Permetrina Scabinol Forte

Leaflet attached to the packaging: information for the user

Permetryna Scabinol Forte, 50 mg/g, gel

Permethrinum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Permetryna Scabinol Forte is a topical anti-scabies medicine. The gel is used for the treatment of scabies infections in adults, adolescents, and children aged at least 2 months.

2. Important information before using Permetryna Scabinol Forte

When not to use Permetryna Scabinol Forte:

Warnings and precautions

Before starting treatment with Permetryna Scabinol Forte, you should discuss it with your doctor or pharmacist:

Note:

For topical use only! Do not swallow this medicine.

People applying the gel may wear gloves to avoid potential irritation of the hands. Avoid contact with the eyes and mucous membranes (inside the nose or throat, genital areas) and open wounds. 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. Permetryna Scabinol Forte is harmful to all types of insects and aquatic organisms (fish, algae, water fleas). You should avoid getting the medicine into an aquarium or terrarium. This medicine is also harmful to invertebrates and organisms living in sediments and soil. Permetryna Scabinol Forte may exacerbate symptoms of asthma or eczema.

Children under 23 months

Unless advised by a doctor, Permetryna Scabinol Forte should not be used in newborns and infants under 2 months of age. There is no sufficient experience regarding the use of the medicine in infants and small children. Children under 23 months should only be treated under close medical supervision.

Permetryna Scabinol Forte and other medicines

You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those available without a prescription. There are no known interactions between Permetryna Scabinol Forte and other medicines. If the patient is using topical corticosteroids, they should consult a doctor, as scabies treatment may be less effective.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine. The benefits and risks should be carefully weighed, 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. There are no data indicating the effect of this medicine on fertility in the treatment of scabies.

Driving and using machines

Permetryna Scabinol Forte has no influence or negligible influence on the ability to drive and use machines.

Permetryna Scabinol Forte contains alcohol (ethanol)

This medicine contains 100 mg of alcohol (ethanol) per gram of gel. It may cause a burning sensation on damaged skin.

3. How to use Permetryna Scabinol Forte

This medicine should always be used as directed by a doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist. Apply a thin layer of the gel to the skin (see the section "How and when to use Permetryna Scabinol Forte?"). Approximate dosage table

The above information is for guidance only. The dose can be adjusted according to the individual needs of the patient and their body surface area. For example, some adults may require a larger amount of gel. How and when to use Permetryna Scabinol Forte?

Permetryna Scabinol Forte is for topical use only.

To pierce the tube, remove the cap and place it on the other end of the tube neck, press firmly, and twist. Be careful not to get the gel into the eyes, and avoid contact with mucous membranes (inside the nose or throat, genital areas) or open wounds. If accidental contact occurs, rinse the area thoroughly with water. Adults should apply the gel to the entire body, including the neck, hands, and soles of the feet. The head and face can be omitted unless they are affected by scabies. When applying, pay special attention to the areas between the fingers and toes (also under the fingernails and toenails), wrists, elbows, armpits, external genital areas, and buttocks. Children and adolescents should evenly distribute the gel over the entire body, including hands, soles of the feet, neck, face, ears, and scalp. The areas around the mouth (as the gel can be licked off) and around the eyes should be omitted. Children should not be allowed to lick the gel off their hands. If necessary, children should wear gloves. There is no sufficient experience regarding the use of the medicine in infants and small children. Therefore, treatment of children under 23 months should only be carried out under close medical supervision. Elderly patients (over 65 years) should use the gel in the same way as adults but also apply it to the face, ears, and scalp, avoiding the areas around the eyes. How long to use Permetryna Scabinol Forte? Usually, one application of Permetryna Scabinol Forte is sufficient. Leave the gel on the skin for at least eight hours, for example, overnight. Avoid bathing, showering, or washing during this period, as it may reduce the effectiveness of the treatment. If you need to wash your hands within eight hours, reapply the gel to the hands and wrists. The same applies to washing other treated skin areas (buttocks, external genital areas). After 8-14 hours, take a shower or wash the skin with soap and water. Provided the instructions are followed, a single application is usually sufficient for effective treatment. However, in the case of persistent or recurrent infection, it may be necessary to repeat the treatment after 14 days, but not earlier than 7 days after the first application. It is also important to follow the general principles of parasite control:

• people in contact with the infected person should be treated at the same time, even if they do not show symptoms of infection;
• clothing and bedding should be changed before and after treatment.

Using more than the recommended dose of Permetryna Scabinol Forte:

If you apply more Permetryna Scabinol Forte to the skin than recommended, wash it off with warm water and soap. In the case of topical use, systemic overdose of the medicine is unlikely due to very low skin absorption. Accidental ingestion of a large amount of the medicine may cause overdose symptoms. If an adult or child accidentally swallows Permetryna Scabinol Forte, they should contact a doctor or the nearest medical center.

4. Possible side effects

Like all medicines, Permetryna Scabinol Forte can cause side effects, although not everybody gets them. If you experience severe hypersensitivity reactions, you should consult a doctor immediately! In such a case, you should not use Permetryna Scabinol Forte again. Common: may affect up to 1 in 10 people Common side effects are itching (pruritus), redness of the skin, or abnormal skin sensations (paresthesia), such as tingling, stinging, burning sensation of the skin, and dryness of the skin. However, such symptoms may also occur due to the disease itself. As a continuation of skin care, moisturizing preparations and oil baths are recommended. Itching and skin rash (post-scabies eczema) may persist for up to four weeks after the end of treatment. This is due to a reaction to dead scabies mites. If, after using Permetryna Scabinol Forte, the patient feels that the disease has not subsided, they should consult a doctor before reapplying. Rare: may affect up to 1 in 1000 people Headache may occur rarely. Very rare: may affect up to 1 in 10,000 people During the use of Permetryna Scabinol Forte, very rare cases of skin changes (exfoliation), folliculitis, and decreased skin pigmentation have been reported. Sensitive or allergic individuals have reported breathing difficulties when using pyrethrin derivatives. Frequency not known: frequency cannot be estimated from the available data Skin intolerance reactions (contact allergy reactions) may occur, manifested by itching, redness, blisters, or urticaria. These reactions may also spread beyond the treated skin area. Nausea may occur. Vomiting has not been reported after using Permetryna Scabinol Forte, but it is known in connection with other permethrin-containing medicines. If you experience any side effects, you should contact your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should 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 Forte

The medicine should be stored out of sight and reach of children. Store in a temperature below 25 ºC. Do not use Permetryna Scabinol Forte after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment. This medicine is toxic to aquatic organisms, sediment-dwelling organisms, and soil organisms. Therefore, it is particularly important to follow the above instructions and ask your pharmacist about the correct disposal of this product to protect the environment.

6. Contents of the packaging and other information

What Permetryna Scabinol Forte contains

• The active substance of the medicine is permethrin 50 mg/g;
• The other ingredients are ethanol (96%), carbomer 980, tromethamine, purified water.

What Permetryna Scabinol Forte looks like and what the pack contains

Permetryna Scabinol Forte is a non-transparent gel with a white to creamy color. Aluminum tube with a membrane coated with epoxy-phenolic lacquer on the inside, with a polypropylene cap with a piercer, containing 30 g or 60 g of gel, packaged in a cardboard box with a patient information leaflet.

Marketing authorization holder and manufacturer

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

Representative of the marketing authorization holder

Mercapharm Sp. z o.o. ul. Świętopełka 39 81-524 Gdynia e-mail: [email protected] Tel.: +48 509 368 531

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

Czech Republic Permethrin Axonia Estonia Permetriin LMP Netherlands Permetrine Prolepha 50 mg/g, gel Poland Permetryna Scabinol Forte Portugal Permetrina LMP Slovakia Permethrin Axonia 50 mg/g gel Hungary Scabithrin

Date of last revision of the leaflet: 09/2023