imiquimod: package leaflet

thoroughly.

Apply Aldara cream 3 times per week. For example, apply the cream on Monday, Wednesday and Friday. One sachet contains enough cream to cover an area of 25 cm2 (approx. 4 square inches).
Continue treatment for four weeks. Four weeks after finishing this first treatment, your doctor will

assess your skin. If the lesions have not all disappeared, further four weeks of treatment may be necessary.

If you use more Aldara cream than you should

Wash the extra away with mild soap and water. When any skin reaction has gone you may then continue with your treatment.

If you accidentally swallow Aldara cream please contact your doctor.

If you forget to use Aldara cream

If you miss a dose, apply cream as soon as you remember and then continue in your regular schedule.
Do not apply the cream more than once per day.

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

4.
Possible side effects

The frequency of side effects is classified as follows:
Very common side effects (likely to occur in more than 1 in 10 patients)
Common side effects (likely to occur in fewer than 1 in 10 patients)
Uncommon side effects (likely to occur in fewer than 1 in 100 patients)
Rare side effects (likely to occur in fewer than 1 in 1,000 patients)
Very rare side effects (likely to occur in fewer than 1 in 10,000 patients).

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aldara cream.
Some patients have experienced changes in skin colour in the area where Aldara cream was applied.
While these changes have tended to improve with time, in some patients they may be permanent.
If your skin reacts badly when using Aldara cream, stop applying the cream, wash the area with mild soap and water and contact your doctor or pharmacist.
In some individuals a lowering of blood counts was noted. A lowering of blood counts might make you more susceptible to infections, make you bruise more easily or cause fatigue. If you notice any of these symptoms, tell your doctor.
Some patients who suffer from autoimmune disorders may experience worsening of their condition. If you notice any change during treatment with Aldara cream, tell your doctor.
Serious skin reactions have been reported rarely. If you experience 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, stop using Aldara cream and tell your doctor immediately.
A small number of patients have experienced hair loss at the treatment site or surrounding area.

● If you are being treated for genital warts:

Many of the undesirable effects of Aldara cream are due to its local action on your skin.

Very common effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling. Hardening under the skin, small open sores, a crust that forms during healing, and small bubbles under the skin may also occur. You might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where you have applied Aldara cream (8% patients).
Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after stopping treatment.

Commonly some patients (4% or less) have experienced headache, uncommonly fevers and flu like symptoms joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears;
flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough and colds with sore throat.

Very rarely severe and painful reactions have occurred, particularly when more cream has been used than recommended. Painful skin reactions at the opening of the vagina have very rarely made it difficult for some women to pass urine. If this occurs you should seek medical help immediately.

● If you are being treated for basal cell carcinoma:

Many of the undesirable effects of Aldara cream are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended.

Very Commonly the treated skin may be slightly itchy.

Common effects include: pins and needles, small swollen areas in the skin, pain, burning, irritation, bleeding, redness or rash.
If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).
If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include swollen glands and back pain.
Uncommonly some patients experience changes at the application site (discharge, inflammation, swelling, scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flu-like symptoms and tiredness.

● If you are being treated for actinic keratosis

Many of the undesirable effects of Aldara cream are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended.

Very commonly the treated skin may be slightly itchy.

Common effects include pain, burning, irritation or redness.
If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).
If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain and tiredness.

Uncommonly some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small swollen areas in the skin, pins and needles, scabbing, scarring, ulceration or a feeling of warmth or discomfort), or inflammation of the lining of the nose, stuffy nose, flu or flu-like symptoms, depression, eye irritation, swelling of the eyelid, throat pain, diarrhoea, actinic keratosis, redness, swelling of the face, ulcers, pain in extremity, fever, weakness or shivering.

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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.
How to store Aldara cream

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

Do not store above 25 °C.

Do not use this medicine after the expiry date which is stated on the outer carton and the label after EXP.

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.

6.
Contents of the pack and other information

What Aldara cream contains

• The active substance is imiquimod. Each sachet contains 250 mg cream (100 mg cream contains 5 mg imiquimod).
• The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl hydroxybenzoate (E 216), xanthan gum, purified water (see also section 2 “Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol”).

What Aldara cream looks like and contents of the pack

• Each Aldara 5% cream sachet contains 250 mg of a white to slightly yellow cream.
• Each box contains 12 or 24 single-use polyester/aluminium foil sachets. Not all pack sizes may

be marketed.

Marketing Authorisation Holder and Manufacturer

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 any information about this medicine, please 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
Tel: +356 21 22 01 74

Danmark
Viatris ApS
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
Viatris AS
Hagaløkkveien 26
1383 Asker
Tlf: +47 66 75 33 00
Eesti
Viatris OÜ
Tel: +372 63 63 052

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 Santé
1 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 2350 599
Slovenija
Viatris d.o.o.
Tel: +386 1 23 63 180

Ireland
Viatris Limited
Tel: +353 1 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
Puh/Tel: +358 20 720 9555
Italia
Viatris Italia
Via Vittor Pisani, 20
20124 Milano
Tel: +39 (0) 2 612 46921
Sverige
Viatris AB
Box 23033
104 35 Stockholm
+46 (0) 8 630 19 00
Κύπρος
CPO Pharmaceuticals Limited
Τηλ: +357 22863100

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

This leaflet was last revised in (MM/YYYY).

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

treatment area carefully with mild soap and water. Dry hands thoroughly and allow the area to dry.

squeeze some cream onto your fingertip. No more than 2 sachets should be used per application.

gently into the area until the cream vanishes. Avoid contact with the eyes, lips and nostrils.

sachet. Wash hands well with soap and water.

shower or bathe the area during this time. Do not cover the treated area with bandages or other dressings.

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.

4.
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.
Some patients who suffer from autoimmune disorders may experience worsening of their condition. If you notice any change during treatment with Zyclara, 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 the national reporting system listed in Appendix 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 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.

6.
Contents of the pack and other information

What Zyclara contains
- The active substance is imiquimod. Each sachet contains 9.375 mg of imiquimod in 250 mg cream (100 mg of cream contains 3.75 mg imiquimod).
- The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft 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”).

What Zyclara looks like and contents of the pack

• Each Zyclara 3.75% cream sachet contains 250 mg of a white to slightly yellow cream with a uniform appearance.
• Each box contains 14, 28 or 56 single-use polyester/ white low density polyethylene/aluminium foil sachets. 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 any information about this medicine, please 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
Tel: +356 21 22 01 74
Danmark
Viatris ApS
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
Viatris AS
Hagaløkkveien 26
1383 Asker
Tlf: +47 66 75 33 00

Eesti
Viatris OÜ
Tel: +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 Santé
1 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 2350 599
Slovenija
Viatris d.o.o.
Tel: +386 1 23 63 180

Ireland
Viatris Limited
Tel: +353 1 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
Puh/Tel: +358 20 720 9555
Italia
Viatris Italia
Via Vittor Pisani, 20
20124 Milano
Tel: +39 (0) 2 612 46921
Sverige
Viatris AB
Box 23033
104 35 Stockholm
+46 (0) 8 630 19 00
Κύπρος
CPO Pharmaceuticals Limited
Τηλ: +357 22863100

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

This leaflet was last revised in (MM/YYYY).

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.