Crotamiton Farmapol

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

Crotamiton Farmapol is an ointment for topical use, exclusively on the skin. It is an anti-scabies and anti-itch medicine. The medicine easily penetrates the skin.

Indications for use:

• treatment of scabies,
• symptomatic treatment of itching of various origins, including allergic itching and itching after 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 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 use on the eyes, on the skin around the eyes, or on damaged skin.
• Do not use in infants in the first year of life.
• Do not use on a large area of skin in children (over 1 year of age).

Warnings and precautions

• When applying the ointment, be careful not to get it on the face, eyes, skin around the eyes, mucous membranes, or damaged skin. If the medicine gets into the eyes or on the mucous membranes, rinse them with water and contact a doctor.
• Use the medicine with caution in sensitive areas, such as the armpits and genital area.
• If irritation occurs after the first application of the medicine, do not continue using it.
• If itching symptoms persist or occur in the genital area, contact a doctor.

Crotamiton Farmapol and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
There are no known interactions between Crotamiton Farmapol and other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
No adequate studies have been conducted on the safety of using the medicine during pregnancy and breastfeeding. It is not known whether the medicine passes into breast milk.

Driving and using machines

The medicine used as directed does not affect the ability to drive vehicles or operate machinery, or mental and physical performance.

3. How to use Crotamiton Farmapol

Always use this medicine exactly as your doctor or pharmacist has told you.
In case of doubt, consult your doctor or pharmacist.
Crotamiton Farmapol is for use on the skin only.

Recommended dosage

Symptomatic treatment of itching
Apply a thin layer of ointment to the itchy area on the skin. Use the medicine 2 to 3 times a day.
Symptoms usually disappear within 6-10 hours of using the medicine.
After using the medicine, wash your hands thoroughly.
When using Crotamiton Farmapol, be careful not to get it into the eyes or on the mucous membranes. If this happens, rinse your eyes or mucous membranes with water and contact a doctor.
Treatment of scabies
Before using the medicine, take a bath and dry your skin. Apply a thin layer of ointment to the skin, avoiding the face and hairy scalp.
Use the medicine once a day, preferably at night, for 3 to 5 days.
During scabies treatment, follow the detailed instructions below.

• Be careful not to get the ointment into the eyes or on the mucous membranes. If this happens, rinse your eyes or mucous membranes with water and contact a doctor.
• After each use of the medicine, wash your hands thoroughly.
• During scabies treatment, it is recommended to bathe only after 2-3 days from the last application. During this time, maintain basic personal hygiene, such as daily change of underwear and washing of body parts that were not treated.
• Clothing, bedding, and towels used during the illness should be washed at high temperatures and ironed (to effectively remove the source of infection); these items should be stored separately and not used for at least 2 weeks.
• Household members and people in contact with the patient should be treated prophylactically, even if they do not have symptoms of infection.

Use in children and adolescents

Crotamiton Farmapol should not be used in infants in the first year of life.
In children (over 1 year of age), a single application of the medicine is sufficient.

Using more than the recommended dose of Crotamiton Farmapol

If you use more than the recommended dose, contact a doctor immediately.
Mild local skin irritation and hives (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 abdominal pain.
If you accidentally ingest the medicine, contact a doctor immediately.

Missing a dose of Crotamiton Farmapol

Apply the ointment as soon as possible, and apply the next dose at the usual time.

Stopping use of Crotamiton Farmapol

If you have any further doubts about using 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 may occur:

• transient allergic reactions (hypersensitivity), such as local redness and itching of the skin (so-called erythema), feeling of heat; if such symptoms occur, stop treatment and contact a doctor,
• skin irritation (if the medicine gets on the skin damaged by scabies mites - parasites that cause scabies).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather 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 in a temperature below 25°C.
Store the medicine in its original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not throw away medicines 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 Crotamiton Farmapol contains

• The active substance of the medicine is crotonyl-N-ethyl-o-toluidine (crotamiton). 1 g of ointment contains 100 mg of crotamiton.
• Other ingredients (excipients): macrogol 400, macrogol 4000, purified water.

What Crotamiton Farmapol looks like and what the package contains

Crotamiton Farmapol is an ointment.
The ointment is packed in an aluminum tube placed in a cardboard box. The package contains 40 g of ointment.

Marketing authorization holder and manufacturer

Przedsiębiorstwo Farmaceutyczne Farmapol Sp. z o.o.
ul. Święty Wojciech 29
61-749 Poznań
tel.: +48 61 852 63 53
e-mail: info@farmapol.pl
To obtain more detailed information, contact the marketing authorization holder.
Information for the blind and visually impaired:the content of the leaflet is available on a free phone number: 800 706 848.
Date of last update of the leaflet:06/2021