TADALAFIL Aurovit 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Aurovit 20 mg Film-Coated Tablets EFG

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

• Keep this leaflet, 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 Package Leaflet

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

1. What is Tadalafil Aurovit and what is it used for

Tadalafil Aurovit contains the active substance tadalafil.

Tadalafil 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 in 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 Tadalafil Aurovit

Do not takeTadalafil Aurovit

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of nitrate medicines (such as amyl nitrite) that are used to treat chest pain (angina), as tadalafil may increase the effects of these medicines. If you are taking any form of nitrate or are unsure, consult your doctor.
• if you have previously experienced loss of vision - 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 tadalafil, 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 or pharmacist before starting treatment with Tadalafil Aurovit.

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

• any heart problems other than your pulmonary hypertension.
• blood pressure problems.
• any inherited eye disease.
• a red blood cell disorder (sickle cell anemia).
• bone marrow cancer (multiple myeloma).
• blood cell cancer (leukemia).
• any deformity of your penis, or erections that are painful or have lasted more than 4 hours.
• severe liver problems.
• severe kidney problems.

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

A sudden 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 loss of hearing, contact your doctor immediately.

Children and adolescents

Tadalafil 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 Tadalafil Aurovit

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

DO NOT take tadalafil if you are already using nitrates.

Some medicines may be affected by tadalafil or may affect how tadalafil 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 HIV/AIDS treatment).
• tablets for erectile dysfunction treatment (PDE5 inhibitors).

Taking Tadalafil Aurovit with alcohol

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, 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 tadalafil 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. In some men, a reduction in sperm has been observed. 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 the medicines before driving or using machines.

Tadalafil Aurovit contains lactose and sodium

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

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

3. How to take Tadalafil Aurovit

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

Tadalafil is available in 20 mg film-coated tablets. Swallow the tablets whole with a glass of water. The tablets can be taken with or without food.

Pulmonary arterial hypertension in adults

The usual 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 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 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 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 1 tablet of 20 mg 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 Tadalafil Aurovit than you should

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

If you forget to take Tadalafil 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 stop taking Tadalafil Aurovit

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

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 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 tadalafil (uncommon). If you experience this type of erection, with a continuous duration of more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, or diminished vision (frequency not known).

The following side effects have been reported very frequently in patients taking tadalafil (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (stuffy nose), nausea, indigestion (including abdominal pain and discomfort), muscle aches, 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 heartbeats, 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 heartbeat, sudden cardiac death, and ringing in the ears.

PDE5 inhibitorsare also used to treat erectile dysfunction in men. The following side effects have been rarely reported:

• decrease or loss of vision of one or both eyes, which may be temporary or permanent, and severe allergic reaction that causes swelling of the face or throat. Cases of sudden loss of hearing have also been reported.

Some side effects have been reported in men taking tadalafil for erectile dysfunction treatment. These effects have not been observed during clinical trials for pulmonary arterial hypertension and, therefore, 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:

• distorted, blurred, or diminished vision, or sudden loss of vision (frequency not known).

Most men who reported cases of rapid heartbeat, irregular heartbeats, 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Aurovit

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 after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Aurovit

• The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other ingredients are:

Tablet core:copovidone, macrogolglyceride hydroxystearate, lactose monohydrate, anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Tablet coating:hypromellose, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), triacetin.

Appearance of the product and contents of the pack

Yellow, oval, film-coated tablets with "20" marked on one face and "TL" on the other.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: December 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).