Adcirca 20 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet Contents

1. What ADCIRCA is and what it is used for
2. What you need to know before taking 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 indicated for the treatment of pulmonary arterial hypertension in adults and children from the age of 2 years.

It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors, which work by helping the blood vessels around the lungs to relax, thereby improving blood flow in the lungs. This results in improved ability to exercise.

2. What you need to know before taking ADCIRCA

Do not take ADCIRCA

• if you are allergic to tadalafil or to any of the other ingredients (see section 6).
• if you are taking any type of nitrates such as amyl nitrite, which are administered to relieve "chest pain". ADCIRCA may increase the effects of these medicines. If you are taking any type of nitrate 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 within 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 been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to take 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
• a red blood cell disorder (sickle cell anemia)
• bone marrow cancer (multiple myeloma)
• blood cell cancer (leukemia)
• any deformity of the penis, or unexpected and unwanted erections lasting more than 4 hours
• severe liver problems
• severe kidney problems.

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking ADCIRCA, stop taking ADCIRCA and contact your doctor immediately.

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

Although it is not known whether the event is directly related to tadalafil, if you experience 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, as 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 need to 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 how ADCIRCA works. Inform your doctor or pharmacist if you are taking:

• bosentan (another treatment for pulmonary arterial hypertension)
• nitrates (for chest pain)
• alpha-blockers to treat high blood pressure or prostate problems
• riociguat
• rifampicin (to treat bacterial infections)
• ketoconazole tablets (to treat fungal infections)
• ritonavir (for the treatment of HIV/AIDS)
• tablets for the treatment of erectile dysfunction (PDE5 inhibitors).

Taking ADCIRCA with alcohol

Drinking alcohol may 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 this may increase the risk of dizziness upon standing.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Do not take ADCIRCA during pregnancy unless strictly necessary and only after discussing it with your doctor.

Do not breast-feed while taking these tablets, as it is unknown whether the medicine passes into breast milk. Consult your doctor or pharmacist before taking any medicine if you are pregnant or breast-feeding.

In treated dogs, a reduction in sperm production by the testes has been observed. Some men have shown reduced sperm counts. It is unlikely that these effects would lead to infertility.

Driving and using machines

Dizziness has been reported. Carefully assess how you react to this medicine before driving or operating machinery.

ADCIRCA contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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 instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

ADCIRCA is available as 20 mg tablets. Swallow the tablet(s) whole with a glass of water. The tablet(s) may be taken with or without food.

Pulmonary arterial hypertension in adults

The usual dose is two 20 mg tablets taken once daily. 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) weighing at least 40 kg

The recommended dose is two 20 mg tablets taken once daily. 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) weighing less than 40 kg

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

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

If you take more ADCIRCA than you should

If you or someone else takes more tablets than prescribed, contact your doctor or go immediately to a hospital, taking the medicine or packaging with you. You may experience any of the adverse effects described in section 4.

If you forget to take ADCIRCA

Take your dose as soon as you remember, provided it is within 8 hours of the time you were supposed to take it. DO NOT take a double dose to make up for the missed dose.

If you stop taking ADCIRCA

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. These effects are generally mild to moderate in intensity.

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

• allergic reactions, including skin rash (common).
• chest pain – do not use nitrates; instead, seek immediate medical help (common).
• priapism, a prolonged and possibly painful erection after taking ADCIRCA (uncommon). If you experience this type of erection lasting continuously for more than 4 hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency), distorted or dimmed vision, blurred central vision, or sudden decrease in vision (frequency not known).

The following adverse effects have been reported very commonly 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 adverse effects that have been reported:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• seizures, transient memory loss, hives, excessive sweating, penile bleeding, blood in semen and/or urine, high blood pressure, rapid pulse, sudden cardiac death, and tinnitus.

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

• Decrease or partial, temporary, or permanent 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 adverse effects have been reported in men taking tadalafil for the treatment of erectile dysfunction. These effects were not observed during clinical trials for pulmonary arterial hypertension, and therefore their frequency is unknown:

• eyelid swelling, eye pain, red eyes, heart attack, and stroke.

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

• distorted, dimmed, blurred central 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 whether these events were directly related to tadalafil.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging and blister pack after “CAD” and “EXP”, respectively. The expiry date refers to the last day of the month indicated.

Store in the original packaging 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 any unused medicines and their packaging. 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 components are:
Tablet core: lactose monohydrate, sodium croscarmellose, 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 of the product and contents of the pack

ADCIRCA 20 mg is presented as orange, film-coated tablets (tablets) in an almond shape, marked with "4467" on one side.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 further information on this medicinal product, contact the local representative of the Marketing Authorization Holder:

Spain

Lilly S.A.

Tel: +34-91 663 50 00

Date of the most recent revision of this leaflet: September 2023

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