Leaflet: information for the user

Sarcop 50 mg/g Cream

Permethrin

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, 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.

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

2. What you need to know beforestarting touse Sarcop Cream

3.How to use Sarcop Cream

4.Possible side effects

5.Storage of Sarcop Cream

6. Contents of the pack and additional information

It contains permethrin as its active ingredient, an effective antiparasitic substance against various parasites such asSarcoptes scabieia type of mite and the cause of scabies or mange.

Sarcop is indicated for the local treatment of scabies or mange infestations (skin disease).

No use Sarcop

• If you are allergic to permethrin, other pyrethrins, both synthetic and natural, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Sarcop.

- Scabies is usually accompanied by itching, swelling, and redness of the skin or erythema. Treatment with Sarcop may temporarily increase these symptoms, although these manifestations usually disappear when the scabies are eliminated, they may continue for a period of 2 to 4 weeks, as it is a hypersensitivity reaction; if they persist for longer, you should consult your doctor.

- If you know you are allergic to chrysanthemums or other plants in the composite family, Sarcop should only be used after talking to your doctor.

-This medication is used in a single application, only another application will be made if your doctor prescribes it.

• Caregivers are recommended to use gloves for the application of the cream.

-Avoid contact of Sarcop with the eyes. If contact occurs, wash the eyes immediately with plenty of water.

- Do not apply on wounds or mucous membranes (such as inside the nose, mouth, or vagina) or in case of persistent skin irritation.

Children under 23 months of age

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

Other medications and Sarcop

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

No interactions with other medications are known.

Pregnancy, breastfeeding, and fertility

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

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

No information is known about whether this medication passes into breast milk, so the doctor will decide whether to interrupt breastfeeding or interrupt treatment with Sarcop, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machinery

Sarcop does not affect your ability to drive or operate machinery.

Sarcop contains alcohol cetoestearílico, ricinoleato de macrogolglicerol (ricino oil polyoxetilenado) and cetearil sulfato sódico, and parahidroxibenzoato de propilo (E216), de etilo (E214), de metilo (E218) and de butilo and propilenglicol

This medication may cause skin reactions because it contains ricino oil polyoxetilenado.

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

It may cause allergic reactions (possibly delayed) because it contains parahidroxibenzoato de propilo, etilo, metilo, and butilo.

This medication contains 40 mg of propilenglicol in each 1 g of cream. Propilenglicol may cause skin irritation. Do not use this medication in babies under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

Follow exactly the administration instructions of thismedicationindicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Cutaneous use.

One standard tube is usually sufficient for a normal treatment.

The recommended dose is:

Adults and children over 2 months:a dose of about 30 grams of cream is usually sufficient for an application.

Use in children

Do not apply Sarcop to children under two months. (See section 2).

The medication should be applied in the manner indicated below.

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

Use in people over 65 years old

No special precautions are necessary, nor should the dose be adjusted in people over 65 years old.

Method of use:

Apply Sarcop Cream all over the body, in a thin layer from the lowest part of the neck to the tips of the feet, not applying to the face or head. Children and the elderly may sometimes be affected on the scalp and face; in this case, apply the cream also to the scalp, neck, forehead, and temples.

Be especially careful when applying the medication to areas most affected by the disease, such as the spaces between the fingers, palms, and soles of the hands and feet, armpits, and groin, testicles, and anal cleft (always avoiding mucous membranes, both genital and anal). Note that the nails may contain the parasites that caused scabies or their eggs, as they may have been dragged along by scratching, so you should also apply cream to them.

Avoid contact of Sarcop with the eyes, mucous membranes, and sensitive areas of the skin and wounds.

Make only one application and do not bathe or shower until at least 12 hours have passed since the application of the cream, and then you can shower or bathe. It is recommended to use warm water to wash.

Be aware that the itching may continue after scabies treatment due to excessive sensitivity. This itching will disappear gradually.

Be careful to change your clothes every day, both clothing and bedding, to avoid re-infection. Clothing can be washed normally in the washing machine. Be aware of the possible transmission of scabies among family members.

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

If you use more Sarcop than you should

If you have used Sarcop more than you should or in case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used, or go to a medical center.

In case of accidental ingestion of Sarcop, gastric lavage and general measures are recommended.

If you forgot to use Sarcop

Do not use a double dose to compensate for the missed doses.

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

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

Cases of patients with itching and/or irritation that continued for two weeks have been reported. If it lasts longer, you should consult with the doctor who established the treatment.

Very frequently (may affect more than 1 in 10 people), symptoms such as transient burning and itching after application have been detected. Also, itching at different times after application and redness, numbness.

Frequently: skin sensations (paresthesias) such as tingling, pinpricks, a burning sensation on the skin.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es

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

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

No special storage conditions are required.

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

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

Composition of Sarcop

-The active principle is permethrin. Each gram of cream contains 50 mg of permethrin (5%).

-The other components (excipients) are: cetearyl alcohol, macrogolglycerol ricinoleate, sodium cetearyl sulfate, deionized water, petrolatum, propylene glycol, and phenoxyethanol, propylparaben (E216), ethylparaben (E214), methylparaben (E218), butylparaben.

Appearance of the product and content of the packaging

Sarcop is presented in the form of a homogeneous, white, easy-to-extend, and smooth cream.

Aluminum tube containing 40 or 70 g of cream, depending on the presentation.

Holder of the marketing authorization and Responsible for the manufacture

Holder of the marketing authorization

Unipharma, S.A.

C/ Lagasca, 26

28001 Madrid

Responsible for the manufacture

Industria Química y Farmacéutica VIR, S.A.

c/ Laguna 66-68-70, Pol. Industrial Urtinsa II

28923 - Alcorcón (Madrid)

LABORATORIOS BOHM, S.A.

c/ Molinaseca, 23. Pol. Industrial Cobo Calleja

28947 - Fuenlabrada (Madrid)

Last review date of this leaflet: April 2024

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