ACNIDAZIL * DERM CREAM 30G
Vulgar acne treatment.
Dosage and method of use
Apply the cream in a thin layer on the skin affected by acne, and massage lightly with the fingertips until completely absorbed. During the first week, apply the cream only once a day, preferably in the evening. Starting from the second week, apply the cream twice a day (morning and evening). Before applying the cream it is recommended to wash with warm water and soap and to dry the skin thoroughly. It is necessary to continue the treatment until the symptoms disappear; this usually occurs within 4-8 weeks. Should the symptoms reappear over time, it is possible to repeat the treatment as described above. If necessary, treatment with Acnidazil can be combined with antibiotic therapy and dietary measures.
Known hypersensitivity to the active substances or to any of the excipients.
Adverse reactions, reported in this section, are adverse events that were considered to be reasonably associated with the use of ACNIDAZIL based on the overall assessment of the available adverse event information. A correlation between Acnidazil and adverse reactions cannot be reliably established from individual cases. Also, as clinical trials are conducted under very different conditions, the incidence of adverse reactions observed in clinical trials of one drug cannot be directly compared to the incidence of clinical trials of another drug and may not reflect the observed incidence. in clinical practice. Clinical study data Four benzoyl peroxide controlled clinical trials were performed in which ACNIDAZIL was used to treat acne. All 4 studies included both pediatric patients (12 to 17 years) and adult patients (≥ 18 years). Adverse reactions (ADRs) occurring from ≥ 1% of the patients treated with ACNIDAZIL (N = 149) in these studies are shown in Table 1
| Table 1. Adverse reactions reported since ≥ 1% of patients treated with ACNIDAZIL-in the 4 controlled clinical trials |
| Organ classification Adverse reaction || ACNIDAZIL % (N = 149) |
| Disorders of the skin and subcutaneous tissue || |
|Erythema ||12.1 |
|Skin irritation Itching ||12.8 7.4 |
Adverse drug reactions first identified during post-marketing experience with ACNIDAZIL are presented in Table 2. In the table, frequencies are provided according to the following convention: Very common: ≥ 1/10 Common: ≥ 1/100 and Table 2: Adverse reactions identified during post-marketing experience with ACNIDAZIL and estimated by frequency category based on the incidence of spontaneous reporting Disorders of the immune system Very rare
Hypersensitivity Disorders of the skin and subcutaneous tissue Very rare
Contact dermatitis, rash, urticaria, burning sensation of the skin General and application site related disorders Very rare
Application site reaction
ACNIDAZIL is for cutaneous use only. Any contact with eyes and oral mucosa must be carefully avoided. ACNIDAZIL can discolour colored clothing and fabrics. Patients who have sensitive skin or who have reacted negatively to other acne products should be advised to apply and leave a small amount of the cream for 24 hours on a small area of skin behind the ear or on the inner surface of the forearm. If pronounced irritation or redness occurs, they should not use the product. Avoid prolonged exposure to ultraviolet rays (sun or artificial sources). Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with miconazole for cutaneous use. If hypersensitivity or irritation phenomena occur, the treatment must be stopped. Important information about some of the ingredients The medicinal product contains propylene glycol and cetyl alcohol which may cause skin irritation and local skin reactions (eg contact dermatitis).
Pregnancy and breastfeeding
Systemic absorption after cutaneous application of miconazole is very limited. Systemic absorption of benzoyl peroxide is not expected with the use of ACNIDAZIL. However, as no data are available for benzoyl peroxide, this drug should be used during pregnancy and breastfeeding only as needed. There are no well-controlled studies in pregnant women treated with ACNIDAZIL. Topical animal reproduction studies have not been conducted with miconazole, benzoyl peroxide or their combination.
Expiration and retention
This medicine does not require any special storage conditions
Interactions with other drugs
Systemically administered miconazole is known to inhibit CYP3A4 / 2C9. Clinically relevant interactions occur very rarely due to limited systemic availability after skin application. Care should be taken in patients on oral anticoagulants, such as warfarin, and the anticoagulant effect should be closely monitored. The efficacy and undesirable effects of some drugs (e.g. some oral hypoglycemic agents and phenytoin), when co-administered with miconazole, may be increased and, therefore, Acnidazil should be used with caution.
Symptoms Excessive skin application can cause skin irritation and erythema. Treatment This adverse event can be resolved with temporary interruption of treatment or a reduction in the frequency of application. In case of accidental ingestion, an adequate method of gastric emptying can be used if deemed appropriate.
One gram of cream contains: miconazole nitrate 20 mg benzoyl peroxide hydrate 100 mg (equivalent to benzoyl peroxide 50 mg) Excipients: cetyl alcohol, propylene glycol For the full list of excipients, see section 6.1
Each gram of cream contains: cetyl alcohol, stearyl alcohol, white wax, propylene glycol, sodium lauryl sulfate, polysorbate 20, purified water.