Infectoscab

Package leaflet: Information for the patient

InfectoScab 50 mg/g cream

Permethrin (25:75)
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What InfectoScab is and what it is used for

The active substance of InfectoScab is permethrin.
Permethrin belongs to a group of medicines called pyrethroids, which are antiparasitic agents.
InfectoScab is used for the treatment of scabies (caused by scabies mites) in adults,
adolescents, and children aged at least 2 months.

2. What you need to know before using InfectoScab

Do not use InfectoScab

• If you are allergic to permethrin, to other pyrethrins, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using InfectoScab

• if you are treating infants: see the section below "Children up to 23 months of age"
• if you have a known allergy to chrysanthemums or other compositae – you must use InfectoScab only after discussing it with your doctor.

Warning
For external use only. Do not swallow this medicine.
The cream may cause eye conjunctiva irritation. Avoid contact with the eyes or mucous membranes (inside the nose or throat, in genital areas) or with open wounds. In case of contact, immediately rinse the affected area with water.
Family caregivers are advised to wear gloves when applying permethrin.
InfectoScab is harmful to all types of insects, cats, and also to aquatic animals, such as fish. Avoid contact of these animals with InfectoScab. Take care that InfectoScab does not enter aquariums or terrariums.
InfectoScab may worsen asthma or eczema.

Children up to 23 months of age
Do not use InfectoScab in newborns and infants under 2 months of age, unless your doctor tells you to. Experience with use in infants and young children is insufficient. Treatment in children up to 23 months of age should be administered only under strict medical supervision.

Other medicines and InfectoScab
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
A moderate number of data on the use of permethrin in pregnant women do not indicate harmful effects. Nevertheless, as a precautionary measure, you should avoid using InfectoScab during pregnancy unless your doctor specifically instructs you to use it.
Permethrin, the active substance in InfectoScab, may be excreted in breast milk. For safety reasons, you must not breastfeed for a period of five days after using InfectoScab.

InfectoScab contains paraffins
These excipients in the cream may reduce the effectiveness and consequently the reliability of latex products (e.g. condoms, diaphragms) used simultaneously.

InfectoScab contains cetostearyl alcohol and sorbic acid
Cetostearyl alcohol and sorbic acid may cause local skin reactions (e.g. contact dermatitis).

3. How to use InfectoScab

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of cream carefully to the skin (see "How and when to use InfectoScab").

Adults and adolescents over 12 years of age
Apply up to 30 g of cream (equivalent to one 30 g tube or ½ of a 60 g tube).

Children aged 6 to 12 years
Apply up to 15 g of cream (equivalent to ½ of a 30 g tube or ¼ of a 60 g tube).

Children aged 2 months to 5 years
Apply up to 7.5 g of cream (equivalent to ¼ of a 30 g tube or ⅛ of a 60 g tube).

Newborns and infants under 2 months of age
Only a limited amount of data is available for this age group, and no dose can be recommended (see also section 2, "Warnings and precautions").

The information above is merely indicative. The dose may be adjusted according to the individual patient's needs and body surface area. For example, some adults may require a larger amount of cream. A higher dose may be used if the head, face, ears, or scalp are being treated.

How and when to use InfectoScab
InfectoScab is for cutaneous use only.

Take care to avoid the cream entering the eyes or coming into contact with mucous membranes (inside the nose or throat, genital areas) or open wounds. In case of accidental contact, rinse thoroughly with water.

Adults should apply the cream to the entire body, including the neck, palms of the hands, and soles of the feet. The head and face may be avoided unless these areas are affected by scabies (scabies mites). During application, particular attention should be paid to the areas between the fingers and toes (including under the fingernails and toenails), wrists, elbows, armpits, external genitalia, and buttocks.

Children
Children should apply the cream evenly over the entire body, including the palms of the hands and soles of the feet, neck, face, ears, and scalp. Avoid the skin around the mouth (to prevent licking of the cream) and around the eyes.

Ensure that your child does not lick the cream from their hands. If necessary, children should wear gloves.

There is insufficient experience in infants and young children. Therefore, treatment in children up to 23 months of age should be administered only under strict medical supervision.

Elderly
Elderly patients (over 65 years of age) should use the cream in the same way as adults, but the face, ears, and scalp should also be treated. Care should be taken to avoid applying the cream to the skin areas around the eyes.

How long to use InfectoScab
Generally, a single application of InfectoScab is sufficient.

The cream should be left on the skin for 8–14 hours, for example, overnight. To avoid compromising the success of treatment, avoid bathing, showering, or washing during this period. If, exceptionally, you need to wash your hands during this time, reapply the cream to the hands and wrist area. This also applies if you need to wash other treated skin areas (buttocks, external genitalia).

After 8–14 hours, take a shower or wash the skin with water and soap.

Provided these instructions for use are followed, a single application is generally sufficient for successful treatment. However, in cases where persistent or renewed infestation cannot be ruled out, a repeated treatment may be considered once 7–14 days after the first application.

Additional instructions you must follow
Every person who has been in contact with you, especially family members and sexual partners, should see a doctor as soon as possible. The doctor will decide whether these individuals also need treatment.

If people who have been in contact with you are not treated promptly, there is a risk they may re-infect you with scabies.

Additionally, you must:

• Keep fingernails short and clean them carefully
• Change clothes, bed linen, and towels daily for a period of 4 days and wash them at a temperature of at least 60°C
• Store non-washable items at a temperature of at least 60°C (e.g., outer garments) for several days in a sealed plastic bag
• Thoroughly vacuum carpets and upholstered furniture

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

If you use more InfectoScab than you should
You need not be concerned about overdose when the medicine is applied externally.
However, if the cream has been accidentally or intentionally ingested, consult a doctor immediately. The doctor will decide on the appropriate course of action.

If you forget to use InfectoScab
Apply the cream as soon as possible to make up for the missed application.

If you stop using InfectoScab
Generally, a single application of InfectoScab is sufficient. However, if your doctor has instructed you to reapply the cream, follow their instructions. Otherwise, the disease may not be completely cured.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
If severe hypersensitivity reactions occur, consult a doctor immediately. In such a case, do not use InfectoScab any longer.

Common: may affect up to 1 in 10 people
Itching, skin redness, or skin sensations (paraesthesia) such as tingling, pricking, burning, as well as dry skin are common. However, these symptoms may also occur as a consequence of the disease itself. The use of moisturizing products and oil baths is recommended for the treatment of dry skin. Itching and skin rash (post-scabies eczema) may persist for up to four weeks after completion of treatment and are caused by a reaction to dead scabies mites. If, after using InfectoScab, you feel that the condition persists, consult your doctor before reapplying the cream.

Rare: may affect up to 1 in 1,000 people
Headache may occur rarely.

Very rare: may affect up to 1 in 10,000 people
Very rarely, skin lesions (excoriations), inflammation of hair follicles (folliculitis), and reduced skin pigmentation have been reported with the use of InfectoScab.
People who are sensitive/allergic have reported difficulty breathing when substances belonging to the pyrethrin group have been used.

Not known: frequency cannot be estimated from the available data
Intolerance reactions may occur on the skin (allergic contact reactions) in the form of itching, redness, blisters, and urticaria. These reactions may spread beyond the treated area of skin. Nausea may occur. Vomiting has not been reported after the use of InfectoScab; however, vomiting is a known reaction associated with medicines containing permethrin.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store InfectoScab

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and the carton, following "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
InfectoScab should be used within 3 months after first opening the tube.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Since permethrin is known to be highly toxic to aquatic organisms, sediment organisms, and soil
organisms, it is important to avoid contaminating aquariums and terrariums, and to prevent the
medicine from coming into contact with invertebrates, particularly insects (including contact with skin to which the medicine has been applied).

6. Package contents and other information

What InfectoScab contains

• The active substance is permethrin. 1 g of cream contains 50 mg of permethrin (25:75).
• The other components are: cetostearyl alcohol (type A), emulsifying agent, liquid paraffin, white soft paraffin, sorbic acid, purified water.

Description of the appearance of InfectoScab and contents of the pack
InfectoScab is a soft, white cream.
InfectoScab is available in packs containing 30 g and 60 g of cream.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Strasse 1
64646 Heppenheim
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Perxine
Finland: Perxine 50 mg/g emulsiovoide
Germany: Permethrin Infectopharm 50 mg/g Creme
Italy: InfectoScab
Netherlands: Permetrine InfectoPharm, 50 mg/g, crème
Norway: Perxine
Portugal: InfectoScab