Package Insert: Information for the User

Fourcream Cream

Read this entire package insert carefully before you start using this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert, report them to your doctor or pharmacist. See section 4.

It is a combination of an anti-inflammatory (a corticosteroid), an aminoglycoside antibiotic, and two antifungal agents for administration on the skin.

It is indicated for the local treatment of inflammatory manifestations of dermatosis (skin conditions) that respond to corticosteroids in complicated cases with mixed infections caused by sensitive microorganisms to the components of the medication.

Do not use Cuatrocrem cream

• if you are allergic (to betamethasone or other corticosteroids, gentamicin or other antibiotics, aminoglycosides, clioquinol, tolnaftate, iodine, or any of the other components of this medicine (listed in section 6).
• if you have tuberculosis, syphilis, or viral infections (such as herpes or chickenpox)
• in areas of skin affected by rosacea (inflammation with redness of the skin on the face) or in an inflammation around the mouth (perioral dermatitis)
• in skin conditions with thinning of the skin (atrophy)
• in areas of skin showing a vaccine reaction, that is, redness or inflammation after the vaccine
• in the eyes or in deep wounds
• in children under 2 years.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cuatrocrem cream.

• Do not apply the cream to large areas of the body or for prolonged periods.
• Do not apply the cream with dressings or impermeable materials, or in skin folds, such as the groin or armpits.
• If any hypersensitivity reaction occurs with the use of Cuatrocrem cream, discontinue treatment and seek appropriate therapy.
• Cross-allergic reactions with aminoglycoside antibiotics have been described.
• Systemic effects of corticosteroids, including adrenal suppression, may also occur with topical use, especially with large surface area treatment, prolonged treatment, and in children.
• The use of the second component of this medicine, gentamicin, may also cause adverse reactions typical of internal use, especially with excessive use and in the presence of skin lesions.
• Prolonged use of topical antibiotics such as gentamicin may occasionally lead to the proliferation of non-susceptible organisms. In these cases, discontinue treatment with Cuatrocrem and consult a doctor.
• The use of clioquinol with occlusion may cause an increase in blood iodine levels.
• This medicine may slightly stain clothing and skin due to its content of clioquinol.
• Cuatrocrem cream should not come into contact with the eyes, mouth, open wounds, or mucous membranes (such as the genital area).
• If you use this medicine for conditions other than those for which it has been prescribed, you may mask symptoms and make it difficult to diagnose and treat correctly.
• Interference with diagnostic tests: If you are to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc...) inform your doctor that you are using this medicine, as it may alter the results.
• The absorption of clioquinol may interfere with thyroid function tests and the ferric chloride test for phenylketonuria may show a false positive result
• Notify your doctor if you experience blurred vision or other visual disturbances.

Children

This medicine is not recommended for use 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 parts of the body than in adult patients.

In children treated with topical corticosteroids, adrenal suppression has been reported, which may cause symptoms such as obesity (Cushing's syndrome), growth retardation, etc.

Other medicines and Cuatrocrem Cream

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

No interactions of Cuatrocrem cream with other medicines are known.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

As a general rule, the cream should not be applied during the first trimester of pregnancy.

Cuatrocrem cream will not be used during pregnancy unless your doctor considers that the potential benefits of its use justify the potential risk to the fetus.

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

Breastfeeding

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

Do not use this medicine on large areas of the skin, for prolonged periods, or with occlusive dressings.

Driving and operating machinery

The treatment with Cuatrocrem cream does not affect the ability to drive or operate machinery.

Cuatrocrem cream contains alcohol cetoestearate and chlorocresol

This medicine may cause local skin reactions (such as contact dermatitis) due to its content of alcohol cetoestearate.

This medicine may cause allergic reactions due to its content of chlorocresol.

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

The recommended doses are:

Adults and patients over 12 years old

Apply a thin layer of Cuatrocrem cream to the entire affected area 2 times a day, in the morning and at night.

The treatment duration should not exceed one or two weeks. If you use the medication for a condition on the face, the treatment should be as short as possible, a maximum of one week.

In cases oftinea pedis(athlete's foot), a longer treatment may be necessary (2 to 4 weeks), but if you do not see an improvement in 3 weeks, consult your doctor.

Use in children

Cuatrocrem cream is contraindicated in children under 2 years old and is not recommended for children under 12 years old.

Cutaneous use.

The cream should be applied with a gentle massage in a thin layer to the entire affected area, previously cleaned with care.

If you use more Cuatrocrem cream than you should

The excessive use of topical corticosteroids (repeated overdoses or misuse) may cause adverse effects (see section 4).

A single overdose of gentamicin is not expected to cause symptoms. The excessive or prolonged use of topical antibiotics may cause an overgrowth of fungal or bacterial lesions that are not sensitive.

If it enters the body, tolnaftate is pharmacologically inactive.

Clioquinol rarely causes iodism and its prolonged use may cause overgrowth of non-sensitive organisms.

The treatment of overdose is symptomatic. The acute symptoms of excessive use of corticosteroids are usually reversible. In cases of chronic toxicity, it is recommended to withdraw corticosteroids gradually and, if there is an overgrowth of non-sensitive microorganisms, to interrupt Cuatrocrem treatment and apply the appropriate therapy.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

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

The following side effects have been reported, occasionally, with the use of Cuatrocrem cream: erythema (redness), pruritus, and changes in skin color.

Rash (eruption), irritation, and hypersensitivity have been reported with the use on the skin of gentamicin sulfate, clioquinol, and rarely with tolnaftate.

An increase in levels of iodine bound to proteins may occur with the use on extensive areas or skin wounds and/or with occlusive dressing.

The following reactions have been reported with the use of topical corticosteroids, especially after prolonged application, in extensive areas, with dressings or occlusive materials, and/or in children:

• Thinning of the skin (atrophy)
• Dryness of the skin
• Itching or burning
• Maceration (softening of the skin by moisture)
• Erythema (redness)
• Appearance of red patches
• Haematomas
• Inflammation of hair follicles (folliculitis)
• Striae (stretch marks) on the skin
• Appearance of small blisters
• Acne
• Contact dermatitis (allergic reaction of the skin)
• Infections
• Blurred vision (frequency unknown).

Side effects may 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, may increase eye pressure (glaucoma) or could produce a condition characterized by a rounded face, accumulation of fat, delayed healing, psychiatric symptoms, etc. (Cushing's syndrome); increased intracranial pressure, increased blood sugar levels (hyperglycemia), increased blood pressure, fluid retention (edema), thyroid dysfunction (hyperthyroidism), cataracts, increased hair growth, specific inflammation of the skin around the upper lip and chin (perioral dermatitis), changes in skin color, paresthesia (an abnormal sensation of the skin, such as numbness, tingling, stinging, or burning in the skin)

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Store below 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Fourcrem cream

• The active principles are betamethasone (as valerate), gentamicin (as sulfate), clioquinol, and tolnaftate.
• Each gram of cream contains 0.5 mg of betamethasone (0.05%) (which corresponds to 0.61 mg of betamethasone valerate), 1 mg of gentamicin (0.1%), 10 mg of tolnaftate (1%), and 10 mg of clioquinol (1%).
• The other components are: chlorocresol, cetoestearic ether of macrogol, cetoestearic alcohol, white vaseline, liquid paraffin, dihydrogen phosphate dihydrate of sodium, and purified water.

Appearance of the product and content of the packaging

Fourcrem cream is a white cream with a smooth texture.

It is presented in tubes with 15 and 30 g of cream.

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:

SAG Manufacturing S.L.U.

Crta. N-I, Km 36

28750 San Agustin del Guadalix (Madrid)Spain

Date of the last revision of this prospectus: April 2019.

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