Aldara

Imiquimod.

Each sachet contains 250 mg cream (100 mg cream contains 5 mg imiquimod).
Excipients/Inactive Ingredients: Isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate, propyl hydroxybenzoate, xanthan gum, purified water.

Aldara cream may be used for three different conditions. For the treatment of: Warts (condylomata acuminata) on the surface of the genitals (sexual organs) and around the anus (back passage).
Superficial basal cell carcinoma: This is a common slow-growing form of skin cancer with a very small likelihood of spread to other parts of the body. It usually occurs in middle-aged and elderly people, especially those who are fair-skinned and is caused by too much sun exposure. If left untreated, basal cell carcinoma can disfigure, especially on the face - therefore early recognition and treatment are important.
Actinic keratosis: Actinic keratoses are rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime. Some are skin coloured, others are greyish, pink, red or brown. They can be flat and scaly, or raised, rough, hard and warty. Aldara should only be used for flat actinic keratoses on the face and scalp in patients with a healthy immune system where it is the most appropriate treatment.
Aldara cream helps the body's own immune system to produce natural substances which help fight basal cell carcinoma, actinic keratosis or the virus that has caused warts.

Children and adolescents: Use in children and adolescents is not recommended.
Adults: Advise patient to wash hands carefully before and after applying the cream. Do not cover the treated area with bandages or other dressings after applying Aldara 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).
Treatment for genital warts: Application Instructions - (Mon, Wed and Fri): 1. Before bedtime, wash hands and the treatment area with mild soap and water. Dry thoroughly.
2. Open a new sachet and squeeze some cream onto the fingertip.
3. Apply a thin layer of Aldara cream onto clean, dry wart area and rub gently into the skin until cream vanishes.
4. After application of the cream, throw away the opened sachet and wash hands with soap and water.
5. Leave Aldara cream on the warts for 6 to 10 hours. Do not shower or bathe during this time.
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 cm² (approx. 3 square inches).
Men with warts under the foreskin should pull the foreskin back each day and wash underneath it (see Precautions).
Continue to use Aldara cream as instructed until the 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.
Treatment for basal cell carcinoma: Application Instructions - (Mon, Tues, Wed, Thurs and Fri): 1. Before bedtime, wash hands and the treatment area with mild soap and water. Dry thoroughly.
2. Open a new sachet and squeeze some cream onto the fingertip.
3. Apply Aldara cream to the affected area and 1 cm (approx. 0.5 inch) around the affected area. Rub gently into the skin until the cream vanishes.
4. After application of the cream, throw away the opened sachet. Wash hands with soap and water.
5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this time.
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 ½ 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.
Treatment for actinic keratosis: Application Instructions - (Mon, Wed and Fri): 1. Before bedtime, wash hands and the treatment area with mild soap and water. Dry thoroughly.
2. Open a new sachet and squeeze some cream onto the fingertip.
3. Apply the cream to the affected area. Rub gently into the area until the cream vanishes.
4. After application of the cream, throw away the opened sachet. Wash hands with soap and water.
5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this time.
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 cm² (approx. 4 square inches).
Continue treatment for four weeks. Four weeks after finishing this first treatment, assess the skin. If the lesions have not all disappeared, further four weeks of treatment may be necessary.
Missed dose: Advise patient to apply cream as soon as remembered and then continue in the regular schedule. Do not apply the cream more than once per day.

Advise the patient to wash the extra away with mild soap and water. When any skin reaction has gone, continue with the treatment.

Hypersensitivity to imiquimod or any of the ingredients of this medicine (listed in Description).

Know if the patient has previously used Aldara cream or other similar preparations prior to treatment initiation.
Patients who have problems with the immune system.
Do not use Aldara cream until the area to be treated has healed after previous drug or surgical treatment.
Avoid contact with the eyes, lips and nostrils. In the event of accidental contact, remove cream by rinsing with water.
Do not apply the cream internally.
Advise patient to not use the cream more than the prescribed.
Do not cover the treated area with bandages or other dressings after Aldara cream has been applied.
If the treated site becomes too uncomfortable for the patient, advise patient to wash the cream off with mild soap and water. As soon as the problem has stopped, the patient may restart to apply the cream.
Patients who have an abnormal blood count.
Because of the way Aldara works, there is a possibility that the cream may worsen existing inflammation in the treatment area.
Additional precautions for patients treated for genital warts: Men with warts under the foreskin should pull the foreskin back each day and wash underneath it. If not washed daily the foreskin may be more likely to show signs of tightness, swelling and wearing away of the skin and result in difficulty in pulling it back. If these symptoms occur, stop the treatment immediately.
Patients with open sores: Advise patient to not start using Aldara cream until after the sores have healed.
Patients with internal warts: Advise patient to not use Aldara cream in the urethra (the hole from which urine is passed), the vagina (birth canal), the cervix (internal female organ), or anywhere inside the anus (rectum).
This medication should not be used for more than one course if the patient has problems with the immune system, either due to illness or because of the current medications.
Aldara cream has not been shown to be as effective in HIV positive patients.
Advise patient to apply Aldara cream after - not before - sexual activity. Aldara cream may weaken condoms and diaphragms, therefore the cream should not be left on during sexual activity. Remember, Aldara cream does not protect against giving HIV or other sexually transmitted diseases to someone else.
Additional precautions for patients treated for basal cell carcinoma or actinic keratosis: Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Aldara cream. Wear protective clothing and wide brimmed hats when outdoors.
Whilst using Aldara cream and until healed, the treatment area is likely to appear noticeably different from normal skin.
Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol: Methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed). Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 5 mg benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions and mild local irritation.
Driving and using machines: This medicine has no or negligible influence on the ability to drive and use machines.

Know if the patient is pregnant or intends to become pregnant. Discuss the risks and benefits of using Aldara cream during pregnancy.
Studies in animals do not indicate direct or indirect harmful effects in pregnancy.
Patient should not breast-feed infant during treatment with Aldara cream, as it is not known whether imiquimod is secreted in human milk.

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, this medicine can cause side effects, although not everybody gets them.
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 the skin reacts badly when using Aldara cream, advise patient to stop applying the cream, wash the area with mild soap and water.
In some individuals, a lowering of blood counts was noted. A lowering of blood counts might make the patient more susceptible to infections, bruise more easily or cause fatigue.
Serious skin reactions have been reported rarely. If the patient experiences skin lesions or spots on the 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, advise patient to stop using Aldara cream.
A small number of patients have experienced hair loss at the treatment site or surrounding area.
Patients treated for genital warts: Many of the undesirable effects of Aldara cream are due to its local action on the 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. The patient might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where Aldara cream is applied (8% patients). Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after stopping treatment.
Common: 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 rare: 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.
Patients treated for basal cell carcinoma: Many of the undesirable effects of Aldara cream are due to its local action on the skin. Local skin reactions can be a sign that the drug is working as intended.
Very common: 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 for the patient during treatment, advise 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 with the patient. Apart from reactions in the skin, other common effects include swollen glands and back pain.
Uncommon: 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.
Patients treated for actinic keratosis: Many of the undesirable effects of Aldara cream are due to its local action on the skin. Local skin reactions can be a sign that the drug is working as intended.
Very common: The treated skin may be slightly itchy.
Common: Effects include pain, burning, irritation or redness.
If a skin reaction becomes too uncomfortable for the patient during treatment, advise 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 with the patient. Apart from reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain and tiredness.
Uncommon: 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.

Know if the patient is currently taking, have recently taken or might take any other medicines.
There are no medicines known to be incompatible with Aldara cream.

Do not store above 25 °C.
Sachets should not be re-used once opened.

Warts & Calluses Preparations

D06BB10 - imiquimod ; Belongs to the class of topical antivirals used in the treatment of dermatological diseases.

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