Crotamiton farmapol

Package leaflet: Information for the patient

CROTAMITON FARMAPOL
100 mg/g, ointment
Crotamitonum
Please read the entire leaflet carefully 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. This includes any possible adverse reactions not mentioned in the leaflet (see section 4).

Table of contents

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 an ointment for topical use, applied exclusively to the skin. It is an
antiscabietic and antipruritic medicine. The drug penetrates the skin easily.
Indications:

• treatment of scabies,
• symptomatic treatment of pruritus of various origins, including allergic pruritus and pruritus following insect bites.

2. 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, to the skin around the eyes, or to 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 ointment, take care 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 contact a doctor.
• Use Crotamiton Farmapol cautiously in particularly sensitive areas, such as underarms and genital areas.
• If irritation occurs after the first application, discontinue further use.
• If itching symptoms persist or if itching occurs in the genital area, consult a doctor.

Crotamiton Farmapol and other medicines
Tell your doctor or pharmacist if you are currently using, have recently used, or plan to use any other medicines.
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 are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Appropriate studies on the safety of Crotamiton Farmapol 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, Crotamiton Farmapol does not affect the ability to drive motor vehicles or operate machinery, or psycho-physical 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
A thin layer of the cream should be gently rubbed into the itchy area of skin. The medicine should be applied from 2 to
a maximum of 3 times daily.
Symptoms usually subside within 6–10 hours after application.
After applying the medicine, hands should be thoroughly washed.
When using Crotamiton Farmapol, care should be taken to avoid contact with the eyes and mucous membranes. If this occurs, rinse the eyes or mucous membranes with water and contact
your doctor.
Scabies treatment
Before applying the medicine, it is recommended to take a bath and dry the skin. A thin layer of the cream should be rubbed
into the skin, avoiding the face and hairy areas of the scalp.
The medicine should be applied once daily, preferably at bedtime, for 3 to 5 days.
During scabies treatment, follow the detailed recommendations below.

• Take care to prevent the cream from entering 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, clothing, and garments 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 orally, contact your doctor immediately.
Missed dose of Crotamiton Farmapol
Apply the cream as soon as possible, and apply 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 should be discontinued immediately and a doctor should be consulted,
• skin irritation (if the medicine penetrates damaged skin caused 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 Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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.
Keep the medicine in the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Crotamiton Farmapol contains

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

What Crotamiton Farmapol looks like and contents of the pack
Crotamiton Farmapol is an ointment.
The ointment is packed in an aluminium tube placed in a cardboard box. The pack contains
40 g of ointment.
Marketing Authorisation Holder and Manufacturer
Farmaceutical Company Farmapol Sp. z o.o.
Święty Wojciech Street 29
61-749 Poznań
Phone: +48 61 852 63 53 Email: [email protected]
For more detailed information, please contact the Marketing Authorisation Holder.
Information for the blind and visually impaired: the leaflet content is available free of charge by calling
the toll-free number: 800 706 848.