Patient Information Leaflet

SCABIANIL 5% cream

Permethrin
Please read all of this leaflet carefully before you use 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, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Scabianil is and what it is used for
What you need to know before using Scabianil
How to use Scabianil
Possible side effects
How to store Scabianil
Contents of the pack and other information

1. What Scabianil is and what it is used for

Scabianil contains the active substance permethrin and belongs to a group of medicines that kill external parasites (ectoparasites), known as "pyrethroid ectoparasiticides". Scabianil is used to treat scabies, a skin disease caused by microscopic mites that burrow into the upper 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 skin-to-skin contact 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 substance, to other pyrethroids or pyrethrins (natural compounds with insecticidal properties), or to any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Scabianil.
Scabianil is for external use only.
If you need to apply the cream to other people, wear gloves.
Avoid contact of the cream with the eyes; if accidental contact occurs, rinse the eyes immediately with water.
If you have a known allergy to chrysanthemums or other compositae plants, you must use Scabianil only after discussing it with your doctor.

Children and adolescents
Treatment with Scabianil in children under two years of age must be carried out under medical supervision. Self-application of the cream by older children should be supervised by an adult.

Other medicines and Scabianil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you develop inflammatory skin reactions (eczema), your doctor should evaluate whether treatment with corticosteroids (medicines with anti-inflammatory properties) is necessary before treatment with Scabianil. Corticosteroids reduce the immune response to the mite, potentially worsening scabies infestation. However, the likelihood of interaction between these two treatments is very low.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, this medicine should be used only when clearly needed and under direct medical supervision.
Available data on the use of permethrin cream during pregnancy do not indicate a risk to the fetus, although permethrin may cross the placenta.
Systemic exposure (whole-body exposure) to permethrin following local cutaneous application of the cream is very low, and only a small amount passes into breast milk; therefore, treatment with Scabianil in breastfeeding women is unlikely to pose a risk to the newborn.

Driving and using machines
Scabianil does not affect the ability to drive vehicles or operate machinery.

Scabianil contains:
Cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
450 mg of Benzyl alcohol per 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 exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Usually, a single application of Scabianil is sufficient to eliminate the infestation; if lesions do not heal or new ones appear, a second application may be performed after 7 days.
The 30 g tube packaging of Scabianil 5% cream is generally sufficient for a single application over the entire body. However, some adults may require a larger amount of cream. In this case, the 60 g tube may be used.
Since the amount of cream required for treatment varies depending on the body surface area to be treated, it is not possible to define an exact dosage.

How much Scabianil to use

Use in adults, elderly patients, and children over 12 years of age
The recommended dose is 30 g of Scabianil. Some adults may require a larger amount of cream; in this case, an additional 30 g tube may be used. However, the total amount must 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 of 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 one 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 one eighth of a 30 g tube).

Method of administration
Apply Scabianil to clean, dry, and cool skin. Avoid application immediately after taking a hot bath.
Leave the cream on the skin for at least 8 hours. If you need to wash your hands before 8 hours have passed since application, reapply the cream to the hands.
You may wash your body only after 8 to 12 hours have passed since 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, paying particular attention to the areas between the fingers and toes, under the nails, wrists, armpits, palms, soles of the feet, external genitals, and buttocks. Do not apply the cream around the mouth or near the eyes.
Prevent your child from licking the cream off their hands. Gloves should be worn by the child if necessary.

Adults and children over 2 years of age
Apply the cream to the entire body except the head and face, paying particular attention to the areas between the fingers and toes, under the nails, wrists, armpits, external genitals, breasts, and buttocks.

Elderly patients
Apply the cream to the entire body, including neck, face, ears, and scalp, paying particular attention to the areas between the fingers and toes, under the nails, wrists, armpits, external genitals, breasts, and buttocks. Do not apply the cream around the eyes.

If you use more Scabianil than you should
In case of accidental ingestion/overdose of Scabianil, contact your doctor immediately or go to the nearest hospital.
The recommended treatment in case of accidental ingestion of the cream by a child is gastric lavage, which should be performed within 2 hours of ingestion.
No cases of overdose with permethrin have been reported since Scabianil was first marketed.
Excessive application of the cream on the skin may cause local irritation (hypersensitivity reaction). Treatment of these conditions should be symptomatic, aimed solely at relieving symptoms.
It is highly unlikely that accidental exposure of a two-month-old child to an entire 30 g tube of cream would result in systemic toxicity.

If you stop treatment with 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 will experience them.
The following side effects have been reported:

short-lived burning or irritation, usually mild and more frequently observed in patients with severe scabies.
transient signs and symptoms of skin irritation, such as skin rash or itching, erythema, skin swelling (edema), skin inflammation (eczema).

Itching may persist for up to 4 weeks after completion of treatment. This is due to an allergic reaction to dead scabies mites. This is a normal phenomenon and does not mean that the treatment was ineffective.
Common side effects (may affect up to 1 in 10 people):
skin sensations (paresthesia) such as tingling, pricking, or skin burning.

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
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 applies to the medicine in its original, unopened packaging, correctly stored.
Do not store above 30°C. Do not freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Scabianil contains

The active substance is: permethrin. 100 g of 5% cream contains 5 g 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 aluminium tube with a polypropylene cap, available in 30 g or 60 g packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO), Italy
Manufacturer
SOFAR S.p.A.,
Via Firenze 40,
20060 Trezzano Rosa (MI),
Italy