Tadalafil Pensa 5 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Tadalafil Pensa 5 mg Film-coated Tablets EFG

Read the entire package 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 others, even if they have the same symptoms as you, as it may 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. Storage of Tadalafilo Pensa
6. Contents of the pack and other information

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

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

Tadalafilo Pensa 5 mg is used for the treatment of 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.

Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow 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 warn you that tadalafil is not effective in the absence of 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.

• 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 during the 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 starting to take Tadalafil Pensa

Do not take Tadalafil Pensa if:

• you are allergic to tadalafil or to any of the other ingredients 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 involves a potential risk in patients with heart problems, due to the additional strain it places on the heart. If you have a heart condition, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will perform a prostate cancer evaluation 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 the red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukemia (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 involving total or partial removal of the prostate with damage to the nerves supplying the prostate (radical prostatectomy without neurovascular bundle preservation).

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or diminished 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 itraconazol.
• other treatments for erectile dysfunction.

Tadalafil Pensa and beverages and alcohol

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

Fertility

A decrease in sperm production by the testes has been observed in treated dogs. A reduction in sperm has also been observed in some men. It is unlikely that these effects would result in 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 him before taking this medicine.

3. How to take Tadalafil Pensa

Follow exactly the instructions for use of this medicine 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 some water. The tablets may be taken with or without food.

Alcohol consumption can 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 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 that sexual stimulation is present. Daily tadalafil may be beneficial for men who anticipate having sexual activity two or more times per week.

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 sexual stimulation in the same way as you would if you were not taking a medication 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.

Do not take tadalafil more than once a day.

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, stating the medication and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

. You may experience adverse effects described in section 4.

If you forget to take Tadalafil Pensa

Take your dose as soon as you realize, but do not take a double dose to make up for missed doses. You should not take tadalafil 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 taking the medicine and seek medical help immediately:

• allergic reactions including rashes (uncommon).

• chest pain – do not use nitrates but seek medical help immediately (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 effects 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, tinnitus (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, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy welts on the skin), bleeding from 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 pre-existing heart conditions before taking this medicine.

Rare cases of decreased or sudden, partial or complete, temporary or permanent vision loss in one or both eyes have 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, serious skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, 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 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 via 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 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 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 container and additional information

Composition of Tadalafil Pensa

• The active substance is tadalafil. Each film-coated tablet contains 5 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 product and contents of the pack

Tadalafil Pensa 5 mg is a light brown, film-coated, oblong, biconvex tablet.

Tadalafil Pensa 5 mg is available in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturing Responsible Party:

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 most recent review of this leaflet: August 2023

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