Infectoscab 5% cream
Poland
Table of Contents
Patient Information Leaflet
Warning! Please keep this leaflet. Information on the immediate packaging is in a foreign language.
Infectoscab 5% cream
50 mg/g, cream
Permethrinum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please consult 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, inform your doctor or pharmacist. See section 4.
Table of contents
- What Infectoscab 5% cream is and what it is used for
- Important information before using Infectoscab 5% cream
- How to use Infectoscab 5% cream
- Possible side effects
- How to store Infectoscab 5% cream
- Contents of the pack and other information
1. What Infectoscab 5% cream is and what it is used for
The active substance in Infectoscab 5% cream is permethrin.
Permethrin belongs to a group of medicines called pyrethroids, which are antiparasitic agents.
Infectoscab 5% cream is used for the treatment of scabies (itch caused by scabies mites).
2. Important information before using Infectoscab 5% cream
When not to use Infectoscab 5% cream
- if the patient is allergic to permethrin, other substances from the pyrethroid group, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting to use Infectoscab 5% cream, discuss this with your doctor or
pharmacist
- In case of treatment of children under 2 years of age – see below under "Children up to 23 months of age".
- If the patient knows they are allergic to chrysanthemums or other plants from the Asteraceae family, Infectoscab 5% cream should only be used after discussing it with a doctor.
Warning:
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 insect species and aquatic organisms, e.g. fish. Care must be taken to ensure that Infectoscab 5% cream does not enter aquariums or terrariums.
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Persons applying Infectoscab 5% cream are advised to wear disposable gloves.
Infectoscab 5% cream may worsen symptoms of asthma or eczema.
Children up to 23 months of age
Infectoscab 5% cream should not be used in newborns and infants under 2 months of age unless otherwise decided by a doctor. There is insufficient experience with use in infants and young children. Treatment of children up to 23 months of age should be carried out exclusively under strict medical supervision.
Infectoscab 5% cream and other medicines
You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
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 before using this medicine.
Data obtained from a limited number of cases of permethrin use in pregnant women do not indicate harmful effects. However, as a precaution, Infectoscab 5% cream should not be used during pregnancy unless advised by a doctor.
Permethrin, the active substance in Infectoscab 5% cream, may pass into human milk. For safety reasons, patients should not breastfeed for five days after completing treatment with Infectoscab 5% cream.
Infectoscab 5% cream contains paraffins. These excipients in the cream may reduce the effectiveness and thus the reliability of latex products (e.g. condoms, diaphragms) used at the same time.
Infectoscab 5% cream contains cetostearyl alcohol, emulsifying (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 in doubt, consult your doctor or pharmacist.
Carefully apply a thin layer of cream to the skin (see "Instructions for using Infectoscab 5% cream").
Adults and adolescents aged above 12 years:
Apply up to 30 g of cream (equivalent to one 30 g tube or half a 60 g tube).
Children aged 6–12 years:
Apply up to 15 g of cream (equivalent to half a 30 g tube or one-quarter of a 60 g tube).
Children aged 2 months–5 years:
Apply up to 7.5 g of cream (equivalent to one-quarter of a 30 g tube or one-eighth of a 60 g tube).
Newborns and infants under 2 months of age:
Only limited data are available in this age group, and no dosage recommendation can be made (see also section 2, "Warnings and precautions").
The dosages given above are intended only as a guide. The amount of cream should be adjusted according to clinical indication and body surface area (e.g., some adult patients may require a larger amount of cream).
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Instructions for using Infectoscab 5% cream
Infectoscab 5% cream is intended for topical use only.
When using Infectoscab 5% cream, take care to avoid contact with the eyes or mucous membranes (nose, throat, genital organs) or open wounds. If contact occurs, wash the affected area thoroughly with water.
Adults:
Apply the cream evenly to the entire body, including the neck, hands, and soles of the feet. Application to the face and scalp is not necessary unless these areas are also affected by scabies (itch caused by the mite Sarcoptes scabiei).
Special attention should be paid to the areas between the fingers and toes (including under the fingernails and toenails), wrists, elbows, armpits, genital area, and buttocks.
Children:
Apply the cream evenly to the entire body, including the palms, soles of the feet, neck, face, ears, and hairy scalp. Do not apply the cream around the mouth (to prevent the child from licking it off) or near the eyes.
Prevent children from licking the cream from their hands. If necessary, children should wear gloves. There is insufficient experience with use in infants and young children. Treatment of children under 23 months of age should therefore be performed only under strict medical supervision.
Elderly patients:
This cream should be used in the same way as in adults, but it should also be applied to the face, ears, and hairy scalp. Care should be taken to avoid applying the cream to the skin around the eyes.
How long to use Infectoscab 5% cream
Usually, a single application of Infectoscab 5% cream is sufficient.
Leave the cream on the skin for at least 8 hours, for example overnight. To ensure effective treatment, avoid bathing or showering during this time. If the patient washes their hands within these eight hours, reapply the cream to the hands and wrists. The same applies to other treated areas (buttocks, genital area).
After at least eight hours, take a shower or wash the skin with water and soap.
A single application is usually sufficient to successfully complete treatment, provided the above instructions are followed. However, in cases of persistent or recurring infection, repeat treatment after 14 days may be necessary.
Additional precautions
Individuals in close contact with infected persons, especially family members or partners, should consult a doctor as soon as possible to determine whether treatment is necessary. If infected individuals do not begin treatment promptly, there is a risk they may re-infect others.
In addition:
- Keep fingernails short and clean them thoroughly.
- Change clothing, bed linen, 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., outer garments) in a sealed plastic bag for several days.
- Vacuum carpets and upholstered furniture thoroughly.
If you feel that the effect of Infectoscab 5% cream is too strong or too weak, consult your doctor or pharmacist.
Use of more than the recommended dose of Infectoscab 5% cream
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With topical use, overdose is not expected to be a concern.
However, if the cream is accidentally or intentionally swallowed, contact a doctor immediately. The doctor will decide on further management.
Missed application of Infectoscab 5% cream
Apply the cream as soon as possible to compensate for the missed dose.
Stopping treatment with Infectoscab 5% cream
Usually, a single application of Infectoscab 5% cream is sufficient. However, if your doctor has advised repeating the application, follow their instructions. Otherwise, the disease may not be completely cured.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If a severe allergic reaction occurs, consult a doctor immediately! In such a case, Infectoscab 5% cream must never be used again.
Common: may affect up to 1 in 10 people
Itching, redness of the skin, or disturbances in skin sensation (paraesthesia), such as tingling, pricking, burning of the skin, as well as dry skin, are common adverse effects. However, the above symptoms may also occur as a result of the disease itself. In case of dry skin, moisturizing products and bath oils are recommended. Itching and 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 you feel that the condition persists after using Infectoscab 5% cream, consult your doctor before reapplying the medicine.
Rare: may affect up to 1 in 10,000 people
Headache may rarely occur.
Very rare: may affect fewer than 1 in 10,000 people
Very rarely, skin damage (epidermal abrasions), inflammation of hair follicles (folliculitis), and decreased skin pigmentation have been observed with the use of Infectoscab 5% cream.
Very rarely, sensitive or hypersensitive individuals have reported breathing difficulties during the use of substances from the pyrethrin group.
Frequency not known: frequency cannot be estimated from available data
In addition to the above symptoms, skin manifestations of intolerance (contact allergic reactions) may occur, presenting as itching, redness, blisters, or urticaria. These changes may spread beyond the treated area. Nausea may also occur. Vomiting has not been observed after administration of Infectoscab 5% cream; however, cases of vomiting are known in connection with the use of other medicines containing permethrin.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
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By reporting adverse effects, additional information on the safety of the medicine can be collected.
5. How to store 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. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Keep the tube tightly closed.
After first opening, Infectoscab 5% cream can be used for 12 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the pack and other information
What Infectoscab 5% cream contains
The active substance is permethrin.
1 g of cream contains 50 mg of permethrin.
Other ingredients are: cetostearyl alcohol emulsifying (type A), liquid paraffin, white soft paraffin,
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 tubes.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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 Authorisation number in Slovakia, country of export: 25/0230/06-S
Marketing Authorisation number for parallel import: 30/25
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Infectoperm 5% Creme
Austria, Poland, Slovakia, Slovenia, Hungary: Infectoscab 5% cream
Czech Republic: Infectoscab 50 mg/g krém
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