Product Details

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 (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Zyclara: • if you have previously used this medicine or other similar preparations in a different concentration. • if you suffer from autoimmune disorders • if you have had an organ transplant • if you have an abnormal blood count. 2 General instructions during treatment • If you have recently had surgery or medicinal treatment, wait until the area to be treated has healed before using this medicine. • Avoid contact with the eyes, lips and nostrils. In the event of accidental contact, remove cream by rinsing with water. • Only use the cream externally (on the skin of face or scalp). • 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 this medicine. • If the treated site becomes too uncomfortable, wash the cream off with mild soap and water. Once the discomfort stops you can resume your treatment schedule as recommended. The cream should not be applied more than once daily. • Do not use sunlamps or tanning-beds, and avoid exposure to sunlight as much as possible during treatment with this medicine. If you go outside during the day use sunscreen and wear protective clothing and a wide-brimmed hat.

Local skin reactions While using Zyclara, you may experience local skin reactions because of the way it acts on your skin. These reactions can be a sign that the medicine is working as intended. Whilst using Zyclara and until healed, the treatment area is likely to appear noticeably different from normal skin. There is also a possibility that existing inflammation may temporarily worsen. This medicine may also cause flu-like symptoms (including tiredness, nausea, fever, muscle and joint pain, and shivering) before or during the occurrence of local skin reactions. If flu-like symptoms or feeling discomfort or intense local skin reactions occur, a rest period of several days may be taken. You could resume treatment with imiquimod cream after the skin reaction has moderated. However, neither 2-week treatment cycle should be extended due to missed doses or rest periods. The intensity of the local skin reactions tend to be lower in the second cycle than in the first treatment cycle with Zyclara. Response to treatment cannot be adequately assessed until resolution of local skin reactions. You should continue treatment as prescribed. This medicine may reveal and treat actinic keratosis that have not be seen or felt before, and these may later go away. You should continue application for the full treatment course even if all actinic keratosis appear to be gone. Children and adolescents This medicine should not be given to children below the age of 18 years because the safety and efficacy in patients below the age of 18 years have not been established. There are no data available of 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 receive immunosuppressive medicinal products which inhibit the immune system, tell your doctor before starting the treatment. Avoid the concomitant use of Zyclara and any other imiquimod cream in the same treatment area. 3 Pregnancy and breast-feeding 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 using this medicine. Your doctor will discuss the risks and benefits of using Zyclara during pregnancy. Studies in animals do not indicate direct or indirect harmful effects in pregnancy. It is not known whether imiquimod passes into breast milk. You should not use Zyclara if you are breast-feeding or plan to breast-feed. Your doctor will discuss if you should discontinue breast-feeding or discontinue Zyclara treatment.

Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines. Zyclara contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol Methyl parahydroxybenzoate (E 218), and propyl parahydroxybenzoate (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.