Betazontrio ointment 15g.

1. What BetazonTrio is and what it is used for

BetazonTrio ointment is a combined medicinal product intended for application to the skin. Betamethasone, a corticosteroid contained in the product, reduces redness, swelling, soothes itching, due to its pronounced anti-inflammatory and anti-allergic effect.

The antibiotic gentamicin effectively destroys a large number of microorganisms that cause infections in humans, incl. those of the skin. Clotrimazole has a pronounced antifungal effect.

BetazonTrio ointment is used in adults and children over 3 years of age for the treatment of various skin inflammations (dermatitis and eczema) suitable for the application of corticosteroids, in which an infection has developed, manifested by redness, irritation and worsening of the condition.

2. What you need to know before you use BetazonTrio

Do not use BetazonTrio:

if you are allergic to betamethasone, clotrimazole, gentamicin or any of the other ingredients of this medicine (listed in section 6);

you have certain skin infections such as herpes simplex or herpes zoster, chicken pox (a type of chicken pox known as chicken pox), skin syphilis, acne;

if you suffer from skin inflammation and redness around the mouth or itching in the genital area and anus.

The product should not be used in children under 3 years of age

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using BetazonTrio.

It is necessary to know that the continuous application:

of highly active corticosteroids can lead to thinning of the skin and dilation of superficial blood vessels in the treated areas, especially when the drug is applied to the skin of the face;

of topical corticosteroids, the use of high doses or the treatment of large skin areas can lead to their significant passage through the skin into the blood and suppress the activity of the adrenal gland. These manifestations are more common in young children. It is possible to develop hypercorticism (see section 4 Possible side effects), growth retardation, delayed weight gain and increased intracranial pressure.

of local antibiotics, incl. gentamicin and clotrimazole, may lead to the development of resistant microorganisms and susceptibility to additional infection. In these cases, treatment with the product should be discontinued and appropriate therapy with another antibacterial product should be initiated.

in psoriasis, it is possible to lead to chronicity of the disease, development of resistance to treatment and deterioration of the condition.

The application of the product should be discontinued if redness, irritation, itching, swelling appear, as these may be manifestations of allergy or secondary infection.

The drug should not be administered:

in or near the eyes, as it can cause glaucoma (increased intraocular pressure) if it gets into the eye.

on open wounds or damaged skin.

The use of tight dressings facilitates the penetration of corticosteroids through the skin and favors the development of infection.

The drug should be administered to children and adolescents only in the absence of other possible treatment.

Other medicines and BetazonTrio:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

There is no evidence of adverse interactions with other drugs.

BetazonTrio with food, drink and alcohol

There is no evidence of the need for a special diet or restrictions on certain types of food and drink during treatment with this medicine.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

The results of animal studies have shown evidence of harm to the fetus and the newborn with the administration of betamethasone and clotrimazole. The product should not be used by pregnant women.

Breastfeeding

The product should not be used in nursing women or, if necessary for the mother, breastfeeding should be discontinued.

Driving and using machines

BetazonTrio does not affect the performance of activities requiring increased attention such as driving or operating machinery.

3. How to use BetazonTrio

Always use this medicine exactly as your doctor or pharmacist has told you.

If you are not sure about something, ask your doctor or pharmacist, depending on the complaints, the doctor will determine the necessary dose to treat your disease and the duration of treatment.

The recommended dose is:

Adults

A small amount of the product is applied twice a day to the affected skin.

Children and adolescents

Adverse reactions associated with the application of the product are more common in children, therefore it should be used only according to the exact instructions of the doctor.

Persons in old age

In elderly patients, no change in dosage is required.

Application method

The product is applied in tons

layer, it is also possible through a light massage. The smallest possible amount of ointment should be used, sufficient to achieve an effect.

After applying the medicine, it is necessary to wash your hands well. In this way, a possible fall of even small amounts of ointment into the eyes will be avoided.

If no improvement is detected after 3-4 weeks of treatment, your doctor will assess whether you should continue treatment with this product.

If you forget to use BetazonTrio

Do not use more than necessary to make up for a missed application. Administer the usual dose as soon as possible after you have detected the omission and continue treatment as usual.

If you have any further questions related to the use of this product, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although everyone gets them.

During treatment with the product, the following side effects can be observed:

Disorders of the blood and lymphatic system

Hypochromia (pathological condition of erythrocytes /red blood cells/ in which they are pale colored due to reduced hemoglobin content).

Disorders of the skin and subcutaneous tissue

Discoloration of the skin, burning sensation of the skin, redness, itching.

General disorders and administration site conditions

Secretion from the site of application

When using topical corticosteroids, especially when using an occlusive (covering) dressing, the following local side effects have been reported: burning, itching, irritation, dry skin, inflammation of hair follicles (roots), increased hair growth, acne, discoloration of the skin, inflammation of the skin around the mouth, allergic skin reaction, moisturizing and softening of the skin, secondary infection, thinning of the skin, appearance of stretch marks and blisters on the skin.

In the treatment of fungal skin infections with local application of clotrimazole, the following side effects have been recorded: stinging, blistering of the skin, peeling, edema, urticaria and general skin irritation.

Treatment with gentamicin causes transient skin irritation (redness and itching), which generally does not require discontinuation of treatment.

5. How to store BetazonTrio

To be stored in a place inaccessible to children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.

After first opening the package, you can use this medicine for up to 28 days.

Do not use this medicine if you notice a change in the appearance of the ointment.

Do not dispose of medicines down the drain or in the household waste container.

Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What BetazonTrio contains:

The active ingredients of Big Ointment are Betamethasone dipropionate, eq. of Betamethasone 0.500 mg, Clotrimazole 10.0 mg, Gentamicin sulfate equiv. of Gentamicin (Gentamicin) 1.0 mg.

The other ingredients (excipients) are paraffin, liquid and paraffin, white soft.

What BetazonTrio looks like and contents of the pack

BetazonTrio is an ointment with a uniform consistency without air bubbles, white or almost white in color.

15 g of BetazonTrio ointment in aluminum tubes, varnished, closed with a plastic screw cap, with a latex ring at the lower end of the tube.

One tube together with a patient leaflet is packed in a cardboard box.