Midacina 2 mg/g + 5 mg/g + 0.5 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Midacina 2 mg/g + 5 mg/g + 0.5 mg/g cream

fluocinolone acetonide/neomycin sulfate/gramicidin

Read this 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Midacina is and what it is used for
2. What you need to know before using Midacina
3. How to use Midacina
4. Possible adverse effects
5. How to store Midacina
6. Contents of the pack and other information

1. What Midacina is and what it is used for

Midacina cream contains, as active ingredients, two antibiotics (neomycin and gramicidin) and a corticosteroid, fluocinolone acetonide, which provides anti-inflammatory and vasoconstrictive activity. It belongs to the group of medicines called topical corticosteroids.

Midacina cream is indicated in adults, adolescents, and children over 12 years of age for the local treatment of localized, inflammatory skin conditions affecting small areas that require treatment with a high-potency glucocorticoid, in cases where a bacterial infection is also present.

2. What you need to know before using Midacina

Do not use Midacina

• If you are allergic (hypersensitive) to the active substances, to other corticosteroids, to other aminoglycoside antibiotics, or to any of the other components of this medicine (listed in section 6).
• If you have tuberculosis, syphilis, or viral infections (for example, herpes or chickenpox).
• In areas of skin affected by red/pink facial inflammation (rosacea), ulcers, or skin diseases with thinning of the skin (atrophy).
• In skin inflammation occurring around the mouth (perioral dermatitis).
• In areas of skin showing a vaccine reaction, i.e., redness or inflammation after vaccination.
• If you have a fungal infection of the skin.
• In the auricle and external auditory canal if you have a perforated eardrum.
• In children under 1 year of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Midacina.

Take special care in the following situations:

• If any hypersensitivity reaction occurs, treatment must be discontinued and appropriate therapy initiated.
• Anti-inflammatory drugs (corticosteroids), such as the active ingredient fluocinolone, have significant systemic effects. Treatment over large areas and for prolonged periods should be avoided, as this significantly increases the risk of adverse effects.
• Avoid contact with the eyes, mouth, open wounds, or mucous membranes (e.g., the genital area).
• Do not apply Midacina in skin folds such as the groin or armpits.
• If you have circulatory problems, do not apply corticosteroid medicines, as this could lead to ulceration of the area.
• Do not use Midacina under air- and water-impermeable materials such as non-breathable dressings, bandages, or diapers. Note that diapers may act as occlusive dressings.
• With the use of neomycin, adverse reactions typical of systemic use may also occur, especially with excessive use and in the presence of skin wounds.
• Cross-allergic reactions with aminoglycoside-type antibiotics have been reported.
• Prolonged use of topical antibiotics may occasionally lead to overgrowth of non-susceptible organisms, including fungi. In such cases, treatment with this medicine should be discontinued and medical advice sought.
• This medicine should not be used during the first trimester of pregnancy.
• Women of childbearing age should use effective contraceptive methods during treatment.
• If you use Midacina for conditions other than those for which it was prescribed, it may mask symptoms and complicate correct diagnosis and treatment.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

Midacina cream is contraindicated in children under one year of age.

The use of high-potency corticosteroids is not recommended in children under 12 years of age. This is because the skin surface area relative to body weight is greater in children, making them more susceptible to systemic toxicity.

In children and adolescents during growth periods, prolonged and continuous topical treatment with corticosteroids should be avoided whenever possible. Cases of adrenal suppression, Cushing's syndrome, growth retardation, and increased intracranial pressure due to systemic absorption of topical corticosteroids have been reported. If such a situation occurs, the topical corticosteroid should be gradually withdrawn under medical supervision due to the risk of adrenal insufficiency (see section 4 Possible side effects). Therefore, administration should be strictly controlled by a pediatrician.

Other medicines and Midacina

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even those obtained without a prescription, especially if you are receiving treatment with other steroids. No interaction studies have been conducted with Midacina cream to date.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Midacina cream should not be used during pregnancy unless your doctor considers that the potential benefit justifies the potential risk to the fetus.

Women of childbearing age should use effective contraceptive methods during treatment.

Breastfeeding

A risk to breastfed infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue treatment with this medicine, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother. Do not apply Midacina cream to the breasts during breastfeeding; avoid contact of the infant with treated areas.

Fertility

No studies have been conducted to evaluate the effect of topical fluocinolone/neomycin/gramicidin on human fertility.

Driving and use of machines

No negative effects affecting the ability to drive or operate machinery have been reported.

Midacina contains propylene glycol

This medicine contains 50 mg of propylene glycol per gram of cream. Propylene glycol may cause skin irritation.

Midacina contains cetyl alcohol

It may cause local skin reactions (such as contact dermatitis).

Midacina contains methyl parahydroxybenzoate (E-218)

It may cause allergic reactions (possibly delayed).

3. How to use Midacina

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Use in adults and children over 12 years of age

Apply two to three times a day depending on the severity and extent of the lesion.

Midacina cream is for external use only. Avoid contact with the eyes.

Before use, the affected area should be cleaned. Afterwards, apply a small amount of Midacina to the affected area.

Prolonged use is not recommended, especially under occlusive dressings or on extensive skin areas.

Use in children

Midacina cream is contraindicated in children under 1 year of age, and its use is not recommended in children under 12 years of age (see sections 2 and 4).

Method of administration

Cutaneous use.

Apply a small amount of cream directly to the affected area with gentle massage. Clean the area before applying the cream. Avoid touching any surface with the tube opening to prevent possible contamination of the tube contents.

Wash your hands after applying the cream.

If you use more Midacina than you should

If you have used Midacina excessively or for excessively prolonged periods, you should consult a doctor immediately, as this may cause certain disorders (e.g., Cushing's syndrome, fungal colonization of wounds, or infection by non-sensitive pathogens) that require treatment.

Due to the characteristics of the preparation, intoxication phenomena are not expected with topical use of the medicine.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Midacina

Remember to always use your medicine as prescribed.

Do not use a double dose to make up for missed doses. If you forget to apply a dose, apply it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule.

If you stop using Midacina

The original symptoms of your skin condition may reappear. Contact your doctor before stopping treatment prematurely, without having completed the prescribed duration.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Midacina may cause adverse effects, although not everyone will experience them.

The use of anti-inflammatory drugs (corticosteroids) on the skin may produce adverse effects, especially after prolonged application, over large areas, under dressings or occlusive materials, and/or in children.

Midacina may cause some adverse effects, such as:

Frequent (may affect up to 1 in 10 people):

• Pruritus (itching), burning, local cutaneous atrophy (thinning of the skin), pain, stinging, irritation, inflammation, or erythema (redness at the site of application).

Uncommon (may affect up to 1 in 100 people):

• Striae1, papular facial rosacea dermatitis (facial allergic reaction), ecchymosis (appearance of eczema-like or bruise-like spots), foliculitis (inflammation of hair follicles).

Rare (may affect up to 1 in 1,000 people):

• Hypercortisolism (increased levels of corticosteroids), adrenal suppression (reduced production of cortisone by the body), decreased plasma cortisol, hypertrichosis (excessive hair growth), hirsutism (excessive hair growth in women), alopecia, sensitization, hyper/hypopigmentation, telangiectasias (spider veins), perioral dermatitis, contact dermatitis.

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

• Microbial or fungal skin infections, molluscum contagiosum, condylomata acuminata (warts).
• Hypersensitivity reactions.
• Condition characterized by rounded face, fat accumulation, weakness, etc. (Cushing's syndrome).
• Reduced weight gain in children, hypokalemia (low potassium levels in blood), hyperglycemia (high blood glucose levels).
• Blurred vision, worsening of glaucoma, cataracts (subcapsular).
• Glucosuria (glucose in urine).
• Intracranial hypertension in children, edema.
• Acne, purpura, pustules, atypical papular-vesicular eruptions, vitiligo, paresthesia, skin discoloration (changes in skin pigmentation), dryness, cracking.
• Delayed wound healing.

1Adverse dermatological effects usually improve when treatment is discontinued, but striae may be permanent.

Adverse effects may occur not only in the treated area but also in completely different areas of the body. This may happen if the active substance passes into the body through the skin.

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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Midacina

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

Store in a dry place.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice deterioration of the packaging or any change in colour or odour.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicine containers you no longer need. In this way, you will help protect the environment.

6. Contents of the package and other information

Composition of Midacina

The active substances are fluocinolone acetonide, neomycin sulfate and gramicidin. Each gram of cream contains 2 mg of fluocinolone acetonide, 5 mg of neomycin (as sulfate) and 0.5 mg of gramicidin.

The other excipients are cetyl alcohol, XALAFIN 15 (PEG-8-C-12-C18 Alkyl ether), propylene glycol, glycerol (E-422), methyl parahydroxybenzoate (E-218) and distilled water.

Appearance of the product and contents of the pack

Midacina is a white, uniform cream and is supplied in an aluminium tube containing 15 g of cream.

Marketing Authorization Holder and Manufacturer

Date of the most recent review of this leaflet: September 2024