Leaflet: information for the user

Perme-cure 50 mg/g cream

permethrin

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

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

Perme-cure contains permethrin as its active ingredient, which belongs to a group of medications known as scabicides.

Perme-cure is indicated for the treatment of scabies in adults and children over 2 months old.

No use Perme-cure

• if you are allergic to permethrin or any pyrethrin or pyrethroid natural or synthetic, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Perme-cure.

The infestation by scabies is usually accompanied by itching, mild burning or stinging sensations after application with Perme-cure. The treatment with Perme-cure may temporarily exacerbate these symptoms, although these manifestations usually disappear within 2 to 4 weeks. If irritation persists for a longer period, you should consult your doctor.

In case of a hypersensitivity reaction to Perme-cure, its use should be discontinued.

You should exercise special caution with this cream if you are susceptible to asthma attacks, as the use of permethrin may cause breathing difficulties.

If you know that you are allergic to chrysanthemums or other plants of the composite family, you should only use Perme-cure after consulting your doctor.

It is recommended that caregivers use gloves when applying permethrin.

Avoid contact of Perme-cure with the eyes. If accidental contact occurs, wash the eyes immediately with plenty of water.

Do not apply on wounds or mucous membranes.

Children under 23 months of age

Do not use Perme-cure in newborns and infants under 2 months, unless your doctor advises you to do so. There is no adequate experience in infants. Treatment for children up to 23 months should only be administered under close medical supervision.

Other medicines and Perme-cure

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

No interactions with other medicines have been described.

Pregnancy and breastfeeding

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

There is no experience in pregnant women, so Perme-cure should only be used during pregnancy when the doctor recommends it as strictly necessary.

It is not known whether this medicine passes into breast milk, so the doctor will decide whether to interrupt breastfeeding or interrupt treatment with Perme-cure, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machines

No effects on the ability to drive or operate machines have been described.

Perme-curecontains ricin oil, butylhydroxyanisole, butylhydroxytoluene, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, methyl parahydroxybutyrate, butyl parahydroxybenzoate, and isobutyl parahydroxybenzoate.

This medicine may cause skin reactions because it contains ricin oil.

This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole and butylhydroxytoluene.

It may cause allergic reactions (possibly delayed) because it contains ethyl parahydroxybenzoate, propyl parahydroxybenzoate, methyl parahydroxybenzoate, butyl parahydroxybenzoate, and isobutyl parahydroxybenzoate.

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

Perme-cure must be used exclusively for external use. Generally, a single application is sufficient to end the infestation.

In any case, your doctor must indicate the duration of your treatment with Perme-cure 50mg/g cream.

Apply a sufficient amount of cream to cover the area to be treated.

Before applying the cream, ensure that the skin is clean and dry.

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Apply the cream to the entire body from the base of the neck to the tips of the feet, paying special attention to areas between the fingers of the hands and feet (including the underside and between the nails), wrists, armpits, genitals, and buttocks (always respecting the genital and anal mucosa).

The cream must be in contact with the skin for 8 to 14 hours. After that time, the cream that has not been absorbed must be removed by taking a bath or shower with warm or cold water.

Reapply the cream to the hands if they are washed before 8 hours to complete the correct treatment.

Generally, a single application is usually sufficient to end the infection. Only in cases where live mites are observed, after 14 days of using the cream, a second application will be performed.

It is recommended that you consult your doctor for a review at 2 or 4 weeks after treatment.

Avoid contact with the eyes. In case of accidental contact, immediately rinse with abundant water.

Adults and children over 2 years old

They must apply the cream to the skin of the entire body, including the palms of the hands and the soles of the feet. It will not be applied to the head or face.

Adults over 65 years old

In addition to taking into account the same application conditions as adults and children over 2 years old, it will be applied to the neck, face, and scalp. Be careful not to apply the cream around the eyes and mouth.

Children between 2 months and 2 years old

The treatment must be performed under medical supervision.

It is not recommended to use this medication in children under 2 months. (See section 2).

Avoid children sucking the cream from their hands. If necessary, it is recommended to use gloves on children.

If you use more Perme-cure than you should

If you have used more Perme-cure than you should, consult your doctor or pharmacist immediately.

In case of accidental ingestion, notify your doctor or pharmacist. Gastric lavage and symptomatic treatment are recommended.

For further information, call the National Toxicology Information Service at Teléfono 91 562 04 20.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very Common: may affect more than 1 in 10 people:

• skin burning sensation
• burning or itching sensation. This sensation is usually brief and disappears quickly.

Common: may affect up to 1 in 10 people:

• sensations on the skin (paresthesias) such as tingling, pinpricks, skin burning sensation, pruritus, erythema, numbness, and skin rash,
• itching sensation that may persist for two to four weeks after treatment. This is not common and is caused by an allergic reaction to sensitization to the remnants of dead mites that cause scabies, and is not a sign that the treatment has failed.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly throughthe Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

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

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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

Do not dispose of medications through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Perme-cure

The active ingredient is permethrin. Each gram of cream contains 50 mg of permethrin.

• The other components are: Castor oil, Distilled water, Steareth-2 (polyoxyethylene(2)stearyl ether), butylhydroxyanisole (E-320), citric acid, Ceteareth-2 (C16-18 alcohol, ethoxylated-phosphate)-phosphate, Sodium hydroxide (E-524) at 20%, Vitamin E acetate, parahydroxybenzoates (2-phenoxietanol, parahydroxybenzoate of methyl (E-218), parahydroxybenzoate of ethyl (E-214), parahydroxybenzoate of butyl, parahydroxybenzoate of isobutyl, parahydroxybenzoate of propyl (E-216)), Citric acid, EDTA disodium, Butylhydroxytoluene (E-321) and Perfume Timly.

Appearance of the product and content of the container

Perme-cure is anexternal oily phase cream for cutaneous usepresented in polyethylene tubes of 40 and 70 grams.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization

Galenicum Derma, S.L.U.

Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid)Spain

Responsible for the manufacture

Laboratorios ERN, S.A.

Polígono Industrial Can Salvatella

Calle Gorcs i Lladó, 188, Barberà del Vallés

08210 (Barcelona) Spain

or

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 -Sant Cugat del Vallés, Barcelona –Spain

or

Laboratorios Bohm S.A.

C/ Molinaseca, 23-25. Polígono Industrial Cobo Calleja

28947 Fuenlabrada.- Madrid (Spain)

Last review date of this leaflet: July 2021

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