Aldara

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
ALDARA 5% cream 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %). 
100 mg of cream contains 5 mg of imiquimod. 
 
Excipients with known effects: 
Methyl hydroxybenzoate (E 218) 2.0 mg/g cream 
Propyl hydroxybenzoate (E 216) 0.2 mg/g cream 
Cetyl alcohol 22.0 mg/g cream 
Stearyl alcohol 31.0 mg/g cream 
Benzyl alcohol 20.0 mg/g cream 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Cream. 
White to slightly yellow cream. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Imiquimod cream is indicated for the topical treatment of: 
 

• External genital and perianal warts (condylomata acuminata) in adults. 
 

• Small superficial basal cell carcinomas (sBCCs) in adults. 
 

• Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or 
scalp in immunocompetent adult patients when size or number of lesions limit the efficacy 
and/or acceptability of cryotherapy and other topical treatment options are contraindicated or 
less appropriate. 

 
4.2 Posology and method of administration 
 
Posology  
 
The application frequency and duration of treatment with imiquimod cream is different for each 
indication.  
 
External genital warts in adults: 
 
Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or 
Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 
6 to 10 hours. Imiquimod cream treatment should continue until the clearance of visible genital or 
perianal warts or for a maximum of 16 weeks per episode of warts. 
For quantity to be applied see section 4.2 Method of administration.  
 



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Superficial basal cell carcinoma in adults: 
 
Apply imiquimod cream for 6 weeks, 5 times per week (example: Monday to Friday) prior to normal 
sleeping hours, and leave on the skin for approximately 8 hours. 
For quantity to be applied see 4.2 Method of administration. 
 
Actinic keratosis in adults 
 
Treatment should be initiated and monitored by a physician. Imiquimod cream should be applied 
3 times per week (example: Monday, Wednesday and Friday) for four weeks prior to normal sleeping 
hours, and left on the skin for approximately 8 hours. Sufficient cream should be applied to cover the 
treatment area. After a 4-week treatment-free period, clearance of AKs should be assessed. If any 
lesions persist, treatment should be repeated for another four weeks. 
The maximum recommended dose is one sachet.  
 
An interruption of dosing should be considered if intense local inflammatory reactions occur (see 
section 4.4) or if infection is observed at the treatment site. In this latter case, appropriate other 
measures should be taken. Each treatment period should not be extended beyond 4 weeks due to 
missed doses or rest periods. 
 
If the treated area does not show complete clearance at a follow-up examination about 8 weeks after 
the last 4-weeks course of treatment, an additional 4-weeks course of Aldara treatment may be 
considered.  
 
A different therapy is recommended if the treated lesion(s) shows insufficient response to Aldara.  
 
Actinic keratosis lesions that have cleared after one or two courses of treatment and subsequently 
recur can be re-treated with one or two further courses of Aldara cream following an at least 12 weeks 
treatment pause (see section 5.1). 
 
Information applicable to all indications: 
 
If a dose is missed, the patient should apply the cream as soon as he/she remember and then he/she 
should continue with the regular schedule.  However the cream should not be applied more than once a 
day. 
 
Paediatric population 

Use in the paediatric patient population is not recommended. There are no data available on the use of 
imiquimod in children and adolescents in the approved indications.  
Aldara should not be used in children with molluscum contagiosum due to lack of efficacy in this 
indication (see section 5.1). 
 
 
Method of administration 
 
External genital warts: 
 
Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream 
vanishes. Only apply to affected areas and avoid any application on internal surfaces. Imiquimod 
cream should be applied prior to normal sleeping hours. During the 6 to 10 hour treatment period, 
showering or bathing should be avoided. After this period it is essential that imiquimod cream is 
removed with mild soap and water. Application of an excess of cream or prolonged contact with the 
skin may result in a severe application site reaction (see sections 4.4, 4.8 and 4.9). A single-use sachet 
is sufficient to cover a wart area of 20 cm2 (approx. 3 inches2). Sachets should not be re-used once 
opened. Hands should be washed carefully before and after application of cream. 



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Uncircumcised males treating warts under the foreskin should retract the foreskin and wash the area 
daily (see section 4.4). 
 
Superficial basal cell carcinoma: 
 
Before applying imiquimod cream, patients should wash the treatment area with mild soap and water 
and dry thoroughly. Sufficient cream should be applied to cover the treatment area, including one 
centimetre of skin surrounding the tumour. The cream should be rubbed into the treatment area until 
the cream vanishes. The cream should be applied prior to normal sleeping hours and remain on the 
skin for approximately 8 hours. During this period, showering and bathing should be avoided. After 
this period it is essential that imiquimod cream is removed with mild soap and water. 
Sachets should not be re-used once opened. Hands should be washed carefully before and after 
application of cream. 
 
Response of the treated tumour to imiquimod cream should be assessed 12 weeks after the end of 
treatment. If the treated tumour shows an incomplete response, a different therapy should be used (see 
section 4.4). 
 
A rest period of several days may be taken (see section 4.4) if the local skin reaction to imiquimod 
cream causes excessive discomfort to the patient, or if infection is observed at the treatment site. In 
this latter case, appropriate other measures should be taken. 
 
Actinic keratosis: 
 
Before applying imiquimod cream, patients should wash the treatment area with mild soap and water 
and dry thoroughly. Sufficient cream should be applied to cover the treatment area. The cream should 
be rubbed into the treatment area until the cream vanishes. The cream should be applied prior to 
normal sleeping hours and remain on the skin for approximately 8 hours. During this period, 
showering and bathing should be avoided. After this period it is essential that imiquimod cream is 
removed with mild soap and water. Sachets should not be re-used once opened. Hands should be 
washed carefully before and after application of cream. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
External genital warts, superficial basal cell carcinoma and actinic keratosis: 
 
Avoid contact with the eyes, lips and nostrils. 
 
Imiquimod has the potential to exacerbate inflammatory conditions of the skin. 
 
Imiquimod cream should be used with caution in patients with autoimmune conditions (refer to section 
4.5). Consideration should be given to balancing the benefit of imiquimod treatment for these patients 
with the risk associated with a possible worsening of their autoimmune condition. 
 
Imiquimod cream should be used with caution in organ transplant patients (refer to section 4.5). 
Consideration should be given to balancing the benefit of imiquimod treatment for these patients with 
the risk associated with the possibility of organ rejection or graft-versus-host disease. 
 
Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or 
surgical treatment. Application to broken skin could result in increased systemic absorption of 
imiquimod leading to a greater risk of adverse events (refer to section 4.8 and 4.9) 
 



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The use of an occlusive dressing is not recommended with imiquimod cream therapy. 
 
The excipients 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). Benzyl alcohol may cause allergic reactions and mild local irritation. 
 
Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a 
few applications of imiquimod cream. Local inflammatory reactions may be accompanied, or even 
preceded, by flu-like systemic signs and symptoms including malaise, pyrexia, nausea, myalgias and 
rigors. An interruption of dosing should be considered. 
 
Imiquimod should be used with caution in patients with reduced haematologic reserve (refer to section 
4.8d). 
 
External genital warts: 
 
There is limited experience in the use of imiquimod cream in the treatment of men with foreskin-
associated warts. The safety database in uncircumcised men treated with imiquimod cream three times 
weekly and carrying out a daily foreskin hygiene routine is less than 100 patients. In other studies, in 
which a daily foreskin hygiene routine was not followed, there were two cases of severe phimosis and 
one case of stricture leading to circumcision. Treatment in this patient population is therefore 
recommended only in men who are able or willing to follow the daily foreskin hygiene routine. Early 
signs of stricture may include local skin reactions (e.g. erosion, ulceration, oedema, induration), or 
increasing difficulty in retracting the foreskin. If these symptoms occur, the treatment should be 
stopped immediately. Based on current knowledge, treating urethral, intra-vaginal, cervical, rectal or 
intra-anal warts is not recommended. Imiquimod cream therapy should not be initiated in tissues 
where open sores or wounds exist until after the area has healed.  
 
Local skin reactions such as erythema, erosion, excoriation, flaking and oedema are common. Other 
local reactions such as induration, ulceration, scabbing, and vesicles have also been reported. Should 
an intolerable skin reaction occur, the cream should be removed by washing the area with mild soap 
and water. Treatment with imiquimod cream can be resumed after the skin reaction has moderated. 
The risk of severe local skin reactions may be increased when imiquimod is used at higher than 
recommended doses (see section 4.2). However, in rare cases severe local reactions that have required 
treatment and/or caused temporary incapacitation have been observed in patients who have used 
imiquimod according to the instructions. Where such reactions have occurred at the urethral meatus, 
some women have experienced difficulty in urinating, sometimes requiring emergency catheterisation 
and treatment of the affected area. 
 
No clinical experience exists with imiquimod cream immediately following treatment with other 
cutaneously applied drugs for treatment of external genital or perianal warts. Imiquimod cream should 
be washed from the skin before sexual activity. Imiquimod cream may weaken condoms and 
diaphragms, therefore concurrent use with imiquimod cream is not recommended. Alternative forms 
of contraception should be considered. 
 
In immunocompromised patients, repeat treatment with imiquimod cream is not recommended. 
 

While limited data have shown an increased rate of wart reduction in HIV positive patients, 
imiquimod cream has not been shown to be as effective in terms of wart clearance in this patient 
group. 
 
Superficial basal cell carcinoma: 
 
Imiquimod has not been evaluated for the treatment of basal cell carcinoma within 1 cm of the eyelids, 
nose, lips or hairline. 



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During therapy and until healed, affected skin is likely to appear noticeably different from normal 
skin. Local skin reactions are common but these reactions generally decrease in intensity during 
therapy or resolve after cessation of imiquimod cream therapy. There is an association between the 
complete clearance rate and the intensity of local skin reactions (e.g. erythema). These local skin 
reactions may be related to the stimulation of local immune response. If required by the patient’s 
discomfort or the severity of the local skin reaction, a rest period of several days may be taken. 
Treatment with imiquimod cream can be resumed after the skin reaction has moderated. 
 
The clinical outcome of therapy can be determined after regeneration of the treated skin, 
approximately 12 weeks after the end of treatment. 
 
 
No clinical experience exists with the use of imiquimod cream in immunocompromised patients. 
 
No clinical experience exists in patients with recurrent and previously treated BCCs, therefore use for 
previously treated tumours is not recommended. 
 
Data from an open label clinical trial suggest that large tumours (>7.25 cm2) are less likely to respond 
to imiquimod therapy. 
 
The skin surface area treated should be protected from solar exposure. 
 
Actinic keratosis 
 
Lesions clinically atypical for AK or suspicious for malignancy should be biopsied to determine 
appropriate treatment. 
 
Imiquimod has not been evaluated for the treatment of actinic keratoses on the eyelids, the inside of 
the nostrils or ears, or the lip area inside the vermilion border. 
 
There are very limited data available on the use of imiquimod for the treatment of actinic keratoses in 
anatomical locations other than the face and scalp. The available data on actinic keratosis on the 
forearms and hands do not support efficacy in this indication and therefore such use is not 
recommended. 
 
Imiquimod is not recommended for the treatment of AK lesions with marked hyperkeratosis or 
hypertrophy as seen in cutaneous horns. 
 
During therapy and until healed, affected skin is likely to appear noticeably different from normal 
skin. Local skin reactions are common but these reactions generally decrease in intensity during 
therapy or resolve after cessation of imiquimod cream therapy. There is an association between the 
complete clearance rate and the intensity of local skin reactions (e.g. erythema). These local skin 
reactions may be related to the stimulation of local immune response. If required by the patient’s 
discomfort or the intensity of the local skin reaction, a rest period of several days may be taken. 
Treatment with imiquimod cream can be resumed after the skin reaction has moderated. 
 
Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods.  
 
The clinical outcome of therapy can be determined after regeneration of the treated skin, 
approximately 4-8 weeks after the end of treatment.  
 
No clinical experience exists with the use of imiquimod cream in immunocompromised patients. 
 
Information on re-treating actinic keratosis lesions that have cleared after one or two courses of 
treatment and subsequently recur is given in section 4.2 and 5.1.  
 



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Data from an open-label clinical trial suggest that subjects with more than 8 AK lesions showed a 
decreased rate of complete clearance compared to patients with less than 8 lesions. 
 
The skin surface area treated should be protected from solar exposure. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. This includes studies with immunosuppressive drugs. 
Interactions with systemic drugs would be limited by the minimal percutaneous absorption of 
imiquimod cream. 
 
Due to its immunostimulating properties, imiquimod cream should be used with caution in patients 
who are receiving immunosuppressive medication (see section 4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
For imiquimod no clinical data on exposed pregnancies are available. Animal studies do not indicate 
direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition 
or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant 
women. 
 
Breast-feeding 
As no quantifiable levels (> 5 ng/ml) of imiquimod are detected in the serum after single and multiple 
topical doses, no specific advice can be given on whether to use or not in lactating mothers. 
 
4.7 Effects on ability to drive and use machines 
 
Aldara cream has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
a) General Description: 
 
External genital warts: 
 
In the pivotal trials with 3 times a week dosing, the most frequently reported adverse drug reactions 
judged to be probably or possibly related to imiquimod cream treatment were application site reactions 
at the wart treatment site (33.7% of imiquimod treated patients). Some systemic adverse reactions, 
including headache (3.7%), influenza-like symptoms (1.1%), and myalgia (1.5%) were also reported. 
 
Patient reported adverse reactions from 2292 patients treated with imiquimod cream in placebo 
controlled and open clinical studies are presented below. These adverse events are considered at least 
possibly causally related to treatment with imiquimod. 
 
Superficial basal cell carcinoma: 
 
In trials with 5 times per week dosing 58% of patients experienced at least one adverse event. The 
most frequently reported adverse events from the trials judged probably or possibly related to 
imiquimod cream are application site disorders, with a frequency of 28.1%. Some systemic adverse 
reactions, including back pain (1.1%) and influenza-like symptoms (0.5%) were reported by 
imiquimod cream patients. 
Patient reported adverse reactions from 185 patients treated with imiquimod cream in placebo 
controlled phase III clinical studies for superficial basal cell carcinoma are presented below. These 
adverse events are considered at least possibly causally related to treatment with imiquimod. 
Actinic keratosis 



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In the pivotal trials with 3 times per week dosing for up to 2 courses each of 4 weeks, 56% of 
imiquimod patients reported at least one adverse event. The most frequently reported adverse event 
from these trials judged probably or possibly related to imiquimod cream was application site 
reactions (22% of imiquimod treated patients). Some systemic adverse reactions, including myalgia 
(2%) were reported by imiquimod treated patients.  
 
Patient reported adverse reactions from 252 patients treated with imiquimod cream in vehicle 
controlled phase III clinical studies for actinic keratosis are presented below. These adverse events are 
considered at least possibly causally related to treatment with imiquimod. 
 
b) Tabular Listing of adverse events: 
 
Frequencies are defined as Very common (1/10), Common (1/100 to <1/10) and Uncommon 
(1/1,000 to <1/100). Lower frequencies from clinical trials are not reported here. 
 
 External genital 

warts  
(3x/ wk,16wks)  
N = 2292 

Superficial basal 
cell carcinoma 
(5x/wk, 6 wks)  
N = 185 

Actinic keratosis  
 
(3x/wk, 4 or 8 wks) 
N = 252 

Infections and infestations:    
Infection Common Common Uncommon 
Pustules  Common Uncommon 
Herpes simplex Uncommon   
Genital candidiasis Uncommon   
Vaginitis Uncommon   
Bacterial infection Uncommon   
Fungal infection Uncommon   
Upper respiratory tract infection Uncommon   
Vulvitis Uncommon   
Rhinitis   Uncommon 
Influenza   Uncommon 

Blood and lymphatic system 
disorders: 

   

Lymphadenopathy Uncommon Common Uncommon 
Metabolism and nutrition disorders:    

Anorexia Uncommon  Common 
Psychiatric disorders:    

Insomnia  Uncommon   
Depression Uncommon  Uncommon 
Irritability  Uncommon  

Nervous system disorders:    
Headache Common  Common 
Paraesthesia Uncommon   
Dizziness Uncommon   
Migraine Uncommon   
Somnolence Uncommon   

Eye disorders    
Conjunctival irritation   Uncommon 
Eyelid oedema   Uncommon 

Ear and labyrinth disorders:    
Tinnitus Uncommon   

Vascular disorders:    
Flushing Uncommon   



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Respiratory, thoracic and 
mediastinal disorders: 

   

Pharyngitis Uncommon   
Rhinitis Uncommon   
Nasal congestion   Uncommon 
Pharyngo laryngeal pain   Uncommon 

Gastrointestinal disorders:    
Nausea Common Uncommon Common 
Abdominal pain Uncommon   
Diarrhoea Uncommon  Uncommon 
Vomiting Uncommon   
Rectal disorder Uncommon   
Rectal tenesmus Uncommon   
Dry mouth  Uncommon  

Skin and subcutaneous tissue 
disorders: 

   

Pruritus Uncommon   
Dermatitis Uncommon Uncommon  
Folliculitis Uncommon   
Rash erythematous Uncommon   
Eczema Uncommon   
Rash Uncommon   
Sweating increased Uncommon   
Urticaria Uncommon   
Actinic keratosis   Uncommon 
Erythema   Uncommon 
Face oedema   Uncommon 
Skin ulcer   Uncommon 

Musculoskeletal and connective 
tissue disorders: 

   

Myalgia Common  Common 
Arthralgia Uncommon  Common 
Back pain Uncommon Common  
Pain in extremity   Uncommon 

Renal and urinary disorders:    
Dysuria Uncommon   

Reproductive system and breast 
disorders: 

   

Genital pain male Uncommon   
Penile disorder Uncommon   
Dyspareunia Uncommon   
Erectile dysfunction Uncommon   
Uterovaginal prolapse Uncommon   
Vaginal pain Uncommon   
Vaginitis atrophic Uncommon   
Vulval disorder Uncommon   

General disorders and 
administration site conditions: 

   

Application site pruritus Very common Very common Very common 
Application site pain Very common Common Common 
Application site burning Common Common Common 
Application site irritation Common Common Common 
Application site erythema  Common Common 
Application site reaction   Common 



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Application site bleeding  Common Uncommon 
Application site papules  Common Uncommon 
Application site paraesthesia  Common Uncommon 
Application site rash  Common  
Fatigue Common  Common 
Pyrexia Uncommon  Uncommon 
Influenza-like illness Uncommon Uncommon  
Pain Uncommon   
Asthenia Uncommon  Uncommon 
Malaise Uncommon   
Rigors Uncommon  Uncommon 
Application site dermatitis   Uncommon 
Application site discharge  Uncommon Uncommon 
Application site hyperaesthesia   Uncommon 
Application site inflammation  Uncommon  
Application site oedema  Uncommon Uncommon 
Application site scabbing  Uncommon Uncommon 
Application site scar   Uncommon 
Application site skin breakdown  Uncommon  
Application site swelling  Uncommon Uncommon 
Application site ulcer   Uncommon 
Application site vesicles  Uncommon Uncommon 
Application site warmth   Uncommon 
Lethargy  Uncommon  
Discomfort   Uncommon 
Inflammation   Uncommon 

 
c) Frequently occurring adverse events: 
 
External genital warts: 
 
Investigators of placebo controlled trials were required to evaluate protocol mandated clinical signs 
(skin reactions). These protocol mandated clinical sign assessments indicate that local skin reactions 
including erythema (61%), erosion (30%), excoriation/flaking/scaling (23%) and oedema (14%) were 
common in these placebo controlled clinical trials with imiquimod cream applied three times weekly 
(see section 4.4). Local skin reactions, such as erythema, are probably an extension of the 
pharmacologic effects of imiquimod cream.  
 
Remote site skin reactions, mainly erythema (44%), were also reported in the placebo controlled trials. 
These reactions were at non-wart sites which may have been in contact with imiquimod cream. Most 
skin reactions were mild to moderate in severity and resolved within 2 weeks of treatment 
discontinuation. However, in some cases these reactions have been severe, requiring treatment and/or 
causing incapacitation. In very rare cases, severe reactions at the urethral meatus have resulted in 
dysuria in women (see section 4.4). 
 
Superficial basal cell carcinoma: 
 
Investigators of the placebo controlled clinical trials were required to evaluate protocol mandated 
clinical signs (skin reactions). These protocol mandated clinical sign assessments indicate that severe 
erythema (31%) severe erosions (13%) and severe scabbing and crusting (19%) were very common in 
these trials with imiquimod cream applied 5 times weekly. Local skin reactions, such as erythema, are 
probably an extension of the pharmacologic effect of imiquimod cream. 
 
Skin infections during treatment with imiquimod have been observed. While serious sequelae have not 
resulted, the possibility of infection in broken skin should always be considered.  



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Actinic keratosis 
 
In clinical trials of imiquimod cream 3 times weekly for 4 or 8 weeks the most frequently occurring 
application site reactions were itching at the target site (14%) and burning at the target site (5%). 
Severe erythema (24%) and severe scabbing and crusting (20%) were very common. Local skin 
reactions, such as erythema, are probably an extension of the pharmacologic effect of imiquimod 
cream. See 4.2 and 4.4 for information on rest periods. 
 
Skin infections during treatment with imiquimod have been observed. While serious sequelae have not 
resulted, the possibility of infection in broken skin should always be considered. 
 
d) Adverse events applicable to all indications:  
 
Reports have been received of localised hypopigmentation and hyperpigmentation following 
imiquimod cream use. Follow-up information suggests that these skin colour changes may be 
permanent in some patients. In a follow-up of 162 patients five years after treatment for sBCC a mild 
hypopigmentation was observed in 37% of the patients and a moderate hypopigmentation was 
observed in 6% of the patients. 56% of the patients have been free of hypopigmentation; 
hyperpigmentation has not been reported. 
 
Clinical studies investigating the use of imiquimod for the treatment of actinic keratosis have detected 
a 0.4% (5/1214) frequency of alopecia at the treatment site or surrounding area. Postmarketing reports 
of suspected alopecia occurring during the treatment of sBCC and EGW have been received. 
 
Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been 
observed in clinical trials. These reductions are not considered to be clinically significant in patients 
with normal haematologic reserve. Patients with reduced haematologic reserve have not been studied 
in clinical trials. Reductions in haematological parameters requiring clinical intervention have been 
reported from postmarketing experience. There have been postmarketing reports of elevated liver 
enzymes. 
 
Rare reports have been received of exacerbation of autoimmune conditions. 
 
Rare cases of remote site dermatologic drug reactions, including erythema multiforme, have been 
reported from clinical trials. Serious skin reactions reported from postmarketing experience include 
erythema multiforme, Stevens Johnson syndrome and cutaneous lupus erythematosus. 
 
e) Paediatric population: 
 
Imiquimod was investigated in controlled clinical studies with paediatric patients (see sections 4.2 and 
5.1). There was no evidence for systemic reactions. Application site reactions occurred more 
frequently after imiquimod than after vehicle, however, incidence and intensity of these reactions were 
not different from that seen in the licensed indications in adults. There was no evidence for serious 
adverse reaction caused by imiquimod in paediatric patients. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
 
 
4.9 Overdose 
 



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When applied topically, systemic overdosage with imiquimod cream is unlikely due to minimal 
percutaneous absorption. Studies in rabbits reveal a dermal lethal dose of greater than 5 g/kg. 
Persistent dermal overdosing of imiquimod cream could result in severe local skin reactions. 
Following accidental ingestion, nausea, emesis, headache, myalgia and fever could occur after a single 
dose of 200 mg imiquimod which corresponds to the content of approximately 16 sachets. The most 
clinically serious adverse event reported following multiple oral doses of  200 mg was hypotension 
which resolved following oral or intravenous fluid administration. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
 
Pharmacotherapeutic group: Chemotherapeutics for topical use, antivirals, ATC Code: D06BB10  
 
Imiquimod is an immune response modifier. Saturable binding studies suggest a membrane receptor 
for imiquimod exists on responding immune cells. Imiquimod has no direct antiviral activity. In 
animal models imiquimod is effective against viral infections and acts as an antitumour agent 
principally by induction of alpha interferon and other cytokines. The induction of alpha interferon and 
other cytokines following imiquimod cream application to genital wart tissue has also been 
demonstrated in clinical studies. 
 
Increases in systemic levels of alpha interferon and other cytokines following topical application of 
imiquimod were demonstrated in a pharmacokinetic study. 
 
External genital warts: 
 
Clinical Efficacy 
 
The results of 3 phase III pivotal efficacy studies showed that treatment with imiquimod for sixteen 
weeks was significantly more effective than treatment with vehicle as measured by total clearance of 
treated warts. 
 
In 119 imiquimod-treated female patients, the combined total clearance rate was 60% as compared to 
20% in 105 vehicle-treated patients (95% CI for rate difference: 20% to 61%, p<0.001). In those 
imiquimod patients who achieved total clearance of their warts, the median time to clearance was 
8 weeks. 
 
In 157 imiquimod-treated male patients, the combined total clearance rate was 23% as compared to 
5% in 161 vehicle-treated patients (95%CI for rate difference: 3% to 36%, p<0.001). In those 
imiquimod patients who achieved total clearance of their warts, the median time to clearance was 
12 weeks. 
 
Superficial basal cell carcinoma: 
 
Clinical efficacy: 
 
The efficacy of imiquimod 5 times per week for 6 weeks was studied in two double-blind vehicle 
controlled clinical trials. Target tumours were histologically confirmed single primary superficial basal 
cell carcinomas with a minimum size of 0.5 cm2 and a maximum diameter of 2 cm. Tumours located 
within 1 cm of the eyes, nose, mouth, ears or hairline were excluded. In a pooled analysis of these two 
studies, histological clearance was noted in 82% (152/185) of patients. When clinical assessment was 
also included, clearance judged by this composite endpoint was noted in 75% (139/185) of patients. 
These results were statistically significant (p<0.001) by comparison with the vehicle group, 3% 
(6/179) and 2% (3/179) respectively. There was a significant association between the intensity of local 



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skin reactions (e.g. erythema) seen during the treatment period and complete clearance of the basal 
cell carcinoma.  
 
Five -year data from a long-term open-label uncontrolled study indicate that an estimated 77.9% 
[95% CI (71.9%, 83.8%)] of all the subjects who initially received treatment became clinically clear 
and remained clear at 60 months.  
 
Actinic keratosis: 
 
Clinical efficacy: 
 
The efficacy of imiquimod applied 3 times per week for one or two courses of 4 weeks, separated by a 
4 week treatment-free period, was studied in two double-blind vehicle controlled clinical trials. 
Patients had clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions on the 
balding scalp or face within a contiguous 25 cm2 treatment area. 4-8 AK lesions were treated. The 
complete clearance rate (imiquimod minus placebo) for the combined trials was 46.1% (CI 39.0%, 
53.1%).  
 
One-year data from two combined observational studies indicate a recurrence rate of 27% 
(35/128 patients) in those patients who became clinically clear after one or two courses of treatment. 
The recurrence rate for individual lesions was 5.6% (41/737). Corresponding recurrence rates for 
vehicle were 47% (8/17 patients) and 7.5% (6/80 lesions).  
 
Two open-label, randomised, controlled clinical trials compared the long-term effects of imiquimod 
with those of topical diclofenac in patients with actinic keratosis with respect to the risk of progression 
to in situ or invasive squamous cell carcinoma (SCC). Treatments were given as officially 
recommended. If the treated AK field was not completely cleared of lesions, additional treatment 
cycles could be started. All patients were followed-up until withdrawal or up to 3 years after 
randomisation. Results are emerged from a meta-analysis of both trials. 
 
A total of 482 patients were included into the trials, of these 481 patients received study treatments, 
and of these 243 patients were treated with imiquimod and 238 patients with topical diclofenac. The 
treated AK field was located on the balding scalp or face with a contiguous area of about 40 cm² for 
both treatment groups presenting with a median number of 7 clinically typical AK lesions at baseline. 
There is clinical experience from 90 patients who got 3 or more imiquimod treatment cycles, 80 
patients received 5 or more courses of imiquimod treatment over the 3-year study period. 
 
Regarding the primary endpoint, histological progression, overall 13 of 242 patients (5.4%) of the 
imiquimod group and 26 of 237 patients (11.0%) of the diclofenac group were found to have a 
histological progression to in situ or invasive SCC within 3 years, a difference of -5.6% (95% CI:  
-10.7% to -0.7%). Thereof 4 of 242 patients (1.7%) of the imiquimod and 7 of 237 patients (3.0%) of 
the diclofenac group were found to have a histological progression to invasive SCC within the 3-year 
period. 
A total of 126 of 242 patients treated with imiquimod (52.1%) and 84 of 237 patients treated with 
topical diclofenac (35.4%) showed complete clinical clearance of the treated AK field at week 20 (i.e. 
about 8 weeks after the end of the initial treatment cycle); a difference of 16.6% (95% CI: 7.7% to 
25.1%). For those patients with complete clinical clearance of the treated AK field recurrence of AK 
lesions was evaluated. A patient was counted as recurrent in these trials if at least one AK lesion was 
observed in the completely cleared field whereby a recurrent lesion could be a lesion which occurred 
at the same location as a formerly cleared lesion or a newly identified lesion anywhere in the treated 
AK field. The risk for recurrence of AK lesions in the treated field (as defined above) was 39.7% (50 
of 126 patients) until month 12 for patients treated with imiquimod compared with 50.0% (42 of 84 
patients) for patients treated with topical diclofenac, a difference of -10.3% (95% CI: -23.6% to 3.3%); 
and 66.7% (84 of 126 patients) for a treatment with imiquimod and 73.8% (62 of 84 patients) for 
topical diclofenac until month 36, a difference of -7.1% (95% CI: -19.0% to 5.7%). 



14 

A patient with recurrent AK lesions (as defined above) in the completely cleared field had a chance of 
about 80% to become completely cleared again following an additional imiquimod treatment cycle 
compared with a chance of about 50% for a re-treatment with topical diclofenac. 
 
Paediatric population  
 
The approved indications genital warts, actinic keratosis and superficial basal cell carcinoma are 
conditions not generally seen within the paediatric population and were not studied. 
Aldara Cream has been evaluated in four randomised, vehicle controlled, double-blind trials in 
children aged 2 to 15 years with molluscum contagiosum (imiquimod n = 576, vehicle n = 313). These 
trials failed to demonstrate efficacy of imiquimod at any of the tested dosage regimens (3x/week 
for ≤16 weeks and 7x/week for ≤8 weeks). 
 
5.2 Pharmacokinetic properties 
 
External genital warts, superficial basal cell carcinoma and actinic keratosis: 
 
Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through 
the skin of human subjects. The small amount of drug which was absorbed into the systemic 
circulation was promptly excreted by both urinary and faecal routes at a mean ratio of approximately 
3 to 1. No quantifiable levels (>5 ng/ml) of drug were detected in serum after single or multiple topical 
doses. 
 
Systemic exposure (percutaneous penetration) was calculated from recovery of carbon-14 from 14C 
imiquimod in urine and faeces. 
 
Minimal systemic absorption of imiquimod 5% cream across the skin of 58 patients with actinic 
keratosis was observed with 3 times per week dosing for 16 weeks. The extent of percutaneous 
absorption did not change significantly between the first and last doses of this study. Peak serum drug 
concentrations at the end of week 16 were observed between 9 and 12 hours and were 0.1, 0.2, and 
1.6 ng/mL for the applications to face (12.5 mg, 1 single-use sachet), scalp (25 mg, 2 sachets) and 
hands/arms (75 mg, 6 sachets), respectively. The application surface area was not controlled in the 
scalp and hands/ arms groups. Dose proportionality was not observed. An apparent half-life was 
calculated that was approximately 10 times greater than the 2 hour half-life seen following 
subcutaneous dosing in a previous study, suggesting prolonged retention of drug in the skin. Urinary 
recovery was less than 0.6% of the applied dose at week 16 in these patients. 
 
Paediatric population 
The pharmacokinetic properties of imiquimod following single and multiple topical application in 
paediatric patients with molluscum contagiosum (MC) have been investigated. The systemic exposure 
data demonstrated that the extent of absorption of imiquimod following topical application to the MC 
lesional skin of the paediatric patients aged 6-12 years was low and comparable to that observed in 
healthy adults and adults with actinic keratosis or superficial basal cell carcinoma. In younger patients 
aged 2-5 years absorption, based on Cmax values, was higher compared to adults. 
 
5.3 Preclinical safety data 
 
Non-clinical data revealed no special hazard for humans based on conventional studies of safety 
pharmacology, mutagenicity and teratogenicity.  
In a four-month rat dermal toxicity study, significantly decreased body weight and increased spleen 
weight were observed at 0.5 and 2.5 mg/kg; similar effects were not seen in a four month mouse 
dermal study. Local dermal irritation, especially at higher doses, was observed in both species.  
 
A two-year mouse carcinogenicity study by dermal administration on three days a week did not induce 
tumours at the application site. However, the incidences of hepatocellular tumours among treated 
animals were greater than those for controls. The mechanism for this is not known, but as imiquimod 



15 

has low systemic absorption from human skin, and is not mutagenic, any risk to humans from systemic 
exposure is likely to be low. Furthermore, tumours were not seen at any site in a 2-year oral 
carcinogenicity study in rats. 
 
Imiquimod cream was evaluated in a photocarcinogenicity bioassay in albino hairless mice exposed to 
simulated solar ultraviolet radiation (UVR). Animals were administered imiquimod cream three times 
per week and were irradiated 5 days per week for 40 weeks. Mice were maintained for an additional 
12 weeks for a total of 52 weeks. Tumours occurred earlier and in greater number in the group of mice 
administered the vehicle cream in comparison with the low UVR control group. The significance for 
man is unknown. Topical administration of imiquimod cream resulted in no tumour enhancement at 
any dose, in comparison with the vehicle cream group. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
isostearic acid  
benzyl alcohol  
cetyl alcohol  
stearyl alcohol  
white soft paraffin  
polysorbate 60  
sorbitan stearate  
glycerol 
methyl hydroxybenzoate (E 218) 
propyl hydroxybenzoate (E 216) 
xanthan gum 
purified water. 
 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
Do not store above 25 °C. 
Sachets should not be re-used once opened. 
 
6.5 Nature and contents of container 
 
Boxes of 12 or 24 single-use polyester/aluminium foil sachets, containing 250 mg of cream. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
No special requirements. 
 
7. MARKETING AUTHORISATION HOLDER 
 
Meda AB 



16 

Pipers väg 2A 
170 73 Solna 
Sweden 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/98/080/001-002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 18/09/1998 
Date of last renewal: 03/09/2008 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 



18 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Swiss Caps GmbH 
Grassingerstraße 9 
83043 Bad Aibling 
Germany  
 
3M Health Care Limited 
Derby Road 
Loughborough 
Leicester 
LE11 5SF 
United Kingdom 
 
MEDA Pharma GmbH & Co. KG 
Benzstraße 1 
61352 Bad Homburg 
Germany 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medicinal prescription. 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 

 
The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the 
same time. 
 



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Aldara 5% cream  
imiquimod 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %). 
100 mg cream contains 5 mg imiquimod  
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, 
polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl hydroxybenzoate 
(E 216), xanthan gum, purified water. 
 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Cream 
12 sachets. Each containing 250 mg of cream. 
24 sachets. Each containing 250 mg of cream. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Cutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
For single use only. Discard any cream remaining in a sachet after use. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 



22 

 
Do not store above 25 C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Meda AB 
Box 906 
170 09 Solna 
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/98/080/001 12 sachets 
EU/1/98/080/002 24 sachets 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Aldara 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



23 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS  
 
SACHET TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Aldara 5% cream  
Imiquimod 
Cutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
250 mg cream  
 
 
6. OTHER 
 
 



24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 

B. PACKAGE LEAFLET 
 
 
 



25 

Package leaflet: Information for the user 
 

Aldara 5% cream 
Imiquimod 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, please ask your doctor or your pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If any get any side effects talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 

1.   What Aldara cream is and what it is used for 
2.   What you need to know before you use Aldara cream 
3.   How to use Aldara cream 
4.   Possible side effects 
5.   How to store Aldara cream  
6.   Contents of the pack and other information 

 
 
1. What Aldara cream is and what it is used for 
 
Aldara cream may be used for three different conditions. Your doctor may prescribe Aldara cream 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 your doctor has decided that Aldara is the most appropriate treatment for you. 

 
Aldara cream helps your body´s own immune system to produce natural substances which help fight 
your basal cell carcinoma, actinic keratosis or the virus that has caused your warts.  
 
2. What you need to know before you use Aldara cream 
 
Do not use Aldara cream 
 
- if you are allergic to imiquimod or any of the other ingredients of this medicine (listed in section 

6). 
Warnings and precautions 
 



26 

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 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. 
• Do not use more cream than your doctor has advised. 
• Do not cover the treated area with bandages or other dressings after you have applied Aldara 

cream. 
• If the treated site becomes too uncomfortable, wash the cream off with mild soap and water. 

As soon as the problem has stopped you may restart to apply the cream. 
• Tell your doctor if you 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. 
 

• If you are being treated for genital warts follow these additional precautions: 
 
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 and call your doctor. 
If you have open sores: do not start using Aldara cream until after the sores have healed. 
If you have internal warts: do 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 your 
anus (rectum). 
Do not use this medication for more than one course if you have problems with your immune 
system, either due to illness or because of the medicines you are already taking. If you think this 
applies to you talk to your doctor. 
If you are HIV positive you should inform your doctor as Aldara cream has not been shown to 
be as effective in HIV positive patients.  
If you decide to have sexual relations while you still have warts, 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. 

 
• If you are being treated for basal cell carcinoma or actinic keratosis follow these additional 

precautions: 
 
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. 
 
Children and adolescents 
 
Use in children and adolescents is not recommended. 
 
 
Other medicines and Aldara cream  
 



27 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
There are no medicines known to be incompatible with Aldara cream. 
 
Pregnancy and breast-feeding 
 
Ask your doctor or pharmacist for advice before taking any medicine. 
You must tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss 
the risks and benefits of using Aldara cream during pregnancy. Studies in animals do not indicate 
direct or indirect harmful effects in pregnancy. 
 
Do not breast-feed your infant during treatment with Aldara cream, as it is not known whether 
imiquimod is secreted in human milk. 
 
Driving and using machines 
 
This medicine has no or negligible influence on the ability to drive and use machines. 
 
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. 
 
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. 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).  
 

 
 
 

• If you are being treated for genital warts: 
 



28 

Application Instructions – (Mon, Wed and Fri) 
1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry 
thoroughly. 
2. Open a new sachet and squeeze some cream onto your 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 
section 2 “Warnings and precautions”) 
 
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. 
 

•  If you are being treated for basal cell carcinoma: 
 
Application Instructions – (Mon, Tues, Wed, Thurs and Fri) 
1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry 
thoroughly. 
2. Open a new sachet and squeeze some cream onto your fingertip. 
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. 
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. 
 

• 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 
thoroughly. 
2. Open a new sachet and squeeze some cream onto your 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, your doctor will 
assess your skin. If the lesions have not all disappeared, further four weeks of treatment may be 
necessary. 



29 

 
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 medicine, 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, 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 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 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 



30 

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. 
 
● 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. 
 
●  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. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
5. How to store Aldara cream 
 
Keep this medicine out of the sight and reach of children. 
 
Do not store above 25 °C. 



31 

 
Do not use this medicine after the expiry date which is stated on the outer carton and the label after 
EXP. 
 
Sachets should not be re-used once opened. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Aldara cream contains 
 
- The active substance is imiquimod. Each sachet contains 250 mg cream (100 mg cream contains 

5 mg imiquimod). 
- The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft 

paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl 
hydroxybenzoate (E 216), xanthan gum, purified water (see also section 2 “Aldara cream 
contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and 
benzyl alcohol”). 

 
What Aldara cream looks like and contents of the pack 
 
- Each Aldara 5% cream sachet contains 250 mg of a white to slightly yellow cream. 
- Each box contains 12 or 24 single-use polyester/aluminium foil sachets. Not all pack sizes may 
 be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 

Meda AB 
Pipers väg 2 
170 73 Solna 
Sweden 

 
Manufacturer 

Swiss Caps GmbH 
Grassingerstraße 9 
83043 Bad Aibling 
Germany 

 
3M Health Care Limited 
Derby Road 
Loughborough 
Leicestershire 
LE11 5SF, United Kingdom 
 
MEDA Pharma GmbH & Co. KG 
Benzstraße 1 
61352 Bad Homburg 
Germany 
 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien Luxembourg/Luxemburg 



32 

Mylan EPD bvba/sprl 
Terhulpsesteenweg, 6A 
B-1560 Hoeilaart 
Tél/Tel: +32 2 658 61 00 
 

Mylan EPD bvba/sprl 
Terhulpsesteenweg, 6A 
B-1560 Hoeilaart 
Tél/Tel: +32 2 658 61 00 
 

България 
Майлан ЕООД 
бул. Ситняково 48, ет. 7 
Офис сграда „Сердика Офиси“ 
1505 София 
Тел: +359 2 44 55 400 
 

Magyarország 
Mylan EPD Kft. 
1138 Budapest 
Váci út 150 
Tel: +36 465 2100 
 

Česká republika 
MEDA Pharma s.r.o. 
Evropská 2590/33C 
Prague 6 160 00 
Tel: +420 222 004 400 
 

Malta 
V.J. Salomone Pharma Limited 
Upper Cross Road 
Marsa, MRS 1542 
Tel: +356 21 22 01 74 
 

Danmark 
Mylan Denmark ApS 
Borupvang 1 
2750 Ballerup 
Tlf: +45 28 11 69 32 
 

Nederland 
Mylan Healthcare B.V. 
Krijgsman 20 
1186 DM Amstelveen 
Tel: +31 (0)20 426 3300 
 

Deutschland 
MEDA Pharma GmbH & Co. KG 
Benzstraße 1 
61352 Bad Homburg 
Tel: +49 (0) 6172 888 01 
 

Norge 
Mylan Healthcare Norge AS  
Hagaløkkveien 26 
1383 Asker 
Tlf: +47 66 75 33 00 
 

Eesti 
Meda Pharma SIA 
Liivalaia 13/15  
11018 Tallinn 
Tel: +372 62 61 025 
 

Österreich 
MEDA Pharma GmbH 
Guglgasse 15 
1110 Wien 
Tel: + 43 (0)1 86 390 0 
 

Ελλάδα 
MEDA Pharmaceuticals A.E. 
Αγίου Δημητρίου 63 
17456 Άλιμος  
Τηλ: +30 210 6 77 5690 
 

Polska 
Mylan Healthcare Sp. z o.o. 
ul. Postępu 21B 
02-676 Warszawa 
Tel: +48 22 546 6400 
 

España 
Mylan Pharmaceuticals, S.L. 
C/Plom, 2-4, 5ª planta 
08038 - Barcelona 
Tel: +34 900 102 712 
 

Portugal 
BGP Products, Unipessoal, Lda. 
Av. D. João II,  
Edifício Atlantis, nº 44C – 7.3 e 7.4 
1990-095 Lisboa 
Tel: +351 214 127 200 
 

France 
Mylan Medical SAS 
40-44 rue Washington 
75008 Paris 
Tél: +33 (0)1 56 64 10 70 
 

România 
BGP PRODUCTS SRL 
Reprezentanța Romania 
Calea Floreasca nr. 169A 
Floreasca Business Park 
014459 București 
Tel.: +40372 579 000 



33 

 
Hrvatska 
Mylan Hrvatska d.o.o. 
Koranska 2 
10 000  Zagreb 
Tel: +385 1 235 059 90 

Slovenija 
Mylan Healthcare d.o.o. 
Dolenjska cesta 242c 
1000 Ljubljana 
Tel: +386 1 23 63 180 
 

Ireland 
Mylan Ireland Limited 
Newenham Court 
Northern Cross, Malahide Road 
Dublin 17 
Tel: +353 (0) 87 1694982 
 

Slovenská republika 
MEDA Pharma spol. s r.o. 
Trnavská cesta 50 
821 02 Bratislava 
Tel: +421 2 32 199 100 
 

Ísland 
Icepharma hf 
Lyngháls 13 
110 Reykjavík 
Sími: +354 540 8000 
 

Suomi/Finland 
Meda Oy 
Vaisalantie 4/Vaisalavägen 4 
02130 Espoo/Esbo 
Puh/Tel: +358 20 720 9550 
 

Italia 
Meda Pharma S.p.A. 
Via Felice Casati, 20 
20124 Milano 
Tel: +39 039 73901 
 

Sverige 
Meda AB 
Box 906 
170 09 Solna 
Tel: +46 (0)8 630 1900 
 

Κύπρος 
Βαρνάβας Χατζηπαναγής Λτδ 
Λεωφ. Γιάννου Κρανιδιώτη 226 
ΤK 2234, Λατσιά, Λευκωσία 
Τηλ.: +357 22207700 
 

United Kingdom 
Mylan Products Ltd. 
Station Close  
Potters Bar  
Hertfordshire  
EN6 1TL 
Tel: +44 1707 853000 

Latvija 
Meda Pharma SIA 
101 Mūkusalas str. 
Rīga LV‐1004 
Tālr: +371 67616137 
 

 

 
Lietuva 
Meda Pharma SIA 
Žalgirio str. 90-100 
Vilnius LT-09303  
Tel. + 370 52059367 
 

 

This leaflet was last revised in (MM/YYYY). 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET