50 mg / g cream 
imikvimod

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Bascellex is and what it is used for 
2. What you need to know before using Bascellex 
3. How to use Bascellex 
4. Possible side effects 
5. How to store Bascellex 
6. Contents of the packaging and other information 

1. What Bascellex is and what it is used for

Your doctor may prescribe Bascellex for the treatment of

– actinic keratosis.

Actinic keratosis is rough skin areas found in people who have been exposed to too much sunlight during their lifetime. Some are skin colored, others are greyish, pink, red, or brown. They can be thin and scaly or raised, rough, hard, and wart-like. Bascellex is only used for thin actinic keratosis of the face and scalp in patients with normal immune systems when your doctor has decided that Bascellex is the most appropriate treatment.

Bascellex helps your body’s own immune system to produce natural substances that help fight your actinic keratosis.

Imiquimod contained in Bascellex may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

2. What you need to know before using Bascellex

Do not use Bascellex

– if you are allergic to imikvimod or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Bascellex

– if you have previously used Bascellex or other similar preparations

– if you have problems with your immune system

– if you have an abnormal blood cell s

– Do not use Bascellex until the area to be treated has healed after previous treatment with medication or surgery

– Avoid getting cream in the eyes, on the lips, or in the nostrils. If this happens by mistake, the cream is removed by rinsing with water

– Do not use cream internally

– Do not use more cream than your doctor has prescribed

– Do not cover the treated area where you lubricated Bascellex with a bandage or similar

– If you experience too much discomfort in the treated area, wash off cream one with mild soap and water. Once the problems are gone, you can start using cream one again

– Do not use sunlight or tanning beds and avoid sunlight as much as possible during treatment with Bascellex. Wear protective clothing and a wide-brimmed headdress when you are outdoors.

Due to the mechanism of action of Bascellex, there is a possibility that the cream may aggravate existing inflammation in the treatment area.

While using Bascellex and until your skin change has healed, the skin in the treatment area will probably look noticeably altered compared to normal skin.

Children and young people

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. No medicines are known to be incompatible with Bascellex.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss both the risks and benefits of using Bascellex during pregnancy.

It is not known whether imikvimod is excreted in human milk. Therefore, do not breast-feed your baby during treatment with Bascellex.

Driving and using machines

This medicine has no or negligible effect on the ability to drive and use machines.

Bascellex cream 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 can cause local skin reactions (eg contact dermatitis). Benzyl alcohol can cause mild local irritation.

3. How to use Bascellex

Children and young people

Use in children and adolescents is not recommended.

Adults

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Wash your hands thoroughly before and after applying the cream. Do not cover the treated area with bandages or compresses after Bascellex has been applied. Open a new sachet each time you use a cream one. Discard any cream left over after use. Do not save the opened bag for later use.

Bascellex cream Application instructions

Application instructions

Application instructions

1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry carefully.

2. Open a new sachet and squeeze the cream on your fingertip.

3. Apply cream to the affected area. Gently massage cream one into the area until it has penetrated the skin.

4. Once the cream has been applied, discard the opened bag. Wash your hands with soap and water.

5. Leave Bascellex on the skin for about 8 hours. Do not shower or bathe during this time.

After about 8 hours, wash the area where Bascellex was lubricated with mild soap and water.

Apply Bascellex three times a week on Monday, Wednesday, and Friday. A sachet contains enough cream to cover an area of ​​25 cm 2 . Continue treatment for 4 weeks. Four weeks after completing the first treatment, your doctor will assess your skin. If not all skin changes have disappeared, you may need to treat for another 4 weeks.

If you forget to take Bascellex

If you forget to take a sachet, apply a cream as soon as you remember and then continue with the regular schedule. Do not use the cream more than once a day.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

  • Severe skin reactions have been reported but are rare. Stop using Bascellex and tell your doctor immediately if you get sores on the skin or spots on the skin that start as small red areas and develop into small circles, possibly with symptoms such as itching, fever, general malaise, sore joints, vision problems, burning, sore or itchy eyes, and cold sores.

Tell your doctor or pharmacist as soon as possible

  • if you do not feel well when using Bascellex
  • if your skin reacts strongly when using Bascellex, do not apply more cream but wash the area with mild soap and water
  • if you become more susceptible to infection, bruise more easily or feel unusually tired. These may be symptoms of a decrease in the number of blood cells observed in some individuals.

Some patients have experienced a change in skin color in the area where Bascellex was applied. Although these changes usually go back over time, in some patients they can become permanent. A small number of patients have experienced some hair loss at the treatment site or in the surrounding area.

Other side effects ar

Many of the side effects of Bascellex are due to its local effect on your skin. Local skin reactions may be a sign that the medicine is working as intended.

Very common (may affect more than 1 user in 10)

  • the skin may be slightly itchy.

Common (may affect up to 1 in 10 people)

  • pain
  • burning sensation
  • irritation
  • redness
  • headache
  • anorexia
  • nausea
  • muscle pain
  • joint pain
  • fatigue.

If the skin reaction becomes too bothersome during treatment, talk to your doctor. He/she may advise you to stop applying Bascellex for a few days (ie have a short break from treatment). If there are any or other signs of infection, discuss this with your doctor.

Uncommon (may affect up to 1 in 100 people)

  • changes in the site of application (bleeding, inflammation, secretion of fluid, sensitivity, swelling, small swollen areas of the skin, tingling, crusting, scarring, sores, or a feeling of heat or discomfort)
  • inflammation of the nasal mucosa
  • stuffy nose
  • flu or flu-like symptoms
  • Depression
  • eye irritation
  • swollen eyelids
  • sore throat
  • diarrhea
  • Actinic keratosis
  • swollen face
  • wound
  • pain in arms or legs
  • fever
  • weakness
  • tremors.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store 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 sachets after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Dosage bags should not be reused once opened.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration for Bascellex

  • The active substance is imiquimod. Each sachet contains 12.5 mg of imiquimod in 250 mg of cream (1 g of cream contains 50 mg of imiquimod).
  • Excipients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), xanthan gum.

What the medicine looks like and the contents of the pack

Bascellex is white to pale yellow cream.

The cream is available in pack sizes of 12 or 24 single foil bags of aluminum foil, which contain (250 mg cream/sachet).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe BV Polarisavenue 87 2132 JH Hoofddorp Netherlands

This medicinal product is authorized under the European Economic Area under the names

Belgium Bascellex
Germany Aksunim
France Bascellex
Netherlands Bascellex
Norway Bascellex
UK Bascellex

Muhammad Nadeem

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