Clotrimazole aflofarm

Package leaflet: Information for the user

Clotrimazolum Aflofarm, 10 mg/g, cream
Clotrimazolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.

Table of contents

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

1. What Clotrimazolum Aflofarm is and what it is used for

Clotrimazolum Aflofarm is a cream intended for topical use.
It contains the active substance clotrimazole, which kills most fungi causing infections in humans.
The medicine is particularly effective against yeasts and dermatophytes—fungi that infect the skin.
Indications
Topical treatment of:

• Athlete's foot, tinea cruris (jock itch), tinea corporis (ringworm), and interdigital skin infections, including athlete's foot with secondary infection (e.g. athlete's foot in sportsmen) caused by dermatophytes;
• Fungal infections of the skin and external genital mucous membranes (labia, foreskin, and glans penis) caused by yeasts (also known as candidiasis);
• Pityriasis versicolor.

2. Information before using Clotrimazolum Aflofarm

When not to use Clotrimazolum Aflofarm

• if the patient is allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has impaired kidney function;
• if the patient is in the first trimester of pregnancy;
• in children under 11 years of age;
• not for vaginal or ocular use.

Warnings and precautions
Before starting treatment with Clotrimazolum Aflofarm, consult your doctor or pharmacist:

• if the patient is taking medicines that suppress the immune system (so-called immunosuppressive drugs, used in organ transplant recipients or e.g. in atopic dermatitis);
• if the patient is undergoing chemotherapy;
• if the patient has diabetes;
• if the patient is infected with HIV;
• if the patient is allergic to itraconazole, fluconazole, ketoconazole, or miconazole (medicines used to treat fungal infections).

Clotrimazolum Aflofarm and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use the following medicines simultaneously with Clotrimazolum Aflofarm:

• topical polyene antibiotics (nystatin and natamycin), because clotrimazole may inhibit their action;
• topical glucocorticosteroids (steroids) used in the treatment of inflammatory conditions, as they may weaken the effect of clotrimazole.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Clotrimazolum Aflofarm must not be used during the first trimester of pregnancy.
In the second and third trimesters of pregnancy, the medicine may be used only on explicit medical advice and when, in the opinion of the doctor, it is necessary.
Breastfeeding women may use the medicine only on medical advice.

Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.

The medicine contains cetyl alcohol, stearyl alcohol, and benzyl alcohol
Cetyl alcohol, stearyl alcohol
The medicine may cause local skin reactions (e.g. contact dermatitis).
Benzyl alcohol
The medicine contains 10 mg of benzyl alcohol per gram of cream.
Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Clotrimazolum Aflofarm

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Apply a thin layer of the medicine to the affected areas and surrounding skin twice daily (morning and evening).
Method of administration
This medicine is intended for topical use only.
Before application, the skin should be thoroughly washed and dried.
Duration of treatment

• Treatment of fungal skin infections – should last for at least 4 weeks, even if symptoms have resolved. Failure to follow this recommendation may result in recurrence of infection. Acute symptoms usually improve within about one week of starting treatment.
• Treatment of fungal infections of external genital mucous membranes – should last from one to two weeks.

If symptoms worsen or no improvement is observed after one week of treatment, consult your doctor.
Children and elderly patients
Children under 11 years of age and elderly patients (over 65 years) should only use this medicine on medical advice.
Use of a higher than recommended dose of Clotrimazolum Aflofarm
There are no known cases of clotrimazole overdose in humans.
If more medicine has been used than recommended, consult your doctor.
Missed dose of Clotrimazolum Aflofarm
Continue using the medicine as prescribed, without increasing the next dose.
Do not use a double dose to make up for a missed dose.
Stopping treatment with Clotrimazolum Aflofarm
Do not stop using the medicine, even if symptoms have improved. Premature discontinuation of treatment may lead to recurrence of infection.
If you have any further questions about 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 will experience them.
You should immediately contact a doctor or go to the nearest hospital emergency department
if the patient experiences any of the following symptoms, as urgent medical care may be required:

• Generalized hypersensitivity reaction (manifesting, among others, as rash, severe swelling of the face, lips or throat making breathing, speaking or swallowing difficult, decreased blood pressure, slow or rapid heartbeat, pallor, restlessness, sweating, dizziness, loss of consciousness, respiratory arrest or cardiac arrest).

The following adverse reactions may also occur:

• Erythema (intense reddening of the skin),
• Rash (itchy red bumps on the skin),
• Urticaria (bright pink, itchy blisters on the skin),
• Localized redness, itching, acne-like eruptions, swelling.

If any of the above symptoms occur, the medicine should be discontinued and medical advice sought.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
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 to provide more information on the safety of the medicine.

5. How to store Clotrimazolum Aflofarm

Keep the medicine out of sight and reach of children.
Store in the original packaging, at a temperature below 25°C. Do not freeze.
The shelf life after first opening the tube is 28 days.
Do not use this medicine after the expiry date stated on the tube and the carton. 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Clotrimazolum Aflofarm contains

• The active substance is clotrimazole. 1 g of cream contains 10 mg of clotrimazole.
• Other ingredients: cetyl alcohol, stearyl alcohol, cetyl palmitate, octyldodecanol, sorbitan stearate, polysorbate 60, benzyl alcohol, purified water.

What Clotrimazolum Aflofarm looks like and contents of the pack
Clotrimazolum Aflofarm is a white cream.
The packaging consists of an aluminium tube with an inner protective epoxy-phenolic varnish coating and a tamper-evident seal, fitted with a white polyethylene (HDPE) cap, containing 20 g of cream, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel.: (42) 22-53-100