Cyclofen

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CYCLOJEN (CYCLOJEN)

Composition:

Active substance: ciclopirox;

1 g of lacquer contains 80 mg of ciclopirox;

Excipients: ethyl acetate, isopropyl alcohol, methoxyethene.

Pharmaceutical form. Therapeutic nail lacquer.

Main physicochemical properties: clear solution.

Pharmacotherapeutic group. Other antifungals for topical use.

ATC code D01AE14.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of Ciclopoli is ciclopirox, which belongs to the pyridone group.

Ciclopirox has a broad spectrum of antifungal activity and is active against dermatophytes (Trichophyton, Microsporum canis, Epidermophyton), yeasts (Candida, Torulopsis, Trichosporum, Geotrichum), mold fungi (Scopulariopsis, Aspergillus), and actinomycetes, as well as against certain Gram-positive and Gram-negative bacteria.

Any other fungal species not listed above should be studied in vitro to determine their sensitivity.

The medicinal product contains 8% ciclopirox in a lacquer base. After application to the nail, the solvents (ethyl acetate and isopropyl alcohol) and the film-forming agent (methoxyethylene) evaporate, ensuring adhesion of ciclopirox to the nail.

The antifungal activity of ciclopirox is based on the inhibition of cellular uptake of certain substances (metal ions, phosphates, and potassium ions) by fungal cells.

Ciclopirox accumulates within fungal cells, where it irreversibly binds to specific structures such as membranes, mitochondria, ribosomes, and microsomes.

Pharmacokinetics.

The behavior of the drug in the body was studied in situ in healthy volunteers (healthy nails).

Ciclopirox rapidly penetrates the nail plate:

• fungicidal concentrations are achieved by day 7 of daily application;

• maximum concentrations in the distal portion of the nail, reflecting saturation of the nail plate, are reached:

  on days 14–30 of treatment for fingernails;

  on days 30–45 of treatment for toenails.

If treatment is discontinued, the residual effect of ciclopirox, demonstrated by active concentrations, persists for 7–14 days.

Clinical characteristics.

Indications.

First-line treatment of mild to moderate onychomycosis without involvement of the nail matrix, caused by dermatophytes and/or other fungi sensitive to ciclopirox.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Due to lack of clinical experience, the drug is not used in children.

Interaction with other medicinal products and other forms of interaction.

During clinical trials, no interaction with other medicinal products was observed.

After the first coat of Ciclopolish nail lacquer has dried, a second coat may be applied without changing its efficacy.

Before the next application of Ciclopolish, the previous layer of lacquer must be removed using nail polish remover.

Special precautions for use.

Ciclopoli is intended for topical use only.

The medicinal product should be applied only to the nails.

Avoid contact of the lacquer with the eyes and mucous membranes.

In the event of sensitization, treatment should be discontinued and appropriate therapy initiated.

When treating onychomycosis, if more than five nails are affected, if more than ⅔ of the nail plate is altered, or if certain risk factors are present, such as diabetes or immunodeficiency disorders, medical advice should be sought.

Exercise caution when performing nail care (cleaning and removal of affected parts) in patients with insulin-dependent diabetes or a history of diabetic neuropathy due to the risk of losing affected nails.

Use during pregnancy or breastfeeding.

Due to the lack of clinical experience with the use of the medicinal product during pregnancy and breastfeeding, its use is not recommended.

Ability to influence reaction speed when driving or operating machinery.

Ciclopoli does not affect reaction speed and does not impair the ability to drive or operate machinery.

Method of Administration and Dosage.

Cikloplen is applied every other day (or once every two days) during the first month. In the second month, the frequency of application may be reduced to at least twice a week; starting from the third month, the frequency may be reduced to once a week.

The nail lacquer should completely cover the nail plate.

After use, the bottle must be tightly closed to prevent evaporation of the solution.

Before starting treatment, it is recommended to remove the free (distal) edge of affected nails with clippers, a file, or nail scissors.

During treatment, once a week, the layer formed on the nail surface should be removed using a nail polish remover, since in the long term this may hinder the penetration of the active substance. Simultaneous removal of the free edge of the affected nail is recommended.

Treatment should be continued until healthy nail regrowth begins and complete clinical and mycological recovery is achieved.

A fungal culture control should be performed 4 weeks after completion of treatment to avoid false results due to possible residual amounts of the active substance.

Since the product is intended for topical use, no specific dosage adjustments are required for special patient groups.

If treatment with the medicinal product Cikloplen does not improve the condition and/or one or more fingernails or toenails are severely affected, additional oral therapy may be advisable.

Treatment usually lasts approximately 3 months (for fingernail onychomycosis) and 6 months (for toenail onychomycosis). The duration of treatment should not exceed 6 months.

Children.

There is no experience with use in children.

Overdose.

Effects of cyclopirox overdose are unknown.

Side effects.

Immune system disorders: Rare (from ≥1/10,000 to <1/1,000) — allergic contact dermatitis.

Skin and subcutaneous tissue disorders: In isolated cases — redness and peeling of the skin around the nails that are in direct contact with Cyclogel.

Prolonged use of the drug may cause sensitization phenomena leading to adverse effects. In such cases, treatment should be discontinued and medical advice should be sought.

Reporting suspected adverse reactions after marketing authorization is highly important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life.

3 years.

After first opening of the container, the shelf life is not more than 6 months.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep in a place protected from light. Store in an upright position. Keep out of reach and sight of children.

Packaging.

3 g of the product in a bottle. 1 bottle per cardboard box.

Supply category. Over-the-counter (without prescription).

Manufacturer.

SERRA PAMIÉS, S.A.

Manufacturer's address and place of business.

Carretera de Castellvell, No. 24, Reus, Tarragona, 43206, Spain.

Marketing Authorization Holder.

PROPHARMA International Trading Limited, Malta.