Adcirca (previously Tadalafil Lilly) - patient leaflet, side effects, dosage

- If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet

• 1. What ADCIRCA is and what it is used for

• 2. What you need to know before you take ADCIRCA

• 3. How to take ADCIRCA

• 4. Possible side effects

• 5 How to store ADCIRCA

• 6. Contents of the pack and other information

1. What ADCIRCA is and what it is used for

ADCIRCA contains the active substance tadalafil.

ADCIRCA is a treatment for pulmonary arterial hypertension in adults.

It 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.

2. What you need to know before you take ADCIRCA

Do not take ADCIRCA if you:

• – are allergic to tadalafil or any of the other ingredients (see section 6).

• – 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.

• – are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as ADCIRCA, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions

Talk to your doctor before taking 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 serious kidney problem.

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

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, contact your doctor immediately.

Children and adolescents

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

Other medicines and ADCIRCA

Tell your doctor if you are taking, have recently taken or might take any other medicines.

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.

• – riociguat.

• – rifampicin (to treat bacterial infections)

• – ketoconazole tablets (to treat fungal infections)

• – ritonavir (for HIV treatment)

• – tablets for erectile dysfunction (PDE5 inhibitors).

ADCIRCA with alcohol

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take ADCIRCA, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 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.

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines

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

ADCIRCA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

ADCIRCA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take ADCIRCA

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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. You may experience any of the side effects described in section 4.

If you forget to take ADCIRCA

Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose. 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects stop using the medicine and seek medical help immediately:

• – allergic reactions including skin rashes (frequency common).

• – chest pain – do not use nitrates, but seek immediate medical assistance (frequency common).

• – priapism, a prolonged and possibly painful erection after taking ADCIRCA (frequency

uncommon). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.

• – sudden loss of vision (rarely reported).

The following side effects have been very commonly reported in patients taking ADCIRCA (may affect more than 1 in 10 people): 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)

Other side effects have been reported:

Common (may affect up to 1 in 10 people)

• – blurred vision, low blood pressure, nosebleed, vomiting, increased or abnormal uterine bleeding, swelling of the face, acid reflux, migraine, irregular heartbeat and fainting.

Uncommon (may affect up to 1in 100 people)

• – seizures, passing memory loss, hives, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, fast heart rate, sudden cardiac death and ringing in the ears.

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

• – Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious allergic reaction which causes swelling of the face or throat. 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 studies for pulmonary arterial hypertension and therefore frequency is unknown:

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

5. How to store ADCIRCA

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

Do not use this medicine after the expiry date stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 30°C.

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 protect the environment.

6. Contents of the pack and other information

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, see section 2 “ADCIRCA contains lactose”.

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., Papendorpseweg 83, 3528 BJ Utrecht, The

Netherlands

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

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

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

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