CUATROCREM CREAM

Introduction

Package Leaflet: Information for the User

Cuatrocrem Cream

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.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Cuatrocrem Cream and what is it used for

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

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

2. What you need to know before you start using Cuatrocrem Cream

Do not use Cuatrocrem Cream

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

Warnings and Precautions

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

• The cream should not be applied to large areas of the body or for prolonged periods.
• The cream should not be applied with bandages or airtight materials, nor in skin folds, such as the groin or armpits.
• If any hypersensitivity reaction occurs with the use of Cuatrocrem Cream, treatment should be discontinued, and appropriate therapy should be indicated.
• Cross-allergic reactions have been described with aminoglycoside antibiotics.
• The adverse effects described with the use of corticosteroids, including alteration of the adrenal glands, may also occur with topical use by absorption into the body, especially if large areas are treated, in prolonged treatments, and in children.
• With the use of the second component of this medicine, gentamicin, adverse reactions typical of internal use may also occur, especially with excessive use and in the presence of skin wounds.
• Prolonged use of topical antibiotics such as gentamicin may occasionally lead to the proliferation of non-sensitive organisms. In these cases, treatment with Cuatrocrem should be discontinued, and the doctor should be consulted.
• Clioquinol used with occlusion may increase iodine levels in the blood.
• This medicine may slightly stain clothing and skin due to its clioquinol content.
• Cuatrocrem Cream should not come into contact with the eyes, mouth, open wounds, or mucous membranes (e.g., the genital area).
• If you use this medicine for diseases other than those for which it has been prescribed, it may mask symptoms and make diagnosis and correct treatment more difficult.
• Interference with laboratory tests: If you are going 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.
• Absorption of clioquinol may interfere with thyroid function tests, and the ferric chloride test for phenylketonuria may show a false-positive result.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

This medicine is not recommended for use 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, adrenal gland alteration has been reported, which can 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

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

Cuatrocrem 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 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 let the child come into contact with treated areas.

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

Driving and Using Machines

Treatment with Cuatrocrem Cream does not affect the ability to drive or use machines.

Cuatrocrem Cream contains cetostearyl alcohol and chlorocresol

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

This medicine may cause allergic reactions because it contains chlorocresol.

3. How to Use Cuatrocrem Cream

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

The recommended dose is:

Adults and patients over 12 years

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 medicine for a condition on the face, the treatment should be as short as possible, up to a maximum of one week.

In cases of tinea pedis(athlete's foot), a longer treatment (2 to 4 weeks) may be necessary, but if you do not observe improvement within 3 weeks, consult your doctor.

Use in Children

Cuatrocrem Cream is contraindicated in children under 2 years of age and is not recommended for children under 12 years of age.

Topical 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

Excessive use of topical corticosteroids (repeated overdoses or misuse) may produce adverse effects (see section 4).

A single overdose of gentamicin is not expected to produce symptoms. Excessive or prolonged use of topical antibiotics may provoke the proliferation of non-sensitive fungi or bacteria in the lesions.

If tolnaftate is absorbed into the body, it is pharmacologically inactive.

Clioquinol rarely produces iodism, and its prolonged use may produce an overgrowth of non-sensitive organisms.

Treatment of overdose is symptomatic. Acute symptoms of excessive corticosteroid use are generally reversible. In cases of chronic toxicity, it is recommended that corticosteroids be withdrawn gradually, and if proliferation of non-sensitive microorganisms occurs, treatment with Cuatrocrem should be discontinued, and appropriate therapy should be applied.

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

If you forget to use Cuatrocrem Cream

Do not apply a double dose to make up for forgotten doses.

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

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.

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

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

• Thinning of the skin (atrophy)
• Dryness of the skin
• Itching or burning
• Maceration (softening of the skin due to moisture)
• Redness (erythema)
• Appearance of red spots
• Bruises
• Inflammation of the hair follicles (folliculitis)
• Stretch marks
• Appearance of small blisters
• Acne
• Allergic skin reaction (contact dermatitis)
• Infections
• Blurred vision (frequency not known).

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any 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://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cuatrocrem Cream

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Store below 25°C.

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.

6. Contents of the Pack and Other Information

Composition of Cuatrocrem Cream

• The active ingredients 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 ingredients are: chlorocresol, cetostearyl alcohol, macrogol, white petrolatum, liquid paraffin, sodium dihydrogen phosphate dihydrate, and purified water.

Appearance of the Product and Contents of the Pack

Cuatrocrem Cream is a white, smooth cream.

It is available in tubes containing 15 and 30 grams of cream.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid), Spain

Manufacturer:

SAG Manufacturing S.L.U.

Crta. N-I, Km 36

28750 San Agustin del Guadalix (Madrid), Spain

Date of the Last Revision of this Leaflet: April 2019.

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/