What Zyclara is and what it is used for
Zyclara 3.75% cream contains the active substance imiquimod, which is an immune response modifier that stimulates the immune system.
This medicine is prescribed for the treatment of actinic keratosis in adults.
This medicine stimulates your body’s immune system to produce natural substances that help fight your actinic keratosis.
Actinic keratoses appear as areas of rough skin that appear on people who have been exposed to large amounts of sunlight during their lifetime. These areas can be the same color as the rest of your skin or be greyish, pink, red, or brown. The skin areas can be flat and scaly or raised, rough, hard, and wart-like.
What you need to know before you use Zyclara
Do not use Zyclara
- if you are allergic to imiquimod or any of the other ingredients of this medicine (see section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Zyclara:
- if you have previously used this medicine or other similar medicines with a different concentration.
- if you suffer from autoimmune diseases
- if you have had an organ transplant
- if you have abnormal blood levels
General instructions during treatment
- If you have recently had surgery or medical treatment, wait until the treated area has healed before you start using this medicine.
- Avoid contact with eyes, lips, and nostrils. In case of accidental contact, remove the cream by rinsing it with water.
- Only use the cream externally ( on the skin of the face or the scalp).
- Do not use more cream than prescribed by your doctor.
- Do not cover the treated area with bandages or other dressings after applying for this medicine.
- If you feel too much discomfort in the treated area, wash off the cream with mild soap and water. Once the discomfort has subsided, you can resume treatment according to your recommended treatment schedule. The cream should not be applied more than once per day.
- Do not use sunlamps or tanning beds and avoid exposure to sunlight as much as possible during treatment with this medicine. If you are outside during the day, use sunscreen and wear protective clothing and a wide-brimmed hat.
Local skin reactions
When using Zyclara, you may experience local skin reactions due to the drug’s mechanism of action on your skin. These reactions may be a sign that the drug is having its intended effect.
While you are using Zyclara and until it has healed, the treatment site will likely look different from your normal skin. There is also a risk that existing inflammation may worsen temporarily.
This medicine may also cause flu-like symptoms (including tiredness, nausea, fever, muscle and joint pain, and chills) before or in conjunction with local skin reactions.
If you get flu-like symptoms or discomfort or a strong local skin reaction, a break of several days can be taken. You can resume treatment with imiquimod cream after the skin reaction has subsided. However, none of the two-week treatments should be extended due to missed doses or periods of rest.
The intensity of local skin reactions may be milder in the second period of treatment than in the first period of treatment with Zyclara.
Response to treatment cannot be adequately assessed until local skin reactions have subsided. You must continue your treatment as prescribed.
This medicine can expose and treat actinic keratoses that have not been seen or felt before, and these may disappear later. You must complete the entire course of treatment even if all actinic keratoses appear to be gone.
Children and young people
This medicine should not be given to children under 18 years of age because its safety and efficacy in patients under 18 years of age have not been established. There are no available data on the use of imiquimod in children and adolescents.
Other medicines and Zyclara
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking immunosuppressive drugs that suppress your immune system, tell your doctor before starting treatment.
Avoid using Zyclara at the same time as other imiquimod creams in the same treatment area.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Your doctor will discuss the risks and benefits of using Zyclara during pregnancy. Animal studies do not show direct or indirect harmful effects on pregnancy.
It is not known whether imiquimod passes into breast milk. You should not use Zyclara if you are breastfeeding or plan to breastfeed. Your doctor will discuss with you whether you should stop breastfeeding or stop treatment with Zyclara.
Driving ability and use of machinery
Zyclara contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearyl alcohol, and benzyl alcohol
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) can cause allergic reactions (possibly delayed).
Cetyl alcohol and stearyl alcohol can cause local skin reactions (e.g. contact dermatitis ).
This medicine contains 5 mg of benzyl alcohol in each sachet. Benzyl alcohol can cause allergic reactions and mild local irritation.
How to use Zyclara
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. Do not use this medicine until your doctor has shown you exactly how to use the medicine.
This medicine should only be used against actinic keratoses on the face and scalp.
Apply this medicine to the affected area once a day just before going to bed.
Maximum daily dose is two sachets (500 mg = two sachets of 250 mg each).
This medicine should not be applied to areas larger than the face or bald areas of the scalp.
Mode of administration
Duration of treatment
Treatment starts with a daily application for two weeks, followed by a treatment-free break of two weeks, and then is completed with the daily application for another two weeks.
If you have used too much Zyclara
If you have applied too much cream, wash off the excess with mild soap and water.
Once any possible skin reactions have subsided, you can continue treatment according to your recommended treatment schedule. The cream should not be applied more than once per day.
If you forget to use Zyclara
If you miss a dose of Zyclara, wait until the next evening to apply the cream and then continue treatment according to your prescribed treatment schedule. The cream should not be applied more than once per day. Each treatment cycle must last for a maximum of two weeks, and must not be extended even if you have missed a dose.
If you stop using Zyclara
Talk to your doctor before stopping treatment with Zyclara.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek medical attention immediately if any of these severe side effects occur while using this medicine:
Serious skin reactions (frequency not known) with skin lesions or spots on the skin that start as small red areas and then progress to larger red areas (which may look like small “targets”) possibly with symptoms such as itching, fever, general malaise, aching joints, visual disturbances, burning sensation, aching or itchy eyes, and mouth ulcers. If you experience these symptoms, stop using this medicine immediately and contact your doctor immediately.
In some individuals, decreased blood values have been observed (frequency not known). It can make you more susceptible to infection, make you bruise more easily, or cause fatigue. If you experience any of these symptoms, contact your doctor.
Some patients suffering from autoimmune diseases may experience worsening of their condition. Tell your doctor if you notice any changes during treatment with Zyclara.
If any other signs of skin infection occur (no known frequency), discuss this with your doctor.
Many of the side effects of this drug are due to its local mechanism of action on your skin. Local skin reactions can be a sign that the medicine has its intended effect. If your skin reacts strongly or if the discomfort becomes too great while using this medicine, stop applying the cream and wash the area with mild soap and water. Then contact your doctor or pharmacist. He/she may advise you to stop using this medicine for a few days (ie take a short break in treatment).
The following side effects have been reported for imiquimod:
Very common (may affect more than 1 in 10 people)
- Skin redness, crusting, scaling, oozing skin, dry skin, skin swelling, skin ulceration, and reduced skin pigmentation at the application site
Common (may affect up to 1 in 10 people)
- Additional application site reactions, e.g. skin inflammation, itching, pain, burning sensation, irritation, and rash
- Swollen glands
- Reduced appetite
- Flu-like symptoms
- Muscle and joint pain
- Chest pain
- Viral infection ( herpes simplex)
- Elevated blood glucose
Uncommon (may affect up to 1 in 100 people)
- Changes at the application site, e.g. bleeding, small swollen areas of skin, inflammation, tingling, increased sensitivity to touch, scarring, feeling of warmth, skin breakdown, blisters or pustules
- Lethargy _ _
- Facial swelling
- Back pain
- Pain in arms/legs
- Stuffy nose
- Sore throat
- Eye irritation
- Swollen eyelids
- Dry mouth
- Stomach ache
Rare (may affect up to 1 in 1,000 people)
- A flare-up of an autoimmune condition (a disease resulting from the abnormal immune response is an autoimmune disease)
- Skin reactions in places other than the application site
Frequency not known (frequency cannot be calculated from available data)
- Changed skin color some patients have experienced a change in skin color in the area where Zyclara was applied. These changes have tended to improve over time, but may be permanent in some patients.
- Hair loss small number of patients have experienced hair loss at the treatment site or surrounding area.
- Elevated liver enzyme levels. Reports of elevated liver enzymes have been reported.
How to store Zyclara
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the outer carton and label after EXP.
The expiration date is the last day of the specified month.
Must not be stored above 25 °C.
Opened sachets must not be reused.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is imiquimod. Each sachet contains 9.375 mg imiquimod in 250 mg cream (100 mg contains 3.75 mg imiquimod).
- Other ingredients 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, purified water (see also section 2 “Zyclara contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearyl alcohol, and benzyl alcohol”).
Appearance and package sizes of the medicine
- Each sachet of Zyclara 3.75% cream contains 250 mg of white to slightly yellowish cream with a uniform appearance.
- Each pack contains 14, 28, or 56 single-use polyester/white low-density polyethylene/aluminum foil sachets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Swiss Caps GmbH
83043 Bad Aibling
MEDA Pharma GmbH Co. KG
61352 Bad Homburg