Clotrimazole amara
PolandTable of Contents
Package leaflet: Information for the user
CLOTRIMAZOLUM AMARA, 10 mg/g, cream
Clotrimazolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed
by your doctor, pharmacist, or nurse.
- Keep this leaflet. You may need to read it again.
- If you need advice or more information, please contact your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
- If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.
Contents of the leaflet:
- What CLOTRIMAZOLUM AMARA is and what it is used for
- Important information before using CLOTRIMAZOLUM AMARA
- How to use CLOTRIMAZOLUM AMARA
- Possible side effects
- How to store CLOTRIMAZOLUM AMARA
- Contents of the pack and other information
1. What CLOTRIMAZOLUM AMARA is and what it is used for
CLOTRIMAZOLUM AMARA cream for topical use contains the active substance clotrimazole, which has a broad spectrum of local antifungal activity. Clotrimazole belongs to the imidazole derivatives and acts particularly against yeasts and dermatophytes (fungi that grow on the skin, hair, and nails, causing various fungal infections).
CLOTRIMAZOLUM AMARA cream is indicated for the topical treatment of:
- Fungal infections of the hands, feet, trunk, lower legs, and thighs caused by dermatophytes,
- Pityriasis versicolor,
- Cutaneous yeast infections and external genital mucocutaneous infections (vulva, labia, and glans penis).
If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.
2. Information before using CLOTRIMAZOLUM AMARA
When not to use CLOTRIMAZOLUM AMARA
- if the patient is allergic to clotrimazole, other antifungal medicines of the imidazole group, or to any of the other ingredients of this medicine listed in section 6).
Warnings and precautions
Before starting treatment with CLOTRIMAZOLUM AMARA, discuss it with your doctor,
pharmacist, or nurse.
Local reactions such as skin irritation may sometimes occur. If allergy or irritation occurs, treatment should be discontinued.
If the patient is allergic to other antifungal medicines – imidazole derivatives, they may also be allergic to clotrimazole.
Topically applied clotrimazole may damage latex-based contraceptive devices (condoms, vaginal diaphragms). Therefore, during application of the medicine to the external genital mucous membranes and for at least 5 days after discontinuation of treatment, mechanical contraceptive devices made of latex should not be used.
Children and adolescents
Before using CLOTRIMAZOLUM AMARA in children, consult your doctor, pharmacist, or nurse.
CLOTRIMAZOLUM AMARA with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
Clotrimazole may inhibit the action of other topically applied antifungal medicines, especially amphotericin B and other antibiotics (nystatin, natamycin). Dexamethasone, when used in high doses, may reduce the antifungal effect of clotrimazole.
CLOTRIMAZOLUM AMARA with food, drink and alcohol
No effect.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The use of this medicine in pregnant women is possible only in cases of clear necessity and under medical supervision, as clinical studies on the use of this medicine during pregnancy have not been conducted.
Breastfeeding
The use of this medicine during breastfeeding is possible only in cases of clear necessity and under medical supervision, as clinical studies on the use of this medicine during breastfeeding have not been conducted.
Fertility
No studies have been conducted on the effect of clotrimazole on fertility in humans.
During treatment of labial infection, this medicine should not be administered intravaginally.
Driving and using machines:
This medicine does not impair the ability to drive or operate machinery.
CLOTRIMAZOLUM AMARA contains cetearyl alcohol and cetyl alcohol. Due to the presence of cetearyl alcohol and cetyl alcohol, this medicine may cause local skin reactions (e.g. contact dermatitis).
The medicine contains 1 g of benzyl alcohol in 100 g of cream. Benzyl alcohol may cause allergic reactions or mild local irritation.
3. How to use CLOTRIMAZOLUM AMARA
This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. The medicine is intended for topical use.
Unless otherwise advised by a doctor, a thin layer of the medicine should be applied to the affected areas two to three times daily for a period of 2 to 4 weeks.
If there is no improvement after 7 days of using the medicine, consult a doctor.
In case of doubt, consult a doctor or pharmacist.
Use of a higher than recommended dose of CLOTRIMAZOLUM AMARA
No data available. There have been no reported cases of overdose with clotrimazole when used according to the indications.
Missed dose of CLOTRIMAZOLUM AMARA
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 use of CLOTRIMAZOLUM AMARA
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, CLOTRIMAZOLUM AMARA may cause adverse reactions, although not
everyone will experience them.
Rare (may affect up to 1 in 1,000 patients):
allergic contact dermatitis, blisters, erythema, swelling, itching, burning pain and stinging, urticaria, and skin fissures.
If any of these symptoms occur, treatment should be discontinued and a doctor should be consulted. If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting suspected adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. 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 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.
By reporting adverse reactions, additional information on the safety of this medicinal product can be collected.
5. How to store CLOTRIMAZOLUM AMARA
Keep CLOTRIMAZOLUM AMARA out of the sight and reach of children.
Do not store above 25°C. Do not freeze. Keep the tube tightly closed.
Do not use CLOTRIMAZOLUM AMARA after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the packaging and other information
What Clotrimazolum Amara contains
The active substance is clotrimazole.
The other ingredients are: cetyl alcohol, cetostearyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, sorbitan monostearate, benzyl alcohol (E1519), purified water.
What Clotrimazolum Amara looks like and contents of the pack
The medicine is in the form of a cream.
Packaging:
Aluminium tube with a membrane and a polyethylene cap, containing 10 g, 15 g, 20 g or 25 g of cream, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer:
Zakład Farmaceutyczny „Amara” sp. z o.o.
ul. Stacyjna 5
30-851 Kraków
Tel. 12 657 40 40
Fax 12 657 40 40 ext. 34