3. HOW TO USE ALDARA CREAM
Always use Aldara cream exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Wash hands carefully before and after applying the cream. Do not cover the treated area with bandages or other dressings after you have applied Aldara cream.
Open a new sachet each time you use the cream. Dispose of any cream left in the sachet after use. Do not save the opened sachet for use at a later date.
The treatment frequency and duration differ for genital warts, basal cell carcinoma and actinic keratosis (see specific instructions for each indication).
Aldara Cream Application Instructions
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If you are being treated for genital warts:
Application Instructions – (Mon, Wed and Fri)
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1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
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2. Open a new sachet and squeeze some cream onto your fingertip.
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3. Apply a thin layer of Aldara cream onto clean, dry wart area and rub gently into the skin until cream vanishes.
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4. After application of the cream, throw away the opened sachet and wash hands with soap and water.
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5. Leave Aldara cream on the warts for 6 to 10 hours. Do not shower or bathe during this time.
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6. After 6 to 10 hours wash the area where Aldara cream was applied with mild soap and water.
Apply Aldara cream 3 times per week. For example, apply the cream on Monday, Wednesday and Friday. One sachet contains enough cream to cover a wart area of 20 square centimetres (approx. 3 square inches).
Men with warts under the foreskin should pull the foreskin back each day and wash underneath it (see section 2 "Take special care with Aldara cream:").
Continue to use Aldara cream as instructed until your warts have completely gone (half the females who clear will do so in 8 weeks, half the males who clear will do so in 12 weeks but in some patients warts may clear as early as 4 weeks).
Do not use Aldara cream for more than 16 weeks in the treatment of each 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.
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If you are being treated for basal cell carcinoma:
Application Instructions – (Mon, Tues, Wed, Thurs and Fri)
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1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
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2. Open a new sachet and squeeze some cream onto your fingertip.
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3. Apply Aldara cream to the affected area and 1cm (approx. 0.5 inch) around the affected area. Rub gently into the skin until the cream vanishes.
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4. After application of the cream, throw away the opened sachet. Wash hands with soap and water.
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5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this time.
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6. After about 8 hours, wash the area where Aldara cream was applied with mild soap and water.
Apply sufficient Aldara cream to cover the treatment area and 1 cm (about half an inch) around the treatment area each day for 5 consecutive days each week for 6 weeks. For example, apply the cream from Monday to Friday. Do not apply the cream on Saturday and Sunday.
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If you are being treated for actinic keratosis
Application Instructions – (Mon, Wed and Fri)
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1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
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2. Open a new sachet and squeeze some cream onto your fingertip.
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3. Apply the cream to the affected area. Rub gently into the area until the cream vanishes.
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4. After application of the cream, throw away the opened sachet. Wash hands with soap and water.
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5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this time.
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6. After about 8 hours, wash the area where Aldara cream was applied with mild soap and water.
Apply Aldara cream 3 times per week. For example, apply the cream on Monday, Wednesday and Friday. One sachet contains enough cream to cover an area of 25 square centimetres (approx. 4 square inches). Continue treatment for four weeks. Four weeks after finishing this first treatment, your doctor will assess your skin. If the lesions have not all disappeared, a further four weeks of treatment may be necessary.
If you use more Aldara cream than you should:
Wash the extra away with mild soap and water. When any skin reaction has gone you may then continue with your treatment.
If you accidentally swallow Aldara cream please contact your doctor.
If you forget to use Aldara cream:
If you miss a dose, apply cream as soon as you remember and then continue in your regular schedule. Do not apply the cream more than once per 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 classified as follows:
Very common side effects (likely to occur in more than 1 in 10 patients)
Common side effects (likely to occur in fewer than 1 in 10 patients)
Uncommon side effects (likely to occur in fewer than 1 in 100 patients)
Rare side effects (likely to occur in fewer than 1 in 1,000 patients)
Very rare side effects (likely to occur in fewer than 1 in 10,000 patients).
Like all medicines, Aldara cream can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aldara cream.
Some patients have experienced changes in skin colour in the area where Aldara cream was applied. While these changes have tended to improve with time, in some patients they may be permanent.
If your skin reacts badly when using Aldara cream, stop applying the cream, wash the area with mild soap and water and contact your doctor or pharmacist.
In some individuals a lowering of blood counts was noted. A lowering of blood counts might make you more susceptible to infections, make you bruise more easily or cause fatigue. If you notice any of these symptoms, tell your doctor.
Serious skin reactions have been reported rarely. If you experience skin lesions or spots on your skin that start out as small red areas and progress to look like mini targets, possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores, stop using Aldara cream and tell your doctor immediately.
A small number of patients have experienced hair loss at the treatment site or surrounding area.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
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If you are being treated for genital warts:
Many of the undesirable effects of Aldara cream are due to its local action on your skin.
Very common effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling. Hardening under the skin, small open sores, a crust that forms during healing, and small bubbles under the skin may also occur. You might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where you have applied Aldara cream (8% patients).
Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after stopping treatment.
Commonly some patients (4% or less) have experienced headache, uncommonly fevers and flu like symptoms joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears; flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough and colds with sore throat.
Very rarely severe and painful reactions have occurred, particularly when more cream has been used than recommended. Painful skin reactions at the opening of the vagina have very rarely made it difficult for some women to pass urine. If this occurs you should seek medical help immediately.
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If you are being treated for basal cell carcinoma:
Many of the undesirable effects of Aldara cream are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended.
Very Commonly the treated skin may be slightly itchy.
Common effects include: pins and needles, small swollen areas in the skin, pain, burning, irritation, bleeding, redness or rash.
If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).
If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include swollen glands and back pain.
Uncommonly some patients experience changes at the application site (discharge, inflammation, swelling, scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flu-like symptoms and tiredness.
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If you are being treated for actinic keratosis:
Many of the undesirable effects of Aldara cream are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended.
Very commonly the treated skin may be slightly itchy.
Common effects include pain, burning, irritation or redness.
If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).
If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain and tiredness.
Uncommonly some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small swollen areas in the skin, pins and needles, scabbing, scarring, ulceration or a feeling of warmth or discomfort), or inflammation of the lining of the nose, stuffy nose, flu or flu-like symptoms, depression, eye irritation, swelling of the eyelid, throat pain, diarrhoea, actinic keratosis, redness, swelling of the face, ulcers, pain in extremity, fever, weakness or shivering.