Clotidal

Leaflet attached to the packaging: patient information

Clotidal, 10 mg/g, vaginal cream

Clotrimazole

Read 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 the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days of use there is no improvement or the patient feels worse, or if the symptoms do not disappear after 7 days of use, they should contact a doctor.

Table of contents of the leaflet:

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

1. What is Clotidal and what is it used for

Clotidal is a vaginal cream that contains the active substance clotrimazole, which belongs to the group of antifungal medicines.
Clotidal is used to treat fungal infections (also called yeast infections) of the mucous membranes of the genital organs (vulvovaginal candidiasis, vaginal candidiasis, balanitis).
Vaginal yeast infection is a common infection in women caused by a fungus called Candida. This fungus (Candida) is found on the skin, in the vagina, and in the gut, and in some cases can become pathogenic. Symptoms of vaginal yeast infection include itching, burning, and discharge (white, odorless discharge from the vagina), which usually worsen before menstruation.
Infection of the glans penis (penile candidiasis) in sexual partners by yeast, which can cause:

• pain and redness of the penis;
• tightness of the foreskin. If after 3 days of using the medicine there is no improvement or the symptoms worsen, consult a doctor. If the symptoms do not disappear after 7 days of using the medicine, consult a doctor.

2. Important information before using Clotidal

When not to use Clotidal:

• 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 to use Clotidal, discuss it with a doctor or pharmacist.
Discuss it with a doctor if:

• the patient is not sure if they have symptoms of a yeast infection or if the symptoms occur for the first time,
• the patient is pregnant or thinks they may be pregnant,
• the patient or their partner has had a sexually transmitted disease,
• there have been at least 2 episodes of fungal infections of the vulva and vagina in the last 6 months.

Consult a doctor if any of the following symptoms occur

• fever or chills
• irregular vaginal bleeding
• abnormal vaginal bleeding or spotting
• ulcers, sores, or blisters on the vulva or vagina
• lower abdominal pain or pain when urinating
• any side effects, such as irritation or swelling, related to treatment
• nausea and vomiting
• diarrhea
• vaginal discharge with an unpleasant odor
• back pain
• pelvic pain.

Clotidal used in the genital area (in women: intravaginally, on the vulva, and surrounding areas; in men: on the foreskin and glans penis) may reduce the effectiveness and safety of latex products such as condoms and diaphragms. Therefore, during the use of Clotidal, additional contraceptive methods should be used.

Children and adolescents

Clotidal is indicated for patients over 16 years of age.

Clotidal and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Clotidal may affect the action of oral medicines containing tacrolimus or sirolimus.
Clotidal also reduces the effectiveness of amphotericin and other polyene antibiotics (e.g., nystatin, natamycin). At the same time, locally used medicines containing strongly acting steroids weaken the action of Clotidal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Clotidal should not be used during pregnancy.
Breastfeeding should be stopped during treatment with Clotidal.
There is no data on the effect on fertility.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.
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Clotidal contains cetostearyl alcohol and 30 mg of benzyl alcohol in each gram of vaginal cream.

Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis).
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol may cause mild local irritation.

3. How to use Clotidal

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
If Clotidal has been prescribed by a doctor, follow the doctor's instructions for use. If the medicine has been purchased without a prescription, follow the instructions below:
The medicine is intended for the treatment of adults and adolescents over 16 years of age.
If after 3 days of use there is no improvement or the patient feels worse, or if the symptoms do not disappear after 7 days of use, consult a doctor.
Vaginal yeast infection
Unless otherwise directed by a doctor, the medicine should be used once a day, before bedtime, for 6 consecutive days in the following way:

• 1. Fully retract the applicator plunger to feel resistance.
• 2. Open the tube and attach the applicator to the tube. Holding them together, fill the applicator by gently squeezing the tube.
• 3. Detach the applicator from the tube. Insert the applicator as far as possible into the vagina (best in a lying position with slightly bent legs) and press the plunger to empty the applicator completely.
• 4. Remove the applicator and discard it.
• 5. Wash your hands before and after using the medicine.

Although the vaginal cream is administered inside the vagina, it often happens that a small amount of cream leaks out after application.

• Do not use the medicine during menstruation. The full treatment cycle should be completed before the start of menstruation.
• Do not use tampons, vaginal douches, spermicides, or other vaginal medicines while using this medicine.
• If there is also an infection of the vulva or surrounding areas, in addition to using the vaginal cream, local treatment (combined treatment) should also be used with a medicine in an appropriate pharmaceutical form (cream).
• In the case of vaginal infection and the use of this medicine, it is recommended to avoid vaginal intercourse, due to the possibility of infecting the partner.
• If the partner experiences symptoms such as itching or inflammation of the genital organs, they should inform the doctor, as the partner may also need treatment.

Penile candidiasis (infection of the glans penis by yeast)
Apply a thin layer of the medicine 2 to 3 times a day to the affected area, gently rubbing it in. The typical treatment period is 1 to 2 weeks.

Children and adolescents

Do not use in children and adolescents under 16 years of age.

Duration of therapy

Vaginally, Clotidal should be used for 6 consecutive days.
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Locally, in the case of treatment of balanitis (inflammation of the glans penis) in a partner, the treatment time is 1 to 2 weeks.
Consult a doctor if there have been 2 episodes of fungal infections of the vulva and vagina in the last 6 months.

Using more than the recommended dose of Clotidal

In case of using more than the recommended dose of the medicine or accidental ingestion, consult a doctor.

Missing a dose of Clotidal

If a dose is missed, continue treatment. However, never use more medicine than recommended (1 full applicator per day in the treatment of vaginal yeast infection).
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Clotidal can cause side effects, although not everybody gets them.
Consult a doctor immediately if symptoms of hypersensitivity occur, which may include fainting, low blood pressure (hypotension), breathing problems (dyspnea), swelling (edema), and hives. Skin peeling of the genital area, itching (pruritus), skin rashes, redness (erythema), discomfort, burning, irritation, pelvic pain, genital bleeding, abdominal pain may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, tell the doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
ul. Al. Jerozolimskie 181C

• 02 - 222 Warszawa Tel.: + 48 22 49 21 301 Faks: + 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 to gather more information on the safety of the medicine.

5. How to store Clotidal

Do not freeze. There are no special precautions for storage temperature of the medicinal product.
Shelf life after first opening of the tube: 6 months.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton after the words "EXP". The expiry date refers to the last day of the month. The batch number is stated on the packaging after the abbreviation "Lot".
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Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Clotidal contains

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

What Clotidal looks like and contents of the pack

White cream of uniform consistency.
Aluminum tube with an internal coating and a polyethylene cap.
The tube contains 35 g of vaginal cream.
Packaging:
Tube and 6 vaginal applicators of 5 ml, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer:

Laboratórios Basi – Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal
To obtain more detailed information, contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warszawa
tel.+48 (22) 543 60 00

Date of last revision of the leaflet: June 2021

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