SUMMARY OF PRODUCT CHARACTERISTICS

Name of the medicinal product: CICLOCHEM® Cream; CICLOCHEM® Powder; CICLOCHEM® Solution; CICLOCHEM® Vaginal cream; CICLOCHEM® Nail Lacquer. CICLOCHEM® Shampoo

Qualitative and quantitative composition: Per g of cream: Ciclopiroxolamine (INN) 10 mg, Excipient q.s. Per g of nail solution: Ciclopirox (INN) 80 mg, Excipient q.s. Per 100 g of shampoo contains: Ciclopirox olamine (I.C.I.) 1.5 g.

Clinical particulars. Therapeutic indications: CICLOCHEM® Cream, Powder and Solution: Topical treatment of superficial mycoses of the skin and mucosas, such as: dermatophytosis: tinea pedis (athlete’s foot), tinea cruris (eczema marginatum), tinea corporis (ringworm), candidiasis, pityriasis versicolor and erythrasma. CICLOCHEM® Vaginal cream; Mycotic vaginitis and vulvovaginitis. CICLOCHEM® Nail Lacquer; Onychomycosis. CICLOCHEM® Shampoo. Treatment of seborrheic dermatitis of the scalp.

Dosage and method of administration. CICLOCHEM® Cream, Powder and Solution: CICLOCHEM® is applied on and around the affected surfaces twice daily, morning and night. The required treatment duration is variable, depending on the aetiological agent and the location of the lesion. Generally speaking, the symptoms will disappear after the first week of treatment, but it is convenient to continue treatment for a further week or two to avoid relapses. CICLOCHEM® Vaginal cream; One application a day (5 g of cream), preferably at night before bedtime, using the applicator. Generally speaking healing is achieved after six consecutive days of treatment. If necessary, application may continue for up to a fortnight at most. CICLOCHEM® Nail Lacquer: Before the first application, cut the affected nail with scissors as far as possible. Then file the surface of the rest of the nail. Apply CICLOCHEM® Nail Lacquer every two days for the first month. In the second month, application may be reduced to at least twice a week; as of the third month it may be once a week. The preparation should be applied as a fine layer on the affected nail, thus guaranteeing that the nail will be saturated with active substance. During treatment, the layer of lacquer should be removed once a week with a commercial nail varnish remover. During this process the part of the affected nail should be removed as best as possible with a nail file. If the layer of lacquer is damaged between applications, only the affected areas need be treated again. The duration of the treatment depends on the degree of the condition, although a maximum of six months is recommended. Do not reuse the hygiene material of the infected nails, particularly the file, on healthy nails. CICLOCHEM® Shampoo. It should be used twice or three times a week. Apply enough CICLOCHEM® 1.5% shampoo to produce generous foam on wet hair. Vigorously massage the scalp and adjacent areas using fingertips. Then, thoroughly rinse the hair and repeat the process. Let the shampoo stand on the scalp for 3-5 minutes. The recommended treatment period is 4 weeks. Soft shampoo may be used between applications of CICLOCHEM® 1.5% shampoo.

Contraindications. Hypersensitivity to Ciclopirox/Ciclopiroxolamine or any of the other ingredients of the presentations of CICLOCHEM®. Due to the lack of clinical experience, treatment with CICLOCHEM® Nail Lacquer is contraindicated in children.

Special warnings and precautions for use. Avoid contact with the eyes. CICLOCHEM® Nail Lacquer: Avoid contact with the eyes and mucosas. CICLOCHEM® Shampoo should be exclusively for external use. The safety and efficacy of Ciclopirox has not been assessed in children. On rare occasions, hair discoloration has been observed mainly in subjects whose hair is damaged by chemicals or in white or gray hair. As with all other shampoos, eye contact should be prevented. In case of accidental contact with the eyes, flush with plenty of water. CICLOCHEM® 1.5% shampoo may rarely result in skin irritation. Discontinue treatment if irritation persists. Patients with known hypersensitivity to Fragrance AF 17050 should not use CICLOCHEM® 1.5% shampoo.

Pregnancy and Lactation. In view of the high penetration power of Ciclopirox/Ciclopiroxolamine, intensive and prolonged administration should be avoided during the first quarter of pregnancy and lactation. The administration of CICLOCHEM® Nail Lacquer during pregnancy and lactation is not indicated due to the lack of clinical experience in these cases. CICLOCHEM® Shampoo. There is not enough data available on the use of ciclopirox olamine during pregnancy. Data obtained from animals on the use of ciclopirox olamine does not show harmful effects on the embryo or fetus. Given the short period of contact with the skin and the low systemic absorption level of CICLOCHEM® 1.5% shampoo, it can be used during pregnancy. CICLOCHEM® 1.5% shampoo can be used while nursing.

Other drug interactions and other forms of interaction. Not described.

Effects on the ability to drive and use machines. CICLOCHEM® does not alter the ability to drive vehicles or use machinery.

Undesiderable effects. The prolonged use of the product may cause sensitization phenomena, giving rise to side effects; in such cases the treatment should be interrupted and a doctor consulted. CICLOCHEM® Cream, Powder and Solution: In hypersensitive patients, symptoms of local irritation, burning sensation and itching may appear, normally moderate and transient, which do not usually require the suspension of the treatment and are more frequent in the first few days of application. In very isolated cases, flare and desquamation of the periungual skin that is in contact with CICLOCHEM® Nail Lacquer has been reported. CICLOCHEM® Shampoo may rarely produce skin irritation. Discontinue treatment if irritation persists. During clinical trials, all adverse effects were mild and localized and no differences as regards incidence between the placebo receiving group and the active ingredient receiving group were observed. Overdose: In case of accidental ingestion, proper standard measures should be implemented.

Pharmacological properties. See Technical Report. Pharmacodynamic properties.

Pharmaceutical particulars. List of excipients. CICLOCHEM® Cream; CICLOCHEM® Powder; CICLOCHEM® Solution; CICLOCHEM® Vaginal cream; CICLOCHEM® Nail Lacquer; Methoxyethene polymer with 2-butenedioic acid, monobutyl ester, (Gantrez ES-435), ethyl acetate, 2-propanol. CICLOCHEM® Shampoo: Sodium lauryl ether sulfate 70%, cocamidopropyil betaine, disodium phosphate 12-hydrate, monohydrate citric acid (pH adjuster), coconut diethalonamide, hexylene glycol, oleic alcohol, polysorbate 80, polyquartenium 10, sodium hydroxide (pH adjuster), purified water, fragrance AF17050.

Incompatibilities. No pharmacological incompatibilities were observed during the clinical tests.

Shelf-life Shelf-life 3 years. The medicinal product should not be used after the expiry date indicated on the container.

Special precautions for storage. CICLOCHEM® Shampoo: There are no special storage precautions.CICLOCHEM® Nail Lacquer should be stored at room temperature and away from the light. After the first opening, CICLOCHEM® Nail Lacquer is stable for 6 months at most in the aforementioned conditions. Nature and content of the container: CICLOCHEM® Nail Lacquer: Colorless clear glass container with 3 g of solution provided with a brush for its application. CICLOCHEM® Shampoo: HDPE bottle with plypropylene threaded plug. 100 ml. bottle.

Instructions for use/handling. After each application of CICLOCHEM® Nail Lacquer, the bottle should be kept tightly closed to stop the solution from evaporating. To prevent the stopper from sticking to the bottle, do not let the lacquer wet the thread. CICLOCHEM® Shampoo does not require any special instruction.

Name and registered offices of the authorisation holder. LABORATORIOS NOVAG, S.A. Gran Vía Carlos III, 94 – 08028 Barcelona.

Not all dosage forms are available.