PATIENT INFORMATION LEAFLET

Abicrem 0.25 mg/g + 5 mg/g cream

Fluocinolone Acetonide/Framycetin

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, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do 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

This medication contains two active principles, a corticosteroid (acetonide of fluocinolone) and an antibiotic (framicetin).

Antibiotics are used to treat bacterial infections and do not serve to treat viral infections.

It is essential that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If there is any leftover antibiotic once the treatment is completed, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

It is used for the superficial treatment, in adults and adolescents over 12 years old, of eczematous dermatitis, such as: atopic eczema, discoid eczema (in the form of circular patches), stasis eczema (eczema in the legs that appears in some patients with hypertension), contact eczema, and seborrheic eczema, if your doctor confirms or suspects that it is due to the presence of a secondary bacterial infection.

You should consult a doctor if it worsens or does not improve after 14 days.

Do not use Abicrem cream

• If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
• If you currently have a skin infection caused by fungi, viruses, or if you have tuberculosis.
• If you have ulcers (wounds) on your extremities
• In children under two years of age.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Abicrem Cream.

-Corticosteroids should be used at the lowest possible dose and only for the time necessary to achieve the desired therapeutic effect. The use of this medication should be limited to 14 days. Long-term treatment may result in skin thinning, and an increased risk of hiding infections for which this medication is not suitable.

-If a local hypersensitivity reaction occurs, treatment should be suspended, the treated area washed, and antihistamines and/or topical or systemic corticosteroids applied to the skin or via the bloodstream, under the supervision of a healthcare professional.

-Do not apply impermeable, water-resistant dressings to large areas of skin, as this may cause the medication to be absorbed into the bloodstream, increasing the risk of toxicity.

- Do not stop treatment abruptly

-Avoid contact with the eyes, open wounds, or mucous membranes. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary (see section 4).

Notify your doctor if you experience blurred vision or other visual disturbances

Children and adolescents

-This medication is contraindicated in children under 2 years of age and not recommended in adolescents under 12 years.

-Children and adolescents in the growth phase have a higher absorption rate through the skin, making them more susceptible to adverse effects, such as Cushing's syndrome symptoms (obesity, growth retardation, etc.). Avoid prolonged treatments, large amounts of medication, and occlusion of the affected area. Consult your doctor at all times.

Other medications and Abicrem cream

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

During treatment with Abicrem cream, do not use other local antibiotics or antimicrobials (substances that prevent the growth of microorganisms, such as bacteria, fungi, parasites, or viruses), as there may be a chemical interaction between them.

Do not use Abicrem cream with synthetic anionic detergent substances.

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

Abicrem cream should only be used during pregnancy if the potential benefits outweigh the risk to the fetus.

Breastfeeding

Do not apply this medication to the breast during breastfeeding; do not put the baby in contact with treated areas.

Driving and operating machinery

This medication does not affect the ability to drive or operate machinery.

Abicrem cream contains cetomacrogol, methyiparaben (E-218), and propylene glycol (E-1520)

This medication contains 10 mg of propylene glycol (E-1520) per gram of cream.

This medication may cause local skin reactions (such as contact dermatitis) due to the presence of cetomacrogol.

This medication may cause allergic reactions (possibly delayed) due to the presence of methyiparaben (E-218).

Information for athletes

Consult your doctor before using this medication, as it may cause a positive result in the antidoping test. It is difficult to avoid using Abicrem cream, unless treating large areas of skin

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

Administration: topical.

Clean the affected area, preferably with mild neutral detergents, allowing it to dry, without rubbing the lesion.

The recommended dose in adults and adolescents over 12 years old is one thin layer of cream applied to the affected area, two to three times a day, gently rubbing until completely absorbed, for a maximum of 14 days.

After applying this medication, wash your hands carefully, unless your hands are the affected area.

Once the cream is applied, do not cover the area with impermeable materials to air and water, poorly breathable, unless your doctor advises you to do so.

If you use more Abicrem cream than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service: Phone (91) 562 04 20, indicating the medication and the amount used/taken.

If you forgot to use Abicrem cream

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

Apply the dose as soon as possible and then continue with your regular treatment.

If you interrupt the treatment with Abicrem cream

Do not stop treatment abruptly. It is recommended to gradually reduce and discontinue it to avoid the so-called suppression syndrome or rebound syndrome due to the sudden suspension of treatment.

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

Like all medications, Abicrem cream may produce adverse effects, although not everyone will experience them.

By hypersensitivity (allergy), a local reaction may appear, which disappears by decreasing or interrupting treatment.

The use of corticosteroids on the skin may cause the following adverse effects. It may appear with an unknown frequency (the frequency cannot be estimated from the available data):

Blurred vision, cataracts

Skin infections, Inflammation of hair follicles (Folliculitis), skin thinning (atrophy), skin dryness or cracking, itching or burning, redness (erythema), appearance of red spots, vascular spiders, skin striations, acne, hair loss or increased hair growth, skin allergic reaction (contact dermatitis), specific skin inflammation around the upper lip and chin (perioral dermatitis), and skin color changes.

Adverse effects may occur not only in the treated area, but may affect the entire body. This occurs if administered for prolonged periods, in extensive areas, with bandages or occlusive materials and/or in children (in whom absorption is increased). A condition characterized by round face, fat accumulation, weakness… (Cushing's syndrome), high blood pressure (hypertension), fluid retention (edema), numbness and tingling in the extremities, increased blood glucose (hyperglycemia), presence of glucose in the urine (glucosuria), low potassium levels in the blood, and gastric ulcer.

Children and Adolescents

In the case of prolonged use, growth may be altered, as well as other symptoms such as general discomfort, weight loss, abdominal pain, nausea, vomiting, confusion, and muscle weakness.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.esMBy reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

After the first opening, the cream is stable for up to 2 weeks. Once opened, store below 25°C. Any remaining medication should be discarded after 2 weeks have passed since opening.

Do not use Abicrem cream after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Abicrem cream

• The active principles are acetonic fluocinolone and framycetin (as sulfate). Each gram of cream contains 0.25 mg of acetonic fluocinolone and 5 mg of framycetin (as sulfate).
• The other components are Eumulgin B-1, cetyl alcohol, cutina MD, isopropyl myristate, propylene glycol (E-1520), liquid paraffin, para-hydroxybenzoate of methyl (E-218) and purified water.

Appearance of the product and contents of the packaging

Abicrem cream is presented in the form of a bright white, odorless cream, in 50 g tubes.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Galenicum Derma, S.L.U.

Ctra N-1, Km 36,

28750 San Agustin del Guadalix (Madrid)

Spain

Responsible for manufacturing:

Laboratorios Salvat, S.A.

C/ Gall, 30-36,

08950 – Esplugues de Llobregat. Barcelona (Spain)

Last review date of this leaflet:

August 2024

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