ALDARA 5% Cream

Зміст інструкції

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

Aldara 5% cream

imiquimod

Read this leaflet carefully before you start using 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 their symptoms are the same as yours, as it could 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 Aldara cream is and what it is used for
• 2. What you need to know before you use Aldara cream
• 3. How to use Aldara cream
• 4. Possible side effects
• 5. How to store Aldara cream
• 6. Contents of the pack and other information

1. What is Aldara cream and what is it used for

Aldara cream can be used in three different situations. Aldara cream may be prescribed by your doctor
for the treatment of:

• Warts (condylomata acuminata) that appear on the surface of the genitals (sexual organs) and around the anus (perianal area)
• Superficial basal cell carcinoma. This is a common, slow-growing skin cancer with a very low probability of spreading to other parts of the body. It usually occurs in elderly or middle-aged people, particularly those with fair skin, and is due to excessive exposure to sunlight. If left untreated, basal cell carcinoma can have disfiguring effects, especially on the face. It is therefore important to recognize it and intervene early.
• Actinic keratosis. Actinic keratosis is characterized by rough areas of skin found in people who have been excessively exposed to the sun's rays throughout their lives. Some of these are colored, others are grayish, pink, red or brown. They can be flat and partially overlapping, or raised, rough, hardened and warty. Aldara should only be used for flat actinic keratoses of the face and scalp in patients with an intact immune system, when the doctor has decided that Aldara is the most appropriate treatment for you. Aldara cream helps your body's immune system produce natural substances that help fight superficial basal cell carcinoma, actinic keratosis or the virus responsible for warts.

2. What you need to know before using Aldara cream

Do not use Aldara cream

• if you are allergic to imiquimod or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsTalk to your doctor or pharmacist before using Aldara cream
• If you have previously used Aldara cream or another similar medicine, tell your doctor before starting this treatment.
• If you suffer from autoimmune diseases.
• If you have undergone an organ transplant.
• Do not use Aldara cream until the area to be treated has healed after a previous medical or surgical treatment.
• Avoid contact with the eyes, lips and nostrils. In case of accidental contact, remove the cream by rinsing with water.
• Do not apply the cream to internal areas.
• Do not apply a quantity of cream greater than that prescribed by the doctor.
• Do not cover the warts with bandages or similar after applying Aldara cream.
• If you should experience discomfort in the affected area, remove the cream by washing with water and mild soap. As soon as the discomfort disappears, you can resume applications.
• Tell your doctor if you have abnormal hematological values (blood cell count).

Due to the way Aldara cream works, there is a possibility that the cream may worsen a
pre-existing inflammation of the treatment area.

• If you are being treated for genital warts, follow these additional precautions:

men with warts under the foreskin must retract the foreskin and wash the underlying part
daily. If this washing is not performed daily, it is very
likely that symptoms of hardening, edema and loss of the skin lining may appear
resulting in difficulty retracting the foreskin. If you should experience such symptoms,
immediately stop treatment and inform your doctor.
If you have open wounds: do not start treatment with Aldara cream, until they are
completely healed.
If you have internal warts: do not use Aldara cream in the urethra (opening through which urine passes),
in the vagina, in the cervix or in any position inside the anus (rectum).
Do not use this medicine for more than one treatment cycle if your doctor has diagnosed you with serious
problems with the immune system, either due to the disease or because of the medicines you are already
taking.
If you are HIV-positive, you must inform your doctor, as Aldara cream has proven to be of limited efficacy
for this category of patients.
If you decide to have sexual intercourse when warts are still present, apply Aldara
cream after - not before - sexual intercourse. Aldara cream can damage condoms or
diaphragms, so it should not be left on the skin during sexual intercourse. Remember that Aldara
cream does not protect against the risk of HIV transmission or other sexually
transmitted diseases.

• If you are being treated for basal cell carcinoma or actinic keratosis, follow these additional precautions: do not use sunbeds or tanning beds and avoid exposure to sunlight as much as possible during treatment with Aldara cream. Wear protective clothing and wide-brimmed hats when going outside. During therapy with Aldara cream and until healing, the treatment area will likely look very different from normal skin. Children and adolescentsUse is not recommended in children and adolescents. Other medicines and Aldara creamTell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. No medicines are known to be incompatible with Aldara cream. Pregnancy and breastfeedingAsk your doctor or pharmacist for advice before taking any medicine. You must inform your doctor about your pregnancy or intention to become pregnant. The doctor will then explain the risks and benefits of using Aldara cream during pregnancy. Studies in animals have not shown any evidence of direct or indirect harmful effects on pregnancy. Do not breastfeed during treatment with Aldara cream, as it is not known whether imiquimod is excreted in breast milk. Driving and using machinesThis medicine does not impair or negligibly alter the ability to drive and use machines. Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol,stearyl alcohol and benzyl alcohol.Methyl hydroxybenzoate (E218), and propyl hydroxybenzoate (E216) can cause allergic reactions (even delayed). Cetyl alcohol and stearyl alcohol can cause local skin reactions, e.g. contact dermatitis). This medicine contains 5 mg of benzyl alcohol per sachet. Benzyl alcohol can cause allergic reactions and mild local irritation.

3. How to use Aldara cream

Children and adolescents:
Use is not recommended in children and adolescents.

Adults:
Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Wash your hands thoroughly before and after applying the cream. Do not cover the treated area with bandages or
plasters after applying Aldara cream.
Open a new sachet each time you use the cream. Dispose of the sachet with the remaining cream after use. Do not
keep the open sachet for a subsequent application.
The frequency and duration of treatment vary depending on whether it refers to genital warts, basal cell
carcinoma or actinic keratosis (see specific instructions for each indication).

Aldara Cream Instructions for application

• If you are being treated for genital warts: Instructions for application - (Monday, Wednesday and Friday)
• 1.Before going to bed, wash your hands and the area to be treated with water and mild soap. Dry well.
• 2.Open a new sachet and squeeze a little cream onto your fingertips.
• 3.Apply a thin layer of Aldara cream to the area of warts previously washed and dried and gently massage until the cream is completely absorbed.
• 4.After applying the cream, discard the open sachet and wash your hands with water and soap.
• 5.Leave Aldara cream on the warts for about 6-10 hours. During this period avoid bathing or showering.
• 6.After about 6-10 hours, wash the application area of Aldara cream with water and mild soap. Apply Aldara cream 3 times a week. For example, apply the cream on Monday, Wednesday and Friday. Each sachet contains enough cream to cover a surface area of warts of 20 cm .

Men who have warts located under the foreskin should retract it and wash the area
daily (see paragraph 2 «Special care should be taken»).
Continue to use Aldara cream following the instructions until the warts are completely healed (about half of
women and men who achieve complete healing undergo treatment for 8 and 12 weeks respectively, although, in
some cases, healing of the warts can be achieved even after 4 weeks of treatment).
Do not use Aldara cream for more than 16 weeks for the treatment of each episode of warts.
If you feel that the effect of Aldara cream is too strong or too weak, tell your doctor or
pharmacist.

• If you are undergoing treatment for basal cell carcinoma:

Instructions for application – (Monday, Tuesday, Wednesday, Thursday and Friday)

• 1. Before going to bed, wash your hands and the area to be treated with water and mild soap. Dry well.
• 2. Open a new sachet and squeeze a little cream onto your fingertips.
• 3. Apply Aldara cream to the affected area and for 1 cm (approximately 0.5 inches) of the surrounding area. Gently massage the area until the cream is completely absorbed.
• 4. After applying the cream, discard the open sachet. Wash your hands with water and soap.
• 5. Leave Aldara cream on the skin for about 8 hours. During this period avoid bathing or showering.
• 6. After about 8 hours, wash the application area of Aldara cream with water and mild soap. Apply an amount of Aldara cream sufficient to cover the area to be treated and 1 cm of the surrounding area, every day for 5 consecutive days a week for 6 weeks. For example, apply the cream from Monday to Friday. Do not apply the cream on Saturday and Sunday.
• If you are being treated for actinic keratosis Instructions for application - (Monday, Wednesday and Friday)
• 1. Before going to bed, wash your hands and the area to be treated with water and mild soap. Dry well.
• 2. Open a new sachet and squeeze a little cream onto your fingertips.
• 3. Apply the cream only to the affected area. Gently massage the area until the cream is completely absorbed.
• 4. After applying the cream, discard the open sachet. Wash your hands with water and soap.
• 5. Leave Aldara cream on the skin for about 8 hours. During this period avoid bathing or showering.
• 6. After about 8 hours, wash the application area of Aldara cream with water and mild soap. Apply Aldara cream 3 times a week. For example, apply the cream on Monday, Wednesday and Friday. Each sachet contains enough cream to cover an area of 25 cm (approximately 4 inches). Continue treatment for 4 weeks. Four weeks after completion of the first treatment, the doctor will observe the skin. If the lesions have not disappeared, a further 4 weeks of treatment may be necessary. If you use more Aldara cream than you should:Remove the excess by washing it off with water and mild soap. When any skin reaction disappears, treatment can be resumed. In case of accidental ingestion of Aldara cream, contact your doctor. If you forget to use Aldara cream:If you forget a dose, apply the cream as soon as possible and continue according to the established schedule. Do not apply the cream more than once a day. If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

The frequency of side effects is defined as follows:
Very common side effects (may affect more than 1 in 10 patients)
Common side effects (may affect up to 1 in 10 patients)
Uncommon side effects (may affect up to 1 in 100 patients).
Rare side effects (may affect up to 1 in 1,000 patients).
Very rare side effects (may affect up to 1 in 10,000 patients).
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you feel unwell during treatment with Aldara cream, tell your doctor or pharmacist as soon as possible.
Some patients have noticed changes in skin color in the area where Aldara cream was applied.
Although these changes usually tend to improve over time, they may be permanent for some patients.
If your skin reacts badly to the application of Aldara cream, stop treatment, wash the area with
water and mild soap and contact your doctor or pharmacist.
In some patients, a decrease in the number of blood cells has been observed. A decrease
in the number of blood cells can make you more susceptible to infections, can cause you to bruise more
easily or cause fatigue.
Some patients who suffer from autoimmune diseases may experience a worsening of their
condition. If you notice any changes during treatment with Aldara, tell your doctor.
Rarely, serious skin reactions have been reported. If you notice lesions or spots on the skin that
start as small red areas and increase, becoming similar to small target-shaped lesions
accompanied by symptoms such as itching, fever, feeling generally unwell, joint problems,
visual disturbances, burning, pain or itching in the eyes and pain in the mouth, stop using Aldara
cream and tell your doctor immediately.
In a small number of patients, hair loss has occurred in the treated area or the surrounding
area.

• If you are being treated for genital warts:

many of the side effects of Aldara cream are due to the action exerted locally on the skin.
Very commonside effects include redness (in 61% of patients), erosions (in 30% of patients),
scaling and swelling. It is also possible to experience hardening under the skin, small
ulcers, scab formation during the healing process and small blisters under the skin. You may
also experience itching (in 32% of patients), burning (in 26% of patients) or pain
(in 8% of patients) in the areas where Aldara cream is applied. Most of these reactions
are moderate and the skin returns to normal within 2 weeks of stopping applications.

Commonlyin some patients (in 4% or less) headache has been reported, uncommonly
fever and flu-like syndrome and muscle and joint pain; uterine prolapse; pain during sexual
intercourse in women; erectile dysfunction; increased sweating; feeling of nausea; symptoms in the
stomach and intestines; ringing or whistling in the ears; redness; fatigue; dizziness; migraine;
tingling; insomnia, depression; loss of appetite; enlargement of the glands; bacterial, fungal and
viral infections (e.g. cold sores); vaginal infections and oral thrush; cough and
colds with sore throat.

Very rarely, serious or painful reactions have occurred, particularly in cases of excessive use of
the product compared to the recommended amount. Painful skin reactions on the vaginal opening have
created difficulty in urination in women. If such situations occur, you should consult your doctor immediately.

• If you are being treated for basal cell carcinoma:

many of the side effects of Aldara cream are due to the action exerted locally on the skin.
Local skin reactions can be a sign that the medicine is working properly.

Very commonly, you may experience mild itching on the treated skin.
Commonside effects include: tingling, small swellings of the skin, pain, burning, irritation,
bleeding, redness or rash.
If a skin reaction becomes excessively bothersome during treatment, contact
your doctor. They may advise you to stop applying Aldara cream for a few days.
If there is pus or other signs of infection, talk to your doctor. In addition to skin reactions,
other common side effects are enlarged lymph nodes and back pain.

Uncommonly, some patients have reported changes at the application site
(secretions, inflammation, swelling, scab formation, skin lesions, blisters, dermatitis) or
irritability, nausea, dry mouth, flu-like symptoms and fatigue.

• If you are undergoing treatment for actinic keratosis

many of the side effects of Aldara cream are due to the action exerted locally on the skin.
Local skin reactions can be a sign that the medicine is working properly.

Very commonly, you may experience mild itching on the treated skin.
Commonside effects include: pain, burning, irritation or redness.
If a skin reaction becomes excessively bothersome during treatment, contact
your doctor. They may advise you to stop applying Aldara cream for a few days
(i.e. take a little break from treatment).
If there is pus or other signs of infection, talk to your doctor. In addition to skin reactions, other
common side effects are headache, anorexia, nausea, muscle and joint pain and fatigue.

Uncommonly, some patients have observed changes in the application area
(bleeding, inflammation, secretions, sensitization, edema, small swellings of the skin,
chills, scab or scar formation, ulcerations or a feeling of warmth or discomfort), or
inflammation of the nasal lining, nasal congestion, flu or flu-like symptoms, depression,
eye irritation, eyelid swelling, sore throat, diarrhea, actinic keratosis, redness,
facial swelling, ulcers, pain in the extremities, fever, weakness or tremors.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex 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 at a temperature above 25° C.
Do not use this medicine after the expiry date which is stated on the package and on the label after Exp.
Once the sachets are opened, they must not be reused.
Do not dispose of any medicine in 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 Aldara Cream contains

• The active ingredient is Imiquimod. Each sachet contains 250 mg of cream (100 mg of cream contains 5 mg of imiquimod). The other ingredients are: isostearic acid ,benzyl alcohol ,cetyl alcohol ,stearyl alcohol ,white petrolatum ,polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), xanthan gum, purified water (see also paragraph 2 “Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol”). Description of the appearance of Aldara Cream and contents of the pack
• Each sachet of Aldara 5% cream contains 250 mg of a cream of a yellowish-white colour.
• Each pack contains 12 or 24 single-use sachets in a polyester/aluminium laminate. Not all pack sizes may be marketed. Marketing Authorisation HolderViatris Healthcare Limited Damastown Industrial Park Mulhuddart Dublin 15 DUBLIN Ireland ManufacturerSwiss 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 800Tel: +49 (0) 6172 888 01

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

Polska
ViatrisHealthcare 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
Τηλ: +30 210 010 0002

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.: +40372 579 000

Hrvatska
Viatris Hrvatska d.o.o.
Koranska 2
10 000 Zagreb

Slovenija
Viatris d.o.o.
Tel: +386 1 23 63 180
Tel: +385 1 235 059 9

Ireland
Mylan Ireland 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
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 UAB
Žalgirio str. 90-100
Vilnius LT-09303
Tel. + 370 52051288

This leaflet was last updated on:
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .