CLOTRIMAZOLUM 10 mg /G Cream

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Clotrimazolum GSK, 10 mg/g, Cream
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Clotrimazolum GSK and what is it used for
4. Important information before using Clotrimazolum GSK
   1. When not to use Clotrimazolum GSK
   2. Warnings and precautions
   3. Clotrimazolum GSK and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Clotrimazolum GSK contains cetostearyl alcohol and benzyl alcohol
5. How to use Clotrimazolum GSK
   1. Using more than the recommended dose of Clotrimazolum GSK
   2. Missing a dose of Clotrimazolum GSK
   3. Stopping the use of Clotrimazolum GSK
6. Possible side effects
   1. Reporting side effects
7. How to store Clotrimazolum GSK
8. Contents of the package and other information
   1. What Clotrimazolum GSK contains
   2. What Clotrimazolum GSK looks like and contents of the package
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Clotrimazolum GSK, 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, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 7 days or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

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

Clotrimazolum GSK cream is for topical use. It contains the active substance clotrimazole, which kills most fungi that cause infections in humans. Clotrimazole is an imidazole derivative. The medicine is particularly effective against yeasts and dermatophytes. Clotrimazolum GSK cream is indicated for the topical treatment of:

• fungal skin infections of the hands and feet, trunk, groin, and legs, caused by dermatophytes,
• pityriasis versicolor,
• skin and mucous membrane infections of the external genitalia (vulva, glans penis, and foreskin), caused by yeasts (such infections are also known as candidiasis).

If there is no improvement after 7 days or the patient feels worse, a doctor should be consulted.

2. Important information before using Clotrimazolum GSK

When not to use Clotrimazolum GSK

• If the patient is allergic (hypersensitive) to the active substance clotrimazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• The medicine should not be used in the eyes. It should not be swallowed.
• All areas that may be infected should be treated at the same time.

Clotrimazolum GSK and other medicines

The doctor or pharmacist should be informed about all medicines being taken or are planned to be taken.

• Clotrimazole used topically on the mucous membranes of the external genitalia may damage mechanical contraceptives made of latex (condoms and diaphragms), and thus reduce their effectiveness. Therefore, during treatment with clotrimazole and for at least 5 days after its completion, other contraceptive methods should be used. A doctor should be consulted to choose another method of contraception.

Pregnancy and breastfeeding

If the patient is pregnant, thinks she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine. The doctor will weigh the benefits and risks for the patient and the fetus associated with the use of Clotrimazolum GSK. Clotrimazolum GSK can be used during breastfeeding. If it is applied to the nipple area, the breast should be washed before breastfeeding the baby.

Driving and using machines

Clotrimazolum GSK has no influence or negligible influence on the ability to drive and use machines.

Clotrimazolum GSK contains cetostearyl alcohol and benzyl alcohol

100 grams of cream contains 11.5 grams of cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis, manifested by itching, blistering, or sometimes swelling). 100 grams of cream contains 1 gram of benzyl alcohol. Benzyl alcohol may cause allergic reactions and mild local irritation. 100 grams of cream contains 1.5 grams of polysorbate 60. Polysorbates may cause allergic reactions.

3. How to use Clotrimazolum GSK

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted. The medicine is for topical use. Recommended doseThe cream should be applied thinly to the affected areas 2 or 3 times a day. The cream should be applied to all infected areas at the same time. Duration of treatmentThe medicine should be used for 2 to 4 weeks, even if the symptoms of the infection disappear. Not following this recommendation may lead to a relapse of the infection. If the symptoms worsen or do not improve after 7 days of using the medicine, a doctor should be consulted again.

Using more than the recommended dose of Clotrimazolum GSK

In case of using a larger dose than recommended or accidental ingestion, a doctor or pharmacist should be consulted.

Missing a dose of Clotrimazolum GSK

The use of the medicine should be continued without increasing the next dose. A double dose should not be used to make up for a missed dose.

Stopping the use of Clotrimazolum GSK

The use of the medicine should not be stopped, even if the symptoms of the infection disappear. Stopping the treatment may lead to a relapse of the infection. In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The patient should stop using the medicine and immediately consult a doctor or seek medical attention if the following side effects occur with unknown frequency (frequency cannot be estimated from the available data):

• anaphylactic reaction (severe, potentially life-threatening generalized hypersensitivity reaction),
• angioedema (sudden, localized swelling of the skin and subcutaneous tissues or internal organs, most commonly involving the face, lips, mouth, tongue, throat, limbs, and joints, and sometimes the mucous membranes of the respiratory and gastrointestinal tracts),
• hypersensitivity (allergy with symptoms such as: hives, shortness of breath, decreased blood pressure, fainting). Other side effects that may occur with unknown frequency:
• itching, rash, blisters, peeling, feeling of pain or discomfort, burning, stinging, swelling, irritation, redness, contact dermatitis, feeling of tingling, reactions at the application site.

Reporting side effects

If any side effects occur, including any not listed in this package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 GSK

The medicine should be stored out of sight and reach of children. It should be stored at a temperature below 25°C. It should not be frozen. The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Clotrimazolum GSK contains

The active substance of the medicine is clotrimazole. 1 gram of cream contains 10 mg of clotrimazole. The excipients are: cetostearyl alcohol, octyldodecanol, polysorbate 60, sorbitan stearate, synthetic olbrot, benzyl alcohol, purified water.

What Clotrimazolum GSK looks like and contents of the package

The medicine is a white cream. The packaging of the medicine is an aluminum tube containing 20 grams of cream, placed in a cardboard box.

Marketing authorization holder

GSK PSC Poland sp. z o.o. ul. Grunwaldzka 189, 60-322 Poznań

Manufacturer

Delpharm Poznań Spółka Akcyjna ul. Grunwaldzka 189, 60-322 Poznań For more detailed information, the representative of the marketing authorization holder should be contacted. GSK Services Sp. z o.o. tel. (22) 576-90-00

Date of last revision of the package leaflet: