SARCOP 50 MG/G CREAM

Introduction

Package Leaflet: Information for the User

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

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

It contains permethrin as the active ingredient, an antiparasitic substance effective against various parasites such as Sarcoptes scabiei, which is a mite and causes scabies or scabiosis.

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

2. What you need to know before using Sarcop Cream

Do not use Sarcop

• If you are allergic to permethrin, other pyrethroids, both synthetic and natural, or to 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 often accompanied by itching, swelling, and redness of the skin or erythema. Treatment with Sarcop may temporarily increase these symptoms, although they usually disappear when the scabies is eliminated, they may continue for a period of about 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 of the composite family, you should only use Sarcop after talking to your doctor.
• This medication is used in a single application, and another application will only be made if your doctor prescribes it.
  • It is recommended that caregivers use gloves when applying the cream.

• Avoid contact of Sarcop with the eyes. If contact occurs, the eyes should be rinsed immediately with plenty of water.

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

of persistent skin irritation.

Children up to 23 months of age

Do not use Sarcop in newborns and infants under 2 months, unless your doctor indicates it. 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

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 are known.

Pregnancy, Breastfeeding, and Fertility

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 Sarcop should only be used during pregnancy when the doctor recommends it as strictly necessary.

It is not known if this medication passes into breast milk, so the doctor will decide whether to interrupt breastfeeding or treatment with Sarcop, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and Using Machines

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

Sarcop contains cetyl stearyl alcohol, macrogolglycerol ricinoleate (polyoxyethyleneated castor oil) and sodium cetearyl sulfate, and propyl parahydroxybenzoate (E216), ethyl (E214), methyl (E218), and butyl and propylene glycol

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

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

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

This medication contains 40 mg of propylene glycol in each 1 g of cream. Propylene glycol 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.

3. How to use Sarcop Cream

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

Topical use.

A single tube is usually sufficient for a normal treatment.

The recommended dose is:

Adults and children over 2 months: about 30 grams of cream are usually sufficient for one application.

Use in Children

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

The medication should be applied as indicated below.

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

Use in People over 65 Years

No special precautions or dose adjustments are necessary in people over 65 years.

Mode of use:

Apply Sarcop Cream all over the body, in a thin layer from the lowest part of the neck to the tip of the toes, without applying it to the face or head. Children and the elderly may sometimes be affected on the scalp and face; in this case, the cream should also be applied to the scalp, neck, forehead, and temples.

Insist with special care when applying the medication to the areas most affected by the disease, such as the spaces between the fingers, the palms and soles of the hands and feet, the armpits and groin, testicles, and anal fold (always avoiding mucous membranes, both genital and anal). Note that the nails may contain the parasites that caused the scabies or their eggs, as they may have been dragged while scratching, so cream should also be applied to them.

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

A single application should be made, and you should not bathe or shower until at least 12 hours have passed since the application of the cream, after which you can shower or bathe. The use of warm water for washing is recommended.

Note that itching may continue after scabies treatment due to excessive sensitivity. This itching will disappear slowly.

Be careful to change your clothes, both clothing and bedding, every day to avoid reinfection. Clothes can be washed normally in the washing machine. You should be aware of the possible contagion of scabies among family members.

It is recommended that you consult your doctor for a review 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 Toxicology 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 forget to use Sarcop

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will 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 the doctor who established the treatment.

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

Frequent: skin sensations (paresthesia) such as tingling, pinching, burning sensation on the skin.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect 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 Sarcop Cream

Keep this medication out of 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Sarcop Composition

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

-The other components (excipients) are: cetyl stearyl alcohol, macrogolglycerol ricinoleate, sodium cetearyl sulfate, purified water, vaseline oil, propylene glycol, and propyl parahydroxybenzoate (E216), ethyl (E214), methyl (E218), butyl, and phenoxyethanol.

Appearance of the Product and Package Contents

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Unipharma, S.A.

C/ Lagasca, 26

28001 Madrid

Manufacturer

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)

Date of the Last Revision of this Package Leaflet: April 2024

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