ADCIRCA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

ADCIRCA 20mg film-coated tablets

tadalafil

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is ADCIRCA and what is it used for
2. What you need to know before you take ADCIRCA
3. How to take ADCIRCA
4. Possible side effects
5. Storing ADCIRCA
6. Contents of the pack and other information

1. What is ADCIRCA and what is it used for

ADCIRCA contains the active substance tadalafil.

ADCIRCA is indicated for the treatment of pulmonary arterial hypertension in adults and in children from 2 years of age.

It belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5) that work by helping to relax the blood vessels around your lungs, improving blood flow in the lungs. The result is an improved ability to perform 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).
• if you are taking any nitrate medicines, such as amyl nitrite, which are used to relieve "chest pain". ADCIRCA can increase the effects of these medicines. If you are taking any nitrate medicine or are unsure, consult your doctor.
• if you have previously experienced vision loss - a condition described as "eye stroke" (non-arteritic anterior ischemic optic neuropathy, NAION).
• if you have had a heart attack in the last 3 months.
• if you have low blood pressure.
• if you are taking riociguat. This medicine 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 caused by blood clots). PDE5 inhibitors, such as ADCIRCA, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before starting to take ADCIRCA.

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

• any heart problems other than pulmonary hypertension
• blood pressure problems
• any inherited eye disease
• a blood disorder (sickle cell anemia)
• bone marrow cancer (multiple myeloma)
• blood cell cancer (leukemia)
• any penile deformity, or unexpected and unwanted erections that last more than 4 hours
• severe liver problems
• severe kidney problems.

If you experience sudden or decreased vision loss or distorted vision while taking ADCIRCA, stop taking ADCIRCA and contact your doctor immediately.

A sudden decrease or loss of hearing has been observed in some patients taking tadalafil.

Although it is not known if the event is directly related to tadalafil, if you experience a sudden decrease or loss of hearing, contact your doctor immediately.

Children and adolescents

ADCIRCA is not recommended for the treatment of pulmonary arterial hypertension in children under 2 years of age because it has not been studied in this age group.

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 being treated with nitrates.

Some medicines may be affected by ADCIRCA or may affect the way ADCIRCA works. Tell your doctor or pharmacist if you are taking:

• bosentan (another treatment for pulmonary arterial hypertension)
• nitrates (for chest pain)
• alpha-blockers for high blood pressure or prostate problems

• riociguat

• rifampicin (for bacterial infections)
• ketoconazole tablets (for fungal infections)
• ritonavir (for AIDS - HIV)
• tablets for the treatment of erectile dysfunction (PDE5 inhibitors).

Taking ADCIRCA with alcohol

Consuming alcohol can temporarily lower your blood pressure. If you have taken or are planning to take ADCIRCA, avoid excessive alcohol consumption (more than 5 units of alcohol), as it may increase the risk of dizziness when standing up.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 during pregnancy, unless it is strictly necessary and you have discussed it with your doctor.

Do not breastfeed while taking these tablets, as it is not known if the medicine passes into breast milk. Consult your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.

In dogs treated with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

There have been reports of dizziness. Check carefully how you react to this medicine before driving or using machines.

ADCIRCA contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

ADCIRCA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take ADCIRCA

Follow exactly the administration instructions of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

ADCIRCA is available in the form of 20 mg film-coated tablets. Swallow the tablet(s) whole with a glass of water. The tablet(s) can be taken with or without food.

Pulmonary arterial hypertension in adults

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

Pulmonary arterial hypertension in children (from 2 years of age) who weigh at least 40 kg

The recommended 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 mild to moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet per day.

Pulmonary arterial hypertension in children (from 2 years of age) who weigh less than 40 kg

The recommended dose is one 20 mg tablet taken once a day. If you have mild to moderate liver or kidney problems, your doctor may advise you to take 10 mg once a day.

Other pharmaceutical forms of this medicine may be more suitable for children; consult your doctor or pharmacist.

If you take more ADCIRCA than you should

If you or someone else takes more tablets than you should, consult your doctor or go to the hospital immediately, taking the medicine or the packaging 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 the time you should have taken your dose. DO NOT take a double dose to make up for the one you missed.

If you stop taking ADCIRCA

Do not stop taking your tablets unless your doctor has told you to.

If you have any further questions on the use of this product, 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 generally mild to moderate.

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

• allergic reactions, including skin rash (frequent).
• chest pain - do not use nitrates, but seek medical help immediately (frequent).
• priapism, a prolonged and possibly painful erection after taking ADCIRCA (uncommon). If you experience this type of erection, with a continuous duration of more than 4 hours, you should contact a doctor immediately.
• sudden vision loss (rare), distorted, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

The following side effects have been reported very frequently in patients taking ADCIRCA (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (stuffy nose), nausea, indigestion (including abdominal pain and discomfort), muscle pain, back pain, and limb pain (including limb discomfort)

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

• blurred vision, low blood pressure, nosebleeds, vomiting, increased or abnormal uterine bleeding, facial swelling, reflux, migraines, irregular heartbeat, and fainting.

Uncommon(may affect up to 1 in 100 people)

• seizures, transient memory loss, hives, excessive sweating, bleeding from the penis, presence of blood in the semen and/or urine, high blood pressure, rapid pulse, sudden cardiac death, and ringing in the ears.

PDE5 inhibitorsare also used for the treatment of erectile dysfunction in men. The following side effects have been rarely reported:

• partial, temporary, or permanent decrease or loss of vision in one or both eyes and severe allergic reaction causing swelling of the face or throat. Cases of sudden decrease or loss of hearing have also been reported.

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

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

Some additional rare side effects have been reported in men taking tadalafil that were not reported during clinical trials. These include:

• distorted, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

Most men who reported cases of rapid pulse, irregular heartbeat, heart attack, stroke, and sudden cardiac death had pre-existing heart problems before taking tadalafil. It is not possible to determine if these events were directly related to tadalafil.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing ADCIRCA

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 carton and blister after "EXP". The expiry date refers to the last day of the month shown.

Store in the original package 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. This will help protect the environment.

6. Contents of the pack and other information

Composition of ADCIRCA

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 lauryl sulfate, magnesium stearate; see section 2 "ADCIRCA contains lactose" and "ADCIRCA contains sodium".

Film coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc.

Appearance and packaging

ADCIRCA 20 mg is available in film-coated tablets (tablets) of orange color. They are almond-shaped and marked with "4467" on one side.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

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

For more information about this medicine, contact the local representative of the marketing authorization holder:

Spain

Lilly S.A.

Tel: +34-91 663 50 00

Date of last revision of this leaflet: September 2023

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