Infectoscab 5% krem

Leaflet accompanying the packaging: information for the user

INFECTOSCAB 5% CREAM

Permethrin (Permethrinum)
50 mg/g, cream
You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your 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 INFECTOSCAB 5% CREAM and what is it used for
• 2. Important information before using the medicine INFECTOSCAB 5% CREAM
• 3. How to use INFECTOSCAB 5% CREAM
• 4. Possible side effects
• 5. How to store the medicine 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 the medicine INFECTOSCAB is permethrin.
Permethrin belongs to a group of medicines called pyrethroids, which are anti-parasitic agents.
INFECTOSCAB 5% CREAM is used to treat scabies (itching caused by scabies mites).

2. Important information before using the medicine INFECTOSCAB 5% CREAM

When not to use the medicine INFECTOSCAB 5% CREAM

Warnings and precautions

Before starting to use the medicine INFECTOSCAB, you should discuss it with your doctor or pharmacist

• In the case of treating children under 2 years of age - see below in the section "Children up to 23 months".
• If the patient knows that they are allergic to chrysanthemums or other plants of the aster family, they may use the medicine INFECTOSCAB 5% CREAM only after discussing it with their doctor. Warning: For external use only! Do not swallow this medicine.

Avoid contact with the eyes or mucous membranes (in the nose or throat, genital area) or open wounds.
INFECTOSCAB is harmful to all species of insects and aquatic organisms, e.g. fish. You should be careful not to get INFECTOSCAB 5% into aquariums or terrariums.
People applying INFECTOSCAB 5% CREAM are recommended to wear disposable gloves.
INFECTOSCAB may exacerbate symptoms of asthma or eczema.

Children up to 23 months

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The medicine 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 the use of this medicine in infants and small children. Treatment of children up to 23 months should only be carried out under strict medical supervision.

Medicinal interactions

You should tell your doctor or pharmacist about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor before using this medicine.
Data from a limited number of applications of permethrin in pregnant women do not indicate a harmful effect. However, as a precaution, INFECTOSCAB should not be used during pregnancy, unless the doctor recommends it.
Permethrin, the active substance of the medicine INFECTOSCAB, may pass into breast milk. For safety reasons, patients should not breastfeed for five days after finishing the treatment with the medicine INFECTOSCAB.
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 contains cetearyl alcohol 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 in accordance with the doctor's recommendations. If you have any doubts, you should ask your doctor or pharmacist.
Apply a thin layer of cream to the skin (see "Method of application of the medicine INFECTOSCAB 5% CREAM").
Adults and adolescents over 12 years of age:
Apply up to 30 g of cream (corresponds to 1 tube of 30 g or 1/2 tube of 60 g)
Children from 6 to 12 years of age:
Apply up to 15 g of cream (corresponds to 1/2 tube of 30 g or 1/4 tube of 60 g)
Children from 2 months to 5 years of age:
Apply up to 7.5 g of cream (corresponds to 1/4 tube of 30 g or 1/8 tube of 60 g)
Newborns and infants under 2 months of age
There is only limited data available for this age group and no dose can be recommended (see also section 2 "Warnings and precautions").
The above dosage should be treated only as a guide. The dose of the medicine should be adjusted according to the indications and body surface area (e.g. in some adult patients, a larger amount of cream may be necessary).
Method of application of the medicine INFECTOSCAB 5% CREAM
INFECTOSCAB is intended for external use only.
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When using the medicine INFECTOSCAB 5% CREAM, you should be careful not to get the cream into the eyes or onto the mucous membranes (in the nose or throat, genital area) or onto open wounds. In case of contact with the eyes or mucous membranes, the affected areas should be rinsed thoroughly with water.
In adults, the cream should be applied evenly to the entire body, including the neck, hands, and the sole 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, special attention should be paid to the areas between the fingers of the hands and feet (also under the fingernails of the hands and feet) and to 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, the sole of the feet, neck, face, ears, and hairy scalp. The cream should not be applied to the skin around the mouth (as the child may lick the cream) and around the eyes.
Children should be protected from licking the cream off their hands. If necessary, children should wear gloves. There is no sufficient experience with the use of this medicine in infants and small children. Treatment of children under 23 months should only be carried out under strict medical supervision.
Elderly people:
In patients over 65 years of age, 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. You should be careful not to apply the cream to the skin around the eyes.
How long to use the medicine INFECTOSCAB
Usually, one application of the medicine INFECTOSCAB is sufficient.
The cream should be left on the skin for at least 8 hours, e.g. overnight. To make the treatment effective, you should avoid bathing during this time, both in the bathtub and in the shower. If the patient washes their hands during these eight hours, the cream should be reapplied to the hands and wrists. The same applies to other areas treated with the cream (buttocks, genital area).
After at least 8 hours, you should take a shower or wash the skin with water and soap.
Single use of the cream is usually sufficient to successfully complete the treatment, provided that 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, you should:

• Keep the fingernails short and clean.
• Change 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 closed plastic bag for a few days.
• Vacuum carpets and upholstered furniture thoroughly.

If you feel that the effect of the medicine INFECTOSCAB is too strong or too weak, you should consult your doctor or pharmacist.

Using a higher dose of the medicine INFECTOSCAB 5% CREAM than recommended

In the case of external use of the medicine, you do not need to worry about overdosing.
However, in case of accidental or intentional ingestion of the cream, you should contact a doctor as soon as possible, who will decide on further action.
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Missing a dose of the medicine INFECTOSCAB 5% CREAM

The cream should be applied as soon as possible to make up for the missed dose.

Stopping the use of the medicine INFECTOSCAB 5% CREAM

Usually, a single use of the medicine INFECTOSCAB is sufficient. However, if the doctor has recommended re-applying the cream, you should follow this recommendation. Otherwise, the disease will not be fully cured.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of a severe allergic reaction, you should consult a doctor immediately!
In such a case, you should never use the medicine 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, stinging, burning of the skin, as well as dryness of the skin are common side effects. However, the above symptoms may occur due to the disease itself. In 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 the end of treatment. This is due to the reaction to dead scabies mites. If you feel that the disease persists after using the medicine INFECTOSCAB, you should 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 (skin abrasions), folliculitis (inflammation of the hair follicles), and decreased skin pigmentation have been reported in connection with the use of the medicine INFECTOSCAB.
Very rarely, sensitive or hypersensitive people have reported breathing difficulties during the use of 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 urticaria. These changes may spread beyond the treated area. Nausea may also occur. Vomiting has not been observed after the use of the medicine INFECTOSCAB, but cases of vomiting have been reported in connection with the use of other medicines containing permethrin.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration 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
By reporting side effects, you can help provide more information on the safety of this medicine.
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5. How to store the medicine INFECTOSCAB 5% CREAM

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (EXP). The expiry date refers to the last day of the specified month.
Do not store above 25°C.
The tube with the medicine must be kept tightly closed.
After the first opening of the tube, the medicine INFECTOSCAB 5% CREAM can be used for 12 weeks.
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 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: cetearyl alcohol, emulsifying agent (type A), liquid paraffin, white petrolatum, sorbic acid, purified water.

What INFECTOSCAB 5% CREAM looks like and what the packaging contains

INFECTOSCAB 5% CREAM is a soft, white cream.
INFECTOSCAB 5% CREAM is available in packs of 30 g and 60 g.

Marketing authorisation holder and manufacturer

INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
D-64646 Heppenheim
Germany
To obtain more detailed information, you should contact the representative of the marketing authorisation holder:
SOLPHARM Sp. z o.o.
ul. Zakątek 1
05-270 Marki
Tel.: +48 22 616 28 08

This medicine is authorised 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

Date of last revision of the leaflet: 22.09.2021

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