TADALAFIL Aurovitas 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Aurovitas 5 mg film-coated tablets EFG

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

• Keep this package leaflet, as 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 other information

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

Tadalafil Aurovitas contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil Aurovitas 5 mg is used for the treatment of adult men with:

• Erectile dysfunction. 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.

After sexual stimulation, tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into the 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.

• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty starting to urinate, feeling like the bladder is not completely empty, needing to urinate more often, even at night. Tadalafil improves blood flow and relaxes the muscles in the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms in as little as 1-2 weeks after starting treatment.

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 for the treatment of angina pectoris (“chest pain”). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• If you have a severe heart condition or have had a heart attack in the last 90 days.
• If you have had a stroke in the last 6 months.
• If you have low blood pressure or uncontrolled high blood pressure.
• If you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• 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). Phosphodiesterase type 5 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

Talk to your doctor or pharmacist before you start taking Tadalafil Aurovitas.

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

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will check you for prostate cancer before you start taking tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

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

• Sickle cell anemia (a condition that affects red blood cells).
• Multiple myeloma (cancer of the bone marrow).
• Leukemia (cancer of blood cells).
• Any deformation of the penis.
• A severe liver problem.
• A severe kidney problem.

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

• Had surgery in the pelvic area.
• Had an operation in which the prostate was removed (prostatectomy).

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

A 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 a sudden decrease or loss of hearing, stop taking tadalafil and contact your doctor immediately.

Tadalafil is not intended for use by women.

Children and adolescents

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

Other medicines andTadalafilAurovitas

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 works. Tell your doctor or pharmacist if you are using:

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

TakingTadalafilAurovitaswith drinks and alcohol

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

Fertility

In dogs treated with tadalafil, a decrease in sperm production 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

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

Tadalafil Aurovitascontains lactose

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

Tadalafil Aurovitascontains sodium

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

3. How to take Tadalafil Aurovitas

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet per day, taken at approximately the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be done by taking a 2.5 mg tablet.

Do not take tadalafil more than once a day.

Tadalafil taken daily allows you to get an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Tadalafil taken daily may be useful in men who anticipate having sexual activity twice or more per week.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medicine for erectile dysfunction.

Consuming alcohol may affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet per day, taken at approximately the same time.

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet per day.

Do not take tadalafil more than once a day.

If you take moreTadalafilAurovitasthan you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to useTadalafilAurovitas

Take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. Do not take Tadalafil Aurovitas more than once a day.

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 usually mild to moderate.

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

• Allergic reactions including rash (uncommon).
• Chest pain - do not use nitrates but seek medical help immediately (uncommon).
• Priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If you have this type of erection, which can last for more than 4 hours, you should contact a doctor immediately.
• Sudden loss of vision (rare), distorted, blurred, central blurred vision, or sudden loss of vision (frequency not known).

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

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

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

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems.

Rarely, cases of decreased or loss of vision, partial, transient, or permanent in one or both eyes have been reported.

Some additional rare side effectshave been reported in men taking tadalafil that were not seen in clinical trials, including:

• Migraine, swelling in the face, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• Distorted, blurred, central blurred vision, or sudden loss of vision (frequency not known).

In men over 75 years old taking tadalafil, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafil, the most frequently reported side effect was diarrhea.

Reporting of side effects

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. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website (http://www.aemps.gob.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 stated on the blister, carton, or bottle after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and other information

Composition ofTadalafilAurovitas

• The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other ingredients are:

Core of the tablet:Copovidone, macrogolglycerol hydroxystearate, 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 pack contents

Light yellow film-coated tablets, oval, with the mark “56” on one face and “L” on the other.

Tadalafil Aurovitas is available in PVC/PVdC transparent-Aluminum blister packs and HDPE bottles.

Blister pack sizes: 4, 8, 12, 14, 28, 56, 84, and 90 film-coated tablets.

Bottle pack sizes: 100 and 250 film-coated tablets.

Not all 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

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 authorized 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 Healthcare Products (AEMPS) (http://www.aemps.gob.es/).