TADALAFIL PENSA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafil Pensa 20 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Tadalafil is indicated for the treatment of erectile dysfunction in adult men. 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 obtain a hard erect penis suitable for sexual activity.

Tadalafil Pensa contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your 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. You and your partner will still need to use foreplay to get an erection.

2. What you need to know before you take Tadalafil Pensa

Do not take Tadalafil Pensa if:

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

• you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.

• you have a severe heart or liver problem.

• you have recently had a heart attack (within the last 90 days) or stroke (within the last 6 months).

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

• you have ever had loss of vision 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 effects of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before taking this medicine.

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.

Before taking the tablets, tell your doctor if you:

• have sickle cell anaemia (a disease of the red blood cells).
• have multiple myeloma (cancer of the bone marrow).
• have leukaemia (cancer of the blood cells).
• have any deformation of your penis.
• have a serious liver or kidney problem.

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

• undergone pelvic surgery.
• had a radical prostatectomy (removal of the prostate gland) or have a spinal cord injury.

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

A sudden decrease or loss of hearing has been reported in some patients taking tadalafil. Although it is not known if the 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 by women.

Children and adolescents

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

Taking Tadalafil Pensa with other medicines

Tell your doctor or pharmacist 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 high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).

• medicines such as ketoconazole (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.

Taking Tadalafil Pensa 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 more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm count has been observed in some men. These effects are unlikely to lead to infertility.

Driving and using machines

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

Tadalafil Pensa contains 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.

3. How to take Tadalafil Pensa

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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

The recommended doseis one 10 mg tablet taken before sexual activity. However, you have been given the dose of one 20 mg tablet because your doctor has decided that the recommended dose of 10 mg is too weak.

When you take tadalafil, you may be able to have sexual activity at any time between 30 minutes and 36 hours after taking the tablet.

Do not take Tadalafil Pensa more than once a day. Tadalafil Pensa 10 mg and 20 mg will be taken before anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that tadalafil is not effective if there is no sexual stimulation. You and your partner will still need to use foreplay to get an erection.

Drinking too much alcohol can reduce 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 drinking of alcohol (blood alcohol level of 0.08 % or higher), as it may increase the risk of dizziness when standing up.

If you take more Tadalafil Pensa than you should

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

You may experience side effects described in section 4.

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 normally mild to moderate.

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

• allergic reactions including skin 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 experience this type of erection, which can last for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted vision, blurred vision, or loss of vision (frequency not known).

Other side effects that have been reported:

Common(seen in 1 to 10 in every 100 patients)

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

Uncommon(seen in 1 to 10 in every 1,000 patients)

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

Rare(seen in 1 to 10 in every 10,000 patients)

• fainting, seizures and temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), bleeding from the penis, blood in the 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 partial, temporary or permanent loss of vision in one or both eyes have been reported.

Additional rare side effectshave been reported in men taking tadalafil that were not seen in clinical trials. These include:

• migraine, swelling of 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 heartbeats, angina pectoris and sudden cardiac death.
• Distorted vision, blurred vision, or loss of vision (frequency not known).

In men over 75 years old treated with tadalafil, the most frequently reported adverse event was dizziness. In men over 65 years old treated with tadalafil, the most frequently reported adverse event was diarrhoea.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, 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 which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are lactose monohydrate, 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 and packaging

Tadalafil Pensa 20 mg is a light pink, oblong, biconvex, film-coated tablet with a score line on one side. The score line is not intended to break the tablet.

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

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 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/