5% cream
Imiquimod
1. What Aldara cream is and what it is used for
Aldara cream can be used for three different disease states. Your doctor may prescribe Aldara cream for the treatment of:
- Warts ( condyloma ) on the outer parts of the genitals and around the rectal opening.
- Superficial basal cell carcinoma is a common, slow-growing form of skin cancer with very little likelihood of spreading to other parts of the body. It usually occurs in middle age and in older people, especially in those who are fair-skinned and caused by too much sun exposure. If the basal cell carcinoma is not treated, it can cause disfiguring injuries, especially to the face – therefore early detection and treatment are important.
- Actinic keratosisActinic keratosis is rough skin areas found in people who have been exposed to too much sunlight during their lifetime. Some are skin-colored, others are greyish, pink, red, or brown. They can be thin and scaly or raised, rough, hard, and wart-like. Aldara is only used for thin actinic keratosis of the face and scalp in patients with normal immune systems when your doctor has decided that Aldara is the most appropriate treatment.
Aldara cream helps your body’s own immune system to form natural substances that help fight your basal cell carcinoma, actinic keratosis, or the virus that caused warts.
2. What you need to know before using Aldara cream
Do not use Aldara cream:
- if you are allergic to imiquimod or any of the other ingredients of this medicine (see section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Aldara cream
- If you have previously used Aldara cream or other similar preparations, tell your doctor before starting this treatment.
- Tell your doctor if you have problems with your immune system.
- Do not use Aldara cream until the area to be treated has healed after previous treatment with medication or surgery.
- Avoid getting cream in the eyes, on the lips, or in the nostrils. If this happens by mistake, the cream is removed by rinsing with water.
- Do not use cream internally.
- Do not use more cream than your doctor has prescribed.
- Do not cover the treated area where you applied Aldara cream with a bandage or similar.
- If you experience too much discomfort in the treated area, wash off the cream with mild soap and water. Once the problems are gone, you can start using the cream once again.
- If you have an abnormal number of blood cells, tell your doctor.
Due to Aldara’s mode of action, there is a possibility that the cream may aggravate existing inflammation in the treatment area.
- If you are being treated for genital warts, follow these extra precautions:
- Men who have warts under the foreskin should pull back the foreskin every day and wash the area. If the area is not washed daily, the foreskin is more likely to show signs of narrowing, swelling, and flaking of the skin, which can make it difficult to pull it back. If these symptoms occur, treatment should be stopped as soon as possible and a doctor should be consulted.
- If you have open wounds: do not start treatment with Aldara until the wounds have healed.
- If you have internal warts: Do not use Aldara in the urethra, in the vagina, on the cervix or inside the rectum, or in its opening.
- Do not use this medicine for more than one treatment period if you have problems with your immune system, either due to illness or other medicines you are already taking. Talk to your doctor if you think this is affecting you.
- You should tell your doctor if you are HIV- positive, as Aldara has been shown to be less effective in HIV- positive patients. If you intend to have sexual intercourse while still having warts, use Aldara after – not before – sexual activity. Aldara can weaken condoms and pessaries and therefore you should not have lubricated yourself before sexual activity. Remember that Aldara does not protect against the transmission of HIV or other sexually transmitted diseases to another person.
- If you are being treated for basal cell carcinoma or actinic keratosis, follow these extra precautions:
- Do not use sunlight or tanning beds and avoid sunlight as much as possible during treatment with Aldara cream. Wear protective clothing and a wide-brimmed headdress when you are outdoors.
While you are using Aldara cream and until your skin change has healed, the skin in the treatment area will probably look noticeably altered compared to normal skin.
Children and young people
Use in children and adolescents is not recommended.
Use of other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or will take any other medicines.
No medicines are known to be incompatible with Aldara cream.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
You should tell your doctor if you are or are planning to become pregnant. Your doctor will discuss both the risks and benefits of using Aldara during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy.
It is not known whether imiquimod is excreted in human milk. Therefore, do not breast-feed your baby during treatment with Aldara.
Driving and using machines
This medicine has no or negligible effect on the ability to drive and use machines.
Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol, and benzyl alcohol
Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) may cause allergic reactions (possibly delayed). Cetyl alcohol and stearyl alcohol can cause local skin reactions (eg contact dermatitis). This medicine contains 5 mg of benzyl alcohol in each sachet. Benzyl alcohol can cause allergic reactions and mild local irritation.
3. How to use Aldara cream
Children and adolescents:
Use in children and adolescents is not recommended.
Adults:
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Wash your hands thoroughly before and after applying the cream. Do not cover the treated area with bandages or compresses after Aldara cream has been applied.
Open a new sachet each time you use a cream one. Discard any cream left over after use. Do not save the opened bag for later use.
How often and for how long Aldara cream should be used depends on whether you are being treated for genital warts, basal cell carcinoma, or actinic keratosis (see special instructions for each area of use).
Aldara Cream Application Instructions
If you are being treated for genital warts:
Application instructions – (Mon, Wed, and Fri)
1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry carefully.
2. Open a new sachet and squeeze the cream on your fingertip.
3. Apply a thin layer of Aldara cream onto the clean, dry wart area and rub in the cream gently until it entered the skin.
4. After smearing on cream one, discard the opened bag and wash your hands with soap and water.
5. Leave Aldara cream on warts for 6 to 10 hours. Do not shower or bathe during that time.
6. After 6 to 10 hours wash the area where Aldara cream with mild soap and water.
Aldara cream is applied 3 times a week. For example, you can apply the cream on Monday, Wednesday, and Friday. Cream one in a disposable bag is enough to cover a 20 cm 2 large area with warts.
Men who have warts under the foreskin must pull back the foreskin daily and wash the area thoroughly (see section 2 “Take special care with Aldara cream:”).
Continue to use Aldara cream as prescribed until the warts are completely gone (half of the women who heal do so within 8 weeks, half of the men who heal do so within 12 weeks, but warts can disappear already after 4 weeks in some patients).
Do not use Aldara cream for longer than 16 weeks per episode of warts.
If you have the impression that the effect of Aldara cream is too strong or too weak, talk to your doctor or pharmacist.
If you are being treated for basal cell carcinoma:
Application instructions – (Mon, Tue, Wed, Thurs, and Fri)
1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry carefully.
2. Open a new sachet and squeeze the cream on your fingertip.
3. Apply Aldara cream on the affected area and 1 cm around the affected area. Gently massage cream one into the area until it has penetrated the skin.
4. Once the cream has been applied, discard the opened bag. Wash your hands with soap and water.
5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this time.
After about 8 hours, wash the area where Aldara cream was lubricated with mild soap and water.
Apply enough Aldara cream to cover the treatment area and 1 cm around the treatment area every day for 5 consecutive days every week for 6 weeks. For example, apply cream from Monday to Friday. Do not apply the cream on Saturday and Sunday.
If you are being treated for actinic keratosis:
Application instructions – (Mon, Wed, and Fri)
1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry carefully.
2. Open a new sachet and squeeze the cream on your fingertip.
3. Apply the cream to the affected area. Gently massage cream one into the area until it has penetrated the skin.
4. Once the cream has been applied, discard the opened bag. Wash your hands with soap and water.
5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this time.
After about 8 hours, wash the area where Aldara cream was lubricated with mild soap and water.
Apply Aldara cream three times a week. For example, apply the cream on Monday, Wednesday, and Friday. A sachet contains enough cream to cover an area of 25 cm 2. Continue treatment for four weeks. Four weeks after completing the first treatment, your doctor will assess your skin. If not all skin changes have disappeared, you may need to treat for another four weeks.
If you use more Aldara cream than you should
Wash off the excess cream one with mild soap and water. Once any skin reactions have disappeared, you can continue treatment. If you happen to swallow Aldara, contact your nearest emergency department or your doctor immediately.
If you forget to take Aldara cream
If you forget to take a sachet, apply a cream as soon as you remember and then continue with the regular schedule. Do not use the cream more than once a day.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
The frequency of side effects is divided as follows:
Very common side effects (likely to affect more than 1 in 10 patients)
Common side effects (likely to affect less than 1 in 10 people)
Uncommon side effects (likely to affect less than 1 in 100 patients)
Uncommon side effects (likely to affect less than 1 in 1,000 patients)
Very rare side effects (likely to affect less than 1 in 10,000 patients)
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist as soon as possible if you do not feel well when you use Aldara.
Some patients have experienced a change in skin color in the area where Aldara cream was applied. Although these changes usually go back over time, in some patients they can become permanent.
If your skin reacts strongly when using Aldara, do not apply more cream but wash the area with mild soap and water and consult a doctor or pharmacist.
In some individuals, a decrease in the number of blood cells was noted. A decrease in the number of blood cells can make you more susceptible to infections, bruise more easily, or can cause fatigue. Tell your doctor if you get any of these symptoms.
Rare cases of severe skin reactions have been reported. If you get sores on the skin or spots on the skin that start as small red areas and develop into small circles, possibly with symptoms such as itching, fever, general malaise, sore joints, vision problems, burning, sore or itchy eyes, and cold sores, you should stop using Aldara and inform your doctor immediately.
A small number of patients have experienced some hair loss at the treatment site or in the surrounding area.
If you are being treated for genital warts:
Many of the side effects of Aldara are due to its effect on the skin at the treatment site.
Very common problems are redness (61% of patients), worn skin (30% of patients), flaking, and swelling. Hardening of the skin, small open wounds, scabs that form during healing, and small bubbles under the skin can also occur. You may also experience itching (32% of patients), burning (26% of patients), or pain in areas where you have applied Aldara cream (8% of patients). Most of these skin reactions are mild and the skin will return to normal about 2 weeks after stopping treatment.
Common: some patients (4% or less) have experienced headache, less common are fever and flu-like symptoms, joint and muscle pain; uterine prolapse; pain in women during intercourse; erection difficulties; increased sweating; feeling sick; gastrointestinal symptoms; ringing in the ears; redness; fatigue; dizziness; migraine; knitting; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (eg herpes ); vaginal infection, including candida infection; cough and cold with a sore throat.
In very rare cases, severe and painful reactions have occurred, especially when a larger amount of cream than recommended has been used. Painful reactions at the opening to the vagina have in very rare cases made it difficult for some women to urinate. If this happens, see a doctor immediately.
If you are being treated for basal cell carcinoma:
Many of the unwanted effects of Aldara cream are due to its local effect on your skin. Local skin reactions may be a sign that the medicine is working as intended.
It is very common for the area to be treated to itch a little.
Common effects include tingling, small swollen areas of the skin, pain, burning sensation, irritation, bleeding, redness, or rash. If the skin reaction becomes too bothersome during treatment, talk to your doctor. He/she may advise you to stop applying Aldara cream for a few days (ie have a short rest period from the treatment). If there are any or other signs of infection, discuss this with your doctor. Apart from skin reactions, other common effects include swollen glands and back pain.
Uncommon (1% or less) is that some patients experience changes at the application site (fluid secretion, inflammation, swelling, crusting, breakdown of the skin, blisters, dermatitis) or irritation, malaise, dry mouth, flu-like symptoms, and fatigue.
If you are being treated for actinic keratosis:
Many of the unwanted effects of Aldara cream are due to its local effect on your skin. Local skin reactions may be a sign that the medicine is working as intended.
It is very common for the area to be treated to itch a little.
Common effects include pain, burning sensation, irritation, or redness.
If the skin reaction becomes too bothersome during treatment, talk to your doctor. He/she may advise you to stop applying Aldara cream for a few days (ie have a short rest period from the treatment).
If there are any or other signs of infection, discuss this with your doctor. Apart from skin reactions, other common effects include headache, anorexia, nausea, muscle aches, joint pain, and fatigue.
Uncommon effects are that some patients (1% or less) experience changes at the application site (bleeding, inflammation, secretion of fluid, sensitivity, swelling, small swollen areas of the skin, tingling, crusting, scarring, sores, or a feeling of heat or discomfort) , or an inflammation of the nasal mucosa, stuffy nose, flu or flu-like symptoms, depression, eye irritation, swollen eyelids, sore throat, diarrhea, actinic keratosis, redness, swollen face, sores, pain in arms or legs, fever, weakness or tremors.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Aldara cream
Keep out of sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the outer carton and label after EXP.
Dosage bags should not be reused once opened.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration for Aldara cream
- The active substance is imiquimod. Each sachet contains 250 mg of cream (100 mg of cream contains 5 mg of imiquimod).
- Excipients are 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 (see also section 2 “Aldara cream includes methyl, propyl, cetyl alcohol, stearyl alcohol, and benzyl alcohol ”).
What the medicine looks like and the contents of the pack
- Each sachet of Aldara 5% cream contains 250 mg of white to pale yellow cream.
- Each package contains 12 or 24 disposable bags of polyester/aluminum foil. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Manufacturer
Swiss Caps GmbH
Grassingerstraße 9
83043 Bad Aibling
Germany
3M Health Care Limited
Derby Road
Loughborough
Leicestershire
LE11 5SF
UK
MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Germany