PERME-CURE 50 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Perme-cure 50 mg/g cream

permethrin

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Perme-cure and what is it used for
2. What you need to know before using Perme-cure
3. How to use Perme-cure
4. Possible side effects
5. Storage of Perme-cure
6. Package Contents and Additional Information

1. What is Perme-cure and what is it used for

Perme-cure contains permethrin as the active ingredient, which belongs to the group of medications called scabicides.

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

2. What you need to know before using Perme-cure

Do not use Perme-cure

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

Warnings and Precautions

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

Scabies infestation is often accompanied by itching, mild burning, or stinging after application with Perme-cure. Treatment with Perme-cure may temporarily exacerbate these symptoms, although they 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.

Be careful with this cream if you are prone to asthma attacks, as the use of permethrin may cause difficulty breathing.

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

Caregivers are recommended to use gloves when applying permethrin.

Avoid contact between Perme-cure and the eyes. If accidental contact occurs, the eyes should be rinsed immediately with plenty of water.

Do not apply to wounds or mucous membranes.

Children up to 23 months of age

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

Other medications and Perme-cure

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

No interactions with other medications have been reported.

Pregnancy and Breastfeeding

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

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 medication 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 Using Machines

No effects on the ability to drive or use machines have been reported.

Perme-cure contains castor oil, butylhydroxyanisole, butylhydroxytoluene, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, methyl parahydroxybenzoate, butyl parahydroxybenzoate, and isobutyl parahydroxybenzoate.

This medication may cause skin reactions because it contains castor oil.

This medication may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation 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.

3. How to use Perme-cure

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

Perme-cure should be used only for external use. Generally, a single application is sufficient to eliminate the infestation.

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

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

Before applying the cream, make sure 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 toes, paying special attention to the 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 mucous membranes).

The cream should be in contact with the skin for 8 to 14 hours. After this time, any unabsorbed cream should be removed by washing or showering with warm or cool water.

Reapply the cream to the hands if they are washed before 8 hours to ensure proper treatment.

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

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

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

Adults and children over 2 years of age

Should apply the cream to the skin of the entire body, including the palms of the hands and the soles of the feet. Do not apply to the head or face.

Adults over 65 years of age

In addition to considering the same application conditions as for adults and children over 2 years of age, apply 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 of age

Treatment should be performed under medical supervision.

The use of this medication is not recommended in children under 2 months of age. (See section 2).

Avoid letting children suck the cream from their hands. If necessary, the use of gloves in children is advised.

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, inform your doctor or pharmacist. Gastric lavage and symptomatic treatment are recommended.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

Common: may affect up to 1 in 10 people:

• skin sensation (paresthesia) such as tingling, pinching, burning sensation on the skin, pruritus, erythema, numbness, and skin rash,
• itching sensation that may persist for 2 to 4 weeks after treatment. This is not common and is caused by an allergic reaction to the remains of dead mites that cause scabies, and it is not a sign that the treatment has failed.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

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

5. Storage of Perme-cure

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 shown on the tube and carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Perme-cure

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

• The other ingredients are: Castor Oil, Purified Water, Steareth-2 (polyoxyethylene (2) stearate), butylhydroxyanisole (E-320), citric acid, Ceteareth-2 (C16-18 alcohol, ethoxylated-phosphate), sodium hydroxide (E-524) 20%, Vitamin E acetate, parahydroxybenzoates (2-phenoxyethanol, methyl parahydroxybenzoate (E-218), ethyl parahydroxybenzoate (E-214), butyl parahydroxybenzoate, isobutyl parahydroxybenzoate, propyl parahydroxybenzoate (E-216)), Citric Acid, Disodium EDTA, Butylhydroxytoluene (E-321), and Perfume Timly.

Appearance of the Product and Package Contents

Perme-cure is an oily external phase cream for cutaneous use, presented in polyethylene tubes of 40 and 70 grams.

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

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)

Date of the Last Revision of this Package Leaflet: July 2021

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