Permethrin scabinol forte

Package leaflet: Information for the user

Permetryna Scabinol Forte, 50 mg/g, gel
Permethrinum
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Permetryna Scabinol Forte is and what it is 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 pack and other information

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

Permetryna Scabinol Forte is an antiscabietic medicine for topical use. The gel is used for the treatment of scabies infestation in adults, adolescents, and children aged at least 2 months.

2. Important information before using Permetryna Scabinol Forte

Do not use Permetryna Scabinol Forte:

• if you are allergic (hypersensitive) to the active substance, to other substances in the pyrethroid group, or to any of the other ingredients of Permetryna Scabinol Forte (listed in section 6).

Warnings and precautions
Before using Permetryna Scabinol Forte, discuss with your doctor or pharmacist:

• if treating infants – see section “Children under 23 months of age”
• if you have an allergy to chrysanthemums/mugwort or other members of the Asteraceae family – Permetryna Scabinol Forte should only be used after consultation with a doctor.

Caution:
For topical application only! Do not swallow this medicine.
Persons applying the gel may wear gloves to avoid possible skin irritation of the hands.
Avoid contact of the medicine with the eyes and mucous membranes (inside the nose or throat, genital area) and open wounds.
Although the acute toxicity of the medicine is low, prolonged use is not permitted, as prolonged exposure to permethrin may lead to neurotoxic effects, particularly in younger children.
Permetryna Scabinol Forte is harmful to all types of insects and aquatic organisms (fish, algae, daphnia). Avoid allowing Permetryna Scabinol Forte to enter aquariums or terrariums. This medicine is also harmful to invertebrates and organisms living in sediment and soil.
Permetryna Scabinol Forte may worsen symptoms of asthma or eczema.

Children under 23 months of age
Unless otherwise directed by a doctor, Permetryna Scabinol Forte should not be used in newborns and infants under 2 months of age. There is insufficient experience regarding use in infants and young children. Children under 23 months of age should be treated only under close medical supervision.

Permetryna Scabinol Forte and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
No interactions between Permetryna Scabinol Forte and other medicines are known.
If you are using topical corticosteroids, consult your doctor, as treatment of scabies may be less effective.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
The benefit-risk ratio should be carefully considered, and the medicine should only be used if clearly necessary. Breastfeeding should be avoided during treatment and for at least one week after application of the medicine. There are no data indicating an effect of this medicine on fertility when used for the treatment of scabies.

Driving and operating machinery
Permetryna Scabinol Forte has no effect or a negligible effect on the ability to drive and operate machinery.

Permetryna Scabinol Forte contains alcohol (ethanol)
This medicine contains 100 mg of alcohol (ethanol) in each gram of gel. It may cause stinging on damaged skin.

3. How to use Permetryna Scabinol Forte

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Carefully apply a thin layer of gel to the skin (see section "When and how to use Permetryna Scabinol Forte?").
Approximate dosing table

The above information is for guidance only. The dose may be adjusted according to
the individual patient's needs and body surface area. For example, some adults
may require a larger amount of gel.

How and when should Permetryna Scabinol Forte be used?
Permetryna Scabinol Forte is intended for topical use on the skin only.
To pierce the tube, remove the cap and place it upside down onto the tube neck, press firmly and
twist.

Take care to avoid contact of the gel with the eyes, mucous membranes (inside the nose or throat, genital area), or open wounds. In case of accidental contact, rinse the affected area thoroughly with water.

Adults
Adults should apply the gel to the entire body, including the neck, hands, and soles of the feet. The head and face may be omitted unless these areas are affected by scabies. Special attention should be paid to the areas between the fingers and toes (including under fingernails and toenails), wrists, elbows, armpits, external genitalia, and buttocks during application.

Children and adolescents
Children and adolescents should evenly apply the gel over the entire body, including hands, soles of the feet, neck, face, ears, and scalp. The area around the mouth (to prevent licking) and around the eyes should be avoided.

Do not allow children to lick the gel from their hands. If necessary, children should wear gloves.
There is insufficient experience regarding use in infants and young children. Therefore, treatment of children under 23 months of age should be performed only under strict medical supervision.

Elderly patients
Elderly patients (over 65 years of age) should use the gel in the same way as adults, but additionally apply it to the face, ears, and scalp. Avoid application around the eyes.

How long should Permetryna Scabinol Forte be used?
Usually, a single application of Permetryna Scabinol Forte is sufficient.
The gel should be left on the skin for at least eight hours, for example, overnight. Avoid bathing, showering, or washing during this time, as this may reduce treatment effectiveness.
If it is necessary to wash the hands within eight hours, reapply the gel to the hands and wrists. The same applies if other treated skin areas (buttocks, external genitalia) need to be washed.
After 8–14 hours, take a shower or wash the skin with soap and water.

Provided this instruction for use is followed, a single application is usually sufficient for effective treatment. However, in cases of persistent or recurrent infestation, repeat treatment may be necessary after 14 days, but not earlier than 7 days after the first application.

It is also important to follow general principles for parasite control:

• All individuals in close contact with an infected person should be treated simultaneously, even if they do not show symptoms of infestation;
• Clothing and bed linen should be changed before and after treatment.

Use of a higher than recommended dose of Permetryna Scabinol Forte:
If more Permetryna Scabinol Forte gel than recommended is applied to the skin, wash it off with warm water and soap. Systemic overdose following topical application is unlikely due to minimal skin absorption.
Accidental ingestion of a large amount of the product may cause symptoms of overdose. If an adult or child accidentally swallows Permetryna Scabinol Forte, contact a physician or the nearest medical care facility immediately.

4. Possible adverse reactions

Like all medicines, Permetryna Scabinol Forte may cause adverse reactions, although not everyone experiences them.
If severe allergic reactions occur, consult a doctor immediately! In such cases, Permetryna Scabinol Forte must not be used any further.

Common: may occur in less than 1 out of 10 people
Common adverse reactions include itching (pruritus), redness of the skin, or unusual skin sensations (paresthesia), such as tingling, pricking, burning sensation of the skin, and dry skin. However, these symptoms may also occur as a result of the disease itself. Moisturizing preparations and oil baths are recommended for continued care of dry skin. Itching and skin rash (scabies rash) may persist for up to four weeks after completion of treatment. This is due to a reaction to dead scabies mites. If, after using Permetryna Scabinol Forte, the patient feels that the condition has not improved, re-treatment should only be carried out after consulting a doctor.

Uncommon: may occur in less than 1 out of 1000 people
Headache may rarely occur.

Very rare: may occur in up to 1 out of 10,000 people
Skin reactions (skin peeling), folliculitis, and decreased skin pigmentation have been very rarely reported during treatment with Permetryna Scabinol Forte.
Sensitized or allergic individuals have reported breathing difficulties during application of pyrethrin derivative substances.

Frequency not known: frequency cannot be estimated from available data
Skin intolerance reactions (contact allergy reactions), manifesting as itching, redness, blisters, or urticaria, may occur. These reactions may also spread beyond the treated area of skin.
Nausea may occur. Vomiting has not been reported after administration of Permetryna Scabinol Forte, but has been observed with other medicinal products containing permethrin.

If any adverse reactions occur, contact a doctor or pharmacist. This includes any possible adverse reactions not listed in this leaflet.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland; tel.: +48 22 492 13 01; fax: +48 22 492 13 09; website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Permetryna Scabinol Forte

Keep the medicine out of the sight and reach of children.
Store below 25 °C.
Do not use Permetryna Scabinol Forte after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment. This medicine is toxic to aquatic organisms, sediment-dwelling organisms, and soil organisms. Therefore, it is especially important to follow the above instructions and consult your pharmacist on the proper disposal of this product to protect the environment.

6. Contents of the package and other information

What Permetryna Scabinol Forte contains

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

What Permetryna Scabinol Forte looks like and contents of the pack
Permetryna Scabinol Forte is an opaque gel, white to creamy in colour. It is supplied in an aluminium tube with an internal epoxy-phenolic lacquer coating, fitted with a polypropylene cap with a piercing device, containing 30 g or 60 g of gel, packed in a cardboard box together with the patient information leaflet.
Marketing Authorisation Holder and Manufacturer
Sabiedrība ar ierobežotu atbildību "LMP"
Vietalvas 1
LV-1009 Riga
Latvia
Representative of the Marketing Authorisation 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 authorised for sale in the European Economic Area countries 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