BETA-MICOTER 10 mg/g + 0.5 mg/g CREAM

Introduction

Package Leaflet: Information for the User

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

Clotrimazole / Betamethasone dipropionate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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 medicine indicated for the cutaneous treatment of certain skin infections caused by fungi in adults and children over 12 years of age.

You should consult a doctor if it worsens or does not improve after 7 days.

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

Do not use Beta-Micoter

• if you are allergic to clotrimazole, betamethasone, other corticosteroids, or imidazoles, or to any of the other ingredients of this medicine (listed in section 6);
• if you have rosacea (a chronic skin disease that affects the face and is characterized by redness), acne, dermatitis (inflammation of the skin) around the mouth;
• in children under 1 year of age;
• in case of eruptions caused by diapers;
• 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, you should discontinue treatment and be indicated the appropriate therapy.

• The anti-inflammatory medicines (corticosteroids), such as the active ingredient betamethasone dipropionate, present in Beta-Micoter cream, have significant effects on the body. It is not recommended to use Beta-Micoter cream on large areas of the body or for prolonged periods, as this significantly increases the risk of side effects.

• The adverse effects described with the use of corticosteroids, including adrenal gland disorders, may also occur with topical use by absorption into the body of the active ingredient, in treatments on large areas or prolonged.

• The medicine should not be applied with occlusive dressings (or air-impermeable materials, such as some diapers).

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

• The medicine should not be applied to skin folds, such as the groin or armpits.

• The medicine should not be applied to the face.

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

• If you use Beta-Micoter cream for diseases other than those for which it has been prescribed, it may mask symptoms and make diagnosis and correct treatment difficult.

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

Children and adolescents

This medicine is contraindicated in children under 1 year of age and is not recommended in children under 12 years of age.

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

In children treated with topical corticosteroids, disorders of the adrenal glands have been reported, which can cause symptoms such as obesity, growth retardation, etc. (Cushing's syndrome) or an increase in intracranial pressure (intracranial hypertension) that can manifest as, among other signs, bulging fontanelle in infants and headaches.

Other medicines and Beta-Micoter

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Beta-Micoter cream should not be used during pregnancy unless your doctor considers that the potential benefit of its use justifies 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 use occlusive dressings.

Breastfeeding

Do not apply Beta-Micoter cream to the breasts during breastfeeding; do not let the child come into contact with treated areas.

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

Driving and using machines

Treatment with Beta-Micoter does not affect the ability to drive or use machines.

Beta-Micoter contains benzyl alcohol, cetyl alcohol, and stearyl alcohol

This medicine contains 10 mg of benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause moderate local irritation.

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.

3. How to use Beta-Micoter

Follow exactly the instructions of administration of this medicine 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 of age:

After cleaning and drying the affected areas, you should spread a thin layer of the preparation to completely cover these areas and the surrounding skin. Apply twice a day, in the morning and at night. Wash your hands after applying the cream. The medicine should not be applied with occlusive dressings (or air-impermeable materials, such as some diapers).

The duration of treatment will be 2 or 4 weeks, depending on the type of infection and its location, and will be indicated by your doctor. It is not advisable to apply this medicine for more than 4 weeks.

Improvement of itching and redness symptoms usually occurs within the first 3-5 days of treatment. If you do not observe improvement after one week of treatment, you should consult your doctor, unless the infection is located on the feet, in which case the assessment 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 contact the Toxicology Information Service, phone 91 562 04 20.

If you forget to use Beta-Micoter

If you forget to use this medicine when you should, 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 make up for forgotten doses.

If you stop treatment with Beta-Micoter

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

If you have any further questions on 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.

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

Frequency not known (cannot be estimated from the available data):

• numbness or tingling (paresthesia),
• maculopapular rash (a type of rash that does not rise above the skin surface, with discolored and reddened skin),
• edema (swelling due to fluid accumulation),
• secondary infection.

The adverse reactions related to the use of clotrimazole 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.

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).

Frequency not known (cannot be estimated from the available data):

• skin thinning (atrophy),
• dryness,
• cracking,
• miliaria (red and white grains in several parts of the body),
• redness at the application site (erythema),
• bruises,
• spider veins (telangiectasia),
• inflammation of the hair follicles (folliculitis),
• changes in hair growth (hypertrichosis),
• allergic skin reaction around the mouth (perioral dermatitis),
• stretch marks,
• acne-like eruptions (acneiform eruptions),
• skin maceration,
• 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 into the body through the skin.

This, for example, can 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 disorders (hyperthyroidism), increased cholesterol and triglycerides, increased blood sugar and urine levels (hyperglycemia and glucosuria), stomach ulcers, cataracts, and blurred vision with frequency not known (cannot be estimated from the available data).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Beta-Micoter

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

30 g tube

Shelf life after opening the container: 30 days

60 g tube

Shelf life after opening the container: 60 days

Do not use Beta-Micoter after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

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

6. Contents of the pack and other information

Composition of Beta-Micoter

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

• The other ingredients are: benzyl alcohol, octyldodecanol, polysorbate 60, cetyl alcohol, stearyl alcohol, sorbitan monostearate, cetyle palmitate, and purified water.

Appearance of the product and contents of the pack

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

Marketing authorization holder and manufacturer

Teofarma S.r.l.

Via F.lli Cervi, 8

I-27010 Valle Salimbene

Pavia-Italy

Date of the last revision of this leaflet:October 2021.

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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