ZYCLARA

Package leaflet: Information for the patient

Zyclara 3.75% cream

imiquimod
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this 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 side 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, 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 immune system to produce natural substances that help fight actinic keratosis.
Actinic keratosis appears as rough skin areas, found in people who have been exposed to sunlight for prolonged periods of time over their lifetime. These areas may be the same colour as the skin or appear greyish, pink, red, or brown. They may be smooth and scaly, or thick, rough, hard, and warty.
This medicine should only be used for actinic keratosis on the face or scalp, if your doctor has decided it is the most appropriate treatment for you.

2. What you should 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 using Zyclara:

• if you have previously used this medicine or other similar preparations at a different concentration
• if you have autoimmune diseases
• if you have undergone an organ transplant
• if you have abnormal blood cell counts.

General instructions during treatment

• If you have recently undergone surgery or treatment with medications, wait until the area to be treated has fully healed before using this medicine.
• Avoid contact with eyes, lips, and nostrils. In case of accidental contact, remove the cream by rinsing with water.
• Use the cream only externally (on the skin of the face or scalp).
• Do not use more cream than prescribed by your doctor.
• After applying this medicine, do not cover the treated area with bandages or other dressings.
• If you experience excessive discomfort at the application site, remove the cream by washing it off with mild soap and water. Once discomfort has subsided, you may resume treatment as directed. The cream should not be applied more than once a day.
• During treatment with this medicine, avoid sun lamps and sunbeds, and minimize exposure to sunlight as much as possible. If you go outdoors during the day, use sunscreen and wear protective clothing and a wide-brimmed hat.

Local skin reactions
During treatment with Zyclara, local skin reactions may occur due to the way the medicine acts on the skin. These reactions may be a sign that the medicine is working as intended.
During treatment with Zyclara and until healing is complete, the treated area may look very different from healthy skin. There is also a possibility that existing inflammation may temporarily worsen.
Before or during the onset of local skin reactions, this medicine may also cause flu-like symptoms (including fatigue, nausea, fever, muscle and joint pain, and chills).
If flu-like symptoms, a general feeling of discomfort, or severe local skin reactions occur, you may take a break for a few days. You may resume treatment with the imiquimod cream after the skin reaction has subsided. However, the 2-week treatment cycle must not be extended, either due to missed doses or treatment breaks.
The intensity of local skin reactions tends to decrease during the second treatment cycle compared to the first cycle with Zyclara.
The treatment response cannot be adequately assessed until the local skin reactions have resolved. Treatment should continue as prescribed.
This medicine may reveal and treat actinic keratosis that was previously unnoticed or undetected and therefore appeared to have disappeared. Continue applying the cream for the entire duration of the treatment cycle, even if all actinic keratosis lesions appear to have disappeared.

Children and adolescents
This medicine is contraindicated for use in children under 18 years of age, as the safety and efficacy of this medicine have not been established in patients under 18 years of age. There are no available data on the use of imiquimod in children and adolescents.

Other medicines and Zyclara
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking immunosuppressive medicines that reduce the immune response, inform your doctor before starting treatment.
Avoid using Zyclara simultaneously with any other imiquimod-containing cream on the same treatment area.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Discuss with your doctor the risks and benefits of using Zyclara during pregnancy. Animal studies do not indicate direct or indirect harmful effects during pregnancy.
It is not known whether imiquimod passes into breast milk. Do not use Zyclara if you are breastfeeding or intend to breastfeed. Discuss with your doctor whether you should discontinue breastfeeding or stop treatment with Zyclara.

Driving and using machines
This medicine does not affect, or affects only negligibly, the ability to drive or operate machinery.

Zyclara contains methylparahydroxybenzoate, propylparahydroxybenzoate, cetyl alcohol, stearyl alcohol, and benzyl alcohol.
Methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).
Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g., contact dermatitis).
Each sachet of this medicine contains 5 mg of benzyl alcohol. Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use Zyclara

Use this medicine exactly as your doctor has instructed you. If you have any doubts, consult your
doctor or pharmacist. Do not use this medicine until your doctor has shown you the correct way
to use it.
This medicine must only be used for actinic keratosis on the face and bald scalp.

Dosage
Apply this medicine to the affected area once daily, just 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 bald scalp.

Instructions for use

1. Before going to bed, wash your hands and the treatment area

thoroughly with mild soap and water. Dry your hands well and allow the treatment area to dry completely.

2. Open a sachet of Zyclara just before use and
   squeeze a small amount of cream onto the tip of your finger. No more than 2 sachets should be used for each application.

3. Apply a thin layer of Zyclara to the affected area.

   

Gently massage the area until the cream is absorbed. Avoid contact with eyes, lips, and nostrils.

4. After applying the cream, discard the opened sachet.
   Wash your hands thoroughly with water and soap.

5. Leave Zyclara on the skin for approximately 8 hours. During

   

this time, do not take showers or baths. Do not cover the treated area with bandages or other dressings.

6. After approximately 8 hours, wash the area where Zyclara was applied
   with mild soap and water.

Duration of treatment
Treatment begins with daily application for two weeks, followed by a two-week break without any application, and then continues with daily application for another two weeks.

If you use more Zyclara than you should
If you have applied too much cream, wash off the excess with mild soap and water.
Once the skin reaction has subsided, you may continue treatment according to the recommended 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 forget to apply a dose of Zyclara, wait until the next evening to apply it, and then continue with the normal treatment 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 using Zyclara
Contact your doctor before stopping treatment with Zyclara.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Seek immediate medical attention if you experience any of the following side effects while using 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 target-like lesions, possibly accompanied by symptoms such as itching, fever, general feeling of illness, joint pain, vision problems, burning, pain or itching in the eyes, and mouth sores. If you experience any of these effects, stop using this medicine immediately and consult your doctor without delay.

A reduction in blood cell count (frequency not known) has been observed in some individuals. This condition may make you more susceptible to infections, cause bruising more easily, or lead to fatigue. If you notice any of these symptoms, inform your doctor.

Some patients with autoimmune diseases may experience a worsening of their condition. If you notice any changes during treatment with Zyclara, inform your doctor.

If you notice pus or any other sign of skin infection (frequency not known), discuss this with your doctor.

Many of the effects of this medicine are due to its local action on the skin. Local skin reactions may be a sign that the medicine is working as intended. If your skin does not react appropriately during treatment or if you experience excessive discomfort, stop applying the cream and wash the area with mild soap and water. Then contact your doctor or pharmacist. They may advise you to temporarily stop applying this medicine for a few days (i.e., take a short break from treatment).

The following side effects of imiquimod have also been reported:

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

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

Common (may affect up to 1 in 10 people)

• Additional reactions at the application site, such as inflammation, itching, pain, burning, irritation, and 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 (blood sugar)

Uncommon (may affect up to 1 in 100 people)

• Changes at the application site, such as bleeding, small swollen areas on the skin, inflammation, tingling, increased sensitivity to touch, scarring, sensation of warmth, pressure ulcers, blisters, or pustules
• Weakness
• Tremor
• Lack of energy (lethargy)
• Discomfort
• Facial swelling
• 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)

• Recurrence of autoimmune diseases (diseases related to abnormal immune responses)
• Skin reactions at sites distant from the application site

Frequency not known (the 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 some changes gradually improved 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 the surrounding area.
• Increased liver enzymes: Increases in liver enzymes have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zyclara

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label
“Exp.”.
The expiry date refers to the last day of that month.
Do not store above 25°C.
The sachets should not be reused once opened.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Zyclara contains

• The active substance is imiquimod. Each sachet contains 9.375 mg of imiquimod in 250 mg of cream (100 mg of cream contain 3.75 mg of imiquimod). The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), xanthan gum, purified water (see also section 2 “Zyclara contains methylparahydroxybenzoate, propylparahydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol.”)

Description of the appearance of Zyclara and contents of the pack

• Each sachet of Zyclara 3.75% cream contains 250 mg of a cream, white to slightly yellow in colour, with a uniform appearance.
• Each carton contains 14, 28 or 56 single-use sachets made of white polyester/low-density polyethylene/aluminium foil laminate. Not all 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Luxembourg/Luxemburg
Viatris Viatris
Tél/Tel: +32 2 658 61 00 Tél/Tel: +32 2 658 61 00
(Belgique/Belgien)

България Magyarország
Майлан ЕООД Viatris Healthcare Kft.
Тел: +359 2 44 55 400 1138 Budapest
Váci út 150
Tel: +36 1 465 2100

Česká republika Malta
Viatris CZ s.r.o. V.J. Salomone Pharma Limited
Tel: +420 222 004 400 Upper Cross Road
Marsa, MRS 1542
Tel: +356 21 22 01 74

Danmark Nederland
ViatrisApS Mylan Healthcare B.V.
Tlf: +45 28 11 69 32 Krijgsman 20
1186 DM Amstelveen
Tel: +31 (0)20 426 3300

Deutschland Norge
Viatris Healthcare GmbH ViatrisAS
Tel: +49 800 0700 800 Hagaløkkveien 26
1383 Asker
Tlf: +47 66 75 33 00

Eesti Österreich
Viatris OÜ Tel: +372 6363 052 Viatris Austria GmbH
Guglgasse 15
1110 Wien
Tel: +43 (0)1 86 390

Ελλάδα Polska
Viatris Hellas Ltd Viatris Healthcare Sp. z o.o.
Τηλ: +30 210 010 0002 ul. Postępu 21B
02-676 Warszawa
Tel: +48 22 546 6400

España Portugal
Viatris Pharmaceuticals, S.L. Viatris Healthcare, Lda.
Tel: +34 900 102 712 Av. D. João II,
Edifício Atlantis, nº 44C – 7.3 e 7.4
1990-095 Lisboa
Tel: +351 214 127 200

France România
Viatris Santé 1 bis place de la Défense – Tour BGP PRODUCTS SRL
Trinity Tel.: +40 372 579 000
92400 Courbevoie
Tél: +33 (0)1 40 80 15 55

Hrvatska Slovenija
Viatris Hrvatska d.o.o. Viatris d.o.o.
Koranska 2 Tel: +386 1 23 63 180
10 000 Zagreb
Tel: +385 1 235 059 9

Ireland Slovenská republika
Tel: +353 8711600 Viatris Slovakia s.r.o. Tel: +421 2 32 199 100

Ísland Suomi/Finland
Icepharma hf Viatris Oy
Sími: +354 540 8000 Vaisalantie 2-8/Vaisalavägen 2-8
02130 Espoo/Esbo
Puh/Tel: +358 20 720 9555

Italia Sverige
Viatris Italia Viatris AB
Via Vittor Pisani, 20 Box 23033
20124 Milano 104 35 Stockholm
Tel: +39 0261246921 +46 (0) 8 630 19 00

Κύπρος United Kingdom (Northern Ireland)
GPA Pharmaceuticals Ltd Mylan IRE Healthcare Limited
Τηλ: +357 22863100 Tel: 353 18711600

Latvija
Viatris SIA
101 Mūkusalas str.
Rīga LV‐1004
Tālr: +371 67616137

Lietuva
Viatris UAB Žalgirio str. 90-100
Vilnius LT-09303
Tel: +370 52051288

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