Tadalafil Teva

Leaflet attached to the packaging: information for the user

Tadalafil Teva,

5 mg, coated tablets

Tadalafilum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should 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 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 tell 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 pack and other information

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

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

• with symptoms of benign prostatic hyperplasia. This is a condition where the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, a feeling of not emptying the bladder completely, and the need to urinate more frequently, even at night. Tadalafil Teva improves blood flow and causes relaxation of the prostate and bladder muscles, which may alleviate the symptoms of benign prostatic hyperplasia within 1-2 weeks of starting treatment.

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

In the absence of sexual stimulation, the patient and their partner should arrange foreplay, just like when the patient is not taking erectile dysfunction medication.

• with symptoms of benign prostatic hyperplasia. This is a condition where the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, a feeling of not emptying the bladder completely, and the need to urinate more frequently, even at night. Tadalafil Teva improves blood flow and causes relaxation of the prostate and bladder muscles, which may alleviate the symptoms of benign prostatic hyperplasia within 1-2 weeks of starting treatment.

2. Important information before taking Tadalafil Teva

When NOT to take Tadalafil Teva

1

• 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 nitrates in any form or other donors of nitric oxide, 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 section "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. The patient should remember that sexual activity is associated with 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. Benign prostatic hyperplasia and prostate cancer may have the same symptoms, so the doctor will perform an examination to rule out prostate cancer before starting Tadalafil Teva for the treatment of benign prostatic hyperplasia symptoms. Tadalafil Teva is NOT used to treat prostate cancer. 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 had pelvic surgery or after a radical prostatectomy without nerve sparing. If the patient experiences sudden worsening of vision or sudden loss of vision, or distorted, blurred, or dimmed vision, they should STOP taking Tadalafil Teva and contact their doctor immediately. Some patients taking tadalafil have reported a decrease in hearing or sudden hearing loss. Although it is not known whether this event is directly related to the use of tadalafil, if the patient experiences a decrease in hearing or sudden hearing loss, they should stop taking Tadalafil Teva and contact 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 18 years of age.

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. The patient should NOT take Tadalafil Teva if they are taking nitrates (see section "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 benign prostatic hyperplasia).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia).
• 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 on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Teva, and the patient should exercise caution when consuming it. For more information, the patient should consult their doctor.

Fertility

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

Driving and using machines

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 previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Tadalafil Teva. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it 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. The tablets of Tadalafil Teva are intended 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. Consuming alcohol may affect the patient's ability to achieve an erection and may cause a temporary 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.

Treatment of erectile dysfunction

Recommended doseis one 5 mg 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 that case, the patient should take a 2.5 mg tablet. The patient should NOT take Tadalafil Teva more than once a day. Taking Tadalafil Teva once a day may be beneficial for men who intend to have sexual intercourse twice a week or more frequently. Taking Tadalafil Teva once a day allows the patient to achieve an erection after sexual stimulation at any time during the 24 hours. It is essential to be aware that Tadalafil Teva does not work without sexual stimulation. The patient and their 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.

Treatment of symptoms of benign prostatic hyperplasia

The dose is one 5 mg tablet, taken once daily, at approximately the same time every day. If the patient has benign prostatic hyperplasia and erectile dysfunction, the 5 mg dose once daily remains unchanged. The patient should NOT take Tadalafil Teva more than once a day.

Use of a higher than recommended dose of Tadalafil Teva

The patient should inform their doctor. Adverse reactions described in section 4 may occur.

Missed dose of Tadalafil Teva

The patient should take the dose as soon as they remember, but they should not take a double dose to make up for the missed tablet. The patient should NOT take Tadalafil Teva 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 the patient experiences any of the following side effects, they should STOP taking Tadalafil Teva and contact their doctor immediately:

• allergic reactions, including rash (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 the patient experiences such an erection and it lasts continuously for more than 4 hours, they should contact their doctor immediately.

• sudden loss of vision (rare), distorted, blurred, or dimmed vision, or sudden worsening of vision (frequency not known).

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

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

Uncommon(occurring 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 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(occurring 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 bumps on the skin),
• penile bleeding,
• blood in 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 loss of vision in one or both eyes. Men taking Tadalafil Teva have reported a few 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 death,
• distorted, blurred, or dimmed vision, or sudden worsening of vision (frequency not known). Dizziness was reported more frequently in men over 75 years of age taking Tadalafil Teva. Diarrhea was reported more frequently in men over 65 years of age taking Tadalafil Teva.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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, 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 gathered 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 patient should 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 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 they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Teva contains

The active substance of the medicine is tadalafil. Each tablet of Tadalafil Teva contains 5 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 contents of the pack

Oval, yellow to ochre-colored, coated tablets with "5" engraved on one side and smooth on the other. Tablet length: 8.1 mm; width: 4.1 mm. The tablets are available in blisters containing 14, 18, 28, 30, or 84 coated tablets or perforated blisters containing 14x1, 28x1, 84x1, or 98x1, or 112x1 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.