Infectoscab 5% krem

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Infectoscab 5% cream

50 mg/g, cream

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 specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• 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 Infectoscab 5% cream and what is it used for
• 2. Important information before using Infectoscab 5% cream
• 3. How to use Infectoscab 5% cream
• 4. Possible side effects
• 5. How to store Infectoscab 5% cream
• 6. Contents of the packaging and other information

1. What is Infectoscab 5% cream and what is it used for

The active substance of Infectoscab 5% cream is permethrin.
Permethrin belongs to a group of medicines called pyrethroids, which are antiparasitic agents.
Infectoscab 5% cream is used to treat scabies (itching caused by scabies mites).

2. Important information before using Infectoscab 5% cream

When not to use Infectoscab 5% cream

Warnings and precautions

Before starting treatment with Infectoscab 5% cream, discuss it with your doctor or pharmacist

• In the case of treating children under 2 years of age - see below under "Children under 23 months".
• If you know you are allergic to chrysanthemums or other plants of the aster family, you can use Infectoscab 5% cream only after discussing it with your doctor.

Hazard:
For external use only! Do not swallow this medicine.
Avoid contact with eyes or mucous membranes (in the nose or throat, genital area)
or open wounds.
Infectoscab 5% cream is harmful to all species of insects and aquatic organisms,
e.g. fish. Be careful not to get Infectoscab 5% cream into aquariums or terrariums.
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It is recommended that people applying Infectoscab 5% cream wear disposable gloves.
Infectoscab 5% cream may exacerbate asthma or eczema symptoms.

Children under 23 months

Infectoscab 5% cream should not be used in newborns and infants under 2 months of age, unless decided by a doctor. There is no sufficient experience with its use in infants and young children. Treatment of children under 23 months should only be carried out under close medical supervision.

Infectoscab 5% cream and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
Data from a limited number of permethrin applications in pregnant women do not indicate a harmful effect. However, as a precaution, Infectoscab 5% cream should not be used during pregnancy unless your doctor recommends it.
Permethrin, the active substance of Infectoscab 5% cream, may pass into breast milk. For safety reasons, breastfeeding women should not breastfeed for five days after finishing treatment with Infectoscab 5% cream.
Infectoscab 5% cream contains paraffins. These excipients in the cream may reduce the effectiveness and reliability of latex products (e.g. condoms, intrauterine devices) used at the same time.
Infectoscab 5% cream contains cetostearyl alcohol, emulsifier (type A), and sorbic acid, which may cause local skin irritation (e.g. contact dermatitis).

3. How to use Infectoscab 5% cream

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Apply a thin layer of cream to the skin (see "How to apply Infectoscab 5% cream").
Adults and adolescents over 12 years old:
Apply up to 30 g of cream (corresponds to 1 tube of 30 g or ½ tube of 60 g)
Children 6-12 years old:
Apply up to 15 g of cream (corresponds to ½ tube of 30 g or ¼ tube of 60 g)
Children 2 months-5 years old:
Apply up to 7.5 g of cream (corresponds to ¼ tube of 30 g or ⅛ tube of 60 g)
Newborns and infants under 2 months old
Only limited data are available for this age group, and no dose can be recommended (see also section 2 "Warnings and precautions").
The above dosage should be considered only as a guideline. The dose of the medicine should be adjusted according to the indications and body surface area (e.g. some adult patients may need to use more cream).
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How to apply Infectoscab 5% cream
Infectoscab 5% cream is for external use only.
When using Infectoscab 5% cream, be careful not to get the cream into your eyes or mucous membranes (in the nose or throat, genital area) or open wounds. If the cream comes into contact with the eyes or mucous membranes, rinse the affected area thoroughly with water.
In adults, the cream should be applied evenly to the entire body, including the neck, hands, and soles of the feet. Applying the cream to the face and head is not necessary unless these areas have also been affected by scabies (itching caused by scabies mites).
When applying the cream, pay special attention to the areas between the fingers and toes (also under the fingernails and toenails) and the skin on the wrists, elbows, under the arms, genital area, and buttocks.
Children:
The cream should be applied evenly to the entire body, including the inner surfaces of the hands, soles of the feet, neck, face, ears, and hairy scalp. Do not apply the cream to the skin around the mouth (as the child may lick the cream) and around the eyes.
Protect children from licking the cream off their hands. If necessary, children should wear gloves. There is limited experience with the use of Infectoscab 5% cream in infants and young children. Treatment of children under 23 months should only be carried out under close medical supervision.
Elderly:
In elderly patients (over 65 years old), the cream should be used in the same way as in adults, but the cream should also be applied to the face, ears, and hairy scalp. Be careful not to apply the cream to the skin around the eyes.
How long to use Infectoscab 5% cream
Usually, one application of Infectoscab 5% cream is sufficient.
The cream should be left on the skin for at least 8 hours, e.g. overnight. To ensure the treatment is effective, avoid bathing during this time. If you wash your hands during these eight hours, reapply the cream to your hands and wrists. The same applies to other areas treated with the cream (buttocks, genital area).
After at least 8 hours, take a shower or wash your skin with water and soap.
Single use of the cream is usually sufficient to complete the treatment successfully, provided the above instructions are followed. However, in cases of persistent or recurrent infection, it may be necessary to repeat the treatment after 14 days.
Additional precautions
People in contact with the patient, especially family members or partners, should consult a doctor as soon as possible, who will decide on the possible need to start treatment. If infected people do not start treatment soon, there is a risk that they may re-infect others.
Additionally:

• Keep your fingernails short and clean.
• Change your clothes, bedding, and towels daily for 14 days and wash them at a temperature of at least 60°C.
• Store items that cannot be washed (e.g. outerwear) in a sealed plastic bag for a few days.
• Vacuum carpets and upholstered furniture thoroughly.

If you feel that the effect of Infectoscab 5% cream is too strong or too weak, talk to your doctor or pharmacist.

Using more than the recommended dose of Infectoscab 5% cream

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In the case of external use, you do not need to worry about overdosing.
However, if the cream is accidentally or intentionally swallowed, contact your doctor as soon as possible, who will decide on further action.

Missing a dose of Infectoscab 5% cream

Apply the cream as soon as possible to make up for the missed dose.

Stopping treatment with Infectoscab 5% cream

Usually, one application of Infectoscab 5% cream is sufficient. However, if your doctor has recommended reapplying the cream, follow this recommendation. Otherwise, the disease may not be fully cured.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Infectoscab 5% cream can cause side effects, although not everybody gets them.
In case of a severe allergic reaction, consult your doctor immediately! In such a case, never use Infectoscab 5% cream again.
Common: may occur in up to 1 in 10 people
Itching (pruritus), redness of the skin, or skin sensation disorders (paresthesia), such as tingling, prickling, burning of the skin, as well as dryness of the skin, are common side effects. However, these symptoms may also occur due to the disease itself. In the case of dry skin, it is recommended to use moisturizing agents and bath oils. Itching and rash (scabies rash) may persist for up to four weeks after treatment.
This is due to a reaction to dead scabies mites. If you feel that the disease persists after using Infectoscab 5% cream, consult your doctor before reusing the medicine.
Rare: may occur in up to 1 in 10,000 people
Headache may occur rarely.
Very rare: may occur in less than 1 in 10,000 people
Very rarely, skin damage (erosion of the epidermis), folliculitis (inflammation of the hair follicles), and decreased skin pigmentation have been reported in association with Infectoscab 5% cream.
Very rarely, sensitive or hypersensitive individuals have reported breathing difficulties while using pyrethrin substances.
Frequency not known: frequency cannot be estimated from the available data
In addition to the above symptoms, skin intolerance symptoms (contact allergic reactions) may occur, which manifest as itching, redness, blisters, or hives. These changes may spread beyond the treated area. Nausea may also occur. Vomiting has not been observed after using Infectoscab 5% cream, but cases have been reported with other permethrin-containing medicines.

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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
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By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Infectoscab 5% cream

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Do not store above 25°C.
Keep the tube tightly closed.
After opening the tube, Infectoscab 5% cream can be used for 12 weeks.
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 Infectoscab 5% cream contains

The active substance is permethrin.
1 g of cream contains 50 mg of permethrin.
The other ingredients are: cetostearyl alcohol, emulsifier (type A), liquid paraffin, white petrolatum, sorbic acid, purified water.

What Infectoscab 5% cream looks like and contents of the pack

Infectoscab 5% cream is a soft, white cream.
Infectoscab 5% cream is available in 30 g packs.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Slovakia, country of export:

Infectopharm Arzneimittel und Consilium GmbH, Von-Humboldt-Str. 1, D-64646 Heppenheim, Germany

Manufacturer:

Infectopharm Arzneimittel und Consilium GmbH, Von-Humboldt-Str. 1, D-64646 Heppenheim, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Slovakia, country of export: 25/0230/06-S

Parallel import authorization number: 30/25

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

Germany: Infectoperm 5% Creme
Austria, Poland, Slovakia, Slovenia, Hungary: Infectoscab 5% cream
Czech Republic: Infectoscab 50 mg/g cream
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Date of leaflet approval: 22.01.2025

[Information about the trademark]
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