Aldara 5% Cream 12 sachets

Aldara 5% Cream 12 sachets

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.