Patient Information Leaflet

Tadalafil Belupo, 20 mg, film-coated tablets
Tadalafilum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

What Tadalafil Belupo is and what it is used for
What you need to know before taking Tadalafil Belupo
How to take Tadalafil Belupo
Possible side effects
How to store Tadalafil Belupo
Contents of the pack and other information

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

Tadalafil Belupo is a medicine intended for adult men with erectile dysfunction. This is a condition in which a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve an erection sufficient for sexual intercourse.

Tadalafil Belupo contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Belupo helps widen the blood vessels in the penis, allowing increased blood flow into the penis. This results in improved erection. Tadalafil Belupo does not benefit men who do not have erectile dysfunction.

It is important to understand that Tadalafil Belupo will not work in the absence of sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.

2. Important information before using Tadalafil Belupo

When not to use Tadalafil Belupo:

if the patient is allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
if the patient is taking organic nitrates in any form or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina (chest pain). It has been shown that tadalafil enhances the effects of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor.
if the patient has severe heart disease or has had a heart attack within the last 90 days.
if the patient has had a stroke within the last 6 months.
if the patient has low blood pressure or uncontrolled high blood pressure.
if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to as "eye stroke".
if the patient is taking riociguat. This is a medicine used to treat pulmonary 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). It has been shown that PDE5 inhibitors, such as tadalafil, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting treatment with Tadalafil Belupo, discuss this with your doctor or pharmacist.
Please remember that sexual activity involves some risk for patients with heart disease,
as it places additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Before taking this medicine, the patient should inform their doctor if any of the following conditions apply:

sickle cell anemia (abnormal shape of red blood cells).
multiple myeloma (a bone marrow cancer).
leukemia (a blood cell cancer).
any deformity of the penis.
severe liver disease.
severe kidney disease.

It is not known whether Tadalafil Belupo is effective in patients:

after pelvic surgery.
after total or partial removal of the prostate gland with nerve cutting (non-nerve-sparing radical prostatectomy).

If sudden worsening of vision, sudden vision loss, or distorted, dimmed vision occurs during treatment with tadalafil, stop taking Tadalafil Belupo immediately and contact a doctor without delay.
In some patients taking tadalafil, worsening or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to tadalafil use, if hearing loss or sudden hearing deterioration occurs, stop taking Tadalafil Belupo immediately and contact a doctor without delay.
Tadalafil Belupo is not intended for use in women.
Children and adolescents
Tadalafil Belupo is not intended for use in children and adolescents under 18 years of age.
Tadalafil Belupo and other medicines
Tell your doctor about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Tadalafil Belupo if the patient is using nitrates.
Tadalafil Belupo may affect the action of other medicines, or other medicines may affect the action of Tadalafil Belupo. Inform your doctor or pharmacist if the patient is taking any of the following medicines:

alpha-blockers (used to treat high blood pressure or urinary symptoms caused by 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 oral ketoconazole (used to treat fungal infections) and protease inhibitors used in the treatment of AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadalafil Belupo, alcohol consumption, and fertility
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Belupo, and therefore caution should be exercised when consuming it. For more information, consult your doctor.
Fertility
When administered to dogs, a decrease in sperm production in the testes was observed.
Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In some men taking tadalafil during clinical trials, dizziness has been reported. Therefore, patients should be aware of their individual response to the medicine before deciding to drive a car or operate machinery.
Tadalafil Belupo contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Tadalafil Belupo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Belupo

This medicine should always be used exactly as your doctor or pharmacist has told you. If in doubt,
you should consult your doctor or pharmacist.
Tadalafil Belupo tablets are intended for oral use only in men. The tablet should be swallowed whole,
with a small amount of water. Tadalafil Belupo tablets may be taken regardless of meals.
The recommended starting dose is one 10 mg tablet, taken prior to planned sexual activity. If your
doctor finds that the recommended 10 mg dose is insufficient, then one 20 mg tablet should be taken
according to your doctor's instructions.
Tadalafil Belupo may be taken at least 30 minutes before planned sexual activity. Tadalafil Belupo may
still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Belupo more than once a day. Tadalafil Belupo 20 mg is intended for use prior
to planned sexual activity and is not recommended for regular, daily use.
It is important to be aware that Tadalafil Belupo does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would if the patient were not taking
medication for erectile dysfunction.
Drinking alcohol may affect the ability to achieve an erection and may cause transient lowering of
blood pressure. If the patient has taken or plans to take Tadalafil Belupo, he should not consume large
amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of
dizziness upon standing.
Use of a higher than recommended dose of Tadalafil Belupo
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the medicine and
seek immediate medical advice:
allergic reactions, including rash (uncommon).
chest pain – do not take nitrates, but seek immediate medical help (uncommon).
priapism, prolonged and possibly painful erection after taking Tadalafil Belupo (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
sudden vision loss (rare), distorted, blurred, or impaired central vision, or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
Common (observed in 1 to 10 out of 100 patients)
headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

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

dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.

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

fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden hearing loss, and urticaria (itchy, red skin eruptions), bleeding from the rectum, presence of blood in semen, and increased sweating.

Heart attack and stroke have also been rarely reported in men taking tadalafil. Most of these men had pre-existing heart problems before starting treatment with this medicine.
There have been reports of rare cases of partial, transient or permanent visual impairment or vision loss in one or both eyes.
Several additional rare adverse reactions have been reported in men taking tadalafil, which were not observed during clinical trials. These include:

migraine, facial swelling, severe allergic reactions causing swelling of the face or throat, severe skin rashes, disorders characterized by blood congestion in the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death,
distorted, blurred, impaired central vision or sudden worsening of vision (frequency not known).

Adverse reaction: dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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 stated on the carton and blister pack following “EXP”.
The expiry date refers to the last day of the stated month. The batch number is indicated after “Lot”.
No special storage instructions are required 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. Such measures will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Belupo contains

The active substance is tadalafil. Tadalafil Belupo 20 mg: one coated tablet contains 20 mg of tadalafil.
Other ingredients are:
Tablet core: anhydrous lactose, sodium croscarmellose, sodium lauryl sulfate, hydroxypropylcellulose, polysorbate 80, magnesium stearate.
Tablet coating: hypromellose 2910, monohydrate lactose, titanium dioxide (E 171), triacetin, talc, iron oxide yellow (E 172).

What Tadalafil Belupo looks like and contents of the pack
Tadalafil Belupo 20 mg: yellow, biconvex, film-coated capsule-shaped tablet marked with
"T20" on one side and plain on the other.
Length: 13.5 mm, width: 6.6 mm.
Tadalafil Belupo 20 mg is available in blister packs containing 2, 4, or 8 tablets.
Not all pack sizes may be marketed.

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 for sale in the European Economic Area under the following names:
Poland Tadalafil Belupo
Portugal Tadalafil Belupo
Czech Republic Tadalafil Belupo
Croatia Tadalafil Belupo 20 mg filmom obložene tablete
Slovakia Tadalafil Belupo 20 mg filmom obalené tablety
Slovenia Tadalafil Belupo 20 mg filmsko obložene tablete