ANTISCABIOSUM

Antiscabiesum 25% Emulsion

Important notes (mandatory information)

Antiscabiosum 25% for adults. Active ingredient: Emulsion with benzyl benzoate. Areas of application: used for the treatment of scabies in adults as a less toxic alternative to sufficiently tested antiscabiosa.

For risks and side effects, read the package leaflet and consult 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 instructed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms do not improve or get worse, you must see a doctor.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package 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 IT?
3. HOW IS ANTISCABIOSUM 25% USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ANTISCABIOSUM 25% BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

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

What is it used for?
Antiscabiosum 25% is used for the treatment of scabies in adults as a less toxic alternative to sufficiently tested antiscabiosa.

2. WHAT SHOULD YOU CONSIDER BEFORE USING IT?

You should not use Antiscabiosum 25% if:

• you are allergic to benzyl benzoate, benzoic acid and benzyl alcohol or any of the other ingredients of this medicine. These other ingredients are listed in section 6.
• you are breastfeeding.

Warnings and precautions

When is special care required when using it?

• Please note that Antiscabiosum 25% must not come into contact with the eyes, mucous membranes and severely irritated skin.
• If you suffer from or have suffered from epileptic seizures in the past, be sure to consult your doctor before using Antiscabiosum.
• Avoid intensive sun exposure (e.g. also solariums) during use.
• If the symptoms persist after treatment, please consult your doctor. Further therapy may only be carried out with the doctor's consent.
• Sensitive surfaces can be attacked by Antiscabiosum. This can lead to changes in colour, for example. It is therefore recommended to wear cotton gloves when touching potentially sensitive surfaces.

Application to the head

In exceptional cases, if the hairy head and/or face are also infested with scabies mites, the doctor may order the application of Antiscabiosum to the head. However, this application should only be carried out under medical supervision. For the method of application, please read section 3.

Use in children

There are no sufficient studies on the use of this medicine in children. It should therefore 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 intend to become pregnant, ask your doctor for advice before using this medicine.

Pregnancy

In animal studies, benzyl benzoate has only been insufficiently investigated. 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 required.

Interactions

Medicines can interact with each other, so that their effect is then stronger or weaker than usual. Therefore, please inform your doctor or pharmacist if you are taking or have recently taken any other medicines or intend to take any other medicines. So far, no interactions between Antiscabiosum 25% and any other medicine are known. However, it should not be used at the same time as other scabies remedies in order to rule out possible interactions.

Notes on other ingredients

Antiscabiosum 25% contains, among other things, cetyl stearyl alcohol and propylene glycol. Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis). Propylene glycol can cause skin irritation.

3. HOW IS ANTISCABIOSUM 25% USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. 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 the skin once a day for 3 consecutive days. Then please stop the treatment, even if the itching persists. See a doctor. A medical follow-up check on the success or failure of the scabies treatment is always necessary. Before starting treatment, you should clean your body thoroughly (full bath or shower) and, if necessary, cut your nails. You may also shower before reapplying on the following two days. Always apply Antiscabiosum 25% only when the skin is completely dry and the body temperature has returned to normal, i.e. about 60 minutes after showering. On 3 consecutive days, rub Antiscabiosum 25% carefully into your body from neck to toes without gaps. Apply the emulsion thinly and spread it evenly, just as you would with a sunscreen. The time interval between applications should be about 24 hours. Treat the visibly affected areas of skin particularly thoroughly. Rub carefully into each finger, each toe and the spaces between them, all body folds, the chest, the external genitals (not the mucous membranes), the belt and the buttocks. These areas are preferred by scabies mites. If your doctor has ordered you to also use Antiscabiosum on your head, you must be sure to carefully avoid the areas around the eyes, mouth and nose. If you wash your hands during the day, you must reapply the emulsion immediately afterwards. On the 4th day, you should definitely shower or bathe to thoroughly wash the medicine off your skin. Change your clothes (underwear and outerwear) completely every day and make your bed fresh.

How long may you use Antiscabiosum 25%?
Three consecutive days. Do not use Antiscabiosum 25% for more than 3 days without medical advice. If the itching persists afterwards, be sure to see a doctor. Follow-up treatment may be necessary. Please talk to your doctor or pharmacist if you have the impression that the effect of Antiscabiosum 25% is too strong or too weak.

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

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

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

What about textiles and objects?
It is important to also clean the surroundings to rule out reinfection as far as possible. Scabies mites can be reliably killed at temperatures above 50°C or without air. Therefore, used bed and underwear, towels and outerwear should be washed at at least 60°C. This also applies to other objects that have been in prolonged contact with the body, such as cuddly toys, blood pressure cuffs, shoes. Objects and clothing that can only be washed at lower temperatures or not at all should be stored in closed plastic bags for 7 days. Carpets, mattresses and upholstered furniture should be thoroughly vacuumed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can have side effects, although not everybody gets them. Possible side effects

Rarely (1 to 10 in 10,000 treated) skin and mucous membrane irritation or persistent itching occurs. Not known (frequency cannot be estimated from the available data): The following side effects have been reported after market launch:

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD ANTISCABIOSUM 25% BE STORED?

Storage conditions: Keep out of reach of children. Do not store above 30°C. Shelf life: Do not use the medicine after the expiry date. This date is stated on the label and the folding box after . The expiry date refers to the last day of the month. If there is still some 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 cetyl stearyl alcohol (type A) (Ph. Eur.), Propylene glycol

What Antiscabiosum 25%

looks like and contents of the pack

Antiscabiosum is a white emulsion. It is filled into brown glass bottles, which are placed in folding boxes. There is a pack size with 200 g of emulsion.

Important notes

The contact persons of scabies patients must be examined without fail. Since itching does not occur until about 3 to 5 weeks after infection, the infection can spread unnoticed, initially in the family, in school classes and kindergartens, in shared accommodation and care facilities. Regardless of whether or not there are any skin changes, it is essential to treat the people in the immediate vicinity. This can cure possible, as yet undetected infections and prevent the scabies from being passed on or re-infected. A preparation with a lower active ingredient content is available for children.

Pharmaceutical entrepreneur

Strathmann GmbH & Co. KG
Postfach 610425
22424 Hamburg
Tel: 040/55 90 5-0
Fax: 040/55 90 5-100
E-Mail: info@strathmann.de

Manufacturer

Biokirch GmbH
Bei den Kämpen 11
21220 Seevetal

This package leaflet was last revised in September 2014.

Source: Information from the package leaflet
Status: 04/2017
Active ingredient: Emulsion with benzyl benzoate. Areas of application: used for the treatment of scabies in adults as a less toxic alternative to sufficiently tested antiscabiosa.