Clotrimazolum Hasco

Leaflet attached to the packaging: patient information

CLOTRIMAZOLUM HASCO

10 mg/g, cream

Clotrimazole

Please read the contents of the 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 patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, please contact a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet

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

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

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

Indications

• Fungal skin infections caused by dermatophytes, yeasts, molds, and other species of fungi: athlete's foot, fungal infection of the hands, fungal infection of the torso, fungal infection of the groin, pityriasis versicolor.
• Candidal skin and mucous membrane infections of the external genital organs (Candida vulvitisand balanitis).

2. Important information before using Clotrimazolum HASCO

When not to use Clotrimazolum HASCO:

• vaginally.

Warnings and precautions

Before starting to use Clotrimazolum HASCO, the patient should discuss it with their doctor, pharmacist, or nurse.
Topically applied clotrimazole may damage latex contraceptives (condoms and diaphragms). Therefore, during the use of the medicine on the mucous membranes of the external genital organs and for at least 5 days after stopping its use, latex contraceptives should not be used.
Contact with the eyes and mouth should be avoided.
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Clotrimazolum HASCO and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Clotrimazole reduces the effectiveness of amphotericin and other polyene antibiotics (e.g., nystatin, natamycin). Conversely, topical corticosteroids 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.
The medicine can be used during pregnancy only if, in the doctor's opinion, it is absolutely necessary.
During the treatment of vulvar infections, the medicine should not be used vaginally.
During breastfeeding, the medicine may be used only in justified cases, under medical supervision.

Driving and using machines

The medicine has no influence or negligible influence on the ability to drive and use machines.

Clotrimazolum HASCO contains cetyl stearyl alcohol and benzyl alcohol

Due to the presence of cetyl stearyl alcohol, the medicine may cause local skin reactions (e.g., contact dermatitis).
The medicine contains 1.5 g of benzyl alcohol per 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 leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
Usually, the medicine is applied 2 to 3 times a day. A thin layer of the medicine should be applied to the affected areas and gently rubbed in.
After the acute symptoms of the disease have subsided, the medicine should be used for at least another month.
The medicine is intended for topical use.

Using a higher dose of Clotrimazolum HASCO than recommended

There are no data available. No cases of clotrimazole overdose have been reported when used topically.

Missing a dose of Clotrimazolum HASCO

A double dose should not be used to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Clotrimazolum HASCO can cause side effects, although not everybody gets them.
Topically applied clotrimazole is well-tolerated. Rarely, skin reactions (redness, erythema, burning sensation, urticaria, papules, exfoliation, irritation) may occur.
Additionally, systemic allergic reactions, pain, and itching and rash may occur.
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Unfavorable skin changes caused by the use of the medicine are transient and usually disappear after stopping the medicine.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 gather more information on the safety of the medicine.

5. How to store Clotrimazolum HASCO

The medicine should be stored out of sight and reach of children.
Store in the original package, 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 specified 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 HASCO contains

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

What Clotrimazolum HASCO looks like and what the package contains

Clotrimazolum HASCO is a white cream with a characteristic odor.
One package of the medicine consists of an aluminum tube containing 20 g of cream, placed in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel.: (22) 742 00 22
e-mail: [email protected]

Date of the last update of the leaflet:

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