Clotrimazole hasco

Patient Information Leaflet

CLOTRIMAZOLUM HASCO
10 mg/g, cream
Clotrimazolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
Always use this medicine 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 additional information, please consult your pharmacist.
• If you experience any side effects, 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 your condition worsens, contact your doctor.

Leaflet Contents

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

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

Clotrimazolum HASCO is a cream for topical application. The medicine contains the active substance clotrimazole, which has local antifungal activity. The medicine inhibits the growth of most fungi responsible for skin infections in humans.

Indications

• Fungal skin infections caused by dermatophytes, yeasts, moulds, and other fungal species: athlete's foot, tinea manuum, tinea corporis, tinea cruris, pityriasis versicolor.
• Cutaneous candidiasis and external genital mucocutaneous candidiasis (Candida vulvitis and balanitis).

2. Important information before using Clotrimazolum HASCO

When not to use Clotrimazolum HASCO:

• if the patient is allergic to clotrimazole or to any of the other ingredients of this medicine (listed in section 6);
• for vaginal use.

Warnings and precautions
Before starting treatment with Clotrimazolum HASCO, consult a doctor,
pharmacist, or nurse.
Topically applied clotrimazole may damage latex-based contraceptive devices
(such as condoms and vaginal diaphragms). Therefore, during application of the medicine to the mucous membranes of external genital organs and for at least 5 days after discontinuation of treatment, latex-based mechanical contraceptives should not be used.
Avoid contact of the medicine with eyes and mouth.
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Clotrimazolum HASCO and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to use.
Clotrimazole reduces the effectiveness of amphotericin and other polyene antibiotics (e.g. nystatin, natamycin). Concurrent topical use of drugs containing potent corticosteroids 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 child, she should consult a doctor or pharmacist before using this medicine.
The medicine may be used during pregnancy only if, in the opinion of the physician, it is clearly necessary.
When treating infection of the labia, the medicine must not be used vaginally.
During breastfeeding, the medicine may be used only when justified, under medical supervision.
Driving and operating machinery
Clotrimazolum HASCO has no effect or has a negligible effect on the ability to drive and operate machinery.
Clotrimazolum HASCO contains cetearyl alcohol and benzyl alcohol
Due to the presence of cetearyl alcohol, this medicine may cause local skin reactions (e.g. contact dermatitis).
The medicine contains 1.5 g of benzyl alcohol in 100 g of cream. Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Clotrimazolum Hasco

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
The usual dose is 2 to 3 times daily. Apply a thin layer of the medicine to the affected areas and rub it in gently.
After acute symptoms have subsided, continue treatment with this medicine for at least one additional month.
This medicine is for topical use only.
Use of more than the recommended dose of Clotrimazolum Hasco
No data available. There have been no reports of overdose with clotrimazole when applied to the skin.
Missed dose of Clotrimazolum Hasco
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
Topically applied clotrimazole is well tolerated. Skin reactions may rarely occur
(such as erythema, redness, burning sensation, urticaria, blisters, desquamation, irritation).
Additionally, systemic allergic reactions, pain, itching, and rash may occur.
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Unfavourable skin changes caused by the use of the medicine are transient in nature and usually
subside after discontinuation of the medicine.

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet,
inform a 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 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 enables further information on the safety of the medicine to be collected.

5. How to store Clotrimazolum Hasco

Keep the medicine out of sight and reach of children.
Store in a tightly closed, original container, at a temperature below 25°C.
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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Clotrimazolum HASCO contains

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

What Clotrimazolum HASCO looks like and contents of the pack
Clotrimazolum HASCO is a white cream with a characteristic odour.
One pack consists of an aluminium tube containing 20 g of cream, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicinal product
tel.: (22) 742 00 22
e-mail: [email protected]
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