Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Bascellex 50 mg/g cream
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Imiquimod may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Your doctor may prescribe Bascellex for the treatment of –
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. Bascellex 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 Bascellex is the most appropriate treatment for you.
Bascellex helps your body's own immune system to produce natural substances which help fight your actinic keratosis. 2.
What you need to know before you take it
e Bascellex
Do not use Bascellex if you are allergic to imiquimod or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Bascellex: if you have previously used Bascellex or other similar preparations if you suffer from autoimmune disorders if you have had an organ transplant if you have an abnormal blood count –
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Do not use Bascellex until the area to be treated has healed after previous drug or surgical treatment
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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 Bascellex 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 Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Bascellex. Wear protective clothing and wide brimmed hats when outdoors.
Because of the way Bascellex works, there is a possibility that the cream may worsen existing inflammation in the treatment area. Whilst using Bascellex 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 Bascellex 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 Bascellex. 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 Bascellex during pregnancy. Do not breast-feed your infant during treatment with Bascellex, 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. Bascellex contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed). Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Benzyl alcohol may cause mild local irritation. 3.
How to take it
Bascellex
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 Bascellex. 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.
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Bascellex Cream Application Instructions
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Application Instructions 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 and wash hands with soap and water. 5. Leave Bascellex on the skin for about 8 hours. Do not shower or bathe during this time. 6. After about 8 hours, wash the area where Bascellex was applied with mild soap and water. Apply Bascellex 3 times per week, e.g. on Monday, Wednesday and Friday. One sachet contains enough cream to cover an area of 25 cm2 (approx. 4 square inches). Continue treatment for 4 weeks. Four weeks after finishing this first treatment, your doctor will assess your skin. If the lesions have not all disappeared, a further 4 weeks of treatment may be necessary. If you use more Bascellex than you should Wash the extra cream away with mild soap and water. When any skin reaction has gone you may then continue with your treatment. If you accidentally swallow Bascellex please contact your doctor. If you forget to use Bascellex 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
Like all medicines, this medicine can cause side effects, although not everybody gets them. –
Serious skin reactions have been reported rarely. Stop using Bascellex and tell your doctor immediately 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 Bascellex and tell your doctor immediately.
Tell your doctor or pharmacist as soon as possible
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if you do not feel well while you are using Bascellex if your skin reacts badly when using Bascellex. Stop applying the cream and wash the area with mild soap and water. if you are more susceptible to infections, you bruise more easily or you feel fatigued. These may be symptoms of a lowering of blood cell counts noted in some individuals.
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Some patients have experienced changes in skin colour in the area where Bascellex was applied. While these changes have tended to improve with time, in some patients they may be permanent. Some patients who suffer from autoimmune disorders may experience worsening of their condition. If you notice any change during treatment with Bascellex, talk to your doctor. A small number of patients have experienced hair loss at the treatment site or surrounding area. Other side effects Many of the undesirable effects of Bascellex are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended. Very common (may affect more than 1 in 10 patients) skin may be slightly itchy. Common (may affect up to 1 in 10 patients) pain burning irritation redness headache anorexia nausea muscle pain joint pain tiredness. If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Bascellex 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. Uncommon (may affect up to 1 in 100 patients) 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) inflammation of the lining of the nose stuffy nose flu or flu-like symptoms depression eye irritation swelling of the eyelid throat pain diarrhea actinic keratosis swelling of the face ulcers pain in extremity fever weakness shivering.
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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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Bascellex
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. 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 protect the environment. 6.
Contents of the pack and other information
What Bascellex contains The active substance is imiquimod. Each sachet contains 12.5 mg of imiquimod in 250 mg cream (1 g of cream contains 50 mg of imiquimod). The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, paraffin white soft, polysorbate 60, sorbitan monostearate, glycerol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), xanthan gum, water, purified. What Bascellex looks like and contents of the pack Bascellex cream is a white to slightly yellow cream. The cream is available in packs containing 12 or 24 single-use aluminium foil sachets (250 mg of cream/sachet). Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87 2132 JH Hoofddorp The Netherlands This medicinal product is authorised in the Member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Belgium: Bascellex Germany: Aksunim France: Bascellex Netherlands: Bascellex Norway: Bascellex Sweden: Bascellex United Kingdom (Northern Ireland): Bascellex
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This leaflet was last revised in 11/2023.
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Frequently asked questions about Bascellex 50 mg/g cream
How do I take Bascellex 50 mg/g cream?
Bascellex 50 mg/g cream comes as cream containing 50mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Bascellex 50 mg/g cream?
The active substance in Bascellex 50 mg/g cream is imiquimod.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Bascellex 50 mg/g cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Bascellex 50 mg/g cream without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: imiquimod
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Imiquimod cream is indicated for the topical treatment of
- 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.
Please also refer to section 5.1.
4.2. Posology and method of administration
Posology
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 imiquimod treatment may be considered.
A different therapy is recommended if the treated lesion(s) shows insufficient response to imiquimod.
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 imiquimod cream following an at least 12 weeks treatment pause (see section 5.1).
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 indication.
Imiquimod should not be used in children with molluscum contagiosum due to lack of efficacy in this indication (see section 5.1).
Method of administration
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
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).
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).
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).
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.
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.
This medicine contains 12.5 mg benzyl alcohol in each sachet which is equivalent to 50 mg/g. Benzyl alcohol may cause mild local irritation.
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
Imiquimod has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
a) General description
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) Tabulated list of adverse reactions
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.
Infections and infestations
Infection
Uncommon
Pustules
Uncommon
Rhinitis
Uncommon
Influenza
Uncommon
Blood and lymphatic system disorders
Lymphadenopathy
Uncommon
Metabolism and nutrition disorders
Anorexia
Common
Psychiatric disorders:
Depression
Uncommon
Nervous system disorders
Headache
Common
Eye disorders
Conjunctival irritation
Uncommon
Eyelid oedema
Uncommon
Respiratory, thoracic and mediastinal disorders
Nasal congestion
Uncommon
Pharyngo laryngeal pain
Uncommon
Gastrointestinal disorders
Nausea
Common
Diarrhoea
Uncommon
Skin and subcutaneous tissue disorders
Actinic keratosis
Uncommon
Erythema
Uncommon
Face oedema
Uncommon
Skin ulcer
Uncommon
Musculoskeletal and connective tissue disorders
Myalgia
Common
Arthralgia
Common
Pain in extremity
Uncommon
General disorders and administration site conditions
Application site pruritus
Very common
Application site pain
Common
Application site burning
Common
Application site irritation
Common
Application site erythema
Common
Application site reaction
Common
Application site bleeding
Uncommon
Application site papules
Uncommon
Application site paraesthesia
Uncommon
Fatigue
Common
Pyrexia
Uncommon
Asthenia
Uncommon
Rigors
Uncommon
Application site dermatitis
Uncommon
Application site discharge
Uncommon
Application site hyperaesthesia
Uncommon
Application site oedema
Uncommon
Application site scabbing
Uncommon
Application site scar
Uncommon
Application site swelling
Uncommon
Application site ulcer
Uncommon
Application site vesicles
Uncommon
Application site warmth
Uncommon
Discomfort
Uncommon
Inflammation
Uncommon
c) Frequently occurring adverse events
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.
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.
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ALDARA 5% prescriptionIMIQUIMODUM · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- AldaraImiquimodum
- ZyclaraImiquimodum
- ImikeradermImiquimodum
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Bascellex 50 mg/g cream. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.