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Aldara 50 mg/g cream (imiquimod) – genital warts, actinic keratoses and superficial basal cell carcinoma
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- Stock: Zabrana online prodaje
- Brand: OSTALO
- Model: BR-60516513521025541
Aldara 50 mg/g cream is a prescription medicine applied to the skin. It contains imiquimod, a substance that stimulates the skin’s immune system to produce natural substances that act against the viruses causing warts, against actinic keratoses and against superficial basal cell carcinoma. It belongs to the group of antiviral medicines for dermatological use.
The cream comes in single-use sachets of 250 mg (12.5 mg imiquimod per sachet). How often and for how long it is applied differs depending on the condition being treated, so it is important to follow exactly the schedule prescribed by your doctor.
Important warning
- Supply status in Serbia: prescription-only medicine.
- For external use only – do not apply inside the urethra, vagina, cervix or anus; avoid contact with the eyes, lips and nostrils.
- The cream may weaken condoms and diaphragms – wash it off before sexual intercourse; the medicine does not protect against HIV or other sexually transmitted infections.
- Do not apply more than once a day and do not cover the treated area with a dressing.
- Use the medicine only according to the official leaflet and your doctor’s advice.
- This page is for information only and is not an offer to buy the medicine online.
What is Aldara cream used for and how is it applied correctly for each of its three indications?
Key facts about the medicine
| Name of the medicine | Aldara™, 50 mg/g, cream |
|---|---|
| Active substance | imiquimod |
| Strength | 50 mg/g (5%); one 250 mg sachet contains 12.5 mg imiquimod |
| Pharmaceutical form | cream for cutaneous use |
| Therapeutic group | antivirals for dermatological use (immune response modifier; ATC D06BB10) |
| Pack | 12 sachets of 250 mg cream |
| Marketing authorisation holder | Viatris Healthcare d.o.o., Belgrade – Novi Beograd |
| Supply status (Serbia) | prescription-only medicine |
What is Aldara cream used for?
According to the patient leaflet and the Summary of Product Characteristics, Aldara cream is indicated in adults for the topical treatment of:
- external genital and perianal warts (condylomata acuminata)
- small superficial basal cell carcinomas of the skin
- clinically typical, flat (non-hyperkeratotic, non-hypertrophic) actinic keratoses on the face or scalp in people with a healthy immune system, when cryotherapy or other topical treatments are not suitable
How is it used and dosed?
The cream is applied at bedtime as a thin layer to clean, dry skin and rubbed in gently until it disappears. A new sachet is opened for each application and any leftover cream is discarded. Wash your hands before and after applying. After the prescribed time, the cream is washed off with mild soap and water. The schedule depends on the indication:
| Indication | Frequency | Left on the skin | Duration |
|---|---|---|---|
| Genital and perianal warts | 3 times a week (e.g. Monday, Wednesday, Friday) | 6–10 hours | until the warts clear, no longer than 16 weeks per episode; one sachet covers about 20 cm² |
| Superficial basal cell carcinoma | 5 days a week (Monday–Friday), on the lesion and 1 cm of surrounding skin | about 8 hours | 6 weeks; the doctor assesses the result 12 weeks after the end of treatment |
| Actinic keratoses (face, scalp) | 3 times a week | about 8 hours | 4 weeks, then assessment after a 4-week break; if needed a further 4 weeks; one sachet covers about 25 cm² |
- Do not shower or bathe while the cream is on the skin.
- Men with warts under the foreskin should pull back the foreskin and wash underneath it every day.
- Relation to meals is not applicable – the medicine is applied to the skin.
Special patient groups
- Children and adolescents: use is not recommended.
- Elderly people: the official documentation does not specify any dose adjustment.
- People with a weakened immune system: do not use for more than one treatment course without discussing it with your doctor; efficacy for warts has not been shown in HIV-positive patients.
- Kidney or liver impairment: the official documentation gives no specific recommendations.
Contraindications – when the medicine must not be used
The medicine must not be used if you are allergic (hypersensitive) to imiquimod or to any of the excipients.
Precautions and warnings
- Tell your doctor if you have used Aldara or a similar product before, if you have an autoimmune disease, have had an organ transplant or have a blood disorder.
- Do not apply until the skin has healed after previous treatment or surgery, and do not apply to open wounds – use on damaged skin may increase absorption of the medicine.
- The cream may worsen existing inflammation at the application site; until healing, the treated area will look noticeably different from normal skin.
- When treating basal cell carcinoma or actinic keratoses, avoid sunbathing, sunbeds and sunlamps, and wear protective clothing and a wide-brimmed hat.
- The medicine contains methyl and propyl hydroxybenzoate (E218, E216), which may cause allergic reactions, cetyl and stearyl alcohol, which may cause local skin reactions, and 5 mg benzyl alcohol per sachet.
Interactions with other medicines, alcohol and food
No medicines are known to be incompatible with Aldara cream. Because of its immunostimulating action, the Summary of Product Characteristics advises caution in people taking immunosuppressive medicines. Interactions with food and alcohol are not described because the medicine is applied to the skin.
Pregnancy and breastfeeding
There are no clinical data on use during pregnancy; animal studies have not shown harmful effects. The doctor decides on use in pregnancy after weighing benefits and risks. According to the patient leaflet, you should not breastfeed during treatment with Aldara cream, as it is not known whether imiquimod passes into breast milk.
Driving and using machines
The medicine has no or negligible influence on the ability to drive and use machines.
Possible side effects
Most side effects are local and may be a sign that the medicine is working; after treatment stops, the skin usually returns to normal within about 2 weeks.
- Genital warts – very common: redness (61%), flaking (30%), itching (32%), burning (26%), scaling and swelling; pain (8%), hardening, small sores, scabs and small blisters may also occur. Common: headache; uncommon: flu-like symptoms, muscle and joint pain, infections and others.
- Basal cell carcinoma – very common: mild itching; common: tingling, small swellings, pain, burning, irritation, bleeding, redness, rash, swollen glands and back pain.
- Actinic keratoses – very common: mild itching; common: pain, burning, irritation, redness, headache, loss of appetite, nausea, muscle and joint pain, tiredness.
- Changes in skin colour at the application site (permanent in some people), hair loss at the treated site, a reduction in blood cell counts and worsening of an autoimmune disease are possible.
- Rare: serious skin reactions (lesions that look like small targets, with fever, joint pain, eye problems or mouth sores) – stop using the cream immediately and contact your doctor.
Suspected side effects can be reported to your doctor, pharmacist or the Medicines and Medical Devices Agency of Serbia (ALIMS).
Overdose, missed dose and stopping treatment
- Overdose on the skin: wash off excess cream with mild soap and water; once the skin reaction has settled, treatment can continue. Persistent local overdose may cause severe skin reactions. If the cream is swallowed accidentally, contact a doctor.
- Missed dose: apply the cream when you remember and continue with the usual schedule; never apply more than once a day.
- Stopping treatment: if the skin reacts too strongly, your doctor may advise a short break of a few days.
When to seek medical help immediately?
- a serious skin reaction: spots or lesions that develop into small target-like shapes, with fever, general malaise, joint pain, eye problems or mouth sores
- a severe, painful reaction at the application site, especially if in women it makes passing urine difficult
- in men: swelling, hardening or peeling of the foreskin that makes it difficult to pull back
- pus or other signs of infection in the treated area
- signs of low blood cell counts: frequent infections, easy bruising, unusual tiredness
Pharmacist's advice
Write down an application schedule for the whole course (e.g. Monday, Wednesday, Friday for warts and keratoses, or five days a week for basal cell carcinoma) and always apply the cream in the evening so that it stays on the skin for the prescribed time.
Each sachet is for single use only – do not keep an opened sachet for next time. Redness and flaking are expected, but if the reaction becomes very uncomfortable, wash the area with mild soap and water and talk to your doctor before the next application. While treating keratoses or basal cell carcinoma, protect the treated area from the sun with clothing and a hat.
Availability and price
This is a prescription-only medicine and cannot be ordered online. This page is for information only.
Please contact a pharmacy to check availability and dispensing conditions.
Related information
- What are condylomas in women and men and how are they treated?
- HPV – how it is transmitted and treated
- Tips for proper sun protection
For additional care and support with warts and condylomas, see also the Warts and condylomas – products for local care of skin changes category – products in this category do not replace the medicine you have been prescribed.
Composition, packaging and manufacturer
- Active substance: imiquimod – one sachet contains 12.5 mg imiquimod in 250 mg cream (100 mg cream contains 5 mg imiquimod).
- Excipients: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), xanthan gum, purified water.
- Appearance and pack: white to slightly yellow cream; polyester/aluminium foil sachets containing 250 mg cream, 12 sachets per carton.
- Marketing authorisation holder: Viatris Healthcare d.o.o., Belgrade – Novi Beograd. Manufacturers: Meda Pharma GmbH & Co. KG, Bad Homburg and Swiss Caps GmbH, Bad Aibling, Germany.
- ALIMS authorisation: 515-01-02874-21-001 of 14.06.2022.
Storage
- Store below 25 °C, out of the sight and reach of children.
- Shelf life: 2 years; do not use after the expiry date on the pack.
- An opened sachet must not be reused – discard any unused cream.
- Return unused medicine to a pharmacy that collects unused medicines.
Frequently asked questions
How long does treatment of genital warts with Aldara cream take?
The cream is applied three times a week until the warts have cleared, but for no longer than 16 weeks per episode. According to the leaflet, in half of women the warts clear completely in about 8 weeks and in half of men in about 12 weeks.
Is redness after applying Aldara cream normal?
Local reactions – redness, flaking, itching and burning – are very common and may be a sign that the medicine is working. If they are very uncomfortable, wash the cream off with mild soap and water; your doctor may advise a short break. Contact a doctor immediately if there are signs of infection or a serious skin reaction.
Can Aldara cream be used with condoms?
The cream may weaken condoms and diaphragms. The leaflet advises applying the cream after, not before, sexual intercourse, or washing it off beforehand. The medicine does not protect against HIV or other sexually transmitted infections.
May I go in the sun while using Aldara cream?
When treating actinic keratoses or basal cell carcinoma, the leaflet advises avoiding sunlight, sunbeds and sunlamps and wearing protective clothing and a wide-brimmed hat.
Sources
- ALIMS – Patient leaflet Aldara™, 50 mg/g, cream (June 2022)
- ALIMS – Summary of Product Characteristics Aldara™, 50 mg/g, cream (authorisation 515-01-02874-21-001)
- ALIMS – New authorisations and renewals 01.04.–30.06.2022 (Aldara™ renewed 14.06.2022)
Sources checked on: 23 October 2026.
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