Tadalafil Aurovitas 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tadalafilo Aurovitas 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start using this medicine, as 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

Tadalafilo Aurovitas 5 mg is used to treat adult men with:

• Erectile dysfunction. This occurs when a man cannot achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity.

After sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow into it. 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 without sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, a sensation that the bladder has not emptied completely, and a need to urinate more frequently, even at night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within as little as 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafilo Aurovitas

Do not take Tadalafilo Aurovitas

• If you are allergic to tadalafil or to any of the other components of this medicine (listed in section 6).
• If you are taking any organic nitrates 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 are taking any type of nitrate or are unsure, tell your doctor.
• If you have a 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 Tadalafilo Aurovitas.

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

Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform a prostate cancer screening before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

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 deformity of the penis.
• Severe liver problems.
• Severe kidney problems.

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

• Pelvic surgery.
• Surgical procedures involving the prostate where the nerves to the prostate have been severed (radical prostatectomy without neurovascular bundle preservation), whether partially or completely.

If you experience a 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 Tadalafilo 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 interact with tadalafil or 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 to treat 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 the treatment of AIDS or HIV infection.
• Phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• Rifampicin, erythromycin, clarithromycin, or itraconazole.
• Other treatments for erectile dysfunction.

Taking Tadalafilo Aurovitas with food and alcohol

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

Fertility

In treated dogs, a reduction 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.

Tadalafilo Aurovitas contains lactose

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

Tadalafilo 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 some water. Tablets may be taken with or without food.

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

For the treatment of erectile dysfunction

The recommended dose is one 5 mg tablet once daily, taken at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to tadalafil. This will be achieved by taking a 2.5 mg tablet.

Do not take tadalafil more than once a day.

Daily administration of tadalafil allows you to achieve an erection at any time during the 24-hour day, provided sexual stimulation is present. Daily tadalafil may be beneficial for men who expect to have sexual activity two or more times per week.

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

Alcohol consumption may affect your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet once daily, taken at approximately the same time each day.

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

You must not take tadalafil more than once a day.

If you take more Tadalafil Aurovitas than you should

Contact 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: 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and patient information leaflet to the healthcare professional.

If you forget to take Tadalafil Aurovitas

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

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 medical help immediately:

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

Other adverse effects that have been reported:

Frequent (may affect up to 1 in 10 people)

• Headache, back pain, muscle pain, 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, and transient memory loss, eyelid swelling, red eyes, sudden partial or complete hearing loss, urticaria (red, itchy skin rashes), penile bleeding, blood in the semen, and increased sweating.

Rare cases of heart attack and stroke have also been 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 swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeats, angina, and sudden cardiac death.
• Distorted, diminished, 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 diarrhoea.

Reporting of adverse effects

If you experience any 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 Medicinal Products: 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, packaging, or bottle 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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, 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 5 mg of tadalafil.
• The other components are:

Tablet core: Copovidone, macrogol glycerol 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 "56" on one side and "L" on the other.

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

Only some 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 European Economic Area member states under the following names:

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

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