Clotrimazole gsk

Package leaflet: Information for the user

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

• Keep this leaflet, so that it can be read again if necessary.
• If advice or further information is needed, please contact the pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if the patient feels worse, contact the doctor.

Contents of the leaflet

1. What Clotrimazolum GSK is and what it is 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 pack and other information

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

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

• fungal infections of the skin of the hands and feet, trunk, lower legs and thighs caused by dermatophytes,
• pityriasis versicolor,
• fungal infections of the skin and external mucous membranes of the genital organs (labia, foreskin and glans), caused by yeasts (such infections are also known as candidiasis).

If there is no improvement after 7 days or if the patient feels worse, consult a doctor.

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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• This medicine should not be used near the eyes. Do not swallow.
• All affected areas should be treated simultaneously.

Clotrimazolum GSK and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking,
have recently taken, or plan to take.

• Clotrimazole, when applied topically to the external genital mucous membranes, may damage latex-based mechanical contraceptive products (e.g. condoms and diaphragms), thereby reducing their effectiveness. Therefore, during treatment with clotrimazole and for at least 5 days after completion of treatment, alternative contraceptive methods should be used. Please consult your doctor to select another method of contraception.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine. The doctor will assess the benefit to the patient and the potential risk to the fetus associated with using Clotrimazolum GSK.
Clotrimazolum GSK may be used during breastfeeding. If applied locally to the nipple area, the breast should be washed thoroughly before feeding the infant.

Driving and operating machinery
Clotrimazolum GSK has no effect or has a negligible effect on the ability to drive and operate machinery.

Clotrimazolum GSK contains cetearyl alcohol and benzyl alcohol
100 grams of cream contains 11.5 grams of cetearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis, manifesting as itchy rash or blisters, sometimes with swelling).
100 grams of cream contains 1 gram of benzyl alcohol, which may cause allergic reactions and mild local irritation.
100 grams of cream contains 1.5 g 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 patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical use only.
Recommended dose
Apply a thin layer of cream to the affected areas twice or three times daily.
The cream should be applied simultaneously to all infected areas.
Duration of treatment
The medicine should be used for a period of 2 to 4 weeks, even if symptoms of the disease have subsided.
Failure to follow this recommendation may result in recurrence of infection.
If symptoms worsen or do not improve after 7 days of treatment, consult a doctor.
Use of a higher than recommended dose of Clotrimazolum GSK
If a higher than recommended dose is used or if the medicine is accidentally ingested orally, contact a doctor or pharmacist.
Missed dose of Clotrimazolum GSK
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 Clotrimazolum GSK treatment
Do not stop using the medicine even if symptoms of the disease have subsided. Discontinuing treatment may lead to recurrence of infection.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The patient should discontinue the medicine and immediately contact a doctor or seek medical help
if any of the following adverse reactions of unknown frequency (frequency cannot be estimated
from the available data) occur:

• anaphylactic reaction (severe, potentially life-threatening generalized hypersensitivity reaction),
• angioedema (sudden, localized swelling of the skin and subcutaneous tissues or internal organs, most commonly affecting the face, lips, oral cavity, tongue, throat, limbs, and joint areas, and sometimes the mucous membranes of the respiratory and gastrointestinal tracts. Difficulty in swallowing or breathing may occur),
• hypersensitivity (allergic reaction with symptoms such as: urticaria, dyspnoea, decreased blood pressure, fainting). Other adverse reactions that may occur with unknown frequency:
• itching, rash, blisters, peeling of the epidermis, pain or discomfort, burning, stinging, swelling, irritation, erythema, contact dermatitis, tingling sensation, local reactions at the site of administration. Reporting of adverse reactions

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
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 GSK

Keep the medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Clotrimazolum GSK contains
The active substance is clotrimazole.
1 g of cream contains 10 mg of clotrimazole.
Excipients: cetostearyl alcohol, octyldodecanol, polysorbate 60, sorbitan stearate, synthetic olbrot, benzyl alcohol, purified water.

What Clotrimazolum GSK looks like and contents of the pack
Clotrimazolum GSK is a white cream.
The medicinal product is packed in an aluminium tube containing 20 g of cream, placed in a cardboard box.

Marketing Authorisation 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 further information, please contact the marketing authorisation holder.
GSK Services Sp. z o.o.
tel. (22) 576-90-00