Beta-Micoter 10 mg/g + 0.5 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Beta-Micoter 10 mg/g + 0.5 mg/g cream
Clotrimazole / Betamethasone dipropionate
Read the entire 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, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Beta-Micoter is and what it is used for
- What you need to know before using Beta-Micoter
- How to use Beta-Micoter
- Possible adverse effects
- How to store Beta-Micoter
- Contents of the pack and other information
1. What Beta-Micoter is and what it is 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 fungal skin infections in adults and children over 12 years of age.
You should consult a doctor if your condition worsens or does not improve after 7 days.
2. What you need to know before using Beta-Micoter
Do not use Beta-Micoter
- if you are allergic to clotrimazole, betamethasone, other corticosteroids or imidazoles, or to any of the other components of this medicine (listed in section 6);
- if you have rosacea (a chronic skin disease affecting the face and characterized by redness), acne, or perioral dermatitis (inflammation of the skin around the mouth);
- in children under 1 year of age;
- in cases 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, treatment must be discontinued and appropriate therapy should be prescribed.
-
Anti-inflammatory medicines (corticosteroids), such as the active ingredient betamethasone dipropionate present in Beta-Micoter cream, have significant effects on the body. The use of Beta-Micoter cream over large areas of the body or for prolonged periods is not recommended, as this significantly increases the risk of adverse effects.
-
Adverse effects associated with corticosteroid use, including adrenal gland suppression, may also occur with topical application when the active ingredient is absorbed into the body, especially during treatment over large areas or for prolonged durations.
-
The medicine must not be applied under occlusive dressings (or air-impermeable materials, such as certain types of diapers).
-
If you are being treated for psoriasis, your doctor should monitor your condition frequently to detect any possible worsening.
-
The medicine must not be applied to skin folds, such as the groin or armpits.
-
It must not be applied to the face.
-
Beta-Micoter cream must 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 conditions other than those for which it was prescribed, it may mask symptoms and hinder correct diagnosis and treatment.
-
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 for children under 12 years.
In children, corticosteroids are more likely to be absorbed through the skin, increasing the risk of systemic adverse effects compared to adult patients.
In children treated with topical corticosteroids, there have been reports of dysfunction of the glands located near the kidneys (adrenal glands), leading to symptoms such as obesity, growth retardation, etc. (Cushing's syndrome), or increased intracranial pressure (intracranial hypertension), which may manifest, among other signs, as bulging of the fontanelle in infants and headaches.
Other medicines and Beta-Micoter
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take or use any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Beta-Micoter cream should not be used during pregnancy unless your doctor considers that the potential benefit justifies the potential risk to the fetus.
Pregnant women or those planning to become pregnant should not use Beta-Micoter cream over large areas of skin, for prolonged periods, or under occlusive dressings.
Breastfeeding
Do not apply Beta-Micoter cream to the breasts during breastfeeding; avoid contact between the infant and treated areas.
Do not use this medicine during breastfeeding unless instructed by your doctor, and avoid use over large skin areas, prolonged treatment periods, or occlusive dressings.
Driving and using machines
Treatment with Beta-Micoter does not affect the ability to drive or operate machinery.
Beta-Micoter contains cetyl alcohol, stearyl alcohol, and benzyl alcohol
This medicine contains 10 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions and may cause moderate local irritation.
This medicine may cause local skin reactions (such as contact dermatitis) as it contains cetyl alcohol and stearyl alcohol.
3. How to use Beta-Micoter
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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, spread a thin layer of the preparation to completely cover these areas and the surrounding skin. Apply twice daily, in the morning and at night. Wash your hands after applying the cream. This medicine must not be applied under occlusive dressings (or air-impermeable materials, such as certain diapers).
The duration of treatment will be two or four weeks, depending on the type and location of the infection, and will be determined by your doctor. Prolonged use of this medicine beyond four weeks is not recommended.
Improvement in symptoms such as itching and redness usually occurs within the first 3–5 days of treatment. If you do not observe any improvement after one week of treatment, you should consult your doctor, unless the infection is located on the feet, in which case improvement should be assessed 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 may also contact the Toxicology Information Service, telephone 91 562 04 20.
If you forget to use Beta-Micoter
If you forget to use this medicine at the scheduled time, apply the missed dose as soon as possible. However, if it is almost time for the next dose, wait until then.
Do not apply a double dose to make up for missed doses.
If you stop treatment with Beta-Micoter
Your doctor will advise you on the duration of your treatment with Beta-Micoter.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Beta-Micoter may cause some adverse effects such as:
Frequency not known (cannot be estimated from available data):
- numbness or tingling sensation (paresthesia),
- maculopapular rash (a type of rash that does not rise above the skin surface, with discolored spots and redness and inflammation of the skin),
- edema (swelling due to fluid accumulation),
- secondary infection.
Adverse reactions related to the use of clotrimazole include:
- 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/stinging sensation.
Adverse reactions related to the use of topical corticosteroids, especially after using occlusive dressings, include:
Very rare (affects less than 1 in 10,000 patients):
- hypersensitivity reactions,
- skin discoloration,
- irritation,
- burning,
- pruritus (itching).
Frequency not known (cannot be estimated from available data):
- thinning of the skin (atrophy),
- dryness,
- cracking,
- miliaria (red and white bumps in various parts of the body),
- redness at the application site (erythema),
- bruising,
- spider veins (telangiectasia),
- inflammation of hair follicles (folliculitis),
- changes in hair growth (hypertrichosis),
- allergic skin reaction around the mouth (perioral dermatitis),
- cutaneous striae (stretch marks),
- acneiform eruptions (acne-like rash),
- skin maceration,
- secondary infection,
- unusual hair loss,
- numbness or tingling sensation (paresthesia).
Adverse effects may occur not only in the treated area but also in completely different areas of the body, which may happen if the active ingredient passes into the body through the skin.
This, for example, could increase eye pressure (glaucoma) or cause a condition characterized by a rounded face, fat accumulation, buffalo hump, delayed wound healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, increased blood pressure, fluid retention (edema), decreased blood potassium levels, osteoporosis, thyroid disorders (hyperthyroidism), increased cholesterol and triglycerides, elevated blood and urine sugar levels (hyperglycemia and glucosuria), gastric ulcer, cataracts, and blurred vision, with frequency not known (cannot be estimated from available data).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Beta-Micoter
Keep this medicine out of sight and reach of children.
Do not store above 25°C.
30 g tube
Shelf life after first opening of the container: 30 days
60 g tube
Shelf life after first opening of the container: 60 days
Do not use Beta-Micoter after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if signs of deterioration are observed.
Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This 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 substances 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, polysorbate 60, cetyl alcohol, stearyl alcohol, sorbitan monostearate, cetyl 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 most recent revision of this leaflet: October 2021.
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/