ADCIRCA 20 mg film-coated tablets

ADCIRCA is a treatment for pulmonary arterial hypertension.

ADCIRCA belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity.

Do NOT take ADCIRCA if you:

• are allergic (hypersensitive) to tadalafil or any of the other ingredients (see Section 6 and end of Section 2).
• are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain. ADCIRCA has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
• have ever had loss of vision ? a condition described as ?stroke of the eye? (non-arteritic anterior ischemic optic neuropathy - NAION).
• have had a heart attack in the last 3 months
• have low blood pressure

ADCIRCA is not intended for use by children and adolescents under the age of 18.

Take special care with ADCIRCA

Before taking the tablets, tell your doctor if you have:

• any heart problems other than your pulmonary hypertension
• problems with your blood pressure
• any hereditary eye disease
• an abnormality of red blood cells (sickle cell anaemia)
• cancer of the bone marrow (multiple myeloma)
• cancer of the blood cells (leukaemia)
• any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours
• a serious liver problem
• a severe kidney problem.

If you experience sudden decrease or loss of vision, contact your doctor immediately.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without prescription.
Do NOT take these tablets if you are already taking nitrates .

Some medicines may be affected by ADCIRCA or they may affect how well ADCIRCA will work. Tell your doctor or pharmacist if you are already taking:

• bosentan (another treatment for pulmonary aterial hypertension)
• nitrates (for chest pain)
• alpha blockers used to treat high blood pressure or prostate problems.
• rifampicin (to treat bacterial infections)
• ketoconazole tablets (to treat fungal infections)
• ritonavir (for HIV treatment)
• tablets for erectile dysfunction (PDE5 inhibitors).

Taking ADCIRCA with food and drink

These tablets can be taken with or without food.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take ADCIRCA, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.

Pregnancy and breastfeeding

If you are pregnant, or think you might be pregnant, tell your doctor as soon as possible. Do not take ADCIRCA when pregnant, unless it is strictly necessary and you have discussed this with your doctor. Do not breastfeed while taking these tablets as it is not known if the medicine passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breastfeeding.

Driving and using machines

Dizziness has been reported. Check carefully how you react to the medicines before driving or using any machinery.

Important information about some of the ingredients of ADCIRCA:

Lactose ? if you know you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take ADCIRCA exactly as your doctor has told you. You should check with him/her if you are unsure.

ADCIRCA is supplied as a 20 mg tablet. The usual dose is two 20 mg tablets taken once a day. You should take both tablets at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.

Swallow the tablets whole with a drink of water. The tablets can be taken with or without food.

If you take more ADCIRCA than you should

If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you.

If you forget to take ADCIRCA

Take your dose as soon as you remember but do NOT take a double dose to make up for the one that you have forgotten.

If you stop taking ADCIRCA

Do not stop taking your tablets, unless advised otherwise by your doctor.

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

Like all medicines, ADCIRCA can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

The following side effects have been reported:

Very common (seen in more than 1 in every 10 patients)

• headache, flushing, nasal and sinus congestion (blocked nose), nausea, indigestion (including abdominal pain or discomfort), muscle aches, back pain and pain in the extremity (including limb discomfort).

Common (seen in 1 to 10 in every 100 patients)

• blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, allergic reactions (including skin rashes), swelling of the face, acid reflux, migraine, chest pain and irregular heartbeat.

Uncommon (seen in 1 to 10 in every 1000 patients)

• seizures, passing memory loss, hives, excessive sweating, prolonged and possibly painful erection, high blood pressure, fast heart rate and sudden cardiac death.

PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. Some side effects have been rarely reported:

• Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes. Sudden decrease or loss of hearing has also been reported.

Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction. These events were not seen in clinical trials for pulmonary arterial hypertension and therefore frequency is unknown:

• swelling of the eyelids, eye pain, red eyes, heart attack and stroke.

Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil. It is not possible to determine whether these events were related directly to tadalafil.

Effects were seen in one animal species that might indicate impairment of fertility in men. Subsequent studies in man suggest that this effect is unlikely; however a decrease in sperm concentration was seen in some men.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.
Do not use ADCIRCA after the expiry date stated on the carton and blister.
Store in the original package in order to protect from moisture. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What ADCIRCA contains
The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), talc.

What ADCIRCA looks like and contents of the pack

ADCIRCA 20 mg comes as orange film-coated tablets. They are in the shape of almonds and have "4467" marked on one side.

ADCIRCA 20 mg is available in blister packs containing 28 or 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V.,Grootslag 1-5, NL-3991 RA, Houten, The Netherlands

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain

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

BelgiqueBelgiëBelgien Eli Lilly Benelux S.AN.V. TélTel 32-0 2 548 84 84 .. - . 359 2 491 41 40 eská republika ELI LILLY R, s.r.o. Tel 420 234 664 111 Danmark Eli Lilly Danmark AS Tlf 45 45 26 60 00 Deutschland Lilly Deutschland GmbH Tel. 49-0 6172 273 2222 Eesti Eli Lilly Holdings Limited. Eesti filiaal Tel 372 6441100 LuxembourgLuxemburg Eli Lilly Benelux S.AN.V. TélTel 32-02 548 84 84 Magyarország Lilly Hungária Kft Tel 36 1 328 5100 Malta Charles de Giorgio Ltd. Tel 356 25600 500 Nederland Eli Lilly Nederland B.V. Tel 31-0 30 60 25 800 Norge Eli Lilly Norge A.S. Tlf 47 22 88 18 00 Österreich Eli Lilly Ges.m.b.H. Tel 43-0 1 711 780 Polska

- ... 30 210 629 4600 España Lilly, S.A. Tel 34 91 663 5000 Eli Lilly Polska Sp. z o.o. Tel. 48 0 22 440 33 00 Portugal Lilly Portugal Produtos Farmacêuticos, Lda. Tel 351-21-4126600 România Eli Lilly România S.R.L. Tel 40 21 4023000 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111 SuomiFinland Oy Eli Lilly Finland Ab. PuhTel 358-0 9 85 45 250 Sverige Eli Lilly Sweden AB Tel 46 0 8 737 88 00 United Kingdom Eli Lilly and Company Limited Tel 44-0 1256 315000 France Lilly France S.A.S Tél. 33-01 55 49 34 34 Ireland Eli Lilly and Company Ireland Limited. Tel 353-0 1 661 4377 Ísland Icepharma hf. Simi 354 540 8000 Italia Eli Lilly Italia S.p.A. Tel 39- 055 42571 Phadisco Ltd 357 22 715000 Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 67364000 Lietuva Eli Lilly Holdings Limited atstovyb Tel. 370 5 2649600

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