Product Information for the Patient

Ciclochem 10 mg/g Vaginal Cream

Ciclopirox olamine

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, 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 only for you, 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 any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this product information. See section 4.

Product Information Content

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

Ciclochem vaginal cream contains an active ingredient 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.

If you are allergic to ciclopirox olamine or to 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 used recently or may have to use any other medication.

Pregnancy, breastfeeding and fertility

There are no data or these are limited relative to the use of ciclopirox olamine in pregnant women. Therefore, use of this medication is not recommended during pregnancy, breastfeeding and in fertile women who do not use contraceptive methods.

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

Driving and operating machines

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

This medication contains benzyl alcohol, cetyl alcohol and stearic alcohol.

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

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

The duration required to achieve healing with the treatment may vary depending on the intensity of the process and the nature of the etiologic agent. In general, healing is achieved after six consecutive days of treatment. If necessary, application may be continued for a maximum of fourteen 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, emptying it slowly by pressing the plunger. The best position is supine (lying on your back) with your legs open and slightly flexed.
• Remove the single-use applicator and discard it.

Nota:

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

Ciclochem vaginal cream contains paraffin, which may cause breakage of latex condoms or leaks, so advise the patient not to use this type of condom during treatment with Ciclochem vaginal cream.

The following terms are used to describe how often 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)

Rare 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 medications, this medication may produce adverse effects, although not everyone will experience them.

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

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

The adverse effects of unknown frequency are contact dermatitis

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in Appendix V*. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

• The active principle is ciclopirox olamine
• The other excipients are benzyl alcohol, octyldodecanol, liquid petrolatum, stearyl alcohol, cetyl alcohol, myristyl alcohol, polisorbate 60, sorbitan monoestearate, lactic acid, and purified water.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

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

28750 San Agustin del Guadalix (Madrid) Spain

Responsible for manufacturing:

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 – San Cugat del Vallés (Barcelona)

Spain

Last review date of this leaflet:AUGUST 2024

Other sources of information

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