Tadalafil Belupo

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Tadalafil Belupo, 5 mg, film-coated tablets

Tadalafilum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tadalafil Belupo and what is it used for
• 2. Important information before taking Tadalafil Belupo
• 3. How to take Tadalafil Belupo
• 4. Possible side effects
• 5. How to store Tadalafil Belupo
• 6. Contents of the pack and other information

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

Tadalafil Belupo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Belupo 5 mg is used to treat adult men with:

• erectile dysfunction. 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 get an erection. After sexual stimulation, Tadalafil Belupo helps the blood vessels in the penis to relax, allowing blood to flow into the penis. This leads to an improvement in erectile function. Tadalafil Belupo does not help patients who do not have erectile dysfunction. It is important to note that Tadalafil Belupo does not work without sexual stimulation. The patient and his partner should engage in foreplay, just as when the patient is not taking erectile dysfunction medication.
• with symptoms of benign prostatic hyperplasia (enlargement of the prostate gland). This is when the prostate gland gets bigger with age. Symptoms include: difficulty starting to pass urine, feeling like the bladder is not completely empty, and needing to pass urine more often, even at night. Tadalafil Belupo improves blood flow and causes relaxation of the prostate and bladder muscles, which can help alleviate symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms after 1-2 weeks of treatment.

2. Important information before taking Tadalafil Belupo

When not to take Tadalafil Belupo:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of organic nitrate 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 nitrates in any form, or are unsure, tell your doctor.
• if you have severe heart disease or have had a heart attack in the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in one or both eyes.
• if you are taking riociguat. This is a medicine used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs due to blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as tadalafil, increase the blood pressure-lowering effect of this medicine. If you are taking riociguat, or are unsure, tell your doctor.

Warnings and precautions

Before taking Tadalafil Belupo, talk to your doctor or pharmacist.
Remember that sexual activity carries a risk for patients with heart disease, because it puts extra strain on the heart. If you have problems with your heart, tell your doctor.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so your doctor will check for prostate cancer before starting treatment with Tadalafil Belupo for benign prostatic hyperplasia.
Tadalafil Belupo is not for the treatment of prostate cancer.
Before taking the medicine, tell your doctor if you have any of the following:

• sickle cell anaemia (abnormal red blood cells).
• multiple myeloma (bone marrow cancer).
• leukaemia (blood cell cancer).
• any deformation of the penis.
• severe liver disease.
• severe kidney disease.

It is not known if Tadalafil Belupo is effective in patients who have:

• had pelvic surgery.
• had their prostate removed (radical prostatectomy without nerve sparing).

If you experience sudden loss of vision or loss of vision, or blurred vision, stop taking Tadalafil Belupo and contact your doctor immediately.
Some patients taking tadalafil have reported a sudden decrease or loss of hearing. Although it is not known if this event is directly related to tadalafil, if you experience a decrease or loss of hearing, stop taking Tadalafil Belupo and contact your doctor immediately.
Tadalafil Belupo is not intended for use by women.

Children and adolescents

Tadalafil Belupo is not intended for use by children and adolescents under 18 years of age.

Tadalafil Belupo and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and any you plan to take.
Do not take Tadalafil Belupo if you are taking nitrates.
Tadalafil Belupo may affect, or be affected by, other medicines. Tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or symptoms of benign prostatic hyperplasia).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha reductase inhibitors (used to treat symptoms of benign prostatic hyperplasia).
• medicines such as ketoconazole (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Belupo with food, drink, and alcohol, and effect on fertility

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Belupo, and caution should be exercised when consuming it. For more information, talk to your doctor.

Fertility

When given to dogs, there was a decrease in sperm production in the testes. Decreased sperm count has been reported in some men. It is unlikely to lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness, so be aware of how this medicine affects you before driving or operating machinery.

Tadalafil Belupo contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tadalafil Belupo contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Tadalafil Belupo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Tadalafil Belupo tablets are for oral use only in men. Swallow the tablet whole with a small amount of water. The tablets can be taken with or without food.
Drinking too much alcohol can cause a temporary drop in blood pressure. If you have taken Tadalafil Belupo or plan to take it, do not drink too much alcohol (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

Treatment of erectile dysfunction

The recommended dose isone 5 mg tablet per day, taken at approximately the same time each day.
Your doctor may lower the dose to 2.5 mg, depending on your individual reaction to Tadalafil Belupo. In this case, take a 2.5 mg tablet.
Tadalafil Belupo 2.5 mg is not registered on the market. It is necessary to take a registered medicine from another marketing authorisation holder that contains tadalafil in a 2.5 mg dose.
Do not take Tadalafil Belupo more than once per day.
Taking Tadalafil Belupo once per day allows for an erection to occur in response to sexual stimulation at any time during the 24-hour period. Taking Tadalafil Belupo once per day may be beneficial for men who plan to have sexual activity twice a week or more often.
It is important to note that Tadalafil Belupo does not work without sexual stimulation. The patient and his partner should engage in foreplay, just as when the patient is not taking erectile dysfunction medication.
Drinking too much alcohol can affect your ability to get an erection.

Treatment of symptoms of benign prostatic hyperplasia

The dose isone 5 mg tablet per day, taken at approximately the same time each day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet per day.
Do not take Tadalafil Belupo more than once per day.

Taking more than the recommended dose of Tadalafil Belupo

Tell your doctor. You may experience side effects as described in section 4.

Missing a dose of Tadalafil Belupo

Take a dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet. Do not take Tadalafil Belupo more than once per day.
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 usually mild or moderate.

If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately:

allergic reactions, including skin rash (uncommon).
chest pain - do not take nitrates, but seek medical help immediately (uncommon).
priapism, prolonged and possibly painful erections after taking Tadalafil Belupo (rare). If you experience this, contact your doctor immediately. If this happens, you should contact your doctor immediately.
sudden loss of vision (rare), blurred vision, or loss of vision (frequency not known).
Other reported side effects include:

• Common(seen in 1 to 10 in every 100 patients)
• headache, back pain, muscle pain, pain in arms and legs, 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 erections, 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 transient memory loss, eyelid swelling, eye redness, sudden hearing loss, and hives (itchy, red swellings on the skin), penile haemorrhage, blood in semen, and increased sweating.

Heart attack and stroke have also been reported rarely in men taking tadalafil. Most of these men had heart problems before taking this medicine.
There have been reports of rare cases of partial, transient, or permanent decrease in vision or loss of vision in one or both eyes.
A few additional rare side effectshave been reported in men taking tadalafil that were not observed in clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face or throat, severe skin rashes, eye disorders, irregular heartbeat, angina, and sudden cardiac death,
• blurred vision, or loss of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years old taking tadalafil. Diarrhoea was reported more frequently in men over 65 years old taking tadalafil.

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 national reporting system listed in the "Contact" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Belupo

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.
The batch number is stated after "Lot".
There are no special storage instructions for this medicine.
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

What Tadalafil Belupo contains

• The active substanceis tadalafil. Tadalafil Belupo 5 mg: one film-coated tablet contains 5 mg of tadalafil.
• The other ingredients are: Tablet core: lactose anhydrous, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, polysorbate 80, magnesium stearate. Tablet coating: hypromellose 2910, lactose monohydrate, titanium dioxide (E 171), triacetin, talc, yellow iron oxide (E 172).

What Tadalafil Belupo looks like and contents of the pack

Tadalafil Belupo 5 mg: yellow, oval, biconvex, film-coated tablet, with "T5" engraved on one side and a smooth surface on the other.
Length 8.2 mm, width 4.1 mm.
Tadalafil Belupo 5 mg: is available in blister packs containing 28 tablets.

Marketing authorisation holder

Belupo lijekovi i kozmetika d.d.
Ulica Danica 5
48 000 Koprivnica
Croatia

Manufacturer/Importer

Belupo lijekovi i kozmetika d.d.
Ulica Danica 5
48 000 Koprivnica
Croatia
Genepharm S.A.
18th km Marathonos Avenue
15351 Pallini Attiki
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Poland
Tadalafil Belupo
Portugal
Tadalafil Belupo
Czech Republic
Tadalafil Belupo
Croatia
Tadalafil Belupo 5 mg film-coated tablets
Slovakia
Tadalafil Belupo 5 mg film-coated tablets
Slovenia
Tadalafil Belupo 5 mg film-coated tablets
Date of last revision of the leaflet:January 2024