Zyclara
(Imiquimod)

Prescription Settings Edit

Brand Name Choices

Zyclara 3.75%
Zyclara 3.75% Cream

Manufactured by Meda Pharmaceuticals Inc

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Generic Choices

No generic medication is available for Zyclara (Imiquimod)

What Zyclara is and what it is used for

Zyclara 3.75% cream contains the active substance imiquimod, which is an Immune Response Modifier (to stimulate the human immune system). This medicine is prescribed for the treatment of actinic keratosis in adults. This medicine stimulates your body’s own immune system to produce natural substances which help fight your actinic keratosis. Actinic keratosis appears as rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime. These areas can be the same colour as your skin or are greyish, pink, red or brown. They can be flat and scaly, or raised, rough, hard and warty. This medicine should only be used for actinic keratosis on the face or scalp if your doctor has decided that it is the most appropriate treatment for you

How to take Zyclara

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not use this medicine until your doctor has shown you the right way to use it. This medicine should only be used for actinic keratosis on the face and scalp. Dosage Apply this medicine to the affected area once a day just before bedtime. Maximum daily dose is 2 sachets (500 mg = 2 sachets of 250 mg each). This medicine should not be applied to areas larger than either the full face or balding scalp. Method of administration 1. Before going to bed, wash your hands and the treatment area carefully with mild soap and water. Dry hands thoroughly and allow the area to dry. 2. Open a new sachet of Zyclara just before use and squeeze some cream onto your fingertip. No more than 2 sachets should be used per application. 3. Apply a thin layer of Zyclara to the affected area. Rub gently into the area until the cream vanishes. Avoid contact with the eyes, lips and nostrils. 4. After application of the cream, throw away the opened sachet. Wash hands well with soap and water. 5. Leave Zyclara on the skin for about 8 hours. Do not shower or bathe the area during this time. Do not cover the treated area with bandages or other dressings. 6. After about 8 hours, wash the area where Zyclara was applied with mild soap and water. Duration of treatment The treatment starts with a daily application for two weeks, followed by a break without any application for two weeks, and then ends with a daily application again for two weeks. If you use more Zyclara than you should If you have applied too much cream, wash the extra away with mild soap and water. When any skin reaction has gone you may then continue with your treatment in the recommended regular schedule. The cream should not be applied more than once daily. If you accidentally swallow this medicine please contact your doctor immediately. If you forget to use Zyclara If you miss a dose of Zyclara, wait until the next night to apply it and then continue with the regular schedule. The cream should not be applied more than once daily. Each treatment cycle should last no longer than two weeks, even if you have missed doses. If you stop using Zyclara Talk to your doctor before you stop treatment with Zyclara. If you have any further questions on the use of this medicine, ask your doctor or pharmacist

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Seek medical attention right away if any of these severe side effects occur when using this medicine: Serious skin reactions (frequency not known) with 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. If you experience these, stop using this medicine and tell your doctor immediately. In some individuals a lowering of blood counts was noted (frequency not known). This might make you more susceptible to infections, make you bruise more easily or cause tiredness. If you notice any of these symptoms, tell your doctor. If there is pus or another sign of skin infection (frequency not known), discuss this with your doctor. Many of the side effects of this medicine are due to its local action on your skin. Local skin reactions can be a sign that the medicine is working as intended. If your skin reacts badly or becomes too uncomfortable when using this medicine, stop applying the cream and wash the area with mild soap and water. Then contact your doctor or pharmacist. He may advise you to stop applying this medicine for a few days (i.e. to have a short rest from treatment).

The following side effects with imiquimod were reported:

Very common (may affect more than 1 in 10 people)
• Skin redness, scabbing, skin scaling, discharge, skin dryness, skin swelling, skin ulcer, and reduced skin pigmentation at the application site

Common (may affect up to 1 in 10 people)
• Further reactions at the application site e.g. skin inflammation, itching, pain, burning, irritation, and rash
• Swollen glands
• Headache
• Dizziness
•Loss of appetite
•Nausea
• Diarrhoea
• Vomiting
• Flu-like symptoms
• Fever
• Pain
• Muscle and joint pain
• Chest pain
• Insomnia
• Tiredness
• Viral infection (herpes simplex)
• Increase in blood glucose

Uncommon (may affect up to 1 in 100 people)
• Changes at the application site, e.g. bleeding, small swollen areas in the skin, inflammation, pins and needles, increased sensitivity to touch, scarring, feeling of warmth, skin breakdown, blisters or pustules
• Weakness
• Shivering
• Lack of energy (lethargy)
• Discomfort
• Swelling of the face
• Back pain
• Pain in limbs
• Stuffy nose
• Throat pain
• Eye irritation
• Swelling of the eyelid
• Depression
• Irritability
• Dry mouth
• Abdominal pain

Rare (may affect up to 1 in 1,000 people)
• Flaring up of autoimmune conditions (a disease that results from an abnormal immune response is an autoimmune disease)
• Skin reactions remote from the application site Frequency not known (frequency cannot be estimated from the available data)
• Changes in skin colour Some patients have experienced changes in skin colour in the area where Zyclara was applied. While these changes have tended to improve with time, in some patients they may be permanent.
• Hair loss A small number of patients have experienced hair loss at the treatment site or surrounding area.
• Increase in liver enzymes There have been reports of increased liver enzymes.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.go.uk/yellowcard Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL – Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

How to Store Zyclara

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 outer carton and the label 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 to protect the environment.

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2 to 3 weeks on average

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About Medix Pharmacy

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We are regulated by a number of executive government agencies in the United Kingdom including the Medicines and Healthcare products Regulatory Agency and the GPhC to ensure we offer our customers the highest level of service and peace of mind knowing that the medicines that you receive are safe, effective and authentic.

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