CANESTEN

Package leaflet: Information for the user

Canesten, 500 mg, vaginal tablet
Clotrimazolum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient information leaflet or as
advised by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If advice or additional information is needed, please consult a pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if symptoms worsen, contact a doctor.

Table of contents

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

1. What Canesten is and what it is used for

The active substance in Canesten is clotrimazole, which belongs to a group of medicines called imidazoles. It has a broad antifungal spectrum, meaning it destroys fungi and inhibits their growth. It is effective against microorganisms such as dermatophytes, yeasts, and molds.
Canesten is used in the treatment of vaginal and external female genital infections caused by microorganisms, such as fungi (usually Candida ) sensitive to clotrimazole. Symptoms include itching, burning, vaginal discharge (thick, white to yellowish, odorless discharge resembling cottage cheese), redness, swelling, and pain.
Only a doctor can reliably diagnose fungal infection and confirm the microorganism's sensitivity to clotrimazole. Please refer to section 2 of this leaflet for information on when to consult a doctor before using Canesten.
This medicine is intended for use in adults and adolescents aged 16 years and older.

2. Important information before using Canesten

When not to use Canesten:

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

Warnings and precautions
Before starting treatment with Canesten, consult a doctor:

• when vaginal infection occurs for the first time,
• when vaginal infection occurs during the first trimester of pregnancy,
• in case of recurrent infections, when at least 2 episodes have occurred within the last 6 months,
• in case of fever of 38°C or higher,
• if the patient experiences lower abdominal pain or back pain,
• in case of foul-smelling vaginal discharge,
• in case of nausea,
• if vaginal bleeding and/or shoulder pain occur.

Do not use Canesten during menstruation. Treatment with this medicine should be discontinued
before menstrual bleeding begins.
During treatment with Canesten, do not use tampons, vaginal douches, spermicides, or other vaginal products.
During treatment with Canesten and while the vaginal infection persists, sexual intercourse should be avoided, as the infection may be transmitted to the sexual partner.
The sexual partner should also receive topical treatment simultaneously if symptoms of fungal infection are present. Treating sexual partners may help prevent reinfection.
The contraceptive effectiveness of latex-based barrier methods, such as condoms and diaphragms, may be reduced.
Canesten must not be swallowed.
Children and adolescents
Canesten should not be used in girls under 16 years of age without consulting a doctor.
Canesten and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
Inform your doctor if the patient is taking tacrolimus or sirolimus, medicines used to control the immune response after organ transplantation.
It is possible that blood concentrations of certain medicines may increase when used concomitantly with Canesten. However, this is unlikely when a single 500 mg dose is used. If in doubt about using another medicine together with Canesten, consult a doctor.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should seek advice from a doctor or pharmacist before using this medicine.

• Pregnancy During the first 3 months of pregnancy, clotrimazole should only be used after consulting a doctor. When using Canesten during pregnancy, do not use the applicator provided in the package. The tablet should be inserted into the vagina with a finger to avoid injury to the cervix.
• Breastfeeding Canesten may be used during breastfeeding. If in doubt, consult a doctor or pharmacist.

Driving and operating machinery
Canesten has no influence on the ability to drive or operate machinery.

3. How to use Canesten

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose
Adults and adolescents aged 16 years and older

• One vaginal tablet, inserted deeply into the vagina as a single dose, in the evening.

Ensure a moist vaginal environment so that the tablet dissolves completely. Otherwise, undissolved parts of the tablet may be expelled from the vagina.
Treatment may be repeated. However, recurrent infections may indicate another underlying condition causing the symptoms. If symptoms recur, the patient should consult her doctor.

Instructions for use
The vaginal tablet should be placed as deeply as possible into the vagina using the applicator provided, preferably while lying down, in the evening before going to sleep.
Wash your hands before removing the vaginal tablet and applicator from the packaging, and again after using the applicator.

1. Remove the applicator from the packaging and pull out the plunger and red safety lock from the barrel.

2. Place the vaginal tablet into the barrel of the applicator with the rounded end facing inward. Insert the plunger and safety lock into the barrel until a click is heard.

3. After hearing the click, remove the safety lock from the plunger, then carefully insert the applicator into the vagina up to the marked zone on the grip.

4. Hold the applicator barrel at the level of the marked zone on the grip and gently push the plunger fully in until it stops, to release the vaginal tablet.

After use, dispose of the applicator safely, out of the reach of children. Do not flush the applicator down the toilet.

Instructions for using vaginal tablets without an applicator:
If the patient is pregnant, the vaginal tablet should be inserted into the vagina using a finger.

Duration of treatment
Canesten is used as a single-dose treatment.
If there is no significant improvement after 7 days, you should consult your doctor to confirm the cause of the infection. If symptoms worsen, contact your doctor immediately.

Use in children and adolescents
Canesten should not be used in girls under 16 years of age without prior consultation with a doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Adverse effects have been observed with the following frequencies:
Common, more than 1 in 100 people:

• burning sensation

Uncommon, more than 1 in 1000 people:

• abdominal pain
• itching
• redness and (or) irritation of the skin

Rare, more than 1 in 10000 people:

• allergic reactions
• swelling
• skin rash
• vaginal bleeding

Frequency not known, based on available data:

• vaginal desquamation
• vaginal discomfort
• vaginal pain
• nausea
• urticaria
• hot flushes
• pain

Treatment should be discontinued if local adverse reactions or allergic reactions occur (including anaphylactic reaction, angioedema (swelling), low blood pressure, dyspnoea and (or) fainting).
Local adverse reactions may resemble symptoms of the disease. Therefore, distinguishing between symptoms of infection and adverse reactions caused by the medicine may be difficult.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting of adverse effects helps to provide more information on the safety of the medicine.

5. How to store CANESTEN

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Canesten contains

• The active substance is clotrimazole.
• The other ingredients (excipients) are: calcium lactate pentahydrate; microcrystalline cellulose; hypromellose 15 cP; lactic acid; lactose monohydrate; corn starch; magnesium stearate; colloidal anhydrous silica; crospovidone.

What Canesten looks like and contents of the pack
A white vaginal tablet marked with "MU" and "Bayer".
One vaginal tablet in a blister with an applicator, in a cardboard box.
Marketing Authorisation Holder
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
tel. +48 22 5723500
Manufacturer
GP Grenzach Produktions GmbH
Emil-Barell-Strasse 7
79639 Grenzach-Wyhlen
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Finland: Canesten, 500 mg vaginal tablet
Poland: Canesten, 500 mg, vaginal tablet