Scabiacid
Italy
Table of Contents
Package leaflet: Information for the user
SCABIACID 5% cream
Permethrin
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.
- Keep this leaflet. You may need to read it again.
- If you want more information or advice, consult your pharmacist.
- If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Scabiacid is and what it is used for
- What you need to know before using Scabiacid
- How to use Scabiacid
- Possible side effects
- How to store Scabiacid
- Contents of the pack and other information
1. What Scabiacid is and what it is used for
Scabiacid contains the active substance permethrin and belongs to a group of medicines known as "pyrethroid ectoparasiticides" used against external parasites (ectoparasites). Scabiacid is used for the treatment of scabies in adults and children from 2 months of age.
What is scabies?
Scabies is a skin disease that causes intense itching. It is caused by microscopic mites that burrow into the outer layer of the skin, leading to the formation of small blisters and red papules. The itching is caused by the skin's reaction.
Scabies is contagious and is usually spread through prolonged skin-to-skin contact or sexual contact with an infected person. Infection spreads more easily in crowded places and situations involving close contact.
2. What you need to know before using Scabiacid
Do not use Scabiacid:
- if you are allergic to the active substance, to other pyrethroids or pyrethrins (natural compounds with insecticidal properties), to chrysanthemums or other similar plants (compositae), 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 Scabiacid:
Scabiacid is for external use only and must not be ingested.
Avoid contact of the cream with eyes, mucous membranes (inside the nose or throat, genital areas), or open wounds; if accidental contact occurs, rinse immediately with water.
If you need to apply the cream to other people, wear gloves.
Other medicines and Scabiacid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will assess whether it is necessary to discontinue any ongoing treatment with corticosteroids (medicines with anti-inflammatory properties) before starting treatment with Scabiacid. Corticosteroids in fact reduce the immune response to the mite, potentially worsening the scabies infestation.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Permethrin can cross the placenta and a small amount may pass into breast milk.
During pregnancy and breastfeeding, this medicine should only be used when clearly needed and under direct medical supervision.
Driving and using machines
Scabiacid does not affect the ability to drive or operate machinery.
Scabiacid is toxic to all types of insects and to aquatic life forms (fish, daphnids, algae).
Avoid contaminating fish tanks and terrariums.
Scabiacid contains paraffins which may reduce the effectiveness and thus the reliability of latex products (e.g. condoms, diaphragms) used at the same time.
Scabiacid contains cetyl stearyl alcohol which may cause localized skin reactions (e.g. contact dermatitis).
Scabiacid contains benzyl alcohol which may cause allergic reactions and mild local irritation.
3. How to use Scabiacid
Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Scabiacid to clean, dry, and cool skin. Avoid applying it immediately after a hot bath.
Leave the cream on the skin for 8–12 hours. If you need to wash your hands before 8 hours have passed since application, reapply the cream to your hands.
You may wash your body only after 8–12 hours have passed since applying the cream.
Usually, a single application of Scabiacid is sufficient to eliminate the infestation. If lesions do not heal or new ones appear, your doctor may prescribe a second application after 7–14 days.
Contact your doctor if you do not notice improvement or if symptoms worsen after the second treatment cycle.
Health education notes
People who have been in contact with you, especially family members and sexual partners, should consult a doctor as soon as possible. The doctor will decide whether these individuals also require treatment. If infected individuals who have been in contact with you are not treated promptly, there is a risk they may re-infect you with scabies.
Additionally, you should:
- keep your nails short and clean them carefully;
- change clothing, bed linen, and towels daily for a period of 7 days and wash them at a temperature of at least 50°C;
- store non-washable items (e.g. outer garments) for 7 days in a sealed plastic bag.
Method of administration
Children
Apply a thin layer of cream to the entire body of the child, including the neck, face, ears, and scalp, paying particular attention to the areas between the fingers and toes, under the nails, and on the wrists, armpits, palms, soles, navel, external genitals, and buttocks. Do not apply the cream around the mouth or near the eyes.
Supervise your child to prevent him or her from licking the cream off the hands (for example, by having the child wear gloves).
Adults
Apply a thin layer of cream to the entire body, including the scalp, neck, palms, and soles, paying particular attention to the areas between the fingers and toes, under the nails, wrists, elbows, armpits, navel, external genitals, breasts, and buttocks. Do not apply the cream around the eyes.
Elderly
Elderly patients (aged 65 years and older) should use the cream in the same way as adults.
How much Scabiacid to use
The 30 g tube of Scabiacid 5% cream is usually sufficient for a single full-body application. However, some adults may require a larger amount of cream. In such cases, the 60 g tube may be used.
Use in adults, elderly, and children over 12 years of age
The recommended dose is up to 30 g of Scabiacid. Some adults may require a larger amount of cream; in this case, a 60 g tube or two 30 g tubes may be used. However, the total amount applied should never exceed 60 g per single application.
Use in children aged 6 to 12 years
The recommended dose is up to 15 g of cream (equivalent to half a 30 g tube or one-quarter of a 60 g tube).
Children aged 2 months and above but under 6 years
The recommended dose is up to 7.5 g of cream (equivalent to one-quarter of a 30 g tube or one-eighth of a 60 g tube).
Children under 2 months of age
Experience with use in this age group is insufficient.
Application of the cream in older children should be performed under adult supervision.
If you use more Scabiacid than you should
If Scabiacid is accidentally swallowed or ingested in excessive amounts, contact your doctor immediately or go to the nearest hospital.
No cases of overdose with permethrin have been reported since Scabiacid has been marketed.
Excessive application of the cream to the skin may cause local irritation (hypersensitivity reaction). Treatment of such reactions should be symptomatic, aimed only at relieving symptoms.
Treatment in case of accidental overdose of Scabiacid
In the event of accidental ingestion of the cream by a child, gastric lavage should be performed within 2 hours of ingestion.
If you have any doubts about how to use 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 are listed by frequency:
Common (may affect up to 1 in 10 people)
- skin sensations such as tingling or itching (paraesthesiae), skin burning;
- itching, skin rash, dry skin.
Rare (may affect up to 1 in 1,000 people)
- headache (cephalalgia).
Very rare (may affect up to 1 in 10,000 people)
- difficulty in breathing (dyspnoea) in patients with allergies, superficial skin lesion (excoriation), skin pimples (folliculitis), skin discolouration.
Not known (frequency cannot be estimated from the available data)
- nausea, contact dermatitis, urticaria.
Itching may persist for 2–4 weeks after treatment has ended. 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.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell 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 Scabiacid
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 kept in its original intact packaging and stored correctly.
Store below 30°C. Do not freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Scabiacid contains
- The active substance is: permethrin. 100 g of 5% cream contain 5 g of permethrin.
- The other components are: cetyl stearyl alcohol, paraffin, cetomacrogol 1000, isopropyl myristate, benzyl alcohol, purified water.
Description of the appearance of Scabiacid and contents of the pack
Scabiacid is a cream contained in a 30 g or 60 g aluminium tube with a polypropylene cap.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Giuliani S.p.a. – Via Palagi, 2 – 20129 Milan
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)
This patient information leaflet has been updated