Antiscabiosum 25% for adults, emulsion for scabies treatment, 200 ml solution

Antiscabiosum 25% for adults. Active ingredient: Emulsion with benzyl benzoate. Indications: Used for the treatment of scabies in adults as a less toxic alternative to well-studied scabies antiseptics.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Antiscabiosum 25% for adults
Emulsion with benzyl benzoate

Read the entire package leaflet carefully before you start using this medicine because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If there is no improvement or your symptoms worsen, you must definitely see a doctor.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What this package leaflet contains

1. WHAT IS ANTISCABIOSUM 25% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING?
3. HOW IS ANTISCABIOSUM 25% TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ANTISCABIOSUM 25% BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS ANTISCABIOSUM 25% AND WHAT IS IT USED FOR?

What is Antiscabiosum 25%?
Antiscabiosum 25% is an antiparasitic medicine applied to the skin.

What is it used for?
Antiscabiosum 25% is used to treat scabies in adults as a less toxic alternative to well-studied antiscabiosa products.

2. WHAT SHOULD YOU KNOW BEFORE USING?

You must not use Antiscabiosum 25% if:

• Do not take this medicine if you are allergic to benzyl benzoate, benzoic acid, benzyl alcohol, or any of the other ingredients. These other ingredients are listed in section 6.
• during breastfeeding.

Warnings and precautions:
When is special care required during use?

• Please note that Antiscabiosum 25% should not come into contact with the eyes, mucous membranes, or severely irritated skin.
• If you suffer from epileptic seizures and/or have suffered from them in the past, be sure to consult your doctor before using Antiscabiosum.
• Avoid intense sun exposure (e.g., tanning beds) during application.
• If your symptoms persist after treatment, please consult your doctor. Further treatment should only be carried out with your doctor's approval.
• Antiscabiosum can damage sensitive surfaces, potentially leading to discoloration. Therefore, wearing cotton gloves is recommended when handling potentially sensitive surfaces.

Application to the head:
In exceptional cases, if the scalp and/or face are also infested with scabies mites, the doctor may prescribe the application of Antiscabiosum to the head. However, this application should only be carried out under medical supervision. For instructions on how to use it, please see section 3.

Use in children:
There are insufficient studies on the use of this medicine in children. Therefore, it should not be used in children under 12 years of age. A preparation with a lower active ingredient content is available for children.

Use during pregnancy and breastfeeding:
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before using this medicine.

Pregnancy:
Benzyl benzoate has only been insufficiently studied in animal studies. There is no experience with the use of benzyl benzoate during pregnancy. Therefore, you should only use Antiscabiosum 25% during pregnancy if your doctor considers it absolutely necessary after weighing all the risks.

Breastfeeding:
There are no data on whether the active ingredient benzyl benzoate passes into breast milk. Therefore, Antiscabiosum 25% must not be used during breastfeeding (see also section 2.1).

Effects on ability to drive and use machines:
No special precautions are necessary.

Interactions:
Medicines can interact with each other, so that their effect may be stronger or weaker than usual. Therefore, please inform your doctor or pharmacist if you are using, have recently used, or intend to use any other medicines. To date, no interactions between Antiscabiosum 25% and any other medicine are known. Nevertheless, it should not be used at the same time as other scabies products to rule out possible interactions.

Information on other ingredients:
Antiscabiosum 25% contains, among other things, cetostearyl alcohol and propylene glycol. Cetostearyl alcohol may cause local skin irritation (e.g., contact dermatitis). Propylene glycol may cause skin irritation.

3. HOW TO USE ANTISCABIOSUM 25%?

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Antiscabiosum 25% is intended for use in adults. A preparation with a lower active ingredient content is available for children.

How and how often should you use Antiscabiosum 25%?
Unless otherwise prescribed by your doctor, the usual procedure is: Apply the emulsion to your skin once a day for three consecutive days. After that, please stop treatment, even if the itching persists. Consult a doctor. A follow-up medical examination to determine the success or failure of the scabies treatment is essential. Before starting treatment, you should thoroughly cleanse your body (full bath or shower) and trim your nails if necessary. You may also shower before reapplying the emulsion on the following two days. Always apply Antiscabiosum 25% only when your skin is completely dry and your body temperature has returned to normal, approximately 60 minutes after showering. For three consecutive days, carefully rub Antiscabiosum 25% into your entire body, from your neck to your toes. Apply the emulsion thinly and spread it evenly, just as you would a sunscreen. The interval between applications should be approximately 24 hours. Please treat visibly affected areas of skin particularly thoroughly. Carefully rub in each finger, each toe and the spaces between them, all skin folds, the chest, the external genitalia (not the mucous membranes), the waist, and the buttocks. These areas are preferred by scabies mites. If your doctor has instructed you to also apply Antiscabiosum to your head, you must take great care to avoid the areas around the eyes, mouth, and nose. If you wash your hands during the day, you must reapply the emulsion immediately afterward. On the fourth day, you should definitely shower or bathe to thoroughly wash the medication off your skin. Change all clothing worn (underwear and outerwear) daily and make your bed with fresh sheets.

How long can you use Antiscabiosum 25%?
Three consecutive days. Do not use Antiscabiosum 25% for more than three days without consulting a doctor. If the itching persists, consult a doctor immediately. Follow-up treatment may be necessary. Please talk to your doctor or pharmacist if you feel that the effect of Antiscabiosum 25% is too strong or too weak.

If you have applied too much Antiscabiosum 25%, remove the excess from your skin with a tissue. Overdoses are not known.

If you forget to apply Antiscabiosum 25% once, do not apply it twice the next day or use a double dose, but consult your doctor immediately. They will decide how you should continue the treatment.

If you stop using Antiscabiosum 25%, the scabies mite will recover and your original symptoms will return.

What about textiles and belongings?
It is important to also clean the environment to prevent reinfection as much as possible. Scabies mites can be reliably killed at temperatures above 50°C or in the absence of air. Therefore, used bed linens, underwear, towels, and outerwear should be washed at a minimum of 60°C. This also applies to other items that have had prolonged contact with the body, such as stuffed animals, blood pressure cuffs, and shoes. Items and clothing that can only be washed at lower temperatures or not at all should be stored in sealed plastic bags for 7 days. Carpets, mattresses, and upholstered furniture should be vacuumed thoroughly.

If you have any further questions about 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. Possible side effects:

Rarely (1 to 10 in 10,000 patients), skin and mucous membrane irritation or persistent itching may occur. Not known (frequency cannot be estimated from the available data): The following side effects have been reported since the product was launched:

• Hypersensitivity reactions, which manifest as malaise, hives (urticaria) and vascular edema (angioedema) as well as a touch-sensitive, inflammatory skin reaction (contact dermatitis),
• Epileptic seizures in children.

Reporting of side effects:
If you experience 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 to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ANTISCABIOSUM 25%?

Storage conditions: Keep out of the sight and reach of children. Do not store above 30°C. Expiry date: Do not use this medicine after the expiry date which is stated on the label and the carton after the date shown.The expiry date refers to the last day of the month. If there is any product left in the bottle after the 3-day application, please do not keep it. It is not intended for further use.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Antiscabiosum 25% contains:
The active ingredient is benzyl benzoate. 100 g of emulsion contains 25 g of benzyl benzoate. The other ingredients are: Purified water, sorbitol 70%, emulsifying cetostearyl alcohol (type A) (Ph. Eur.), propylene glycol.

What Antiscabiosum 25% looks like and contents of the pack:
Antiscabiosum is a white emulsion. It is packaged in amber glass bottles, which are placed in folding cartons. It is available in one pack size containing 200 g of emulsion.

Important information:
It is essential that all contacts of scabies patients are examined. Since itching only appears about 3 to 5 weeks after infection, the infection can spread, initially unnoticed, within families, in school classes and kindergartens, in shared accommodations, and in care facilities. Regardless of whether skin lesions are present or not, it is absolutely essential to treat those in close proximity. This allows for the cure of any undetected infections and prevents the further spread of scabies or reinfection. A preparation with a lower concentration of the active ingredient is available for children.

(Apo) Usually ship out within 3-5 business days