Each gram of cream contains 10 mg of Clotrimazole For the full list of excipients, see section List of excipients.

Cream.

A homogeneous cream is a smooth white colour, odorless.

Therapeutic indications

For the treatment of:

There is no separate dosage schedule for the young or elderly.

The cream should be applied thinly 2-3 times daily and rubbed in gently. A strip of cream (½ cm long) is enough to treat an area of about the size of the hand. Treatment should be continued for at least one month for dermatophyte infections and at least two weeks for candidal infections.

If the feet are infected they should be washed and dried, especially between the toes, before applying the cream.

Hypersensitivity to the active substance or to any of the excipients listed in section List of excipients. Do not use the cream to treat nail or scalp infections.

Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

This medicine contains Propylene glycol. Propylene glycol can cause skin irritation. This medicine contains methylparaben and propylparaben. May cause allergic reactions (possibly delayed).

Interaction with other medicinal products and other forms of interaction

Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.

Fertility

No human studies of the effects of clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility.

Pregnancy

There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section Preclinical safety data). At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.

Lactation

Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration (see section Preclinical safety data). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast- feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Clotrimazole cream has no or negligible influence on the ability to drive or use machines.

As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.

Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity. Vascular disorders: syncope, hypotension.

Respiratory, thoracic and mediastinal disorders: dyspnoea.

Skin and subcutaneous tissue disorders: blister, dermatitis contact, erythema, paraesthesia, skin exfoliation, pruritus, rash, urticaria, stinging skin/burning sensation skin.

General disorders and administration site conditions: application site irritation, application site reaction, oedema, pain.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions online to the Scientific Centre of Drug and Medical Technology Expertise after academician E. Gabrielyan of MoH of RA via www.pharm.am (vigilance@pharm.am) or call the hotline numbers: +374 (10) 20 05 05 and +374 (96) 22 05 05.

No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.

However, in the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of Clotrimazole has been ingested within the preceding hour or if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.

Pharmacotherapeutic group: Antifungals for topical use – imidazole and triazole derivatives

ATC Code: D01A C01

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062-8.0 µg/ml substrate. The mode of action of clotrimazole is primarily fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive. In addition to its antimycotic action, clotrimazole also acts on gram-positive microorganisms (Streptococci / Staphylococci / Gardnerella vaginalis), and gram-negative microorganisms (Bacteroides).

In vitro clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci – with the exception of Enterococci – in concentrations of 0.5-10 µg/ml substrate.

Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.

Pharmacokinetic investigations after dermal application have shown that clotrimazole is minimally absorbed from the intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.001 mcg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity and carcinogenicity.

Clotrimazole was not teratogenic in reproductive toxicity studies in mice, rats and rabbits. In rats high oral doses were associated with maternal toxicity, embryotoxicity, reduced fetal weights and decreased pup survival.

In rats clotrimazole and/or its metabolites were secreted into milk at levels higher than in plasma by a factor of 10 to 20 at 4 hrs after administration, followed by a decline to a factor of 0.4 by 24 hrs.

List of excipients

Ceteareth-12

Ceteareth-20

Paraffin liquid

Cetostearyl alcohol

Methylparaben

Propylparaben

Propylene glycol

Dimethicone

Water purified

Not applicable.

36 months.

Shelf life 6 months from date of opening.

Store in a dry and out of the reach of children place, at a temperature not above 25°C.

15 g 1% cream in aluminum tube, inserted with leaflet in cardboard box.

No special requirements.