Tadalafil PensA 20 mg film-coated tablets EFG

Patient Information Leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tadalafilo Pensa 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking 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, consult 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.

Package leaflet contents

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

1. What Tadalafilo Pensa 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 sufficient for satisfactory sexual activity. Tadalafilo has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

Tadalafilo Pensa contains the active substance tadalafil, which belongs to a group of medicines known as phosphodiesterase type 5 inhibitors. Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing increased 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 warn you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner must engage in sexual 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 Pensa

Do not take Tadalafil Pensa if:

• you are allergic to tadalafil or to any of the other components of this medicine (listed in section 6).

• 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 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.

• you have a severe heart disease or have recently had a heart attack (within the last 90 days).

• you have recently had a stroke (within the last 6 months).

• you have low blood pressure or uncontrolled high blood pressure.

• you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

• 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

Consult your doctor before starting to take this medicine.

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 the red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (cancer of the 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 involving total or partial removal of the prostate with damage to the nerves supplying the prostate (radical prostatectomy without nerve-sparing).

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.

Taking Tadalafil with Other Medicines

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

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 to treat high blood pressure.

• riociguat.

• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).

• medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.

• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).

• rifampicin, erythromycin, clarithromycin, or itraconazole.

• other treatments for erectile dysfunction.

Tadalafil Pensa consumption with food and alcohol

Information regarding the effect of alcohol is located in section 3. Grapefruit juice may affect the effectiveness of tadalafil and should be consumed with caution. Consult your doctor for further information.

Fertility

In treated dogs, a decrease in sperm production by the testes has been observed. A reduction in sperm has been observed in some men. It is unlikely that these effects lead to infertility.

Driving and operating machinery

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 Pensa contains lactose:

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

3. How to take Tadalafil Pensa

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Tadalafil Pensa 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. However, you have been prescribed a dose of one 20 mg tablet because your doctor has decided that the recommended 10 mg dose is too weak for you.

When you take tadalafil, you may begin sexual activity at least 30 minutes after taking the tablet.

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

You must not take Tadalafil Pensa more than once a day. Tadalafil Pensa 10 mg and 20 mg are to be used prior to anticipated sexual activity and are not recommended for continuous daily use.

It is important to warn you 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.

Alcohol consumption may affect your ability to get an erection and 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 Tadalafilo Pensa than you should

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

You may experience adverse effects described in section 4.

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 will experience them. These effects are generally mild to moderate in intensity.

If you experience any of the following adverse reactions, 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 frequency). If you experience this type of erection, which may last continuously for more than 4 hours, you must contact a doctor immediately.
• sudden vision loss (rare frequency), distorted, diminished, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse reactions that have been reported:

Common (observed in 1 to 10 out of every 100 patients)

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

Uncommon (observed in 1 to 10 out of every 1,000 patients)

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

Rare (observed in 1 to 10 out of every 10,000 patients)

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy welts on the skin), bleeding in the penis, 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 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 reactions 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, serious 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 reaction was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse reaction was diarrhea.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Pensa

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

Do not use this medicine after the expiry date stated on the carton and blister pack after “EXP”. The expiry date refers to 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines or their containers, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Pensa

• The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other components are monohydrate lactose, microcrystalline cellulose, povidone K30, poloxamer type 188, sodium lauryl sulfate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

The tablet coating contains polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the medicinal product and contents of the container

Tadalafil Pensa 20 mg is a light pink, film-coated, oblong, biconvex tablet, scored on one side. The score line should not be used to split the tablet.

Tadalafil Pensa 20 mg is available in blister packs containing 4, 8, and 12 tablets.

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Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing:

Pharmacare Premium Ltd

HHF 003 Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Zaklady Farmaceutyczne Polpharma S.A. (Pharmaceutical Works Polpharma S.A.)

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

or

Zaklady Farmaceutyczne POLPHARMA SA

(Pharmaceutical Works POLPHARMA SA)

2, Metalowca Street

39-460 Nowa Deba

Poland

Date of the last revision of this leaflet: August 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/