Permetrina Scabinol

Leaflet attached to the packaging: information for the user

Permetryna Scabinol, 40 mg/g, gel

Permethrin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Permetryna Scabinol and what is it used for
• 2. Important information before using Permetryna Scabinol
• 3. How to use Permetryna Scabinol
• 4. Possible side effects
• 5. How to store Permetryna Scabinol
• 6. Contents of the packaging and other information

1. What is Permetryna Scabinol and what is it used for

Permetryna Scabinol is a topical anti-scabies medicine. The gel is used to treat scabies infections in adults, adolescents, and children aged 2 months and older.

2. Important information before using Permetryna Scabinol

When not to use Permetryna Scabinol:

• if the patient is allergic (hypersensitive) to the active substance, other substances from the pyrethroidgroup, or any of the other ingredients of Permetryna Scabinol (listed in section 6).

Warnings and precautions

For skin use only. Do not swallow.

• avoid contact with the eyes. The gel may cause eye irritation. Avoid contact with other mucous membranes (nose, mouth, genitals, etc.) and open wounds. In case of contact, rinse the area immediately with plenty of water;
• although the acute toxicity of the medicine is low, long-term use is not allowed, as prolonged exposure to permethrin may lead to neurotoxic effects, especially in younger children;
• persons with known hypersensitivity (allergy) to plants of the Chrysanthemumgenus or other plants from the Asteraceaefamily should consult a doctor before using this medicine;
• it is essential to ensure that the treatment is carried out according to the given recommendations (especially the recommendations regarding the time the gel stays on the skin and re-applying the gel to areas that were washed during use), as cases of treatment ineffectiveness have been reported in case of non-compliance with the given rules.

Children

Permetryna Scabinol is not recommended for use in infants under 2 months of age, as the safety of use in this age group has not been established. Children aged 2 months to 2 years should be treated only under the supervision of a doctor.

Permetryna Scabinol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. No interactions between Permetryna Scabinol and other medicines are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine. The benefit-risk ratio should be carefully considered, and the medicine should only be used if clearly necessary. During treatment with the medicine and for at least one week after treatment, breastfeeding should be avoided.

Driving and using machines

Permetryna Scabinol should not affect your ability to drive or use machines. The medicine is harmful to all types of insects and aquatic organisms (fish, algae, daphnia). Avoid contaminating the medicine with aquarium water.

Permetryna Scabinol contains alcohol (ethanol)

This medicine contains 4,000 mg of alcohol (ethanol) in each 40 g tube, which is equivalent to 100 mg/g. It may cause a burning sensation on damaged skin.

3. How to use Permetryna Scabinol

For skin use only. For external use only. Do not swallow.

This medicine should always be used according to the doctor's or pharmacist's recommendations. In case of doubts, consult a doctor or pharmacist. To open the tube, remove the cap and place it on the other side on the neck of the tube, press firmly, and twist. Persons applying the gel may wear gloves to avoid possible hand irritation. Apply a thin layer of the gel to the surface of clean, dry, and cool skin. Do not take a hot bath or shower immediately before using the medicine.The gel can be completely massaged into the skin, so there is no need to apply additional amounts of gel until it is visible on the skin. The dosage recommendations given in this leaflet are for guidance only. Due to the fact that people may differ significantly in size, a slightly larger or smaller amount of gel may be needed to cover the entire body.Permetryna Scabinol should be left on the skin for 14 hours, but not less than 8 hours. If any parts of the body where the medicine was applied were washed during this period, reapply the medicine to those areas. The entire body should be washed thoroughly 8-14 hours after applying the gel, i.e., by taking a bath. Permetryna Scabinol should be used once. The gel is reapplied if the itching does not disappear or if the itching recurs and new skin areas infected with scabies appear. The second application may be done no earlier than 7 days after the first application. It is essential to follow the general rules of eradication (elimination) of parasites:

• persons in contact with an infected person should be treated at the same time, even if they do not show symptoms of infection;
• fingernails should be shortened and kept clean;
• clothing intended for washing, bedding, towels should be changed daily for at least 7 days and washed at high temperatures (at least 60°C);
• clothing (not intended for washing in water, e.g., outerwear) should be stored in airtight plastic bags for at least 7 days;
• carpets, beds, mattresses, and upholstered furniture should be vacuumed.

If there is no improvement or the patient's condition worsens within 4 weeks, consult a doctor or pharmacist. If you feel that the effect of Permetryna Scabinol is too strong or too weak, consult a doctor or pharmacist. Adults, adolescents, and children over 2 years of age:apply Permetryna Scabinol to the entire body, except for the head and face, unless they are infected. Pay attention to skin areas between the fingers of the hands and feet, under the fingernails, on the wrists, under the arms, external genitalia, breasts, and buttocks. Children aged 2 months to 2 years:use as for adults, but also apply the medicine to the neck, face, ears, and scalp. Do not apply the medicine to areas around the mouth, from which it may be licked, and around the eyes. If necessary, gloves can be put on the child. Children under 2 months:experience in this group is very limited, so no recommended dosage can be given. Elderly patients (over 65 years of age):use as for adults, but also apply the medicine to the neck, face, ears, and scalp. Avoid applying the medicine to areas around the eyes.

Dry skin can be treated with moisturizing products after completing the treatment with permethrin.

Using a higher dose of Permetryna Scabinol than recommended:

In case of applying a higher dose of Permetryna Scabinol to the skin than recommended, wash the excess off with warm water and soap. During topical use, systemic overdose is unlikely due to very low skin absorption. Accidental ingestion of a large amount of the medicine may cause an overdose. If a child accidentally ingests Permetryna Scabinol, consult a doctor or the nearest medical center.

4. Possible side effects

Like all medicines, Permetryna Scabinol can cause side effects, although not everybody gets them. The most common side effects are mild and transient skin reactions such as rash, itching, and paresthesia (tingling, burning, or prickling sensation). In patients treated for scabies, such reactions may persist for 2 weeks or, in some cases, even up to 4 weeks, despite effective treatment. It is believed that this is caused by an allergic reaction to dead scabies mites under the skin and does not necessarily indicate treatment ineffectiveness. Disorders of the skin and subcutaneous tissue
Common (1 in 10): rash, itching, redness, eruption, skin peeling/dry skin.
Rare (1 in 10,000): discoloration (hypopigmentation of the skin), skin infection (folliculitis).
Frequency not known (frequency cannot be estimated from the available data): contact dermatitis, urticaria Nervous system disorders
Common (1 in 10): paresthesia, burning, tingling, prickling. Respiratory, thoracic, and mediastinal disorders
Frequency not known (frequency cannot be estimated from the available data): hypersensitivity reactions with symptoms of dyspnea. Gastrointestinal disorders
Frequency not known (frequency cannot be estimated from the available data): nausea, diarrhea. In patients infected with scabies, skin discomfort, usually described as burning, tingling, or prickling, occurs in some people soon after applying the gel. This phenomenon occurs more frequently in patients with severe scabies infection and is usually mild and transient. Other transient objective and subjective skin irritation symptoms, including redness, swelling, eruption, rash, and itching, which may occur after scabies treatment with the gel, are generally considered part of the usual symptoms after scabies infection.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 492 13 01; fax: + 48 22 492 13 09; website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Permetryna Scabinol

Keep the medicine out of the sight and reach of children. Store in a temperature below 25 ºC. Store in the original packaging. Store in a tightly closed container. Do not use Permetryna Scabinol after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Permetryna Scabinol contains

• The active substance of the medicine is permethrin 40 mg/g;
• The other ingredients are ethanol (96%), carbomer 980, tromethamine, purified water.

What Permetryna Scabinol looks like and contents of the packaging

Permetryna Scabinol is a non-transparent gel with a color from white to creamy. The packaging is an aluminum tube with an inner membrane coated with epoxy-phenolic varnish, with a polypropylene cap with a puncture device, containing 40 g of gel, packed in a cardboard box with an informational leaflet.

Marketing authorization holder and manufacturer

Sabiedrība ar ierobežotu atbildību "LMP"
Vietalvas 1
1009 Riga
Latvia

Representative of the marketing authorization holder

Mercapharm Sp. z o.o.
ul. Świętopełka 39
81-524 Gdynia
e-mail: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Latvia
Permetrīns LMP 40 mg/g gels
Poland
Permetryna Scabinol

Date of last revision of the leaflet: 06/2025