercorticism, such as Cushing's syndrome.
Appropriate symptomatic treatment should be initiated. Acute symptoms of hypercorticism (e.g.
moon face) are largely reversible. If necessary, correct any electrolyte imbalances. If chronic toxic
damage has occurred, corticosteroids should be discontinued gradually.
However, no such cases have been reported to date.
Excessive and prolonged application of topical preparations containing salicylic acid may
cause symptoms of salicylate poisoning (tinnitus with hearing loss, nasal bleeding, nausea, vomiting,
irritability, dryness of mucous membranes). In such cases, treatment is symptomatic. Measures to
promote rapid elimination of salicylates should be taken, e.g. oral administration of sodium
hydrogen carbonate to alkalinize the urine and increase diuresis.

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

4. Possible side effects

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

Serious side effects or symptoms to watch for and actions 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.
If skin irritation or side effects such as rosacea-like dermatitis (perioral), skin thinning, striae, blistering, steroid acne, hypopigmentation, dilation and enlargement of cutaneous blood vessels, burning sensation, itching, dry skin, folliculitis, or altered hair growth occur, or if sensitization develops during application of BELASIC ointment, treatment must be discontinued.
Perioral dermatitis and allergic contact dermatitis have also been observed with the use of topical corticosteroids.
The following adverse reactions may occur more frequently when the ointment is applied under occlusive dressings: skin maceration, secondary infections, skin thinning, striae, and blistering.
With external application of salicylic acid, dry skin, skin irritation, and unintended skin desquamation 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 hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome exists.
Blurred vision has been reported during the use of glucocorticoids (frequency: not known).

Additional side effects in children
In children treated with topical corticosteroids, suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, growth retardation, reduced weight gain, and increased intracranial pressure (endocranial hypertension) have been observed.
Hypothalamic-pituitary-adrenal axis suppression in children is characterized by low plasma cortisol levels and lack of response to ACTH stimulation.
Increased intracranial pressure manifests as a bulging fontanelle, headache, and bilateral optic nerve swelling (bilateral papilledema).
Due to their higher skin surface area to body weight ratio, children are more susceptible than adult patients to glucocorticoid-induced suppression of the hypothalamic-pituitary-adrenal axis and to the effects of exogenous corticosteroids.

What measures should be taken if side effects occur?
If side effects such as rosacea-like dermatitis (perioral), skin thinning, striae, blistering, steroid acne, hypopigmentation, or dilation and enlargement of cutaneous blood vessels occur, the drug should be discontinued. The same applies in case of burning sensation, itching, dry skin, folliculitis, or altered hair growth.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BELASIC contains

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

Description of the appearance of BELASIC and contents of the pack
BELASIC is a homogeneous, white, semi-transparent ointment packed in an aluminium tube with
internal protective varnish (epoxy-phenolic varnish), protective membrane, and HDPE screw cap with
perforation tip, contained in a cardboard box.
Tube of 30 g.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 authorized in the European Economic Area Member States under the
following names:
CROATIA Belasic 0.5 mg/g + 30 mg/g mast
ITALY BELASIC