Tadalafil Belupo

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Tadalafil Belupo, 10 mg, film-coated tablets

Tadalafil

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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 is a medicine for adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that tadalafil significantly improves 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. After sexual stimulation, Tadalafil Belupo helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection is improved. 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 their partner should engage in foreplay, just as they would if the patient were not taking erectile dysfunction medication.

2. Important information before taking Tadalafil Belupo

When not to take Tadalafil Belupo:

• if the patient is allergic to tadalafil or 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 pectoris (‘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 in the last 90 days.
• if the patient has had a stroke in the last 6 months.
• if the patient has low blood pressure or uncontrolled high blood pressure.
• if the patient has ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known 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 phosphodiesterase type 5 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, the patient should discuss it with their doctor or pharmacist. It should be remembered that sexual activity carries a certain risk for patients with heart disease, as it puts an additional strain on the heart. If the patient has heart problems, they should inform their doctor. Before taking the medicine, the patient should inform their doctor if they have any of the following:

• sickle-cell anaemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukaemia (blood cell cancer).
• any penile deformity.
• severe liver disease.
• severe kidney disease.

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

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

If sudden vision loss or loss of vision occurs, the patient should stop taking Tadalafil Belupo and seek medical help immediately. In some patients taking tadalafil, a decrease in hearing or sudden hearing loss has been observed. Although it is not known whether this event is directly related to the use of tadalafil, if a decrease in hearing or sudden hearing loss occurs, the patient should stop taking Tadalafil Belupo and seek medical help immediately. 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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Tadalafil Belupo should not be taken if the patient is taking nitrates. Tadalafil Belupo may affect the way other medicines work or other medicines may affect the way Tadalafil Belupo works. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic blocking agents (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha reductase inhibitors (used to treat symptoms of an enlarged prostate).
• medicines such as ketoconazole in tablets (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, alcohol, and fertility

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Belupo and should be consumed with caution. For more information, the patient should consult their doctor.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes was observed. A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and using machines

In some men taking tadalafil during clinical trials, dizziness was reported. Therefore, the patient should be aware of their reaction to the medicine before driving or operating machinery.

Tadalafil Belupo contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

Tadalafil Belupo contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be essentially ‘sodium-free’.

3. How to take Tadalafil Belupo

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. Tadalafil Belupo tablets are for oral use only in men. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food. The recommended starting doseis one 10 mg tablet, taken before planned sexual activity. If this dose is not effective, the doctor may increase the dose to 20 mg. Tadalafil Belupo tablets are for oral use. Tadalafil Belupo can be taken at least 30 minutes before planned sexual activity. Tadalafil Belupo may still be effective up to 36 hours after taking the tablet. The patient should not take Tadalafil Belupo more than once a day. Tadalafil Belupo 10 mg and 20 mg is intended for use before planned sexual activity and is not recommended for continuous, daily use. It is important to note that Tadalafil Belupo does not work without sexual stimulation. The patient and their partner should engage in foreplay, just as they would if the patient were not taking erectile dysfunction medication. Consuming alcohol may cause a temporary decrease in blood pressure. If the patient has taken Tadalafil Belupo or plans to take it, they should not consume large amounts of alcohol (blood alcohol level 0.08% or higher), as this may increase the risk of dizziness when standing up.

Use of higher than recommended dose of Tadalafil Belupo

The patient should inform their doctor. Side effects described in section 4 may occur. In case of any further doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tadalafil Belupo can cause side effects, although not everybody gets them. These effects are usually mild or moderate.

If any of the following side effects occur, the patient should stop taking the medicine and seek medical help immediately:

allergic reactions, including rash (uncommon). chest pain - the patient should not take nitrates, but should seek medical help immediately (uncommon). priapism, prolonged and possibly painful erections after taking Tadalafil Belupo (rare). If such an erection occurs and lasts continuously for more than 4 hours, the patient should seek medical help immediately. sudden vision loss (rare). Other reported side effects: Common(occurring in 1 to 10 in 100 patients) headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion. Uncommon(occurring in 1 to 10 in 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(occurring in 1 to 10 in 10,000 patients)

• fainting, seizures, and transient memory loss, swelling of the eyelids, redness of the eyes, sudden hearing loss, and hives (itchy, red bumps on the skin), bleeding from the penis, blood in semen, and increased sweating.

Heart attack and stroke have also been rarely reported by men taking tadalafil. Most of them had heart problems before taking the 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 by 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 flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.

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

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorisation holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tadalafil Belupo

The medicine should be stored out of 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. The batch number is stated after ‘Lot’. There are no special storage instructions for the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Belupo contains

• The active substanceis tadalafil. Tadalafil Belupo 10 mg: one film-coated tablet contains 10 mg of tadalafil.
• The other ingredientsare: 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); black iron oxide (E 172).

What Tadalafil Belupo looks like and contents of the pack

Tadalafil Belupo 10 mg: yellow, biconvex, film-coated tablet with a capsule shape, with the marking “T10” on one side and a smooth other side. Length 11.0 mm, width 5.0 mm. Tadalafil Belupo 10 mg is available in blister packs containing 4 tablets.

Marketing authorisation holder

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

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 10 mg film-coated tablets Slovakia Tadalafil Belupo 10 mg film-coated tablets Slovenia Tadalafil Belupo 10 mg film-coated tablets

Date of last revision of the leaflet: November 2020