INFECTOSCAB 50 mg /G Krem
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Treść ulotki
InfectoScab 50 mg/g cream
Permethrin (25:75)
Generic medicine
Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 ingredient 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 of at least 2 months of age.
2. What you need to know before you use InfectoScab
Do not use InfectoScab
- If you are allergic to permethrin, to other pyrethrines 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 that follows "Children up to 23 months of age"
- if you have a known allergy to chrysanthemums or other composite plants - you should only use InfectoScab after talking to your doctor.
Warning
For external use only. Do not ingest this medicine.
The cream may cause irritation to the conjunctiva of the eye. Avoid contact with the eyes or the
mucous membranes (inside the nose or throat, in the genital area) or with open wounds. In case
of contact, immediately rinse the affected area with water.
It is recommended that family caregivers wear gloves when applying permethrin.
InfectoScab is harmful to all types of insects, cats and also to animals that live in water, such
as fish. Prevent these animals from coming into contact with InfectoScab. Pay attention 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 do so. Experience with use in infants and young children is insufficient. Treatment in children up to
23 months of age should only be administered 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, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
A moderate amount of data regarding the use of permethrin in pregnant women does not indicate
harmful effects. Nevertheless, as a precaution, you should avoid using InfectoScab during
pregnancy, unless your doctor tells you to use it.
Permethrin, the active ingredient of InfectoScab, may be excreted in breast milk. For reasons of
safety, you should not breastfeed for a period of five days after using
InfectoScab.
InfectoScab contains paraffins
These excipients of the cream may reduce the effectiveness and consequently the reliability of latex products (e.g. condoms, diaphragms) used at the same time.
InfectoScab contains cetostearyl alcohol and sorbic acid
Cetostearyl alcohol and sorbic acid may cause localized skin reactions (e.g. contact dermatitis).
3. How to use InfectoScab
Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask 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 (corresponding to a 30 g tube or ½ of a 60 g tube)
Children aged between 6 and 12 years
Apply up to 15 g of cream (corresponding to ½ of a 30 g tube or ¼ of a 60 g tube)
Children aged between 2 months and 5 years
Apply up to 7.5 g of cream (corresponding to ¼ of a 30 g tube or ⅛ of a 60 g tube)
Newborns and infants under 2 months
Only a moderate 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 purely indicative. The dose may be adjusted based on the individual patient's needs and individual body surface area. For example,
some adults may need 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 external use only.
Take care to avoid getting the cream into your eyes or coming into contact with mucous membranes
(inside the nose or throat, in the genital area) or open wounds. If accidental contact occurs,
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 this area shows areas affected by scabies (scabies mites). During application of the cream, areas between the fingers and toes (also under the fingernails and toenails),
wrists, elbows, armpits, external genitalia and buttocks should be treated with particular attention.
Children
Children should apply the cream evenly to the entire body, including the palms of the hands and
soles of the feet, neck, face, ears and scalp. Areas of skin around the mouth (as the cream could be licked) and around the eyes should be avoided.
Prevent your child from licking the cream off their hands. If necessary, children should wear gloves.
There is no adequate experience in infants and young children. Therefore, in children up to
23 months of age, treatment should only be administered under strict medical supervision.
Elderly
Elderly patients (over 65 years of age) should use the cream in the same way as adults but,
in addition, 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.
For how long should you 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 jeopardizing the success of the treatment, avoid bathing, showering or washing during this period.
If, exceptionally, you need to wash your hands during this period, you should reapply the cream to
your hands and wrist area. This also applies if you need to wash other areas of treated skin (buttocks,
external genitalia).
After 8–14 hours, 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 a persistent or
renewed infestation cannot be ruled out, a repeat treatment should be considered once 7–14
days after the first application.
What other instructions must you follow
Everyone who comes into contact with you, especially your family members and partner, should see a
doctor as soon as possible. The doctor will decide whether these people also need to be treated.
If infected people who have come into contact with you are not treated promptly, there is a
risk that they may re-infect you with scabies.
In addition, you must
- keep your fingernails short and clean them carefully
- change clothes, bed linen and towels every day 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. outerwear) for several days in a closed plastic bag
- thoroughly vacuum carpets and upholstered furniture
If you feel that the effect of InfectoScab is too strong or too weak, talk to your doctor or
pharmacist.
If you use more InfectoScab than you should
You do not need to worry about an overdose when the medicine is applied externally.
However, if the cream has been accidentally or intentionally ingested, you should consult a doctor
as soon as possible, who will decide how to proceed.
If you forget to use InfectoScab
Use the cream as soon as possible to make up for a missed application.
If you stop using InfectoScab
Generally, a single application of InfectoScab is sufficient. However, if your doctor has told you to reapply
the cream, follow their instructions. Otherwise, the disease may not heal completely.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience severe hypersensitivity reactions, consult a doctor immediately. In this case
you should no longer use InfectoScab.
Common: may affect up to 1 in 10 people
Cases of itching, redness of the skin or skin sensations (paresthesia) such as tingling,
prickling, burning skin, as well as dry skin are common. These symptoms may still
occur as a result of the disease itself. The use of moisturizers and oil baths is recommended
as treatment for dry skin. Itching and rash (post-scabies eczema) may
persist for up to four weeks after the end of treatment and are caused by a reaction to the
dead scabies mites. If, after using InfectoScab, you feel that the disease persists, consult
your doctor before reapplying the cream.
Rare: may affect up to 1 in 1,000
Headache may occur in rare cases.
Very rare: may affect up to 1 in 10,000
Very rarely, skin lesions (excoriations), inflammation of the hair follicles (folliculitis)
and reduced skin pigmentation have been reported with the use of InfectoScab.
Sensitive/allergic individuals have reported difficulty breathing when substances belonging to the
pyrethrin group have been used.
Not known: the frequency cannot be estimated based on available data
Intolerance reactions may occur on the skin (allergic contact reactions) in the form
of itching, redness, blisters and hives. These reactions may spread beyond the area of the
treated skin. Nausea may occur. No cases of vomiting have been reported after the use of
InfectoScab, however this is a known reaction in connection with medicines containing permethrin.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you 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 outer packaging after Scad.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
InfectoScab must be used within 3 months after the first opening of the tube.
Do not dispose of any medicine in 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, sediments and soil,
it is important to avoid polluting aquariums and terrariums and to prevent the medicine from coming into
contact with invertebrates, especially insects (including contact with the skin where the
medicine has been applied).
6. Contents of the pack and other information
What InfectoScab contains
- The active ingredient is permethrin. 1 g of cream contains 50 mg of permethrin (25:75).
- The other ingredients are: cetostearyl alcohol (type A), emulsifier, 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 of 30 g and 60 g cream.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Strasse 1
64646 Heppenheim
Germany
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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
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- Kraj rejestracji
- Postać farmaceutycznaCream, 50 mg/g
- Kod ATCP03AC04
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki INFEKTOSKABPostać farmaceutyczna: Cream, 5 %Substancja czynna: permethrinProducent: GIULIANI SPAWymaga receptyPostać farmaceutyczna: Cream, 5 %Substancja czynna: permethrinProducent: ALFASIGMA S.P.A.Wymaga receptyPostać farmaceutyczna: Topical solution, 50%Substancja czynna: Other ectoparasiticides, incl. scabicidesProducent: LOFARMA S.P.A.Bez recepty
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INFEKTOSKAB wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w INFEKTOSKAB jest permethrin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
INFEKTOSKAB jest produkowany przez INFECTOPHARM ARZNEIMITTEL UND CONSILIUM GMBH. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie INFEKTOSKAB jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić INFEKTOSKAB w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (permethrin) to m.in. SKABIAKID, SKABIANIL, PAF. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
