Zyclara 3.75% cream

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Zyclara 3.75% cream

imiquimod

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Zyclara is and what it is used for
2. What you need to know before using Zyclara
3. How to use Zyclara
4. Possible adverse effects
5. How to store Zyclara
6. Contents of the pack and other information

1. What Zyclara is and what it is used for

Zyclara 3.75% cream contains the active substance imiquimod.

This medicine is prescribed for the treatment of actinic keratosis in adults, which is an Immune Response Modifier (to stimulate the human immune system).

This medicine stimulates your own immune system to produce natural substances that help fight your actinic keratosis.

Actinic keratoses appear as rough skin areas in people who have had significant sun exposure over their lifetime. These areas may be the same color as your skin, or may be grayish, pink, red, or brown. They can be flat and scaly, or raised, rough, hard, and warty.

This medicine should only be used for actinic keratoses on the face or scalp, if your doctor has decided it is the most appropriate treatment for you.

2. What you need to know before using Zyclara

Do not use Zyclara

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Zyclara:

• if you have previously used this medicine or another similar preparation at a different concentration.
• if you have autoimmune disorders.
• if you have had an organ transplant.
• if you have abnormal blood counts.

General instructions during treatment

• If you have recently undergone surgical or pharmacological treatment, wait until the area to be treated has healed before using this medicine.
• Avoid contact with eyes, lips, and nostrils. In case of accidental contact, remove the cream by washing the area with water.
• Use the cream only externally (on the skin of the face or scalp).
• Do not use more cream than recommended by your doctor.
• Do not cover the treated area with bandages or other materials after applying Zyclara.
• If you develop excessive discomfort in the treated area, remove the cream with a neutral soap and water. Once discomfort has subsided, you may resume treatment as recommended. The cream should not be applied more than once a day.
• Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with this medicine. If you go outdoors during the day, use sunscreen, wear protective clothing, and wear a wide-brimmed hat.

Local skin reactions

While using Zyclara, you may experience local skin reactions due to the way the medicine works on your skin. These reactions may indicate that the medicine is working as intended.

During use of Zyclara and until healing, the treated area may look clearly different from normal skin. There is also a possibility that any pre-existing inflammation may temporarily worsen.

This medicine may also cause flu-like symptoms (including fatigue, nausea, fever, muscle and joint pain, and chills) before or during the onset of local skin reactions.

If flu-like symptoms, general malaise, or severe local skin reactions occur, you may take a break for several days. You may resume treatment with imiquimod cream once the skin reaction has subsided. However, the 2-week treatment cycle should not be extended due to missed doses or treatment breaks.

The intensity of local skin reactions tends to be lower in the second treatment cycle than in the first cycle with Zyclara.

The response to treatment cannot be adequately assessed until local skin reactions have resolved. You should continue treatment as prescribed.

This medicine may reveal and treat actinic keratoses that were not previously seen or noticed, which may subsequently disappear. Treatment should continue for the full duration of the treatment cycle, even if all actinic keratoses appear to have disappeared.

Children and adolescents

This medicine should not be given to children under 18 years of age, as safety and efficacy have not been established in patients below this age. Data on the use of imiquimod in children and adolescents are not available.

Other medicines and Zyclara

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor before starting treatment if you are receiving immunosuppressive medicines that inhibit the immune system.

Avoid concomitant use of Zyclara and any other imiquimod cream on the same treatment area.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will assess the risks and benefits of using Zyclara during pregnancy. Animal studies do not indicate direct or indirect harmful effects on pregnancy.

It is unknown whether imiquimod passes into breast milk. You should not use Zyclara if you are breastfeeding or plan to breastfeed. Your doctor will decide whether you should discontinue breastfeeding or discontinue treatment with Zyclara.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is none or negligible.

Zyclara contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearyl alcohol, and benzyl alcohol.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.

This medicine contains 5 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions and moderate local irritation.

3. How to use Zyclara

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. Do not use this medicine until your doctor has shown you the correct way to apply it.

This medicine should only be used for actinic keratoses of the face and scalp.

Dosage

Apply this medicine to the affected area once daily, immediately before going to bed.

The maximum daily dose is 2 sachets (500 mg = 2 sachets of 250 mg each).

This medicine must not be applied to areas larger than the entire face or the bald scalp.

Method of administration

Apply the medication topically to the affected skin area. Wash your hands before and after application, unless the hands are the area being treated. Avoid contact with the eyes, lips, and mucous membranes. If accidental contact occurs, rinse thoroughly with water.

Duration of treatment

Treatment starts with one daily application for two weeks, followed by a break without application for two weeks, and ends with one daily application for another two weeks.

If you use more Zyclara than you should

If too much cream has been applied, remove the excess by washing the area with water and a neutral soap.

Once any skin reaction has subsided, you may resume treatment according to the recommended regular schedule. The cream must not be applied more than once a day.

If you accidentally swallow this medicine, contact your doctor immediately.

If you forget to use Zyclara

If you miss a dose of Zyclara, wait until the following night to apply it, then continue with your regular schedule. The cream must not be applied more than once a day. Each treatment cycle must not last longer than two weeks, even if you have missed some doses.

If you stop treatment with Zyclara

Consult your doctor before stopping treatment with Zyclara.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Seek immediate medical attention if you experience any of the following serious adverse effects during use of this medicine:

Severe skin reactions (frequency not known), with skin lesions or spots on the skin that start as small red areas and progress to resemble small targets, possibly accompanied by symptoms such as itching, fever, malaise, joint pain, vision problems, burning sensation, eye pain or itching, and mouth sores. If you experience these conditions, stop using this medicine and inform your doctor immediately.

A decrease in blood cell counts (frequency not known) has been observed in some individuals. This may increase your susceptibility to infections, cause bruising, or lead to fatigue. If you notice any of these symptoms, inform your doctor.

Some patients with autoimmune disorders may experience worsening of their condition. Consult your doctor if you notice any changes during treatment with Zyclara.

If there is pus or any other sign of skin infection (frequency not known), consult your doctor.

Many of the side effects of this medicine are due to its local action on the skin. Local skin reactions may indicate that the medicine is working as intended. If your skin reacts badly or experiences excessive discomfort during use of this medicine, stop applying the cream and wash the area with water and a neutral soap. Then contact your doctor or pharmacist, who may advise you to interrupt treatment for a few days (i.e., take a short break from treatment).

The following adverse effects have been reported with imiquimod:

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

• Redness of the skin, crusting, flaking, oozing, dryness, swelling, skin ulcers, and reduced skin pigmentation at the application site.

Common (may affect up to 1 in 10 people)

• Other additional reactions at the application site, e.g., skin inflammation, pruritus, pain, burning sensation, irritation, and skin rash
• Swollen glands
• Headache
• Dizziness
• Loss of appetite
• Nausea
• Diarrhea
• Vomiting
• Flu-like symptoms
• Fever
• Pain
• Muscle and joint pain
• Chest pain
• Insomnia
• Fatigue
• Viral infection (herpes simplex)
• Increased blood glucose levels

Uncommon (may affect up to 1 in 100 people)

• Changes at the application site, e.g., bleeding, small swollen areas on the skin, inflammation, tingling, increased sensitivity to touch, scarring, sensation of heat, skin lesions, blisters or pustules
• Weakness
• Chills
• Lack of energy (lethargy)
• Discomfort
• Facial swelling
• Lower back pain
• Limb pain
• Nasal congestion
• Sore throat
• Eye irritation
• Swelling of the eyelids
• Depression
• Irritability
• Dry mouth
• Abdominal pain

Rare (may affect up to 1 in 1,000 people)

• Flare-ups of autoimmune diseases (an autoimmune disease is caused by an abnormal immune response)
• Skin reactions distant from the application site

Frequency not known (cannot be estimated from available data)

• Changes in skin color

Some patients have experienced changes in skin color at the site where Zyclara was applied. Although these changes tend to improve over time, in some patients they may be permanent.

• Hair loss

A small number of patients have experienced hair loss at the treatment site or in immediately adjacent areas.

• Elevated liver enzymes

There have been reports of increased liver enzyme levels.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 label and on the outer packaging after EXP.

The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

After opening, the sachets must not be reused.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zyclara

• The active substance is imiquimod. Each sachet contains 9.375 mg of imiquimod in 250 mg of cream (100 mg of cream contains 3.75 mg of imiquimod).
• The other components are: isoestearyl acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, light liquid paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, purified water (see also section 2 “Zyclara contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol”).

Appearance of Zyclara and contents of the pack

• Each sachet of Zyclara 3.75% cream contains 250 mg of a white to slightly yellowish, homogeneous cream.
• Each pack contains 14, 28 or 56 single-use sachets made of white polyester/low-density polyethylene/aluminium foil laminate.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer

Swiss Caps GmbH
Grassingerstraße 9
83043 Bad Aibling
Germany

More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: (MM/YYYY)

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.eu游戏副本.