TADALAFIL Aurovitas 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Aurovitas 10 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Tadalafil is indicated for the treatment of erectile dysfunction in adult men. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

Tadalafil Aurovitas contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before you take Tadalafil Aurovitas

Do not takeTadalafil Aurovitas

• 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 organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.
• If you have a severe heart or liver problem.
• If you have recently had a stroke or heart attack (within the last 90 days).
• If you have low blood pressure or uncontrolled high blood pressure.
• If you have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION).
• 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 due to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects of this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tadalafil Aurovitas.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on your heart. If you have a heart problem, tell your doctor.

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

• Sickle cell anaemia (a disease of the red blood cells).
• Multiple myeloma (cancer of the bone marrow).
• Leukaemia (cancer of the blood cells).
• Any deformation of your penis.
• A severe liver or kidney problem.

It is not known if tadalafil is effective in patients who have:

• Had surgery to remove the prostate gland (prostatectomy).

If you experience sudden decrease or loss of vision or hearing, stop taking tadalafil and contact your doctor immediately.

A sudden decrease or loss of vision in one or both eyes has been reported in patients taking tadalafil. It is not possible to determine whether these events are related directly to tadalafil, to other diseases or medications, to other factors, or to a combination of factors.

Tadalafil is not intended for use by women.

Children and adolescents

Tadalafil should not be used in children and adolescents under 18 years of age.

Other medicines and Tadalafil Aurovitas

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

Do not take tadalafil if you are already taking nitrates.

Some medicines may be affected by tadalafil or may affect how well tadalafil will work. Tell your doctor or pharmacist if you are taking:

• An alpha blocker (used to treat high blood pressure or problems with passing water).
• Other medicines for high blood pressure.
• Riociguat.
• A 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• Medicines such as ketoconazole (for fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• Phenobarbital, phenytoin and carbamazepine (medicines for epilepsy).
• Rifampicin, erythromycin, clarithromycin or itraconazole.
• Other treatments for erectile dysfunction.

Taking Tadalafil Aurovitas with food and drink

Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well tadalafil works and should be taken with caution. Talk to your doctor for further information.

Fertility

In dogs treated with tadalafil, reduced sperm count was observed. In some men, a reduction in sperm count has been observed. It is unlikely that this will lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials had dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Aurovitas contains lactose

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

Tadalafil Aurovitas contains sodium

This medicine contains less than 23 mg sodium (1 mmol) per tablet, i.e., essentially “sodium-free”.

3. How to take Tadalafil Aurovitas

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The tablets are for oral use only in men. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended doseis one 10 mg tablet taken at least 30 minutes before sexual activity.

Tadalafil may still be effective up to 36 hours after taking the tablet.

Do not take Tadalafil Aurovitas more than once a day. Tadalafil Aurovitas 10 mg and 20 mg will be taken before anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Consuming large amounts of alcohol (more than 4 units) may increase your chances of getting a headache or getting dizzy when taking tadalafil.

If you take more Tadalafil Aurovitas than you should

Consult a doctor. You may experience side effects described in section 4.

In case of overdose, contact your doctor or pharmacist or go to the emergency department at your nearest hospital. Take the medicine pack with you.

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 normally mild to moderate in nature.

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

• Allergic reactions including skin rash (uncommon).
• Chest pain - do not use nitrates, but seek medical help immediately (uncommon).
• Prolonged and possibly painful erections after taking tadalafil (rare). If you have an erection that lasts more than 4 hours, contact a doctor immediately.
• Sudden loss of vision (rare), distorted vision, blurred vision, or loss of vision (frequency not known).

Other side effects have been reported:

Common(may affect up to 1 in 10 people)

• Headache, back pain, muscle aches, pain in arms and legs, flushing, nasal congestion and indigestion.

Uncommon(may affect up to 1 in 100 people)

• Dizziness, stomach ache, feeling sick, being sick, reflux, blurred vision, eye pain, difficulty breathing, presence of blood in urine, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

Rare(may affect up to 1 in 1,000 people)

• Fainting, seizures, temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), bleeding from the penis, presence of blood in the semen and increased sweating.

Additional rare side effects have been reported:

• Migraine, swelling of the face, severe allergic reaction which causes swelling of the face or throat, severe skin rashes, certain eye disorders which cause changes in vision, irregular heartbeats, angina pectoris and sudden cardiac death.

In men over 75 years old, the most common side effect was dizziness.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this package 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 Aurovitas

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 that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and further information

What Tadalafil Aurovitas contains

• The active substance is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
• The other ingredients are:

Core of the tablet:Copovidone, hydroxyesterate of macrogolglyceride, lactose monohydrate, colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

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

Appearance and packaging

Light yellow, oval, film-coated tablets marked with “57” on one face and “L” on the other.

Tadalafil Aurovitas is available in PVC/PVdC transparent-Aluminium blister packs.

Blister pack sizes: 2, 4, 8, 12, 24, 28 and 56 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

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

Or

Orion Corporation Orion Pharma

Orionintie 1, Espoo

FI-02200

Finland

Or

Orion Corporation Orion Pharma

Joensuunkatu 7, Salo

FI-24100

Finland

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

Date of last revision of this package 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/).