Aldara Cream
Clinical Summary
Quick overview from the medicine insert
Indication
Topical treatment of superficial basal cell carcinoma, actinic keratosis, and external genital warts.
Dosage (summary)
Apply a thin layer of cream to the affected area once daily before bedtime, for up to 16 weeks, depending on the condition being treated.
Onset of Action / Duration
Therapeutic effects may be observed within 2 to 6 weeks of treatment initiation.
Special Populations
- Elderly patients
- Patients with compromised immune systems
- Patients with skin conditions
Pregnancy & Breastfeeding
Use during pregnancy only if clearly needed. Caution is advised when used during lactation.
Key Drug Interactions
- Topical corticosteroids may reduce the efficacy of Imiquimod.
- Concurrent use with other topical medications should be approached with caution.
Contraindications
- Hypersensitivity to Imiquimod or any component of the formulation.
- Patients with a history of autoimmune diseases.
Common side effects
- Local skin reactions (redness, swelling, itching, burning)
- Flu-like symptoms
- Headache
- Fatigue
Counselling Points
- Instruct patients to apply the cream only to the affected area and wash hands after application.
- Advise patients to avoid sun exposure and use sunscreen on treated areas.
- Inform patients about the potential for local skin reactions and to report severe reactions.
Serious warnings
- Not for ophthalmic, oral, or intravaginal use.
- Caution in patients with a history of skin cancer or those with immunocompromised conditions.
Important Disclaimer
The Aldara Cream professional information leaflet below is the property of Inova Pharmaceuticals and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4. POSSIBLE SIDE EFFECTS
Aldara can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using ALDARA, please consult your doctor, pharmacist or other health care professional for advice.
ALDARA cream can have the following side effects:
Tell your doctor if you notice any of the following:
If you are being treated for external genital warts:
- Frequent side effects:
- skin infections,
- headache,
- nausea (feeling sick),
- burning, stinging, irritation and itching of the treated skin,
- lightening of the treated skin,
- pain of the treated skin,
- rash at the treatment site,
- muscle pain,
- sensitivity or tenderness of the treated skin.
Less frequent side effects:
- infections of the skin,
- genital thrush,
- infections and inflammation of the nose and throat,
- rash and bumps on the skin,
- swelling of the lymph nodes,
- eating disorder (anorexia),
- feeling depressed and irritable,
- insomnia (not being able to sleep),
- dizziness,
- migraine (severe headache),
- tingling feeling of the skin,
- sleepiness or drowsiness,
- ringing in the ears (tinnitus),
- blushing of the skin (redness),
- abdominal pain,
- diarrhoea,
- cramping of discomfort of the rectum,
- vomiting,
- increasing in sweating,
- joint and back pain,
- difficulty urinating,
- genital pain and discomfort,
- feeling weak,
- flu-like symptoms,
- fever,
- feeling cold.
If you are being treated for superficial basal cell carcinoma (a type of skin cancer):
- Frequent side effects:
- skin infections,
- bumps or rash on the skin,
- swelling of the lymph nodes,
- headache,
- back pain,
- bleeding and redness of the treated skin,
- burning and irritation of the treated skin,
- pain of the treated skin,
- tingling sensation of the treated skin,
- general itching of the skin,
- tenderness of the treated skin,
- fatigue,
- fever.
Less frequent side effects:
- irritability,
- dry mouth,
- nausea (feeling sick),
- inflammation and swelling of the skin and treated area,
- swelling of the treated skin,
- discharge of the treated skin,
- scabbing or flaking of the skin,
- flu-like symptoms,
- feeling tired.
If you are being treated for actinic keratosis (rough scaly patches on your skin that develops from years of exposure to the sun):
- Frequent side effects:
- eating disorder or loss of appetite (anorexia),
- headache,
- nausea (feeling sick),
- joint and muscle pain,
- burning of the treated skin,
- irritation, redness and itching of the treated skin,
- pain of the treated skin,
- fatigue.
Less frequent side effects:
- infections of the skin,
- bumps and sores on the skin.
- inflammation of the nasal cavity,
- swelling of the lymph nodes,
- feeling depressed,
- irritation and swelling of the eyes,
- blocked nose,
- pain of the throat,
- redness of the skin,
- swelling of the face,
- general itching, pain and inflammation of the skin,
- pain,
- bleeding and discharge of the treated skin,
- swelling of the treated skin,
- tingling sensation of the treated skin,
- scabbing and scarring of the treated skin,
- heat sensation of the treated skin,
- lack of energy,
- fever,
- feeling cold.
Should an intolerable reaction occur, the cream should be removed by washing the area with mild soap and water. Treatment with ALDARA cream can be resumed after the skin reaction has improved. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information about the safety of ALDARA. Alternately you can contact iNova Pharmaceuticals (Pty) Ltd at +27 11 087 0000. Website: www.inovapharma.co.za.
