PERME-CURE 50 MG/G CREAM

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Perme-cure 50 mg/g cream

permethrin

Read the entire 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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Perme-cure is and what it is used for
2. What you need to know before using Perme-cure
3. How to use Perme-cure
4. Possible side effects
5. How to store Perme-cure
6. Contents of the pack and other information

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

Perme-cure contains the active substance permethrin, which belongs to a group of medicines 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 to any natural or synthetic pyrethrin or pyrethroid, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

Scabies infestation is usually accompanied by itching, mild burning, or stinging after application of Perme-cure. Treatment with Perme-cure may temporarily worsen these symptoms, although such manifestations usually disappear within 2 to 4 weeks. If irritation persists longer than this, you should consult your doctor.

If a hypersensitivity reaction to Perme-cure occurs, treatment should be discontinued.

Take special care with this cream if you are prone to asthma attacks, as the use of permethrin may cause breathing difficulties.

If you are known to be allergic to chrysanthemums or other plants from the Compositae family, Perme-cure should only be used after speaking with your doctor.

Caregivers are advised to wear gloves when applying permethrin.

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

Do not apply on 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 directed by your doctor. There is insufficient experience in infants. Treatment in children up to 23 months of age should only be administered under close medical supervision.

Other medicines and Perme-cure

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

No interactions with other medicines have been reported.

Pregnancy and breastfeeding

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

There is no experience in pregnant women; therefore, Perme-cure should only be used during pregnancy if recommended by a doctor and strictly necessary.

It is not known whether this medicine passes into breast milk; therefore, your doctor will decide whether it is necessary to interrupt breastfeeding or to discontinue 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 operate machinery have been reported.

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

This medicine may cause skin reactions because it contains castor 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.

3. How to use Perme-cure

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

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

In any case, your doctor will determine the duration of your treatment with Perme-cure 50 mg/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.

Apply the cream over the entire body from the base of the neck down to the tips of the feet, paying special attention to the areas between the fingers and toes (including the undersides and under the nails), wrists, armpits, genitals, and buttocks (always avoiding contact with genital and anal mucous membranes).

The cream must remain in contact with the skin for 8 to 14 hours. After this time, any cream not absorbed should be removed by bathing or showering with lukewarm or cool water.

Reapply the cream to the hands if they are washed before the 8-hour period has elapsed, in order to ensure proper treatment.

Generally, a single application is sufficient to eliminate the infestation. Only if live mites are observed after 14 days should a second application be performed.

It is recommended that you consult your doctor for a follow-up examination 2 to 4 weeks after treatment.

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

Adults and children over 2 years of age

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

Adults over 65 years of age

In addition to the same application conditions as for adults and children over 2 years of age, apply to the neck, face, and scalp. Take care not to apply the cream around the eyes or mouth.

Children between 2 months and 2 years of age

Treatment must be performed under medical supervision.

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

Prevent children from sucking on the cream on 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 recommended, consult your doctor or pharmacist immediately.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Common: may affect up to 1 in 10 people:

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

Reporting of adverse effects

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

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

5. Storage of Perme-cure

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the tube and the carton following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Perme-cure

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

• The other components are: Castor oil, deionized water, steareth-2 (polyoxyethylene(2) stearyl ester), butylhydroxyanisole (E-320), citric acid, ceteareth-2 (C16-18 alcohol, ethoxylated-phosphate)-phosphate, sodium hydroxide (E-524) 20%, vitamin E acetate, parahydroxybenzoates (2-phenoxyethanol, methylparaben (E-218), ethylparaben (E-214), butylparaben, isobutylparaben, propylparaben (E-216)), citric acid, disodium EDTA, butylhydroxytoluene (E-321) and Timly perfume.

Appearance of the product and contents of the container

Perme-cure is an oil-in-water emulsion cream for topical use, available 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 Bohm S.A.

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

28947 Fuenlabrada, Madrid (Spain)

Date of the most recent revision of this leaflet: July 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/