Active ingredients: Permethrin
SCABIANIL 5% cream
Why is Scabianil used? What is it for?
Scabianil contains the active substance permethrin and belongs to a group of medicines that kill external parasites (ectoparasites) called 'pyrethroid ectoparasiticides'. Scabianil is used to treat scabies, a skin disease caused by microscopic mites that lurk in the surface layer of the skin, causing small red blisters and papules to form. Scabies causes intense itching and is contagious (it is transmitted through prolonged contact between the skin, or through sexual contact with an infected person).
Contraindications When Scabianil should not be used
Do not use Scabianil:
- if you are allergic to the active substance, to other pyrethroids or pyrethrins (natural compounds with insecticidal properties) or to any of the other ingredients of this medicine.
Precautions for use What you need to know before taking Scabianil
Talk to your doctor or pharmacist before using Scabianil. Scabianil is for external use only.
In case you need to apply the cream to other people, use gloves.
Carefully avoid contact of the cream with the eyes; if this happens accidentally, immediately rinse your eyes with water.
Children and adolescents
Treatment with Scabianil in children less than two years of age should be under medical supervision. Self-application of the cream by older children should be done under adult supervision.
Interactions Which drugs or foods can modify the effect of 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 should consider whether treatment with corticosteroids (medicines with anti-inflammatory properties) is necessary before treatment with Scabianil. Corticosteroids reduce the immune response to the mite, potentially causing a worsening of the scabies infestation. The probability of interaction between the two treatments is however very low.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, the medicine must be used in cases of real need and under the direct supervision of the doctor.
The data available to date on the use of permethrin cream in pregnancy do not, however, show a risk to the fetus, even if permethrin can cross the placenta.
The exposure of the whole organism (systemic exposure) to permethrin, following the local skin application of the cream is very low and only a small part passes into breast milk; it is therefore unlikely that treatment with Scabianil of breastfeeding women will pose a risk to the newborn.
Driving and using machines
Scabianil does not affect the ability to drive or use machines.
Scabianil contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Dose, Method and Time of Administration How to use Scabianil: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, 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, a second application can be used after 7 days.
The package of Scabianil 5% cream in a 30 g tube is usually sufficient for a single application on the whole body. For some adults there may be a need for more cream. In this case, the 60 g pack can be used.
Since the amount of cream needed for the treatment varies according to 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
The recommended dose is 30 g of Scabianil. Some adults may need more cream, in which case an additional 30g tube can be used. However, never exceed 60 g per single application.
Use in children 6 to 12 years of age
The recommended dose is 15 g of cream (up to half a 30 g tube).
Use in children 1 to 5 years of age
The recommended dose is 7.5g of cream (up to a quarter of a 30g tube).
Use in children from 2 months to 1 year of age
The recommended dose is 3.75g of cream (up to one eighth of a 30g tube).
Method of administration
Apply Scabianil on clean, dry and fresh skin, avoid application immediately after taking a hot bath.
Let the cream sit for at least 8 hours. If you need to wash your hands before 8 hours have passed since application, you need to reapply the cream on your hands.
You can wash your body only after 8-12 hours have elapsed from applying the cream.
Children under 2 years of age
Apply the cream all over the child's body including neck, face, ears and scalp, with particular care for the areas between the fingers and toes, under the nails and on the wrists, armpits, palms, soles of the feet, genitals external and buttocks. Do not apply the cream to the area around the mouth and around the eyes.
Adults and children over 2 years
Apply the cream all over the body except the head and face, with particular care for the areas between the fingers and toes, under the nails and on the wrists, armpits, external genitals, breasts and buttocks.
Senior citizens
Apply the cream all over your body including neck, face, ears and scalp, with particular care for the areas between the fingers and toes, 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 stop taking Scabianil
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Scabianil
In case of accidental ingestion / intake of an excessive dose of Scabianil, notify your doctor immediately or go to the nearest hospital.
The treatment to be implemented in case of accidental ingestion of the cream by a child is gastric lavage, to be carried out within 2 hours of ingestion.
There have been no reports of permethrin overdose since Scabianil was marketed.
Excessive application of the cream to the skin could cause local irritation (hypersensitivity reaction). Treatment of these disorders should be symptomatic, meaning only to remedy the symptoms.
Accidental exposure of a two month old baby to a full 30g tube of cream is very unlikely to cause systemic toxicity.
Side Effects What are the side effects of Scabianil
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have occurred:
- short-lived burning or irritation, usually mild and more frequently in patients with severe scabies.
- transient signs and symptoms of skin irritation, such as rash or itching, erythema, swelling of the skin (edema), skin inflammation (eczema).
Itching may continue for up to 4 weeks after stopping treatment. It is due to an allergic reaction to dead scabies mites. This is normal and does not mean that the treatment has not been effective.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after "EXP".
The expiry date refers to the last day of that month. The expiry date refers to the unopened, correctly stored medicine.
Do not store above 30 ° C. Do not freeze.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Scabianil contains
- The active ingredient is: permethrin. 100g of 5% cream contains 5g of permethrin.
- The other ingredients are: cetostearyl alcohol, paraffin, cetomacrogol 1000, isopropyl myristate, benzyl alcohol, purified water.
What Scabianil looks like and contents of the pack
Scabianil is a cream contained in a 30 g or 60 g aluminum tube with a polypropylene cap.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
SCABIANIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Permethrin 5% (isomers cis: trans 25:75).
For excipients see section 6.1
03.0 PHARMACEUTICAL FORM
Cream.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of scabies.
04.2 Posology and method of administration
SCABIANIL should be applied to clean, dry and fresh skin. The product should not be applied immediately after taking a hot bath.
Treatment of children under two years of age should only be carried out under medical supervision. Application of the cream by older children should be done under adult supervision.
SCABIANIL 5% cream is available in tubes of 30 and 60 g.
SCABIANIL 5% cream in a 30 g tube is usually sufficient for a single application on the whole body. For some adults there may be a need for a larger quantity of cream; in this case you can use the 60 g pack, always in a single application on the whole body. Since the amount of cream needed for the treatment varies from the surface to be treated and the type of skin, it is not possible to recommend a precise dosage.
Adults and children over 2 years:
Apply the cream all over the body except the head and face, with particular care for the areas between the fingers and toes, under the nails and on the wrists, armpits, external genitals, breasts and buttocks.
Senior citizens:
Apply the cream all over the body including neck, face, ears and scalp.
Apply the cream with particular care on the areas between the fingers and toes, under the nails and on the wrists, armpits, external genitals, breasts and buttocks. Avoid the area around the eyes.
Children under 2 years:
Apply the cream all over the body including neck, face, ears and scalp, with particular care for the areas between the fingers and toes, under the nails and on the wrists, armpits, palms, soles of the feet, external genitals and buttocks. Avoid the area around the mouth (to prevent the cream from being removed with the tongue) and the area around the eyes.
The cream should be left to act for at least 8 hours. If you wash your hands before 8 hours have passed from applying the cream, you need to reapply it on them.
Wash the body thoroughly 8-12 hours after applying the cream.
In 90% of cases a single application of SCABIANIL is sufficient to eliminate the infestation. If the lesions do not show signs of healing or new lesions appear, a second application of the cream can be used after 7 days.
04.3 Contraindications
Hypersensitivity to the active substance, to any of the excipients or to other pyrethroids or pyrethrins. Generally contraindicated in pregnancy and during lactation.
04.4 Special warnings and appropriate precautions for use
SCABIANIL is for external use only. If you apply the cream to other people, the use of gloves is recommended.
Avoid contact of the product with the eyes; in case of accidental contact, rinse immediately with water.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
04.5 Interactions with other medicinal products and other forms of interaction
Treatment of eczematous-type reactions with corticosteroids should be evaluated prior to treatment with permethrin 5% cream, as there is a risk of exacerbation of scabies infestation due to reduced immune response to the mite. The probability of interactions between the two treatments leading to the enhancement of adverse reactions or reduction of efficacy is however low.
04.6 Pregnancy and breastfeeding
The data available to date on the use of permethrin 5% cream have not shown any risk to the fetus. The amount of permethrin absorbed systemically after applying the cream to the entire body surface is extremely low. However, permethrin can pass the placental barrier Negativity of mutagenicity tests and low mammalian toxicity suggest that treatment with permethrin carries minimal risk to the fetus.
It is shown that following oral administration, very low concentrations of permethrin are excreted in the milk of cows. It is not known whether permethrin is excreted in human milk. However, concentrations of permethrin in milk are unlikely to pose a risk to the newborn as only extremely small amounts of permethrin are absorbed systemically and in theory only a very small percentage can pass into human milk.
During pregnancy and breastfeeding, the medicine must be used in cases of real need and under direct medical supervision.
04.7 Effects on ability to drive and use machines
None known.
04.8 Undesirable effects
Occasionally a few cases of short-lived stinging or urticating irritation have been reported. This is usually in a mild form and happens more frequently in patients with severe scabies.
Transient signs and symptoms of skin irritation such as rash or itching, erythema, edema, eczema.
Itching can continue for up to 4 weeks after treatment and is due to an allergic reaction to dead scabies mites. This is normal and not a sign that the treatment has not been effective.
04.9 Overdose
There are no reports of overdose of permethrin 5% cream.
Excessive application of cream to the skin could lead to local adverse reactions. Application of a full tube (30 g) of cream to a two month old baby would correspond to a dose of approximately 350 mg / kg body weight. It is unlikely that, even if fully absorbed, this dose would cause clear signs of systemic toxicity.
In case of accidental ingestion of the product by a child, gastric lavage could be used, to be carried out within 2 hours of ingestion.
Treatment of hypersensitivity reactions should be symptomatic.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: pyrethroid ectoparasiticides, ATC code: P03AC04
The main physiological action in parasites exposed to permethrin is the induction of electrochemical abnormalities across excitable cell membranes, leading to sensory hyperexcitability, incoordination and prostration.
05.2 Pharmacokinetic properties
In mammals, permethrin is rapidly metabolised via the hydrolysis of esters into inactivated metabolites which are excreted primarily via the kidneys. The major metabolites are detectable in the urine within 7 hours of applying the cream to the whole body of healthy volunteers or affected patients. The highest levels of excretion are detectable within 48 hours, but in some individuals very low levels of metabolites may be found in the urine as long as 28 days after treatment. The overall pattern of excretion indicates that approximately 0.5% of the applied permethrin is absorbed in the first 48 hours.
05.3 Preclinical safety data
In vivo and in vitro genetic toxicity studies were all negative, revealing that permethrin cannot induce mutagenic changes.
Long-term studies in rats did not show oncogenic effects. Similar studies in mice showed a species-specific increase in the incidence of pulmonary edema at high doses and in female mice only, when permethrin was administered with food for two years (approximately 750 mg / kg of body weight / day). These results are not believed to indicate a potential oncogenicity of permethrin in humans.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Cetostearyl alcohol, paraffin, cetomacrogol 1000, isopropyl myristate, benzyl alcohol, purified water.
06.2 Incompatibility
None known.
06.3 Period of validity
2 years
06.4 Special precautions for storage
Do not store above 30 ° C, do not freeze.
06.5 Nature of the immediate packaging and contents of the package
Aluminum tube with polypropylene cap. Pack containing a 30 g tube and pack containing a 60 g tube.
06.6 Instructions for use and handling
Once the package has been opened, use all the contents.
07.0 MARKETING AUTHORIZATION HOLDER
SOFAR S.p.A., viale Isonzo 8, Milan.
08.0 MARKETING AUTHORIZATION NUMBER
30 g tube: 036289015
60 g tube: 036289039
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
July 2006
10.0 DATE OF REVISION OF THE TEXT
March 2009
