Prospecto: information for the user

ADCIRCA 20mg film-coated tablets

tadalafil

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.

1.What is ADCIRCA and for what it is used

2.What you need to knowbefore starting to take ADCIRCA

3.How to take ADCIRCA

4.Possible adverse effects

5.Storage of ADCIRCA

6.Contents of the package and additional information

ADCIRCAcontains the active ingredient tadalafilo.

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

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

Do not take ADCIRCA

• if you are allergic to tadalafil or any of the other ingredients (see section6).
• 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 medications. If you are taking any type of nitrates or are unsure, consult your doctor.
• if you have previously experienced vision loss - a condition described as “eye stroke” (anterior ischemic optic neuropathy - NAION).
• if you have had a heart attack in the last 3months.
• if you have low blood pressure.
• if you are taking riociguat. This medication 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 clots). PDE5 inhibitors, such as ADCIRCA, have shown to increase the hypotensive effect of this medication. 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 problem other than pulmonary hypertension
• problems with your blood pressure
• any inherited eye disease
• any anomaly of red blood cells (sickle cell anemia)
• multiple myeloma (bone marrow cancer)
• leukemia (blood cancer)
• any deformity of your penis, or unexpected and unwanted erections that last more than 4hours
• severe liver disease
• severe kidney disease.

If you experience a decrease or sudden loss of vision or your vision is distorted, blurred while taking ADCIRCA, stop taking ADCIRCA and immediately contact your doctor.

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 sudden decrease or loss of hearing, immediately contact your doctor.

Children and adolescents

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

Other medications and ADCIRCA

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

DO NOTtake these tablets if you are being treated with nitrates.

Some medications may be affected by ADCIRCA or may affect the correct way 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 (to treat HIV/AIDS)
• tablets for erectile dysfunction (PDE5 inhibitors).

ADCIRCA with alcohol

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take ADCIRCA, avoid excessive alcohol consumption (above 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, or think you may be pregnant, consult your doctor before using this medication.Do not take ADCIRCA during pregnancy, unless it is strictly necessary and you have discussed this with your doctor.

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

In dogs treated, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machinery

Cases of dizziness have been reported. Check carefully how you react to this medication before driving or operating machinery.

ADCIRCA contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medication.

ADCIRCA contains sodium

This medication contains less than 1mmol of sodium (23mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

ADCIRCA is available in the form of 20 mg 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 dose is two 20 mg tablets taken once a day. You should take the two tablets at the same time, one after the other. If you have a mild to moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet a day.

Pulmonary arterial hypertension in children (2 years of age or older) weighing at least 40 kg

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

Pulmonary arterial hypertension in children (2 years of age or older) weighing less than 40 kg

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

Other forms of this medication 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 immediately to a hospital, bringing the medication 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 if it is within 8 hours of the time when you should have taken your dose. DO NOT take a double dose to make up for the one you missed.

If you interrupt treatment with ADCIRCA

Do not stop taking your tablets unless advised to do so by your doctor.

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

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

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

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

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, nasal bleeding, vomiting, increased or abnormal uterine bleeding, facial swelling, reflux, migraines, irregular heartbeat and fainting.

Infrequent(may affect up to 1 in 100 people)

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

Phosphodiesterase type 5 inhibitors are also used to treat erectile dysfunction in men. Rarely reported side effects include:

• Decreased or partial, temporary or permanent loss of vision in one or both eyes and severe allergic reaction causing facial or throat swelling. In addition, cases of sudden hearing loss have been reported.

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

• distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and the blister pack after “CAD” and “EXP” respectively. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Do not store at a temperature above 30?°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. This will help protect the environment.

Tadalafilo Composition

The active ingredient is tadalafilo. Each tablet contains 20mg of tadalafilo.

The other components are:
Tablet core: lactose monohydrate, croscarmelose sodium, hydroxypropylcellulose, microcrystalline cellulose, laurilsulfate sodium, magnesium stearate, see section 2 “Tadalafilo contains lactose” and “Tadalafilo contains sodium”.

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

Product appearance and packaging contents

Tadalafilo 20mg is presented in film-coated tablets (tablets) of orange color. They have almond shape and are marked with “4467”on one side.

Tadalafilo 20mg is available in blister packs with 28 or 56tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Responsible Manufacturer: Lilly S.A., Avda. dela Industria30, 28108 Alcobendas, Madrid, Spain.

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

Spain

Lilly S.A.

Phone: + 34-91 663 50 00

Last review date of this leaflet: September2023

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