CICLOCHEM 10 MG/G VAGINAL CREAM

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ciclochem 10 mg/g vaginal cream

Ciclopirox olamine

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if these adverse effects are not listed in this leaflet. See section 4.

Package leaflet

1. What Ciclochem vaginal cream is and what it is used for
2. What you need to know before using Ciclochem vaginal cream
3. How to use Ciclochem vaginal cream
4. Possible side effects
5. How to store Ciclochem vaginal cream
6. Contents of the pack and other information

1. What Ciclochem vaginal cream is and what it is used for

Ciclochem vaginal cream contains an active substance called ciclopirox olamine, which belongs to a group of medicines known as "antifungals".

Ciclochem vaginal cream is used for the treatment of uncomplicated vulvovaginal candidiasis.

2. What you need to know before using Ciclochem vaginal cream

If you are allergic to ciclopirox olamine or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to use Ciclochem vaginal cream.

Other medicines and Ciclochem vaginal cream

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Pregnancy, lactation and fertility

There are no data or data are limited regarding the use of ciclopirox olamine in pregnant women; therefore, the use of this medicinal product is not recommended during pregnancy, lactation, and in women of childbearing age who are not using contraceptive methods.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicinal product.

Driving and operating machinery

No effects on the ability to drive or operate machinery have been reported.

This medicine contains benzyl alcohol, cetyl alcohol, and stearyl alcohol.

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol. This medicine contains 10 mg of benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions.

3. How to use Ciclochem vaginal cream

Ciclochem vaginal cream should be applied once daily, preferably at night before going to bed, using a full applicator (approximately 5 grams).

The duration required to achieve healing with treatment may vary, depending among other factors on the severity of the condition and the nature of the causative agent. In general, healing is achieved after six consecutive days of treatment. If necessary, application may be continued for up to a maximum of fourteen days.

Instructions for using the single-use applicator:

• Attach the applicator to the open tube. (Figure A).
• Squeeze the tube until the applicator is completely filled with cream (5 g of cream) (Figure B).
• Remove the applicator from the tube, and close the tube.
• Gently and deeply insert the applicator into the vagina, and empty it by slowly pressing the plunger. The best position is supine (lying on the back) with legs apart and slightly bent.
• Remove the single-use applicator and discard it.

Note:

Reinfection from the partner (ping-pong effect) is possible. To prevent relapses, the uninfected partner should also consult a physician.

Ciclochem vaginal cream contains paraffin, which may cause latex condoms to break or leak. Patients should therefore be advised not to use this type of condom during treatment with Ciclochem vaginal cream.

4. Possible adverse effects

The following terms are used to describe how frequently adverse effects have been reported:

Very common adverse effects (may affect more than 1 in 10 people)
Common adverse effects (may affect up to 1 in 10 people)
Uncommon adverse effects (may affect up to 1 in 100 people)
Rare adverse effects (may affect up to 1 in 1,000 people)
Very rare adverse effects (may affect up to 1 in 10,000 people, including isolated cases)

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequent adverse effects (may affect up to 1 in 10 people) are burning sensation, worsening of signs at the application site, and erythema and pruritus at the application site

Uncommon adverse effects (may affect up to 1 in 100 people) are hypersensitivity and vesicles at the application site

Adverse effects of unknown frequency are contact dermatitis

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V*. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Ciclochem vaginal cream

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

• The active substance is ciclopirox olamine.
• The other excipients are benzyl alcohol, octyldodecanol, liquid paraffin, stearyl alcohol, cetyl alcohol, myristyl alcohol, polysorbate 60, sorbitan monostearate, lactic acid, and purified water.

Appearance of the product and contents of the package

Ciclochem vaginal cream is marketed in aluminum tubes containing 40 g of practically white cream, with a vaginal applicator.

Marketing Authorization Holder and Manufacturing Responsible Party

GalenicumDerma, S.L.U. Ctra N-1, Km 36

28750 San Agustin del Guadalix (Madrid) Spain

Manufacturing Responsible Party:

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 – San Cugat del Vallés (Barcelona)

Spain

Date of the most recent review of this leaflet: AUGUST 2024

Other sources of information

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.