Expiration date: 09/2025

Active substance: Imiquimod.

Mode of action - immunomodulatory

Pharmacodynamics

Imiquimod - Aldara active ingredient of the drug - is a compound modifier of the immune response. Imiquimod has no direct antiviral effect and its effect is due to the induction of interferon alpha (IFN-?) and other cytokines.

Pharmacokinetics

Less than 0.9% of radiolabeled imiquimod absorbed through human skin after application of a single dose.

A small amount of drug released to the systemic circulation, without delay excreted via the kidneys and intestines in a ratio of about 3: 1. The concentration of drug in the blood serum after single or multiple topical did not reach the level, quantifiable (> 5 ng / ml).

Testimony

Treatment of external genital warts at the location on the external genitals or in the perianal area in adults.

Contraindications

• hypersensitivity to imiquimod cream, or other components;
  
• Children up to age 18 years (due to lack of data).
  

Pregnancy and breast-feeding

Application of pregnancy is possible on strict conditions if the expected benefit to the mother outweighs the potential risk to the fetus.

If necessary, use during lactation should stop breastfeeding.

Side effects

The frequency of side effects is determined as follows: very often (>, 1/10), often (<,1 10="">,1/100), infrequently (<,1 100="">,1/1000), rarely (<,1 1000="">,1/10 000), very rarely (<,1 10="" 000="" p=">",,

Local skin reactions: very often - itching and pain at the site of application of the cream; often - infection, erythema, erosion, excoriation / flaking, and edema; rarely - itching, dermatitis, folliculitis, erythematous rash, eczema, urticaria; rarely - induration, ulceration, scabbing, and the emergence of bubbles, local hypopigmentation and hyperpigmentation.

From the digestive system: rarely - pain in the anus, rectum injury.

With the genitourinary system: Infrequent - fungal and bacterial infection, herpes simplex, vaginitis, vulvitis, painful intercourse, pain in the penis, vagina, atrophic vaginitis.

When the local side effects of the cream should be removed by washing with soap and water. Treatment can be resumed after the relief of a skin reaction.

Interaction

The study of the interaction of imiquimod with other drugs, including immunosuppressive drugs, have been conducted.

Dosing and Administration

Outwardly. Apply a thin layer on clean surface of the affected skin and rub gently until completely absorbed. The cream should only be applied to the affected area, avoiding contact with the inner surface. Aldara cream should be applied 3 times a week at bedtime and leave on the skin for 6-10 hours, do not take a shower or bathe during this time. On cream application site should not be applied bandage. After this time, the cream should be washed with warm soapy water. Treatment should continue until the disappearance of visible genital or perianal warts, but not more than 16 weeks.

The cream is packaged in single-use sachets, containing the necessary amount of cream to be applied to the affected area in 20 cm2.

If the patient has forgotten to put the cream on the schedule, you should apply the missed dose as soon as remembered about it, then follow the normal schedule.

Cream should not be applied more than once a day.

Do not use excessive amounts of cream.

Overdose

Unlikely because of the low absorbability of the drug.

Symptoms: Accidental Ingestion dose of 200 mg imiquimod which corresponds to the content of approximately 16 sachets, may experience nausea, vomiting, headache, myalgia, and fever. The most serious clinical point of view, a side effect of oral administration of multiple doses of 200 mg is to reduce blood pressure.

Treatment: you need immediate access to a doctor; symptomatic therapy.

Special instructions

The cream is applied only to the affected areas.

Avoid getting the cream on the mucous membranes, contact with eyes cream. If you get the cream in your eyes rinse them with water is recommended.

Aldara cream is applied before going to bed.

Using excessive amounts of cream or cream longer contact with the skin can cause pronounced local reaction.

You can not reuse the cream of the opened bag previously.

Before and after applying the cream you must wash your hands with warm soapy water.

Men who do not perform circumcision in the treatment of genital warts, located under the foreskin should wash the affected area on a daily basis, pulling the foreskin. It is recommended to immediately discontinue treatment in the event of detection of early signs of phimosis.

If the local reaction to the drug causes severe discomfort to the patient or in a cream application area there is an infection, it is allowed to take a break in treatment for several days. the necessary measures are taken in case of infection.

Cream Aldara can exacerbate inflammatory diseases of the skin.

Do not use Aldara cream to the skin healing after other types of medical or surgical treatment.

Do not start treatment cream Aldara in areas with open sores or wounds to heal them.

Fillers methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol and stearyl alcohol may cause allergic reactions. If any hypersensitivity reactions is recommended to discontinue therapy.

Do not use occlusive dressing during treatment with Aldara.

Using imiquimod at doses higher than the recommended can lead to increased risk of severe local reactions.

During the period of application of the cream Aldara avoid or minimize exposure to sunlight (including solar lamps), as there is a risk of sunburn.

Since Imiquimod has no direct antiviral and cytotoxic effects after therapy may cause new warts genital and perianal areas.

On the basis of currently available knowledge of the treatment of urethral, ??intravaginal, cervical, rectal or genital warts cream intraanalnyh Aldara not recommended.

Cream Aldara should be rinsed from the skin before sexual intercourse.

Aldara Cream may weaken the effect of condoms or vaginal diaphragms, it is not recommended to use these contraceptives using Aldara cream. It is necessary to choose an alternative method of contraception.

In immunocompromised patients is not recommended Aldara cream again.

Effects on ability to drive and use machines. Studies of the effect of the drug on the ability to drive and operate machinery have not been conducted.

Release Form

Cream for external use 5%. The triple laminated bag, separated by perforations, 0,25, 12 or 24 pack. in a cardboard bundle.

Manufacturer

Glenmark Pharmaceuticals Ltd., India.

Name and address of the legal entity in whose name the registration certificate issued to:. Glenmark Pharmaceuticals Ltd., India.

Storage conditions

In the dark place at a temperature of 2-25 ° C.

Keep out of the reach of children.

The shelf life: 2 years.

Do not use beyond the expiration date printed on the package.