PERMETHRIN SCABINOL

Patient Information Leaflet

Permetryna Scabinol, 40 mg/g, gel
Permethrinum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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.

Contents of the leaflet

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

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

Permetryna Scabinol is a topical antiscabietic medicine. 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

When not to use Permetryna Scabinol:

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

Warnings and precautions
For topical use only. Do not swallow.

• avoid contact of the gel 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 affected areas immediately with large amounts of water;
• although the drug has low acute toxicity, prolonged use is not permitted, as prolonged exposure to permethrin may lead to neurotoxic effects, especially in young children;
• patients with known hypersensitivity (allergy) to plants of the genus Chrysanthemum or to other members of the Asteraceae family should consult a physician before using this medicine;
• it is important to follow the treatment instructions exactly (especially those regarding the duration of gel application on the skin and reapplication of the gel to areas washed during treatment), as treatment failure has been reported when instructions are not followed.

Children
Permetryna Scabinol is not recommended for use in infants under 2 months of age, as safety has not been established in this age group. Children aged 2 months to 2 years should be treated only under medical supervision.
Permetryna Scabinol and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No interactions between Permetryna Scabinol and other medicines are known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The benefit-risk ratio should be carefully evaluated, and the medicine should be used only if clearly necessary. During treatment and for at least one week after application of the medicine, breastfeeding should be avoided.
Driving and operating machinery
Permetryna Scabinol is not expected to affect the ability to drive or operate machinery.
The product is harmful to all types of insects and aquatic organisms (fish, algae, daphnia). Avoid contaminating aquariums with the medicine.
Permetryna Scabinol contains alcohol (ethanol)
This medicine contains 4,000 mg of alcohol (ethanol) in each 40 g tube, equivalent to 100 mg/g.
It may cause stinging on damaged skin.

3. How to use Permetryna Scabinol

For topical application only. External use only. Do not swallow.
This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
To pierce the tube, remove the cap and place it upside down onto the neck of the tube, press firmly and
twist.
Persons applying the gel may wear gloves to avoid possible irritation of the hands.
Apply a thin layer of gel to clean, dry, and cool skin. Do not take a hot bath or shower immediately
before applying the medicine. The gel can be completely massaged into the skin, therefore there is
no need to reapply additional amounts unless the gel is no longer visible on the skin. The dosing
instructions provided in this leaflet are for guidance only. Since individuals may differ significantly in
body size, it may be necessary to use slightly more or slightly less gel to completely cover the body.
Permetryna Scabinol should be left on the skin for 14 hours, but not less than 8 hours.
If any areas of the body treated with the gel are washed during this period, reapply the gel to those areas.
The entire body should be thoroughly washed 8–14 hours after application of the gel, i.e. by bathing.
Permetryna Scabinol is intended for single application. The gel may be reapplied if itching persists or
recurs, or if new skin areas become infected with scabies mites. Reapplication should not occur earlier
than 7 days after the initial application.
It is important to follow general parasitic eradication (elimination) guidelines:

• Individuals in close contact with an infected person should be treated simultaneously, even if they do not show symptoms of infection;
• Nails should be trimmed short and kept clean;
• Clothing, bed linen, and towels intended for washing should be changed daily for at least 7 days and laundered at high temperatures (at least 60°C);
• Clothing not suitable for washing in water (e.g. outerwear) should be stored in sealed plastic bags for at least 7 days;
• Carpets, beds, mattresses, and upholstered furniture should be vacuumed.

If there is no improvement within 4 weeks, or if the patient's condition worsens, 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 the head and face, unless these areas are infected. Pay special attention to the skin between the
fingers and toes, under the nails, wrists, armpits, external genital organs, breasts, and buttocks.
Children from 2 months to 2 years of age: use as in adults, but also apply the medicine to the neck,
face, ears, and scalp. Avoid application around the mouth where the product could be licked off, and
around the eyes. If necessary, child-sized gloves may be worn.
Children under 2 months: experience in this age group is very limited; therefore, no recommended
dosage can be given.
Elderly persons (over 65 years of age): use as in adults, but also apply the medicine to the neck,
face, ears, and scalp. Avoid application around the eyes.
Approximate dosing table

Dry skin can be treated with moisturizing products after completion of treatment with permethrin.
Use of a higher than recommended dose of Permetryna Scabinol:
If a higher than recommended dose of Permetryna Scabinol has been applied to the skin, wash off
the excess with warm water and soap. With topical use, systemic overdose is unlikely due to very low absorption through the skin.
Accidental ingestion of a large amount of the medicine may cause overdose. If a child has accidentally swallowed Permetryna Scabinol, contact a doctor or the nearest medical care center immediately.

4. Possible adverse reactions

Like all medicines, Permetryna Scabinol may cause adverse reactions, although not everyone experiences them.
The most common adverse reactions are mild and transient skin reactions such as rash, itching, and cutaneous paraesthesia, including sensations of pricking, burning, or tingling. In patients treated for scabies, these reactions may persist for 2 weeks or, in some cases, up to 4 weeks, despite effective treatment. This is believed to result from an allergic reaction to dead scabies mites under the skin and does not necessarily indicate treatment failure.

Skin and subcutaneous tissue disorders
Common (1 in 10): rash, itching, erythema, dermatitis, skin peeling/dry skin.
Very rare (1 in 10,000): depigmentation (hypopigmentation of the skin), skin infection (folliculitis).
Frequency not known (frequency cannot be estimated from available data): contact dermatitis, urticaria.

Nervous system disorders
Common (1 in 10): paraesthesia, burning, pricking, tingling.

Respiratory, thoracic and mediastinal disorders
Frequency not known (frequency cannot be estimated from available data): hypersensitivity reactions manifesting as dyspnoea.

Gastrointestinal disorders
Frequency not known (frequency cannot be estimated from available data): nausea, diarrhoea.

In patients infected with scabies, skin discomfort, usually described as burning, pricking, or tingling, may occur shortly after gel application in some individuals. This phenomenon is more frequent in patients with severe scabies infestation and is generally mild and transient.

Other transient objective and subjective skin irritations, including erythema, swelling, dermatitis, rash, and itching, which may occur following treatment of scabies with the gel, are generally considered part of the typical post-scabies symptoms.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 .
Adverse reactions may also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of this medicinal product.

5. How to store Permetryna Scabinol

Keep the medicine out of sight and reach of children.
Store below 25°C.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Permetryna Scabinol contains

• The active substance is permethrin 40 mg/g;
• The other components are ethanol (96%), carbomer 980, trolamine, purified water.

What Permetryna Scabinol looks like and contents of the pack
Permetryna Scabinol is a white to cream-coloured opaque gel. The container is an aluminium tube internally coated with an epoxy-phenolic lacquer, fitted with a polypropylene cap with a piercing device, containing 40 g of gel, packed in a cardboard box with an instruction leaflet.

Marketing Authorisation Holder
Sabiedrība ar ierobežotu atbildību "LMP"
Vietalvas 1
1009 Riga
Latvia

Representative of the Marketing Authorisation Holder
Mercapharm Sp. z o.o.
Świętopełka 39
81-524 Gdynia
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Latvia Permetrīns LMP 40 mg/g gels
Poland Permetryna Scabinol