Aldara 5% Cream 12 sachets
Meda AB
Meda AB
Composition
Each sachet (250 mg of cream) contains: Imiquimod 5 mg.
Excipients: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, soft white paraffin, polysorbate‑60, sorbitan stearate, glycerin, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), xanthan gum, purified water.
Product Description
Imiquimod is an immune response modifier.
It is presumed that specific receptors on immune cell membranes interact with imiquimod.
The drug does not possess direct antiviral activity.
In experimental animal models, imiquimod demonstrates efficacy against viral infections and acts as an antitumor agent by inducing the synthesis of α‑interferon and other cytokines.
Clinical studies have shown increased levels of α‑interferon and cytokines in tissues affected by genital warts, and pharmacokinetic data confirm systemic cytokine elevation following topical application.
It is effective in the treatment of external genital warts, superficial basal cell carcinoma, and actinic keratosis.
Indications for Use
External genital and perianal warts (condylomata acuminata) in adults.
Small superficial basal cell carcinomas (sBCC) in adults.
Clinically typical, non‑hyperkeratotic, non‑hypertrophic actinic keratosis on the face or scalp in immunocompetent patients when cryotherapy is unsuitable or contraindicated.
Method of Administration and Dosage
Frequency and duration of treatment are determined individually by the physician.
External genital warts:
Apply the cream 3 times per week (e.g., Mon‑Wed‑Fri or Tue‑Thu‑Sat) before bedtime and leave on the skin for 6–10 hours.
Continue treatment until the warts disappear, but not longer than 16 weeks per episode.
Apply a thin layer to clean skin only on affected areas.
Avoid showering or bathing for 6–10 hours after application.
After the required time, wash the cream off with warm water and soap.
Excessive application or prolonged contact may cause pronounced local reactions.
One sachet is sufficient for an area up to 20 cm².
Do not reuse an opened sachet.
Wash hands before and after application.
Contraindications
Hypersensitivity to imiquimod or any excipients.
Precautions
Avoid contact with the mucous membranes of the eyes, lips, and nose. Imiquimod may exacerbate inflammatory skin reactions.
Use with caution in patients with autoimmune diseases — worsening of the condition is possible. Use with caution in patients after organ transplantation — risk of rejection or graft‑versus‑host reaction exists.
Do not apply to skin that has not healed after previous medical or surgical treatment to avoid increased systemic absorption.
Occlusive dressings are not recommended.
Adverse Reactions / Side Effects
Local reactions
Very common — itching, pain at the application site.
Common — infection, erythema, erosion, excoriation/peeling, edema.
Uncommon — pruritus, dermatitis, folliculitis, erythematous rash, eczema, urticaria.
Rare — induration, ulceration, crusting, vesicles, local hypo‑ or hyperpigmentation.
Central nervous system:
Common — headache, dizziness.
Uncommon — insomnia, depression, irritability, paresthesia, migraine, drowsiness, tinnitus.
Gastrointestinal system:
Common — nausea.
Uncommon — abdominal pain, diarrhea, vomiting, anorexia, anal pain, rectal lesions.
Reproductive system:
Uncommon — fungal and bacterial infections, herpes simplex, vaginitis, vulvitis, painful intercourse, genital pain, atrophic vaginitis.
Hematologic system:
Very rare — decreased hemoglobin, leukopenia, neutropenia, thrombocytopenia.
Musculoskeletal system:
Uncommon — lower back pain, arthralgia.
Respiratory system:
Uncommon — pharyngitis, rhinitis.
General reactions:
Common — infection, myalgia, fever, flu‑like symptoms, fatigue.
Uncommon — increased sweating, lymphadenopathy.
If pronounced local reactions occur, wash the cream off with water and soap; treatment may be resumed once symptoms subside.
Pregnancy and Lactation
Use only after a physician evaluates the benefit‑risk ratio.
Consultation with a healthcare professional is recommended.
Storage Conditions
Store at temperatures not exceeding 25°C, in a dry place.
Packaging
Carton box containing 12 sachets.