Package leaflet: Information for the user

Tadalafil Teva,
5 mg, film-coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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.

Contents of the leaflet

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

1. What Tadalafil Teva is and what it is 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. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Teva has been shown to significantly improve the ability to achieve an erection sufficient for sexual intercourse. After sexual stimulation, Tadalafil Teva helps widen the blood vessels in the penis, allowing blood to flow into the penis. This results in improved erection. Tadalafil Teva does not help patients who do not have erectile dysfunction. It is important to know that Tadalafil Teva does not work for erectile dysfunction 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.
with urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, feeling of incomplete bladder emptying, and need to urinate more frequently, even at night. Tadalafil Teva improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia within 1–2 weeks of starting treatment.

2. Important information before using Tadalafil Teva

When NOT to use 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, e.g. amyl nitrite. Nitrates are a group of medicines used to treat angina (chest pain). It has been shown that Tadalafil Teva enhances the effects 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 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). PDE5 inhibitors such as Tadalafil Teva have been shown to 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 Tadalafil Teva, consult a doctor.
Please remember that sexual activity involves some risk for patients with heart problems, as it places additional strain on the heart. If there are any heart-related issues, inform the doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms, therefore the doctor will perform tests to rule out prostate cancer before starting treatment with Tadalafil Teva for symptoms of benign prostatic hyperplasia. Tadalafil Teva is NOT used to treat prostate cancer.
Before taking Tadalafil Teva, the patient should inform the doctor if any of the following apply:

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

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

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

If during treatment with tadalafil there is sudden worsening of vision or sudden vision loss, or if vision becomes distorted or blurred, Tadalafil Teva must be discontinued and the patient should contact a doctor immediately.
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 there is worsening or sudden hearing loss, the patient should stop taking Tadalafil Teva and contact a 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
Tell the doctor about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.
Tadalafil Teva must NOT be taken if the patient is using nitrates (see section "When NOT to use Tadalafil Teva").
Tadalafil Teva may affect the action of certain medicines or other medicines may affect the action of Tadalafil Teva. Inform the doctor or pharmacist if the patient is taking any of the following medicines:

alpha-blockers (used to treat high blood pressure or urinary symptoms due to 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 tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction. Tadalafil Teva, food and alcohol Information on the effect of alcohol is provided in section 3. Grapefruit juice may affect the efficacy of Tadalafil Teva and therefore caution should be exercised when consuming it. For further information, consult a doctor.

Fertility
When Tadalafil Teva was administered to dogs, reduced sperm production in the testes was observed.
Reduced sperm count has been observed in some men. It is unlikely that this leads to infertility.
Driving and operating machinery
In clinical trials, some men taking Tadalafil Teva reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.
Tadalafil Teva contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Tadalafil Teva

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult
your doctor or pharmacist.
Tadalafil Teva tablets are intended for oral use in men only. The tablet should be swallowed whole with a small amount of water. Tadalafil Teva tablets can be taken with or without food.
Alcohol consumption may affect the patient's ability to achieve an erection and may cause transient lowering of blood pressure. If the patient has taken or plans to take Tadalafil Teva, 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.
Treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily, at approximately the same time each day.
Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Teva. In such case, use the 2.5 mg tablet.
Do not take Tadalafil Teva more often than once a day.
Daily administration of Tadalafil Teva may be beneficial for men who plan to engage in sexual activity two or more times per week.
Taking Tadalafil Teva once daily allows achieving an erection following sexual stimulation at any time within 24 hours.
It is important to understand that Tadalafil Teva 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.
Alcohol consumption may affect the patient's ability to achieve an erection.
Treatment of signs and symptoms of benign prostatic hyperplasia
The dose is one 5 mg tablet taken once daily, at approximately the same time each day. If the patient has benign prostatic hyperplasia and erectile dysfunction, the dose remains unchanged at 5 mg once daily.
Do not take Tadalafil Teva more often than once a day.
Taking more Tadalafil Teva than prescribed
Inform your doctor immediately. Adverse effects described in section 4 may occur.
Missing a dose of Tadalafil Teva
Take the missed dose as soon as you remember, but do not take a double dose to make up for the missed tablet. DO NOT take Tadalafil Teva more often than once a day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
These effects are usually mild or moderate.
If any of the adverse effects listed below occur, YOU MUST 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, a prolonged and possibly painful erection after taking Tadalafil Teva (rare). If such an erection occurs and lasts continuously for more than 4 hours, you must contact a doctor immediately.
Sudden loss of vision (rare), distorted, blurred, or impaired central vision, or sudden worsening of vision (frequency unknown).

Other reported adverse 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 1,000 patients)

Dizziness,
Abdominal pain,
Nausea,
Vomiting,
Regurgitation of stomach contents into the oesophagus,
Blurred vision,
Eye pain,
Breathing difficulties,
Presence of blood in urine,
Prolonged erection,
Palpitations, rapid heartbeat, high blood pressure, low blood pressure,
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,
Eyelid swelling,
Eye redness, sudden worsening or loss of hearing, and urticaria (itchy, red raised skin rashes),
Bleeding from the penis,
Presence of blood in semen,
Increased sweating.

Heart attack and stroke have been rarely reported in men taking Tadalafil Teva.
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.
In men taking Tadalafil Teva, several additional rare adverse effects have been reported, which were not observed during clinical trials. These include:

Migraine,
Facial swelling,
Severe allergic reactions causing swelling of the face and throat,
Severe skin rashes,
Disorders characterized by increased blood flow to the eyes,
Irregular heartbeat,
Angina pectoris, 5
Sudden cardiac death,
Distorted, blurred, or impaired central vision or sudden worsening of vision (frequency unknown). The adverse effect dizziness was reported more frequently in men over 75 years of age taking Tadalafil Teva. Diarrhoea was reported more frequently in men over 65 years of age taking Tadalafil Teva.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Tadalafil Teva

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 after EXP. The expiry date refers to the last day of the stated month.
This medicinal product does not require any special storage conditions.
Medicines must not be disposed of via the wastewater system 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 Teva contains
The active substance is tadalafil.
Each tablet contains 5 mg of tadalafil.
The other ingredients are:
Tablet core: monohydrate lactose, sodium lauryl sulfate, povidone K12, crospovidone, sodium stearyl fumarate.
Coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, iron oxide yellow (E172).

What Tadalafil Teva looks like and contents of the pack
Oval, film-coated tablets, ochre to yellow in colour, embossed with the number "5" on one side and smooth on the other. Tablet dimensions: length 8.1 mm; width 4.1 mm.
Tablets are available in blisters containing 14, 18, 28, 30 or 84 film-coated tablets, or in perforated blisters containing 14x1, 28x1, 84x1, 98x1 or 112x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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, Poland
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