Tadalafil Aurovitas 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tadalafilo Aurovitas 10 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Tadalafilo is indicated for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafilo has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

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

It is important to inform you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

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

Do not take Tadalafil Aurovitas

• 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 organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina (chest pain). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.
• If you have severe heart disease or have recently had a heart attack (within the last 90 days).
• If you have recently had a stroke (within the last 6 months).
• If you have low blood pressure or uncontrolled high blood pressure.
• If you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
• 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 starting to take Tadalafil Aurovitas.

Be aware that sexual activity carries a potential risk for patients with heart problems, due to the additional strain it places on the heart. If you have a heart condition, consult your doctor.

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

• Sickle cell anemia (an abnormality of red blood cells).
• Multiple myeloma (a cancer of the bone marrow).
• Leukemia (a cancer of blood cells).
• Any penile deformity.
• Severe liver problems.
• Severe kidney problems.

It is not known whether tadalafil is effective in patients who have undergone:

• Pelvic surgery.
• A surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been severed (radical prostatectomy without preservation of neurovascular bundles).

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, stop taking tadalafil and contact your doctor immediately.

Tadalafil is not intended for use in women.

Children and adolescents

Tadalafil must not be used in children or adolescents under 18 years of age.

Other medicines and Tadalafil Aurovitas

Tell your doctor 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 be affected by tadalafil or may affect how well tadalafil works. Inform your doctor or pharmacist if you are taking:

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

Taking Tadalafil Aurovitas with drinks and alcohol

Information about 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 further information.

Fertility

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

Driving and use of machines

Some men who took tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafil Aurovitas contains lactose

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

Tadalafil Aurovitas contains 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 for use of this medicine given by your doctor or pharmacist. If in doubt, 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 may be taken with or without food.

The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil Aurovitas tablets are administered orally.

You may take the Tadalafil Aurovitas tablet at least 30 minutes before sexual activity.

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

You must not take Tadalafil Aurovitas more than once a day. Tadalafil Aurovitas 10 mg and 20 mg tablets are to be taken before anticipated sexual activity and are not intended for daily continuous use.

It is important to inform you that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption 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 this may increase the risk of dizziness when standing up.

If you take more Tadalafil Aurovitas than you should

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

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, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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 may cause adverse effects, although not everyone experiences 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 rashes (uncommon).
• Chest pain – do not use nitrates, but seek immediate medical help (uncommon).
• Priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you experience this type of erection, which may last continuously for more than 4 hours, you must contact a doctor immediately.
• Sudden loss of vision (rare frequency), distorted, dimmed, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse 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, blood in the urine, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (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, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (red, itchy skin rashes), bleeding from the penis, blood in the semen, and increased sweating.

Myocardial infarction (heart attack) and stroke have also been rarely reported in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medicine.

Rare cases of decreased or lost vision, partial, transient or permanent, in one or both eyes have also been reported.

Some additional rare adverse effects have been reported in men taking tadalafil that were not observed during clinical trials. These include:

• Migraine, facial swelling, severe allergic reaction causing facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeats, angina, and sudden cardiac death.
• Distorted, dimmed, blurred central vision or sudden decrease in vision (frequency not known).

In men over 75 years of age receiving tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect was diarrhea.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 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 outer packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to a SIGRE point at your pharmacy. If you have any doubts, 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 Aurovitas

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

Tablet core: Copovidone, macrogolglycerol hydroxystearate, lactose monohydrate, 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 tablets, light yellow, oval-shaped, marked with “57” on one side and “L” on the other.

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

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

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 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 for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).