Clotrimazolum Aflofarm

Package Leaflet: Information for the Patient

Clotrimazolum Aflofarm, 10 mg/g, Cream

Clotrimazolum

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Clotrimazolum Aflofarm and what is it 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. Package contents and other information

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

Clotrimazolum Aflofarm is a cream and is intended for topical use.
It contains the active substance clotrimazole, which kills most fungi that cause infections in humans.
The medicine is particularly effective against yeasts and dermatophytes - fungi that attack the skin.

Indications for Use

Local treatment:

• fungal infections of the feet, groin, body, skin between the toes, including athlete's foot with secondary infection (e.g., athlete's foot in athletes) caused by dermatophytes;
• fungal infections of the skin and mucous membranes of the external genital organs (vulva and penis) caused by yeasts (also known as candidiasis);
• pityriasis versicolor.

2. Important Information Before Using Clotrimazolum Aflofarm

When Not to Use Clotrimazolum Aflofarm

• in children under 11 years of age;
• vaginally or in the eyes.

Warnings and Precautions

Before starting to use Clotrimazolum Aflofarm, the patient should discuss it with their doctor or pharmacist:

Clotrimazolum Aflofarm and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The following medicines should not be used at the same time as Clotrimazolum Aflofarm:

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

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Clotrimazolum Aflofarm should not be used in the first trimester of pregnancy.
In the second and third trimesters of pregnancy, the use of the medicine is possible only on the explicit instruction of a doctor and only if, in the doctor's opinion, it is necessary.
Breastfeeding women may use the medicine only on the instruction of a doctor.

Driving and Using Machines

The medicine does not affect the ability to drive or operate machines.

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 in each 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 package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Recommended Dose

A thin layer of the medicine should be applied to the affected areas and the surrounding skin twice a day (morning and evening).
Method of administration
The medicine is intended for topical use.
Before applying the medicine, the skin should be carefully washed and dried.
Duration of treatment

• Treatment of fungal skin infections - should last at least 4 weeks, even if the symptoms of the disease have disappeared. Failure to follow this recommendation may result in a recurrence of the infection. Acute symptoms of the disease usually disappear after about a week of using the medicine.
• Treatment of fungal infections of the mucous membranes of the external genital organs - should last from one to two weeks.

If the symptoms worsen or do not improve after a week of using the medicine, the patient should contact their doctor.
Children and the Elderly
Children under 11 years of age and the elderly (over 65 years of age) may use the medicine only on the instruction of a doctor.

Using a Higher Than Recommended Dose of Clotrimazolum Aflofarm

There are no known cases of clotrimazole overdose in humans.
If a higher dose of the medicine than recommended is used, the patient should contact their doctor.

Missing a Dose of Clotrimazolum Aflofarm

The patient should continue using the medicine without increasing the next dose.
A double dose should not be used to make up for a missed dose.

Stopping the Use of Clotrimazolum Aflofarm

The patient should not stop using the medicine even if the symptoms of the disease have disappeared. Stopping the treatment may result in a recurrence of the infection.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Clotrimazolum Aflofarm can cause side effects, although not everybody gets them.

The Patient Should Immediately Contact Their Doctor or Go to the Emergency Department of the Nearest Hospital if They Experience Any of the Following Symptoms, as They May Need Urgent Medical Attention:

• general hypersensitivity reaction (manifested by, among other things, rash, severe swelling of the face, lips, or throat, making it difficult to breathe, speak, or swallow, decreased blood pressure, slow or fast heart rate, paleness, restlessness, sweating, dizziness, loss of consciousness, and respiratory or cardiac arrest).

The following side effects may also occur:

• erythema (severe redness of the skin),
• rash (itchy, red bumps on the skin),
• urticaria (light red, itchy blisters on the skin),
• local redness, itching, pimples, swelling.

If the patient experiences any of the above symptoms, they should stop using the medicine and contact their doctor.

Reporting Side Effects

If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Clotrimazolum Aflofarm

The medicine should be stored 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 carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Clotrimazolum Aflofarm Contains

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

What Clotrimazolum Aflofarm Looks Like and What the Package Contains

Clotrimazolum Aflofarm is a white cream.
The package contains: an aluminum tube with a protective membrane, internally coated with epoxy-phenolic varnish, and a white polyethylene HDPE cap, containing 20 g of cream, in a cardboard box.

Marketing Authorization Holder and Manufacturer

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

Date of the Last Update of the Package Leaflet: