ZYCLARA 3.75% Cream

Зміст інструкції

1. Zyclara cream 3.75%
   1. What is Zyclara and what is it 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

Zyclara cream 3.75%

imiquimod

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Zyclara and what is it used for

Zyclara cream 3.75% contains the active substance imiquimod, which is an immune response modulator (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 manifests with rough areas of the skin, found in people who have been
exposed to sunlight for prolonged periods of time over their lifetime. These areas may
be the same color as the skin or be grayish, pink, red, or brown. They can 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 the
doctor has decided that this is the most suitable 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 using Zyclara:

• if you have previously used this medicine or other similar preparations at a different concentration
• if you suffer from autoimmune diseases
• if you have had an organ transplant
• if you have an abnormal number of blood cells.

General instructions during treatment

• If you have recently undergone surgery or treatment with medications, wait until the area to be treated has healed before using this medicine.
• Avoid contact with eyes, lips and nostrils. If accidental contact occurs, 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 treated site, remove the cream by washing it off with mild 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.
• During treatment with this medicine, do not use sunbeds or tanning lamps and avoid exposure to sunlight as much as possible. If you go outside during the day, use sunscreen and wear protective clothing and a wide-brimmed hat.

Local skin reactions
During the use of Zyclara, local skin reactions may occur, due to the way the medicine acts on the skin. These reactions can be a sign that the medicine is working as intended.
During the use of Zyclara and until healing, the treatment area may look very different from healthy skin. There is also a possibility that the inflammation in progress may worsen temporarily.
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 you experience flu-like symptoms or feeling unwell or severe local skin reactions, you may take a break of a few days. You may resume treatment with the imiquimod-based cream after the skin reaction has subsided. However, the 2-week treatment cycle should not be prolonged in case of missed doses or breaks.
The intensity of local skin reactions tends to decrease in the second cycle compared to the first treatment cycle with Zyclara.
The response to treatment 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 had not been detected or identified in the past and which therefore appeared to have disappeared. Continue application for the entire duration of the therapy cycle, even if all actinic keratosis lesions appear to have disappeared.

Children and adolescents
The 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. No data are available on 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 need to take immunosuppressant medicines that reduce the immune response, tell your doctor before starting treatment.
Avoid using Zyclara and any other imiquimod-based cream simultaneously in the same treatment area.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Discuss the risks and benefits of using Zyclara during pregnancy with your doctor. Animal studies do not indicate any direct or indirect harmful effects on 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 stop breastfeeding or stop treatment with Zyclara.

Driving and operating machinery
This medicine has no or negligible effect on the ability to drive and 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 told you. If you have any doubts, ask your
doctor or pharmacist. Do not use this medicine until your doctor has shown you the correct way to use it.
This medicine must be used only for actinic keratosis on the face and scalp.
Dosage
Apply this medicine to the affected area once a day, just before bedtime.
The maximum daily dose is 2 sachets (500 mg = 2 sachets of 250 mg each).
This medicine should not be applied to areas larger than the entire face or the bald scalp.
Method of administration

• 1. Before bedtime, wash your hands and the treatment area thoroughly with mild soap and water. Dry your hands well and let the treatment area dry.

• 2. Open one sachet of Zyclara just before using it and squeeze a little cream onto your fingertips. 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 open sachet. Wash your hands thoroughly with water and soap.

• 5. Leave Zyclara on the skin for about 8 hours. During this time, do not shower or bathe. Do not cover the treated area with bandages or other dressings.

• 6. After about 8 hours, wash the area where you applied Zyclara 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 away the excess with mild soap and water.
Once the skin reaction has passed, you can continue with the treatment according to the normal schedule
recommended.
The cream should not be applied more than once a day.
If you accidentally swallow this medicine, consult your doctor immediately.

If you forget to use Zyclara
If you forget a dose of Zyclara, wait until the next evening to apply it and then continue with the
normal treatment schedule. 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 forgotten some doses.

If you stop using 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical attention if any of these side effects occur during the use of this
medicine:
Severe skin reactions (frequency not known) with skin lesions or spots on the skin that begin
as small red areas and progress to look like small target-shaped lesions accompanied by any
symptoms such as itching, fever, general feeling of unwellness, joint pain, vision problems,
burning, pain or itching in the eyes and mouth soreness. If any of these effects occur, stop using
this medicine and seek immediate medical attention.
In some individuals, a decrease in the number of blood cells has been observed (frequency not
known). This condition may make you more susceptible to infections, cause bruising of the skin
more easily, or cause fatigue. If you notice any of these symptoms, inform your doctor.
Some patients suffering from autoimmune diseases may experience a worsening of their
condition. If you notice any changes during treatment with Zyclara, inform your doctor.
If there is pus or any other sign of skin infection (frequency not known), talk to 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 during the use of this medicine the skin
does not react adequately or experiences too much 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 interrupt the application of 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, scab formation, scaling of the skin, secretion, dryness of the skin, swelling of the skin, skin ulcer and decreased skin pigmentation at the application site

Common(may affect up to 1 in 10 people)

• Further reactions at the application site, such as inflammation, itching, pain, burning, irritation and rash
• Enlargement of the glands
• Headache
• Dizziness
• Loss of appetite
• Nausea
• Diarrhoea
• Vomiting
• Flu-like symptoms
• Fever
• Pain
• Muscle and joint pain
• Chest pain
• Insomnia
• Fatigue
• Viral infection (herpes simplex)
• Increased blood sugar (glucose level in the blood)

Uncommon(may affect up to 1 in 100 people)

• Changes at the application site, for example, bleeding, small swollen areas on the skin, inflammation, tingling, increased sensitivity to touch, scar formation, sensation of heat, pressure ulcer, 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 1000 people)

• Recurrence of autoimmune diseases (diseases related to an abnormal immune response)
• Skin reactions away 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 have 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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the label
“Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
The sachets must not be reused once opened.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zyclara contains

• 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 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 paragraph 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 cream 3.75% contains 250 mg of a cream ranging in colour from white to slightly yellow, with a uniform appearance.
• Each box contains 14, 28 and 56 single-dose sachets of white/low-density polyethylene/aluminium foil. 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 on this medicinal product, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Viatris
Tél/Tel: +32 2 658 61 00

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

България
Майлан ЕООД
Тел: +359 2 44 55 400

Magyarország
Viatris Healthcare Kft.
1138 Budapest
Váci út 150
Tel: +36 1 465 2100

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Malta
V.J. Salomone Pharma Limited
Upper Cross Road
Marsa, MRS 1542
Tel: +356 21 22 01 74

Danmark
ViatrisApS
Tlf: +45 28 11 69 32

Nederland
Mylan Healthcare B.V.
Krijgsman 20
1186 DM Amstelveen
Tel: +31 (0)20 426 3300

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Norge
ViatrisAS
Hagaløkkveien 26
1383 Asker
Tlf: +47 66 75 33 00

Eesti
Viatris OÜTel: +372 6363 052

Österreich
Viatris Austria GmbH
Guglgasse 15
1110 Wien
Tel: + 43 (0)1 86 390

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 210 010 0002

Polska
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa
Tel: +48 22 546 6400

España
Viatris Pharmaceuticals, S.L.
Tel: +34 900 102 712

Portugal
Viatris Healthcare, Lda.
Av. D. João II,
Edifício Atlantis, nº 44C – 7.3 e 7.4
1990-095 Lisboa
Tel: +351 214 127 200

France
Viatris Santé1 bis place de la Défense – Tour
Trinity
92400 Courbevoie
Tél: +33 (0)1 40 80 15 55

România
BGP PRODUCTS SRL
Tel.: +40 372 579 000

Hrvatska
Viatris Hrvatska d.o.o.
Koranska 2
10 000 Zagreb
Tel: +385 1 235 059 9

Slovenija
Viatris d.o.o.
Tel: +386 1 23 63 180

Ireland
Tel: +353 8711600

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

Ísland
Icepharma hf
Sími: +354 540 8000

Suomi/Finland
Viatris Oy
Vaisalantie 2-8/Vaisalavägen 2-8
02130 Espoo/Esbo
Puh/Tel: +358 20 720 9555

Italia
Viatris Italia
Via Vittor Pisani, 20
20124 Milano
Tel: +39 0261246921

Sverige
Viatris AB
Box 23033
104 35 Stockholm
+46 (0) 8 630 19 00

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: 353 18711600

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

Lietuva
Viatris UABŽalgirio str. 90-100
Vilnius LT-09303
Tel. + 370 52051288
More detailed information on this medicinal product is available on the website of the European Medicines Agency:
http://www.ema.europa.eu