Tadalafil Aurovit 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Aurovit 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start using 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Tadalafilo Aurovit contains the active substance tadalafil.

Tadalafil 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 an improved ability to perform physical activity.

2. What you need to know before taking Tadalafilo Aurovit

Do not take Tadalafilo Aurovit

• if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking any type of nitrates, such as amyl nitrite, which are administered to relieve "chest pain". Tadalafil 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 tadalafil, 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 or pharmacist before taking Tadalafilo Aurovit.

Before taking the tablets, inform 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 your 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 tadalafil, stop taking tadalafil 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 this event is directly related to tadalafil, if you experience sudden decrease or 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, as it has not been studied in this age group.

Other medicines and Tadalafilo Aurovit

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

DO NOT take tadalafil if you are already using nitrates.

Some medicines may interact with tadalafil or may affect how tadalafil works. Inform your doctor or pharmacist if you are taking:

• bosentan (another treatment for pulmonary arterial hypertension).
• nitrates (for chest pain).
• alpha-blockers for treating 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 Tadalafilo Aurovit with alcohol

Drinking alcohol can 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 this 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 become pregnant, consult your doctor before using this medicine. Do not take tadalafil during pregnancy unless strictly necessary and discussed with your doctor.

Do not breastfeed 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 breastfeeding.

In dogs treated with tadalafil, reduced sperm production by the testes was observed. In some men, reduced sperm count has been observed. These effects are unlikely to result in infertility.

Driving and using machines

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

Tadalafilo Aurovit contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with 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 instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Pulmonary arterial hypertension in adults

The usual dose is 2 tablets of 20 mg 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; consult your doctor or pharmacist.

If you take more Tadalafil Aurovit than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional. You may experience any of the adverse 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 you were supposed to take it. DO NOT take a double dose to make up for the missed dose.

If you stop taking Tadalafil Aurovit

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 rashes (common).
• chest pain – do not use nitrates, but seek immediate medical help (common).
• priapism, a prolonged and possibly painful erection after taking tadalafil (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), distorted, diminished, blurred central vision, or sudden decrease in vision (frequency not known).

The following adverse effects have been reported very commonly 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 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, urticaria, excessive sweating, penile bleeding, presence of 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 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 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 reported during clinical trials. These include:

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

Most men who reported rapid pulse, irregular heartbeat, heart attack, stroke, and sudden cardiac death had pre-existing heart conditions 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Tadalafil Aurovit

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 components are:

Tablet core: copovidone, macrogol glyceryl hydroxystearate, monohydrate lactose, colloidal anhydrous 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

Film-coated yellow oval tablets marked “20” on one side and “TL” on the other.

Tadalafil Aurovit is available in blister packs containing 28, 56, 112, and 120 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: December 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).