CICLOCHEM 10 MG/G VAGINAL CREAM

Read the entire leaflet carefully before starting to use this medication, 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 or pharmacist or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Ciclochem vaginal cream and what is it used for
2. What you need to know before starting to use Ciclochem vaginal cream
3. How to use Ciclochem vaginal cream
4. Possible side effects
5. Storage of Ciclochem vaginal cream
6. Package contents and additional information

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

Ciclochem vaginal cream contains an active ingredient called ciclopirox olamine, which belongs to the group of medications known as "antifungals".

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

2. What you need to know before starting to use Ciclochem vaginal cream

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

Warnings and Precautions

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

Other Medications and Ciclochem Vaginal Cream

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

Pregnancy, Breastfeeding, and Fertility

There are limited or no data on the use of ciclopirox olamine in pregnant women, so the use of this medication during pregnancy, breastfeeding, and in women of childbearing age who do not use contraceptive methods is not recommended.

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

Driving and Using Machines

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

This Medication Contains Benzyl Alcohol, Cetyl Alcohol, and Stearyl Alcohol.

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

3. How to Use Ciclochem Vaginal Cream

Ciclochem vaginal cream should be applied once a day, preferably at night before bedtime, using the filled applicator (approximately 5 grams).

The duration required to achieve cure with treatment varies depending on the intensity of the condition and the nature of the causative agent. In general, cure is achieved after six consecutive days of treatment. If necessary, application can be continued for up to a maximum of 14 days.

Instructions for using the single-use applicator:

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

Note:

Reinfection by the partner (ping-pong effect) is possible. To prevent recurrences, the uninfected partner should also consult a doctor.

Ciclochem vaginal cream contains paraffin, which may cause latex condoms to break or leak, so the patient should be warned not to use this type of condom during treatment with Ciclochem vaginal cream.

4. Possible Side Effects

The following terms are used to describe the frequency of side effects:

Very common side effects (may affect more than 1 in 10 people) Common side effects (may affect up to 1 in 10 people)

Uncommon side effects (may affect up to 1 in 100 people) Rare side effects (may affect up to 1 in 1,000 people)

Very rare side effects (may affect up to 1 in 10,000 people, including isolated cases)

Like all medications, this medication may cause side effects, although not everyone will experience them.

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Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ciclochem Vaginal Cream

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

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

28750 San Agustin del Guadalix (Madrid) Spain

Manufacturer:

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 – San Cugat del Vallés (Barcelona)

Spain

Date of the Last Revision of this Leaflet:AUGUST 2024

Other Sources of Information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.