Leaflet: information for the user

Beta-Micoter 10 mg/g + 0.5 mg/g cream

Clotrimazole / Betamethasone dipropionate

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Beta-Micoter and what it is used for

2.What you need to know before starting to use Beta-Micoter

3.How to use Beta-Micoter

4.Possible side effects

5.Storage of Beta-Micoter

6.Contents of the pack and additional information

Beta-Micoter combines the antifungal action of clotrimazole with the anti-inflammatory and antipruritic effect of betamethasone dipropionate (a corticosteroid).

Beta-Micoter cream is a medication indicated for the topical treatment of certain skin infections caused by fungi in adults and children over 12 years old.

Consult a doctor if it worsens or does not improve after 7 days.

No use Beta-Micoter

• If you are allergic to clotrimazole, betamethasone, other corticosteroids, or imidazoles, or to any of the other components of this medication (listed in section 6);
• If you have rosacea (a chronic skin condition that affects the face and is characterized by redness), acne, dermatitis (skin inflammation) around the mouth;
• In children under 1 year;
• In case of diaper rash;
• If you have a skin infection caused by bacteria or viruses.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Beta-Micoter.

• If any hypersensitivity reaction occurs, discontinue treatment and seek appropriate therapy.

• Topical corticosteroids, such as the active ingredient betamethasone dipropionate in Beta-Micoter cream, have significant effects on the body. Do not use Beta-Micoter cream on large areas of the body or for prolonged periods, as this significantly increases the risk of adverse effects.

• The adverse effects described with the use of corticosteroids, including adrenal gland alteration, may also occur with topical use of the active ingredient, especially in treatments on large areas or for prolonged periods.

• Do not apply the medication with occlusive dressings (or impermeable materials, such as some diapers).

• If you are being treated for psoriasis, your doctor should regularly monitor your condition to observe any possible worsening.

• Do not apply the medication to skin folds, such as the groin or armpits.

• Do not apply the medication to the face.

• Beta-Micoter cream should not come into contact with the eyes, mouth, open wounds, or mucous membranes (such as the genital area).

• If you use Beta-Micoter cream for conditions other than those for which it was prescribed, you may mask symptoms and make it difficult to diagnose and treat correctly.

• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and Adolescents

This medication is contraindicated in children under 1 year and not recommended in children under 12 years.

In children, it is more likely that the corticosteroid will pass through the skin and cause adverse effects in other areas of the body compared to adult patients.

In children treated with topical corticosteroids, adrenal gland alteration has been reported, which may manifest as symptoms such as obesity, growth retardation, etc. (Cushing's syndrome) or increased intracranial pressure, which may be manifested by other signs, such as fontanelle bulging in infants and headaches.

Other Medications and Beta-Micoter

Inform your doctor or pharmacist if you are using, have used recently, or may need to take or use any other medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Beta-Micoter cream should not be used during pregnancy unless your doctor considers that the potential benefits of its use outweigh the potential risk to the fetus.

Pregnant women or those planning to become pregnant should not use Beta-Micoter cream on large areas of the skin, for prolonged periods, or with occlusive dressings.

Breastfeeding

Do not apply Beta-Micoter cream to the breasts during breastfeeding; do not put the baby in contact with treated areas.

Do not use this medication during breastfeeding unless your doctor advises you to, and do not use it on large areas of the skin, for prolonged periods, or with occlusive dressings.

Driving and Operating Machinery

The treatment with Beta-Micoter does not affect the ability to drive or operate machinery.

Beta-Micoter contains alcohol cetílico, alcohol estearílico, and alcohol bencílico

This medication contains 10 mg of alcohol bencílico in each gram of cream. Alcohol bencílico may cause allergic reactions. Alcohol bencílico may cause moderate local irritation.

This medication may cause local skin reactions (such as contact dermatitis) because it contains alcohol cetílico and alcohol estearílico.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years old:

After cleaning and drying the affected areas, you must apply a thin layer of the preparation to cover completely those areas and the surrounding skin. Apply twice a day, in the morning and at night.Wash your hands after applying the cream.Do not apply the medication with occlusive dressings (or impermeable materials to the air, such as some diapers).

The treatment duration will be two or four weeks depending on the type of infection and its location, and will be indicated by your doctor. It is not recommended to apply this medication for more than four weeks.

Improvement of symptoms such as itching and redness usually occurs within the first 3-5 days of treatment. If you do not observe improvement after one week of treatment, you must consult your doctor, unless the infection is located on the feet, in which case the evaluation of improvement will be made after two weeks of treatment.

If you use more Beta-Micoter than you should

If you apply more cream than you should, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service, phone 91 562 04 20.

If you forgot to useBeta-Micoter

If you forgot to use this medication when it was due, apply the corresponding dose as soon as possible or, if the next application is near, wait until then.

Do not apply a double dose to compensate for the missed doses.

If you interrupt the treatment withBeta-Micoter

Your doctor will indicate the duration of your treatment with Beta-Micoter.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Beta-Micoter may cause some side effects, such as:

Unknown frequency (cannot be estimated from available data):

• Numbness or tingling (paresthesia),
• Maculopapular rash (a type of rash that does not elevate above the skin surface, with discolored skin patches and skin redness and inflammation),
• Swelling (edema),
• Secondary infection.

The adverse reactions related to the use of clotrimazol are:

• Allergic reactions: syncope (loss of consciousness), hypotension, dyspnea (difficulty breathing), urticaria,
• Blisters,
• Discomfort/pain,
• Redness at the application site (erythema),
• Irritation,
• Exfoliation,
• Pruritus (itching),
• Burning sensation/heat.

The adverse reactions related to the use of topical corticosteroids, especially after the use of occlusive dressings, include:

Very rare (affects less than 1 in 10,000 patients):

• Hypersensitivity reactions,
• Skin discoloration,
• Irritation,
• Burning sensation,
• Pruritus (itching).

Unknown frequency (cannot be estimated from available data):

• Skin thinning (atrophy),
• Dryness,
• Wrinkling,
• Miliaria (red and white granules in various parts of the body),
• Redness at the application site (erythema),
• Hematomas,
• Spider veins (telangiectasia),
• Folliculitis (inflammation of hair follicles),
• Changes in hair growth (hypertrichosis),
• Perioral dermatitis (skin reaction around the mouth),
• Striae (skin stretch marks),
• Acneiform eruptions (acne-like rash),
• Moisturizing skin,
• Secondary infection,
• Unusual hair loss,
• Numbness or tingling (paresthesia).

Side effects can occur not only in the treated area, but also in completely different areas of the body, which occurs if the active ingredient passes through the skin into the body.

This, for example, may increase eye pressure (glaucoma) or could cause a condition characterized by a rounded face, fat accumulation, hump, delayed healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, increased blood pressure, fluid retention (edema), decreased potassium levels in the blood, osteoporosis, thyroid dysfunction (hyperthyroidism), increased cholesterol and triglycerides, increased blood sugar and urine glucose (hyperglycemia and glucosuria), gastric ulcers, cataracts, and blurred vision with unknown frequency (cannot be estimated from available data).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of sight and reach of children.

Do not store at a temperature above 25°C.

Tube of 30 g

Period of validity after opening the packaging: 30 days

Tube of 60 g

Period of validity after opening the packaging: 60 days

Do not use Beta-Micoter after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Homogeneous cream of white color, in packaging containing 30 g and 60 g of cream.

Composition of Beta-Micoter

• The active principles are clotrimazole and betamethasone dipropionate. Each gram of cream contains 10 mg of clotrimazole and 0.5 mg of betamethasone dipropionate.

-The other components are: benzyl alcohol, octyldodecanol, poloxamer 60, cetyl alcohol, stearic alcohol, sorbitan monostearate, cetyl palmitate and purified water.

Appearance of the product and contents of the packaging

Beta-Micoter is presented in the form of a homogeneous white cream, in containers containing 30 g and 60 g of cream.

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.r.l.

Via F.lli Cervi, 8

I-27010 Valle Salimbene

Pavia-Italy

Last review date of this leaflet:October 2021.

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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