SCABIANIL 5 % Крем
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Инструкция по применению SKABIANIL
Содержание инструкции
SCABIANIL 5% cream
Permethrin
Read this leaflet carefully before 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 only for you. Do not give it to other people, even if their
- symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Scabianil is and what it is used for
- 2. What you need to know before using Scabianil
- 3. How to use Scabianil
- 4. Possible side effects
- 5. How to store Scabianil
- 6. Contents of the pack and other information
1. What Scabianil is and what it is used for
Scabianil contains the active ingredient permethrin and belongs to a group of medicines that kill external parasites (ectoparasites), called “pyrethroid ectoparasiticides”. Scabianil is used for the treatment of scabies ,a skin disease caused by microscopic mites that nest in the superficial layer of the skin, causing the formation of small blisters and red papules. Scabies causes intense itching and is contagious (it is transmitted through prolonged contact between the epidermis, or through sexual contact with an infected person).
2. What you need to know before using Scabianil
Do not use Scabianil:
- if you are allergic to the active ingredient, to other pyrethroids or pyrethrins (natural compounds with insecticidal properties) or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before using Scabianil.
Scabianil is for external use only.
If you need to apply the cream to other people, use gloves.
Carefully avoid contact of the cream with the eyes; if this should accidentally
happen, immediately rinse your eyes with water.
If you have a known allergy to chrysanthemums or other composite plants - you should only use Scabianil after talking to
your doctor.
Children and adolescents
Treatment with Scabianil in children under two years of age must be carried out under the supervision of a
doctor. Independent application of the cream by older children must be carried out under the
supervision of an adult.
Other medicines and Scabianil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
If you experience inflammatory skin reactions (eczema), your doctor must assess whether
treatment with corticosteroids (medicines with anti-inflammatory properties) is necessary before
treatment with Scabianil. Corticosteroids in fact reduce the immune response to the mite, potentially causing
a worsening of the scabies infestation. The probability of interaction between the two
treatments, however, is very low.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, the medicine should only be used when absolutely necessary and
under the direct supervision of a doctor.
Data available to date on the use of permethrin cream during pregnancy do not show any risk
to the fetus, although permethrin can cross the placenta.
Systemic exposure to permethrin, following local cutaneous application of the cream is very low and only a small amount passes into breast milk; it is therefore
unlikely that treatment with Scabianil by breastfeeding women could pose a risk to the
newborn.
Driving and using machines
Scabianil does not affect the ability to drive vehicles or use machinery.
Scabianil contains:
cetostearyl alcoholwhich may cause local skin reactions (e.g. contact dermatitis).
450 mg of Benzyl alcoholper dose (30 g of cream) equivalent to 1.5%, which may cause mild local irritation
and allergic reactions.
3. How to use Scabianil
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Usually a single application of Scabianil is sufficient to eliminate the infestation; if the lesions do not
heal or if new ones appear, you can resort to a second application after 7 days.
The package of Scabianil 5% cream in a 30 g tube is usually sufficient for a single application to the whole
body. Some adults may require a larger amount of cream. In this case, you can use the 60 g package.
Since the amount of cream needed for treatment varies depending on the body surface to be treated,
it is not possible to define a precise dosage.
How much Scabianil to use
Use in adults, the elderly and children over 12 years of age
The recommended dose is 30 g of Scabianil. Some adults may need a larger amount of
cream, in which case you can use an additional 30 g tube. However, you should never exceed
60 g per single application.
Use in children from 6 to 12 years of age
The recommended dose is 15 g of cream (up to half a 30 g tube).
Use in children from 1 to 5 years of age
The recommended dose is 7.5 g of cream (up to a quarter of a 30 g tube).
Use in children from 2 months to 1 year of age
The recommended dose is 3.75 g of cream (up to an eighth of a 30 g tube).
Method of administration
Apply Scabianil to clean, dry and cool skin, avoid applying it immediately after taking a hot
bath.
Leave the cream on for at least 8 hours. If you need to wash your hands before 8 hours have passed
since application, you must reapply the cream to your hands.
You can wash your body only after 8-12 hours have passed since the application of the cream.
Children under 2 years of age
Apply the cream to the entire body of the child including neck, face, ears and scalp, with
particular care for the areas between the fingers of the hands and feet, under the nails and on the wrists, armpits, palms, soles
of the feet, external genitals and buttocks. Do not apply the cream to the area around the mouth and around the eyes.
Prevent your child from licking the cream off their hands. If necessary, children should wear
gloves.
Adults and children over 2 years of age
Apply the cream to the entire body except the head and face, with particular care for the areas between the fingers of the
hands and feet, under the nails and on the wrists, armpits, external genitals, breasts and buttocks.
Elderly
Apply the cream to the entire body including neck, face, ears and scalp, with particular care for
the areas between the fingers of the hands and feet, under the nails and on the wrists, armpits, external genitals, breasts and buttocks.
Do not apply the cream to the area around the eyes.
If you use more Scabianil than you should
In case of ingestion/accidental intake of an excessive dose of Scabianil, immediately warn
your doctor or go to the nearest hospital.
The treatment to be carried out in case of accidental ingestion of the cream by a child is gastric lavage,
to be performed within 2 hours of ingestion.
No reports of permethrin overdose have been received since Scabianil was
placed on the market.
Excessive application of cream to the skin may cause local irritation (hypersensitivity reaction). The treatment of these disorders must be symptomatic, i.e. intended only to remedy the
symptoms.
It is very unlikely that accidental exposure of a two-month-old child to an entire 30 g tube of
cream could cause systemic toxicity.
If you stop using Scabianil
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
- burning or irritation of short duration, usually mild and more frequently in patients with severe scabies.
- signs and symptoms of transient skin irritation, such as rash or itching, erythema, skin swelling (edema), skin inflammation (eczema).
Itching may continue for up to 4 weeks after the end of treatment. This is due to an allergic reaction to the dead scabies mites. This is a normal phenomenon and does not mean that the treatment
has not been effective.
Common side effects (may affect up to 1 in 10 people)
skin sensations (paresthesia) such as tingling, prickling, burning skin
Reporting of side effects
If you get any side effects, talk to 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 Scabianil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
The expiry date refers to the medicine in intact packaging, correctly stored.
Do not store at a temperature above 30°C. Do not freeze.
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.
6. Contents of the pack and other information
What Scabianil contains
- The active ingredient is: permethrin. 100 g of 5% cream contains 5g of permethrin.
- The other components are: cetostearyl alcohol, paraffin, macrogol cetostearyl ether, isopropyl myristate, benzyl alcohol, purified water.
Description of the appearance of Scabianil and contents of the pack
Scabianil is a cream contained in an aluminum tube of 30 g or 60 g with a polypropylene cap.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturer
SOFAR S.p.A.,
Via Firenze 40,
20060 Trezzano Rosa (MI)
Italy
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- Страна регистрации
- Форма выпускаCream, 5 %
- Код АТХP03AC04
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги SKABIANILФорма выпуска: Cream, 50 mg/gДействующее вещество: перметринПроизводитель: INFECTOPHARM ARZNEIMITTEL UND CONSILIUM GMBHОтпускается по рецептуФорма выпуска: Cream, 5 %Действующее вещество: перметринПроизводитель: GIULIANI SPAОтпускается по рецептуФорма выпуска: Topical solution, 50%Действующее вещество: Other ectoparasiticides, incl. scabicidesПроизводитель: LOFARMA S.P.A.Отпускается без рецепта
Аналоги SKABIANIL в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
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Аналог SKABIANIL в Украина
Аналог SKABIANIL в Испания
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
SKABIANIL требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество SKABIANIL — перметрин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
SKABIANIL производится компанией ALFASIGMA S.P.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения SKABIANIL с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить SKABIANIL в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
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Другие лекарства с тем же действующим веществом (перметрин) включают INFEKTOSKAB, SKABIAKID, PAF. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
