Aldara – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Aldara, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
ℹ️ 1. What Aldara cream is and what it is used for
Aldara cream may be used for three different conditions. Your doctor may prescribe Aldara cream for the treatment of:
- Warts (condylomata a cuminata) on the surface of the genita ls (sexual organs) and around th e anus (back passage)
- Superficial basal cell carcinoma.
This is a common slow -growing form of skin cancer with a very small likelihood of sp read to other parts of the body. It usually occurs in middle -aged an d elderly peop le, especially those who are fai r-skinned and is caused by too much sun exposure. If left untreated, basal cell carcinoma can disfigure, esp ecially on the face – therefore ea rly recog nition and treatment are important.
- Actinic keratosis Actinic keratoses are rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime. Some are skin coloured , others are greyish, pink, red or brown. T hey can be flat and scaly, or raise d, rough, hard and warty . Aldara shoul d only be used for flat actinic keratoses on the face and scalp in patients with a healthy immune system where your doctor has decided that Aldara is the most appropriate tre atment fo r you.
Aldara cream helps your bod y´s own immune system to produce natur al substances which help fight your basal cell carcinoma, actinic keratosis or the virus that has caused your warts.
⚠️ 2. What you need to k now before you use Aldara cream
Do not use Aldara cream
- if you are allergi c to imiquimod or any of the other ingredients of th is medicine (liste d in section 6).
26 Warnings and precautions Talk to your doctor or pharmacist before using Aldara cream
- If you have previously used Aldara cr eam or othe r similar preparations tell your doctor before starting thi s treatment.
- If you suffer from autoimmune d isord ers
- If you have had an organ transplant
- Do not use Aldara cream until the area to be treated has heale d afte r previous drug or surgical treatmen t.
- Avoid contact with the eyes, lips and nostrils. In the event of acciden tal contact, remove cream by rin sing with water.
- Do not apply the cream internally.
- Do not use more cream than your doctor has advised.
- Do n ot cov er the treated area with ban dages or other dressings after you have appl ied Aldara cream.
- If the treated site becomes too uncomfortable, wash the c ream off with mild soap and water.
As soon as the problem has stopped you may restart to apply the crea m.
- Tell your doctor if you have an abnorma l blood count.
Because of the way A ldara works, th ere is a possibility th at the cream may worsen existing inflammation in the treatment area.
- If you are being treated for genital warts follow these additional pre cautio ns:
Men with warts under th e foresk in should pull the foreskin back eac h day and wash underneath it. If not w ashed daily the foreskin may be more likely to show signs of tightness, swelling and wearing away of the skin and result in difficulty in pu lling it back. If these symptoms o ccur, stop the treatment immediately and cal l your doctor.
If you have open sores: do not start using Aldara cream until after the sores have healed.
If you have internal warts: do not use Aldara cream in the urethra (the hole f rom which urine is passed), the vagi na (birth canal), the cervix (intern al female organ ), or anywhere inside y our anus (rectum).
Do not use th is me dication for more than one course if you have problems with your immune system, either due to illness o r beca use of the medicines you are already taking. If you think this applies t o you talk to y our doctor.
If you are HIV positive you should inform y our d octor as Aldara cream has not been shown to be as effective in HIV positive patients.
If you decide to have sexual relations while you s till hav e warts, apply Aldara cream after – not before – sexual activity. Aldara c ream may weaken condoms and diap hragm s, therefore the cream should not be left on during sexual activity. Remember, Aldara cream does not pr otect against giving HIV or other sexually transmitted diseases to someone els e.
- If you are being treated for basal cell carcinoma or actinic kerat osis follow these additional precautions:
Do not use sunlamps or tanning beds, and avoid sunlight as much a s poss ible during treatment with A ldara cr eam. Wear protective clothing and wi de brimmed hats when outdoors.
Whilst using Aldara cream and until he aled, the treatment area is likely to appear noticeably different from normal skin.
Children and adolescent s Use in children and adolescents is not recommended.
27 Other medicines and A ldara cream Tell your doctor or phar macist if you are taking , have r ecent ly taken or might take any other medicines .
There are no medicines known to be incompatible with Aldara cream .
Pregnancy and breast -feeding Ask your doctor or pharmacist for advic e before taking any medicine.
You must tell your doctor if you are pre gnant or intend to become pregnant. Your doctor will discuss the risks and benefits of using Aldara cream du ring p regnancy. Studies in animals do not indicate direct or indirect harmful effects in preg nancy.
Do not breast -feed your infant during treatment with Aldara cream, as it is not known whether imiquimod is secreted in human milk.
Driving and using machi nes This medicine has no or negli gible in fluence on the ability to drive and use machines.
Aldara cream contains m ethyl hydroxybenzoate, propyl hydroxy benzoate, cetyl alcohol , stearyl alcohol and benzyl alcohol Methyl hydroxybenzoate (E 218) and propyl hydrox ybenzoate (E 216) may cause allergic reactions (possibly delayed). Cetyl alcohol and st earyl alcohol may cause local skin reactions (e.g. cont act dermatitis).
This medicine contains 5 mg benzyl alcohol in each sachet . Benzyl alcohol may cause allergi c reactions and mild local irritat ion.
💊 3. How to use Aldara cream
Children and adolescents :
Use in children and a dolescents is not recommended.
Adult s:
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist i f you are not sure.
Wash hands ca refully before and after applying the cream. Do not cover t he treated area with bandages or other dressings after you h ave applied Aldara cream.
Open a new sachet each time you use the cream. Dispose of any cream left in t he sac het after use. Do not save t he opene d sachet for use at a later date.
The treatment f requency and duration d iffer for genital warts, basal c ell carcinoma and actinic keratosis (see specific instructions for each indication).
28 • If you are being treate d for genital warts:
Applic ation In structions – (Mon, Wed and Fri) 1. Before going to bed, wash your hands an d the treatment area with mild s oap a nd water. Dry thoroughly.
2. Open a new sachet and squeeze some cream onto your fingertip.
3. Apply a t hin la yer of Aldara cream onto cle an, dry wart area and rub gently into the sk in until cream vanishes.
4. After appl ication of the cream, throw away the opened sachet and wash hands with soap and water.
5. Leave Aldara cream on the warts for 6 to 10 hours. Do no t shower or bathe during thi s time.
6. After 6 to 10 hours wash the area where Aldara c ream was applied with m ild soap and water.
Apply Aldar a cre am 3 times per week. For example, apply the cream on Monday, Wednesday and Friday. One sachet contains enough cream to cover a wart area of 20 cm2 (approx. 3 square inches).
Men wi th warts under the foreskin should pul l the foreskin back each day and wash underneath it (see section 2 “Warnings and precautions ”) Continue to use Aldara cream as instructed u ntil y our warts have completely go ne (half the females who clear will do so in 8 weeks, half the males who clear wil l do so in 1 2 weeks but in some patie nts warts may clear as early as 4 weeks).
Do not use Aldara cream for more than 1 6 weeks in the treatm ent of each episode of warts.
If you have the impression that the effect of A ldara cream is too strong or too weak, talk to your doctor or pharmaci st.
- If you are being treated for basal cell carcinoma:
Application Instructions – (Mon, Tues, Wed, Thurs and Fr i) 1. Before going to bed, w ash your hands and the treatment area with m ild soap and wa ter. Dry thoroughly.
2. Open a new sachet and squeeze s ome c ream onto your fingertip.
3. Apply Aldara cream to the affected area and 1cm (approx. 0. 5 inch) around the af fected area. Rub gently into the ski n until the cream vanishes.
4. After application of the cream, throw away the opened sachet. Wash hands wi th so ap and water.
5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this t ime.
6. After about 8 hours, wash the area where Aldara cream was applied with mild soap and water.
Apply sufficien t Aldara cream to cover the trea tment area and 1 cm (about ½ an inch) around the treatment area each day for 5 consecutive days each week fo r 6 weeks. For example, apply the cream from Monday to Friday. Do not apply th e cream on Satu rday and Sunday.
- If yo u are being treated for actinic kerat osis Application Instructions – (Mon, Wed and Fri)
1. Before going to bed, wash your hands and the tre atment area with mild soap and wat er. Dry thoroughly.
2. Open a new sachet and squeeze some c ream onto your fingerti p.
3. Apply the cream to the aff ected area. Rub gently into the area until the cream vanishes.
4. After application of the cream, throw away the o pened sachet. Wash hands wit h soap a nd water.
5. Leave Aldara cream on t he skin for abo ut 8 hours. Do not show er or bathe during this time.
6. After about 8 hours, wash the area where Aldara cream was applied with mild soap and water.
Apply Aldara c ream 3 times per week. For example , apply the cream on Monday, Wednesday and Friday. One sach et contains enough crea m to cover an area of 2 5 cm2 (approx. 4 square inches).
Continue treatment for four weeks. Four weeks after finishing this first treatment, your d octor will 29 assess your skin. If the lesions have not all disappeared, fu rther four week s of treatment may be necessary.
If you use more Aldar a cre am than you should
Wash the extra away with mild soap and water. When any skin reaction has gone you m ay the n continue with your treatme nt.
If you accidentally swallow Aldara crea m please contac t your doctor.
If you forget to use Aldara cream
If you mi ss a dose, apply cream as soon as you remember and then continue in your regular schedule.
Do not apply the c ream more than once per day.
If you have any further questions on the u se of this medi cine, ask your doctor o r pharmacist.
❗ 4. Possible side effects
The frequency of side effects is classified as follows:
Very common side effects (likely to occu r in m ore than 1 in 10 patients )
Common si de effects (likely to occur in fewer than 1 in 10 patients)
Uncommon side effects (likely to occur in fewe r than 1 in 100 patients )
Rare side effects (likely to occur in fewer than 1 in 1,000 patients )
Very rare si de eff ects (likely to occur in few er than 1 in 10,000 patients) .
Like all med icines, this me dicine can cause side e ffects, although not everybody g ets them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Al dara cream.
Some patients have ex perience d changes in skin colour in the area where Aldara c ream was applied.
While these changes have tended to im prove with time, in some patients they may be permanent.
If your skin reacts badly when using Aldara cream, stop a pplying the cream, wash the area wit h mild soap and water and contact yo ur doctor or ph armacist.
In some indi viduals a lowering of blood coun ts wa s noted. A lowering of blood counts might make you more susceptible to infections, make you bruise more easily or cause fatigue. If you n otice an y of these symptoms, tell your docto r.
Some patient s who suffer from autoi mmune disorders may experience w orsen ing of their condition. If you notice any change during treatment with Aldara cream , tell your doctor.
Serious skin reactions have been r eported rarely. If you experience skin lesio ns or spots o n your skin that start ou t as small red areas and progres s to look like mini targets, possibly with symptoms such as itching, fever, overall ill feeling, achy joints , vision problems, burning, painfu l or itchy eyes and mouth sores, stop using Aldara cream and tell your doctor imme diately.
A small number of patie nts h ave experienced hair loss at the treatment site or surrounding area. ● If you are being treated for g enital warts:
Many of the undesirab le effects of Aldara cream are due to its local action on your skin.
Very c ommo n effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling. H ardening under the skin, small o pen sores, a crust that forms during healing, and small bubbles under the skin may also occur. You might also feel i tching (32% patients), a burning sensation (26% patients) or pain in areas where you have applied Aldara cre am (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 mus cle pains; prolapse of the womb; pain on intercourse in females; ere ction difficulties; increase in sweating; feeling sick; stomach and bowel sympto ms; ringing in the ears; flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; l oss of appetite; swollen glands; bacterial, viral and fungal infecti ons (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 s kin 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 A ldara 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 ski n, 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 t o 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 change s at the application site (disch arge, inflammation, swelling, scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flu -like symptoms and tiredness. ● If you ar e 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 sli ghtly 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 f rom treatmen t).
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 pat ients experi ence 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 lini ng of the no se, 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
31 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 oute r 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 pro tect the env ironment.
📦 6. Contents of the pack and other information
What Aldara cream contains
- The active substance is imiquimod. Each sachet contains 25 0 mg cream (10 0 mg cream contains 5 mg imiquimod).
- The other ingredients are isostearic acid, ben zyl 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 hyd roxybenzoate , 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 25 0 mg of a white to slightly yellow cream.
- Each box contains 1 2 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 A ibling Germany For any information about this medicin e, please contact the local repres entative of the Marketing Authorisation Ho lder.
België/Belgique/Belgien Viatris Tél/Tel: + 32 2 658 61 00 Luxembourg/ Luxemburg Viatris Tél/Tel: +32 2 65 8 61 00 (Belgique/Belgien) Българ ия Майлан ЕООД Тел.: +359 2 44 55 400 Magyarország Viatris He althcare 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, M RS 1542 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 Viatri s AS Hagaløkkveien 26 1383 As ker Tlf: +47 66 75 33 00 Eesti Viatris OÜ Tel: +372 63 63 052 Öste rreich Viatris Austria GmbH Guglgasse 15 1110 Wien Tel: + 43 (0)1 86 390 Ελλάδα Viatris He llas 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 Pharmaceutical s, S.L.
Tel: +34 900 102 712 Portugal Viatris Healthca re, Lda.
Av. D. João II, Edifíc io Atlantis, nº 44C – 7.3 e 7.4 1990 -095 Lisboa Tel: +351 214 127 200 Franc e Viatris Santé 1 bis place de la Défense – Tour Tri nity 92400 Courbevoie Tél: +33 (0)1 40 80 15 55 Român ia BGP PRODUCTS SRL Tel.: +40372 579 000 Hrvatska Viatris Hrvatska d .o.o.
Koranska 2 10 000 Zagreb Tel: +385 1 235 0 599 Slovenija Viatris d.o.o .
Tel: +386 1 23 63 180 33 Ireland Mylan Ireland L imited Tel: +35 3 1 8711600 Slovenská republika Viatris Slov akia s.r.o.
Tel: +421 2 32 199 100 Ísland Icepharma hf .
Sími: +354 540 8000 Suomi/Finland Viatris Oy Vaisalantie 2-8/Vaisa lavägen 2-8 02130 Espoo/Esbo Puh/Tel: +358 20 720 955 5 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 Κύπρ ος GPA Pharmaceuticals Ltd Τηλ: +357 22863100 United Kingdom (Norther n Ireland) Mylan IRE Heal thcare Limited Tel: +353 18711600 Latvija Viatris SIA 101 M ūkusalas str.
Rīga LV‐1004 Tālr: + 371 67616137 Lietuva Viatris UAB Žalgirio str. 90 -100 Vilnius LT -09303 Tel. + 370 52051288 This leaflet was last revise d in (MM/YYYY) .
Detailed i nformation on this medicine is ava ilable on the European Medicines Agency web site: http://www.ema. europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Aldara (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/98/080).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.