Tadalafil Teva

Leaflet accompanying the packaging: information for the user

Tadalafil Teva,

20 mg, film-coated tablets

Tadalafilum

It is essential to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects 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 Teva and what is it used for
• 2. Important information before taking Tadalafil Teva
• 3. How to take Tadalafil Teva
• 4. Possible side effects
• 5. How to store Tadalafil Teva
• 6. Contents of the packaging and other information

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

Tadalafil Teva is a medicine intended for adult men with erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that Tadalafil Teva significantly improves the ability to achieve an erection sufficient for sexual intercourse. Tadalafil Teva contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Teva helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection improves. Tadalafil Teva does not help patients who do not have erectile dysfunction.

It is essential to be aware that Tadalafil Teva does not work without sexual stimulation.

The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.

2. Important information before taking Tadalafil Teva

When NOT to take Tadalafil Teva:

• 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. Nitrates are a group of medicines used to treat angina pectoris ("chest pain"). It has been shown that Tadalafil Teva enhances the effect of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor (see "Tadalafil Teva and other medicines").
• 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 a 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 Teva, 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 to take Tadalafil Teva, the patient should consult their doctor. It should be remembered that sexual activity is associated with a certain risk in 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 Tadalafil Teva, the patient should inform their doctor if they have any of the following conditions:

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

It is not known whether Tadalafil Teva is effective in patients who have undergone pelvic surgery or have had their prostate removed. If the patient experiences sudden vision loss or sudden hearing loss, they should stop taking Tadalafil Teva and consult their doctor immediately. Tadalafil Teva is not intended for use in women.

Children and adolescents

Tadalafil Teva is not intended for use in children and adolescents under the age of 18.

Tadalafil Teva 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 Teva should NOT be taken if the patient is taking nitrates (see "When NOT to take Tadalafil Teva"). Tadalafil Teva may affect the action of some medicines or other medicines may affect the action of Tadalafil Teva. The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor blockers (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 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 Teva with food and alcohol

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

Fertility

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

Driving and operating machinery

Some men taking Tadalafil Teva during clinical trials reported dizziness, so the patient should be aware of their reaction to the tablets before driving or operating machinery.

Tadalafil Teva contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Tadalafil Teva

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. Tadalafil Teva tablets are intended for oral use only in men. Once-daily dosing The recommended dose is 5 mg (which corresponds to one-quarter of a tablet), taken once daily at approximately the same time every day. The doctor may change the dose to 2.5 mg, depending on the patient's response to Tadalafil Teva. In this case, a 2.5 mg tablet should be taken. Tadalafil Teva should not be taken more than once a day. Taking Tadalafil Teva once a day may be beneficial for men who intend to engage in sexual activity twice a week or more. Taking Tadalafil Teva once a day allows for the achievement of an erection after sexual stimulation at any time during the 24-hour period. Initial dose (on-demand) The recommended initial dose is 10 mg (which corresponds to half a tablet) before planned sexual activity. If this dose is not sufficient, the doctor may increase the dose to 20 mg (which corresponds to one tablet). The dose can be taken at least 30 minutes before planned sexual activity. Tadalafil Teva may be effective for up to 36 hours after taking the dose. The 10 mg and 20 mg doses should not be taken more than once a day. They are intended for use before planned sexual activity and are not recommended for continuous, daily use. It is essential to be aware that Tadalafil Teva does not work without sexual stimulation. The patient and his partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication. Consuming alcohol may affect the patient's ability to achieve an erection and may cause a transient decrease in blood pressure. If the patient has taken Tadalafil Teva or plans to take it, they should not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of dizziness when standing up.

Method of administration

Depending on the dosing schedule used (once daily or on-demand), the tablets can be divided into four parts (once daily) or halves (on-demand). Tadalafil Teva is intended for oral use and can be taken with or without food. The patient should swallow the tablet or part of the tablet with a small amount of water. Dividing the tablet into four equal parts (using tadalafil at a dose of 5 mg once daily)

Place the tablet on a hard, flat surface (e.g., a table) with the dividing groove facing up.
Place your thumb (or index finger) on the surface of the tablet with the dividing groove and press firmly and briefly until the tablet breaks into four equal parts.

Dividing the tablet into halves (using tadalafil at a dose of 10 mg on-demand)

Place the tablet on a hard, flat surface (e.g., a table) with the dividing groove facing up.
Place your thumbs (or index fingers) on both sides of the shorter dividing groove on the tablet. Press firmly and briefly with both thumbs (or index fingers) on the edges of the tablet until it breaks into two equal parts.

Using a higher dose of Tadalafil Teva than recommended

The patient should inform their doctor. Side effects described in section 4 may occur.

Missing a dose of Tadalafil Teva

In the case of once-daily dosing, the patient should take the dose as soon as they remember, but should not take a double dose to make up for the missed dose. Tadalafil Teva should NOT be taken more than once a day. If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tadalafil Teva 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 Tadalafil Teva and consult their doctor immediately:

• allergic reactions, including rashes (not very common).
• chest pain - the patient should not take nitrates, but should seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking Tadalafil Teva (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), distorted, blurred, or impaired vision (frequency not known).

Other reported side effects: Common(observed in 1 to 10 out of 100 patients)

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

Uncommon(observed in 1 to 10 out of 1000 patients)

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

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

• fainting,
• seizures,
• transient memory loss,
• swelling of the eyelids,
• redness of the eyes, sudden worsening or loss of hearing, and hives (itchy, red swellings on the skin surface),
• penile bleeding,
• blood in the semen,
• increased sweating.

Heart attack and stroke have been rarely reported in men taking Tadalafil Teva. Most of them had heart problems before starting to take this medicine. There have been reports of rare cases of partial, transient, or permanent loss of vision or blindness in one or both eyes. Men taking Tadalafil Teva have reported several additional rare side effects, which were not observed during clinical trials. These include:

• migraine,
• facial swelling,
• severe allergic reactions causing facial and throat swelling,
• severe skin rashes,
• eye disorders,
• irregular heartbeat,
• angina pectoris,
• sudden cardiac deaths,
• distorted, blurred, or impaired vision (frequency not known).

Dizziness was reported more frequently in men over 75 years old taking Tadalafil Teva. Diarrhea was reported more frequently in men over 65 years old taking Tadalafil Teva.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products 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, e-mail: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tadalafil Teva

The medicine should be stored out of sight and reach of children. The medicine should not be used after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tadalafil Teva contains

The active substance of the medicine is tadalafil. Each tablet contains 20 mg of tadalafil. The other ingredients are: Tablet core: lactose monohydrate, sodium lauryl sulfate, povidone K12, crospovidone, sodium stearyl fumarate. Coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, yellow iron oxide (E172).

What Tadalafil Teva looks like and what the pack contains

Tadalafil Teva 20 mg is an oval, film-coated tablet, yellow to ochre in color, with two dividing grooves on one side and the marking "20" on the other side. The length of the tablet is 15.0 mm; the width is 9.0 mm. The tablet can be divided into two or four equal doses. The tablets are available in blisters containing 2, 4, 5, 8, 10, 12, 15, 18, 24, 28, 36, 48, or 56 film-coated tablets or perforated blisters containing 2x1, 4x1, 8x1, 12x1, 24x1, or 36x1 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. +48 22 345 93 00

Manufacturer/Importer:

TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical Works Private Limited Company), Pallagi út 13, 4042 Debrecen, Hungary; Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków; TEVA PHARMA S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain; Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany; Merckle GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany; PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, 10000 Zagreb, Croatia; Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria; Date of last revision of the leaflet:February 2024