Label: Information for the Patient

Zyclara 3.75% Cream

imiquimod

Read this label carefully before starting to use this medication, as it contains important information for you.

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

1. What is Zyclara and how is it used

2. What you need to know before starting to use Zyclara

3. How to use Zyclara

4. Possible adverse effects

5. Storage of Zyclara

6. Contents of the package and additional information

Zyclara 3.75% cream contains the active ingredient imiquimod.

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

This medication stimulates your own immune system to produce natural substances that contribute to fighting your actinic keratosis.

Actinic keratoses appear as rough skin areas present in people who have been exposed to a large amount of sunlight over the course of their lives. These areas can be the same color as your skin, or be grayish, pink, red, or brown. They can be flat and scaly, or raised, rough, hard, and wart-like.

This medication should be used exclusively on actinic keratoses of the face or scalp, if your doctor has decided that it is the most suitable treatment for you.

Do not use Zyclara

• If you are allergic to imiquimod or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zyclara:

• If you have previously used this medication or another similar preparation, at a different concentration.
• If you have autoimmune disorders.
• If you have had an organ transplant.
• If you have an abnormal blood count.

General instructions during treatment

• If you have recently undergone surgical or pharmacological treatment, wait until the treated area has healed before using this medication.
• 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 a quantity of cream greater than that recommended by your doctor.
• Do not cover the treated area with bandages or other elements after applying Zyclara.
• If you develop excessive discomfort in the treated area, remove the cream with a neutral soap and water. Once the discomfort has subsided, you can resume treatment as recommended. The cream should not be applied more than once a day.
• Do not use sunlamps or sunbeds, and avoid sunlight as much as possible during treatment with this medication. If you go outside during the day, use sunscreen and protective clothing, as well as a wide-brimmed hat.

Local skin reactions

You may experience local skin reactions while using Zyclara due to the way the medication acts on your skin. These reactions may indicate that the medication is acting as intended.

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

This medication may also cause symptoms similar to the flu (including fatigue, nausea, fever, muscle and joint pain, and chills) before or during the appearance of local skin reactions.

If flu-like symptoms or feelings of discomfort or intense local skin reactions occur, you may take a break of several days. You could resume treatment with imiquimod cream after the skin reaction has moderated. However, do not prolong the treatment cycle of 2 weeks due to dose losses or breaks.

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

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

This medication may reveal and treat actinic keratoses that have not been seen or perceived previously, and that may subsequently disappear. Application should continue throughout the entire treatment cycle even if all actinic keratoses appear to have disappeared.

Children and adolescents

This medication should not be administered to children under 18 years of age, as the safety and efficacy have not been established in patients under that age. There is no data on the use of imiquimod in children and adolescents.

Other medications and Zyclara

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

Avoid concurrent use of Zyclara and any other imiquimod cream in the same treatment area.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

The passage of imiquimod into breast milk is unknown. Do not use Zyclara if you are breastfeeding or plan to breastfeed. Your doctor will decide whether to interrupt breastfeeding or interrupt treatment with Zyclara.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Zyclara contains parahydroxybenzoic acid methyl ester, parahydroxybenzoic acid propyl ester, cetyl alcohol, stearyl alcohol, and benzyl alcohol.

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

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not use this medication until your doctor has taught you the correct way to use it.

This medication should only be used for actinic keratosis of the face and scalp.

Dosage

Apply this medication to the affected area once a day, immediately before bedtime.

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

This medication should not be applied to areas larger than the entire face or alopecia scalp.

Administration Form

Treatment Duration

The treatment begins with a daily application for two weeks, followed by a two-week break without application, and ends with a daily application for two weeks again.

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 neutral soap.

When any skin reaction has subsided, you can resume treatment according to the regular recommended program. Do not apply the cream more than once a day.

If you accidentally ingest this medication, contact your doctor immediately.

If you forgot to use Zyclara

If you forgot a dose of Zyclara, wait until the next night to apply it and then continue with the regular routine. The cream should not be applied more than once a day. Each treatment cycle should not last more than two weeks, even if you have missed some doses.

If you interrupt the treatment with Zyclara

Consult your doctor before discontinuing treatment with Zyclara.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

Seek immediate medical attention if any of the following severe side effects occur during use of this medicine:

Severe skin reactions (unknown frequency), with skin lesions or patches on the skin that start as small red areas and evolve to resemble small pinpricks, possibly accompanied by symptoms such as itching, fever, general malaise, joint pain, vision problems, burning sensation, eye pain or itching, and mouth sores. If you experience these symptoms, discontinue use of this medicine and immediately inform your doctor.

In some people, a decrease in blood formula (unknown frequency) has been observed. This could increase your susceptibility to infections, develop bruises, or cause 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 experience any changes during treatment with Zyclara.

If there is pus or another sign of skin infection (unknown frequency), 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 acting as intended. If your skin reacts poorly or you experience excessive discomfort during use of this medicine, discontinue application of the cream and wash the area with water and a neutral soap. Then, contact your doctor or pharmacist, who may advise you to discontinue application of this medicine for a few days (i.e., take a brief break from treatment).

The following side effects have been reported with imiquimod:

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

• Redness of the skin, crusts, skin peeling, suppurating, skin dryness, skin swelling, skin ulcers, and reduction of skin pigmentation at the application site.

Common(may affect up to 1 in 10 people)

• Other reactions at the application site, e.g., skin inflammation, itching, pain, burning sensation, irritation, and skin rash
• Swollen lymph nodes
• Headaches
• Dizziness
• Loss of appetite
• Nausea
• Diarrhea
• Vomiting
• Symptoms similar to the flu
• Fever
• Pain
• Muscle and joint pain
• Chest pain
• Insomnia
• Fatigue
• Viral infection (herpes simplex)
• Increased blood glucose

Uncommon(may affect up to 1 in 100 people)

• Changes in the application area, e.g., bleeding, small skin swellings, inflammation, tingling, increased sensitivity to contact, scarring, warmth sensation, skin lesions, blisters, or pustules
• Weakness
• Chills
• Lethargy
• Discomfort
• Facial swelling
• Lower back pain
• Pain in extremities
• Stuffy nose
• Sore throat
• Irritation of the eyes
• Swollen eyelids
• Depression
• Irritability
• Dry mouth
• Abdominal pain

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

• Autoimmune disease flares (an autoimmune disease is a disease caused by an abnormal immune response)
• Distant skin reactions

Unknown frequency(cannot be estimated from available data)

• Changes in skin color

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

• Hair loss

A reduced number of patients have experienced hair loss in the treatment area or immediately adjacent

• Elevated liver enzymes

There have been reports of increased liver enzymes.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through thenational reporting systemincluded in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the outer packaging after CAD.

The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Once opened, the pouches should not be reused.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Zyclara

• The active ingredient 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: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, light white paraffin, polisorbate 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 cream of uniform appearance.
• Each pack contains 14, 28 or 56 single-use sachets of low-density polyethylene/polyester white/laminate aluminium.

Only some pack sizes may be marketed.

Marketing authorisation holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

DUBLIN

Ireland

Responsible manufacturer

Swiss Caps GmbH

Grassingerstraße 9

83043 Bad Aibling

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Last update of the leaflet: (MM/YYYY)

Further detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.