Prospect: information for the user

Tadalafilo Aurovit 20 mg film-coated tablets EFG

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

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should 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 Tadalafilo Aurovit and what is it used for

2.What you need to know before starting to take Tadalafilo Aurovit

3.How to take Tadalafilo Aurovit

4.Possible adverse effects

5.Storage of Tadalafilo Aurovit

6.Contents of the package and additional information

TadalafiloAurovitcontains the active ingredient tadalafilo.

Tadalafilo 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 act by helping to relax blood vessels around the lungs, improving blood flow in the lungs. The result of this is an improved ability to perform physical activity.

Do not takeTadalafilo Aurovit

-if you are allergic totadalafiloor to any of the other ingredients of this medication (listed in section 6).

-if you are taking any type of nitrates such as amyl nitrite, administered to relieve chest pain. Tadalafilo 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 infarction” (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 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 astadalafilo, 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 or pharmacist before starting to take Tadalafilo Aurovit.

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

-any heart problem other than pulmonary hypertension.

-problems with your blood pressure.

-any hereditary eye disease.

-anemia (sickle cell disease).

-multiple myeloma (bone marrow cancer).

-leukemia (blood cell cancer).

-any deformity of your penis, or unexpected and unwanted erections that last more than 4 hours.

-severe liver disease.

-severe kidney disease.

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

Sudden decrease or loss of hearing has been observed in some patients taking tadalafilo. Although it is not known if the event is directly related to tadalafilo, if you experience sudden decrease or loss of hearing, contact your doctor immediately.

Children and adolescents

Tadalafilo 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 medications andTadalafilo Aurovit

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

Do not taketadalafiloif you are already using nitrates.

Some medications may be affected bytadalafiloor may affect the correct waytadalafilofunctions. 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 the treatment of erectile dysfunction (PDE5 inhibitors).

TakingTadalafilo Aurovitwith alcohol

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to taketadalafilo, 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 taketadalafiloduring pregnancy, unless it is strictly necessary and you have discussed it 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. In some men, a reduction in sperm has been observed. 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 the medication before driving or operating machinery.

Tadalafilo Aurovitcontains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

Tadalafilo is presented in the form of 20 mg tablets. Swallow the tablets whole with a glass of water. The tablets can be taken with or without food.

Pulmonary Arterial Hypertension in Adults

Theusual doseis 2 tablets of 20 mg taken once a day. You should take the two tablets at the same time, one after the other. If you have any mild to moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet a day.

Pulmonary Arterial Hypertension in Children (Aged 2 Years or Older) Weighing at Least 40 kg

The recommended dose is 2 tablets of 20 mg taken once a day. You should take the two tablets at the same time, one after the other. If you have any mild to moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet a day.

Pulmonary Arterial Hypertension in Children (Aged 2 Years or Older) Weighing Less Than 40 kg

The recommended dose is 1 tablet of 20 mg taken once a day. If you have any mild to moderate liver or kidney problems, your doctor may advise you to take 10 mg once a day.

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

If You Take MoreTadalafilo AurovitThan You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional. You may experience any of the adverse effects described in section 4.

If You Forget to TakeTadalafilo Aurovit

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 withTadalafilo Aurovit

Do not stop taking your tablets, unless advised 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 tadalafil (infrequent). If you experience this type of erection, with continuous duration of more than 4 hours, 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 takingtadalafil(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.

The PDE5 inhibitorsare also used for the treatment of erectile dysfunction in men. Rarely reported side effects include:

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

Some side effects have been reported in men taking tadalafil for erectile dysfunction. These side effects were not observed 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 before taking tadalafil. It is not possible to determine if these events were directly related to tadalafil.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish 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 sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tadalafilo Aurovit

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

- The other components are:

Core of the tablet: copovidone, hydroxyestearate of macrogolglycerol, lactose monohydrate, anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Coating of the tablet: hypromellose, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), triacetin.

Appearance of the product and contents of the package

Film-coated tablets of yellow color, oval shape, with the mark “20” on one face and “TL” on the other.

Tadalafilo Aurovit is available in blister packs with 28, 56, and 120 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: December 2023

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ ).