Crotamiton farmapol

Package leaflet: Information for the patient

CROTAMITON FARMAPOL
100 mg/g, topical solution for skin application
Crotamitonum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. This includes any possible adverse reactions not mentioned in the leaflet (see section 4).

Table of contents of the leaflet

1. What Crotamiton Farmapol is and what it is used for
2. Important information before using Crotamiton Farmapol
3. How to use Crotamiton Farmapol
4. Possible side effects
5. How to store Crotamiton Farmapol
6. Contents of the pack and other information

1. What Crotamiton Farmapol is and what it is used for

Crotamiton Farmapol is a topical solution intended for external use on the skin only. It is an
antiscabietic and antipruritic agent. The active substance readily penetrates the skin.
Indications:

• Treatment of scabies,
• Symptomatic relief of itching of various origins, including allergic itching and itching due to insect bites.

2. Important information before using Crotamiton Farmapol

When not to use Crotamiton Farmapol

• If the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of the medicine (see section 6).
• If the patient has acute, weeping inflammatory skin lesions, regardless of their cause.
• Do not apply to the eyes, on the skin around the eyes, or on damaged skin.
• Do not use in infants during the first year of life.
• Do not use over large areas of skin in children (over 1 year of age).

Warnings and precautions

• When applying the liquid, care should be taken to avoid contact with the face, eyes, skin around the eyes, mucous membranes, or damaged skin. If the medicine gets into the eyes or onto mucous membranes, rinse thoroughly with water and consult a doctor.
• Use Crotamiton Farmapol cautiously in particularly sensitive areas, such as the armpits and genital area.
• If irritation occurs after the first application, do not continue using the medicine.
• If itching persists or if itching develops in the genital area, consult a doctor.

Crotamiton Farmapol and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
No interactions between Crotamiton Farmapol and other medicines are known.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Appropriate studies on the safety of the medicine during pregnancy and breastfeeding have not been conducted. It is not known whether the medicine passes into breast milk.

Driving and operating machinery
When used as directed, this medicine does not affect the ability to drive motor vehicles or operate machinery, or psychomotor performance.

3. How to use Crotamiton Farmapol

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Crotamiton Farmapol is intended for external use on the skin only.
Recommended dosage
Symptomatic treatment of itching
Apply the liquid by rubbing it into the itchy area of skin. The medicine should be applied 2 to a maximum of 3 times
per day.
Symptoms usually resolve within 6–10 hours after application.
After applying the medicine, hands should be thoroughly washed.
When using Crotamiton Farmapol, care must be taken to avoid contact with the eyes or mucous membranes. If this occurs, rinse thoroughly with water and contact your doctor.
Scabies treatment
Before applying the medicine, it is recommended to take a bath and dry the skin thoroughly. Rub the liquid into the skin, avoiding the face and hairy areas of the scalp.
Apply the medicine once daily, preferably at bedtime, for 3 to 5 days.
During scabies treatment, follow the detailed recommendations below.

• Take care to avoid contact of the liquid with the eyes or mucous membranes. If this occurs, rinse the eyes or mucous membranes with water and contact your doctor.
• After each application, hands should be thoroughly washed.
• During scabies treatment, bathing is recommended only after 2–3 days from the last application. In the meantime, maintain basic personal hygiene, such as daily changing of underwear and washing body parts that were not treated.
• Towels, bed linens, underwear, and clothing used during the illness should be washed at a high temperature and ironed (to effectively eliminate the source of infection). These items should be stored separately and not used for at least 2 weeks.
• Household members and close contacts of the infected person should also undergo preventive treatment, even if they do not show symptoms of infection.

Use in children and adolescents
Crotamiton Farmapol should not be used in infants during the first year of life.
In children (over 1 year of age), a single application is sufficient.
Use of a higher than recommended dose of Crotamiton Farmapol
If a higher than recommended dose is used, contact your doctor immediately.
Mild local skin irritation and urticaria (redness and itching of the skin) may occur.
Accidental ingestion of the medicine may cause irritation of the mucous membranes of the cheeks, esophagus, and stomach, nausea, vomiting, and epigastric pain.
If the medicine has been accidentally ingested, contact your doctor immediately.
Missed dose of Crotamiton Farmapol
Apply the liquid as soon as possible, then continue with the next dose at the usual time.
Discontinuation of Crotamiton Farmapol
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse effects may occur:

• transient allergic (hypersensitivity) reactions, such as: local redness and itching of the skin (so-called erythema), sensation of warmth; if such symptoms occur, treatment must be discontinued immediately and a doctor should be contacted,
• skin irritation (if the medicine penetrates skin damaged by scabies mites – parasites causing scabies).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301,
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Crotamiton Farmapol

Keep the medicine out of sight and reach of children.
Store below 25°C.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such practices help protect the environment.

6. Contents of the pack and other information

What Crotamiton Farmapol contains

• The active substance is crotonyl-N-ethyl-o-toluidine (crotamiton). 1 g of the liquid contains 100 mg of crotamiton.
• Other components (excipients): macrogol 400, 96% ethanol, distilled water.

What Crotamiton Farmapol looks like and contents of the pack
Crotamiton Farmapol is a liquid.
The liquid is packed in a dark glass bottle closed with a metal screw cap with a tamper-evident ring. The pack contains 100 g of liquid.

Marketing Authorisation Holder and Manufacturer
Farmaceutical Company Farmapol Sp. z o.o.
Święty Wojciech 29
61-749 Poznań
Poland
Tel.: +48 61 852 63 53
E-mail: [email protected]

For further information, please contact the Marketing Authorisation Holder.

Information for blind and partially sighted people: the package leaflet content is available via a free phone number: 800 706 848.