Infectoscab 5% cream
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep this leaflet! Foreign language information on the immediate packaging.
Infectoscab 5% cream (Permetrine InfectoPharm), 50 mg/g, cream
Permethrinum
Infectoscab 5% cream and Permetrine InfectoPharm are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet so that you can read it again if necessary.
- 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. The medicine may harm another person, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.
Contents of the leaflet
- 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 in the treatment of scabies (itch caused by mites of the species Sarcoptes scabiei).
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 treatment with Infectoscab 5% cream, discuss it 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 consulting 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. Take care to ensure that Infectoscab 5% cream does not enter aquariums or terrariums.
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
Do not use Infectoscab 5% cream in newborns and infants under 2 months of age unless directed 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 under strict medical supervision.
Infectoscab 5% cream and other medicines
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 from a limited number of cases of permethrin use in pregnant women do not indicate harmful effects. However, as a precaution, do not use Infectoscab 5% cream 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 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 exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Apply a thin layer of the cream carefully to the skin (see "Instructions for using Infectoscab 5% cream").
Adults and adolescents over 12 years of age:
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 above dosages are provided as guidance only. The amount of cream should be adjusted according to the indication and body surface area (e.g., some adult patients may require a larger amount of cream).
Instructions for using Infectoscab 5% cream
Infectoscab 5% cream is for topical use only.
When using Infectoscab 5% cream, take care to avoid contact with the eyes or mucous membranes (e.g., 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 surface, including the neck, hands, and the 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), as well as the 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 carried out only under strict medical supervision.
Elderly patients:
In elderly patients (over 65 years of age), 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 thoroughly with water and soap.
Single application is usually sufficient for successful treatment, provided the above instructions are followed. However, in cases of persistent or recurring infestation, treatment may need to be repeated after 14 days.
Additional precautions
Individuals in close contact with an infected person, especially family members or sexual partners, should consult a doctor as soon as possible to determine whether treatment is necessary. If infected individuals do not start treatment promptly, there is a risk of re-infecting others.
In addition:
- Keep fingernails short and clean.
- Change clothes, 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
With external use, overdose is not expected. However, if the cream is accidentally or intentionally swallowed, contact a doctor immediately for further management.
Missed 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, a single application of Infectoscab 5% cream is sufficient. However, if your doctor has advised repeating the application, follow their instructions. Otherwise, complete cure may not be achieved.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, 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 occur in up to 1 in 10 people
Itching, redness of the skin, or disturbances in skin sensation (paraesthesia), such as tingling, pricking, or burning of the skin, as well as dry skin, are common adverse reactions. However, the above symptoms may also occur as a result of the disease itself. In the case of dry skin, the use of moisturizing agents and bath oils is 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 a doctor before reapplying the medicine.
Rare: may occur in up to 1 in 10,000 people
Rarely, headache may occur.
Very rare: may occur in less than 1 in 10,000 people
Very rarely, skin damage (epidermal abrasions), inflammation of hair follicles (folliculitis), and decreased skin pigmentation have been reported with the use of Infectoscab 5% cream.
Very rarely, sensitive or hypersensitive individuals have reported breathing difficulties during the use of substances from the pyrethroid group.
Frequency not known: frequency cannot be estimated from the 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 the use of Infectoscab 5% cream; however, cases of vomiting have been reported with other medicinal products containing permethrin.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows the collection of further information on the safety of the 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 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 packaging 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: sorbic acid, cetostearyl alcohol emulsifying (type A), liquid paraffin,
white soft paraffin, purified water.
What Infectoscab 5% cream looks like and contents of the packaging
Infectoscab 5% cream is a soft, white cream.
Infectoscab 5% cream is available in 30 g and 60 g tubes.
For more detailed information about this medicine, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in the Netherlands, the country of export:
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Strasse 1, 64646 Heppenheim, Germany
Manufacturer:
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Strasse 1, 64646 Heppenheim, Germany
Parallel importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation number in the Netherlands, the country of export: RVG 127560
Parallel import authorisation number: 280/25
This medicinal product is authorised in the European Economic Area member states under the following names:
Germany: Infectoperm 5% Creme
Austria, Poland, Slovakia, Slovenia, Hungary: Infectoscab 5% cream
Czech Republic: Infectoscab 50 mg/g krém