Tadalafil Belupo

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the patient

Tadalafil Belupo, 20 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.
• 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 is a medicine used for the treatment of adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual performance. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for satisfactory sexual performance.
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 relax the blood vessels in the penis, allowing blood to flow into the penis. As a result, it helps to improve 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.

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 in the treatment of angina pectoris ("chest pain"). It has been shown that tadalafil increases the effects of these medicines. If you are taking nitrates in any form, or are unsure, you should 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 connection with previous phosphodiesterase 5 (PDE5) inhibitor use.
• if you are 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 due to blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as tadalafil, increase the effects of this medicine. If you are taking riociguat, or are unsure, you should tell your doctor.

Warnings and precautions

Before taking Tadalafil Belupo, you should discuss this with your doctor or pharmacist.
It should be remembered that sexual activity carries a degree of cardiac risk in patients with pre-existing heart disease. If you have any problems with your heart, you should tell your doctor.
Before taking the medicine, you should tell your doctor if you have any of the following:

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

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

• undergone pelvic surgery.
• had a radical prostatectomy (removal of the prostate gland) with or without preservation of nerve function.

If you experience any of the following side effects, stop taking Tadalafil Belupo and contact your doctor immediately:
sudden loss of vision or loss of vision in one eye, distorted vision, blurred vision.
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 about any medicines 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 an enlarged prostate gland).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha reductase inhibitors (used to treat 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 (medicines used to treat epilepsy).
• rifampicin, erythromycin, clarithromycin or itraconazole.
• other treatments for erectile dysfunction.

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

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Belupo and therefore you should be cautious when taking it. For more information, ask your doctor.

Fertility

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

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness. Therefore, you should be aware of how you react to the medicine 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. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food.
Recommended initial doseis one 10 mg tablet, taken before planned sexual activity. If your doctor has prescribed the 10 mg dose and you find it is too weak, you should take one 20 mg tablet as directed by your doctor.
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.
Do not take Tadalafil Belupo more than once a day. Tadalafil Belupo 20 mg is for use before anticipated sexual activity and is not recommended for continuous, daily use.
It is important to note that Tadalafil Belupo does not work without sexual stimulation.

What to do if you take more Tadalafil Belupo than you should

Inform your doctor. 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 usually mild to moderate.

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

allergic reactions, including 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 have an erection that lasts more than 4 hours, contact your doctor immediately.
sudden loss of vision (rare), distorted vision, blurred vision (frequency not known).
Other reported side effects include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face or throat, severe skin rashes, eye irritation, irregular heartbeat, angina pectoris, and sudden cardiac death,
• distorted vision, 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 conditions 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 20 mg: one film-coated tablet contains 20 mg of tadalafil.
• The other ingredients are: Tablet core: lactose anhydrous, croscarmellose sodium, sodium lauryl sulfate, hydroxypropylcellulose, 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 20 mg: yellow, oval, film-coated tablet, marked with "T20" on one side and a smooth other side.
Length 13.5 mm, width 6.6 mm.
Tadalafil Belupo 20 mg: is available in packs of 2, 4, 8 tablets in a blister pack.
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 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 20 mg film-coated tablets
Slovakia
Tadalafil Belupo 20 mg film-coated tablets
Slovenia
Tadalafil Belupo 20 mg film-coated tablets
Date of last revision of the leaflet:January 2024