Package leaflet: Information for the user

Tadalafil Teva,
10 mg, film-coated tablets
Tadalafilum
Please read all of this leaflet carefully before you start 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
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
Important information 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 is a medicine intended for adult men with erectile dysfunction. This is a condition
in which a man is unable to achieve or maintain an erection sufficient for sexual intercourse.
Tadalafil Teva has been shown to significantly improve the ability to achieve an erection suitable
for sexual intercourse.
Tadalafil Teva contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Teva helps widen
the blood vessels in the penis, allowing blood to flow into it. As a result, erection improves. Tadalafil Teva does not benefit patients who do not have erectile dysfunction.
It is important to be aware 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 when
the patient is not taking medication for erectile dysfunction.

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), sometimes referred to as "eye stroke".
if the patient is taking riociguat. This is a medicine used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (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 in patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Before taking Tadalafil Teva, the patient should inform their doctor if any of the following apply:

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

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

after pelvic surgery.
after radical prostatectomy with nerve-sparing or non-nerve-sparing procedures (surgical removal of the prostate gland involving cutting of the nerves).

If sudden decrease in vision, sudden vision loss, or distorted or blurred vision occurs during treatment with tadalafil, Tadalafil Teva treatment MUST BE STOPPED and the patient should contact a doctor immediately.
In some patients taking tadalafil, decreased hearing or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to tadalafil use, if hearing loss or sudden decrease in hearing occurs, Tadalafil Teva should be discontinued and the patient should 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 your doctor about all medicines you are currently taking, have recently taken, or plan to take.
DO NOT take Tadalafil Teva if you are 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. Tell your doctor or pharmacist if you are 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 oral ketoconazole (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 regarding alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Teva, and therefore caution should be exercised when consuming it. For more information, consult your doctor.

Fertility
When Tadalafil Teva was administered to dogs, a reduction in sperm production in the testes was observed.
Reduced sperm count has been observed in some men. It is unlikely that this would lead 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 prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Tadalafil Teva tablets are intended for oral use only in men. The tablet should be swallowed whole with a small amount of water. Tadalafil Teva tablets may be taken with or without food.
The recommended starting dose is one 10 mg tablet taken prior to planned sexual activity. If this dose is not effective, your doctor may increase the dose to 20 mg. Tadalafil Teva tablets are intended for oral use.
Tadalafil Teva may be taken at least 30 minutes before planned sexual activity.
Tadalafil Teva may remain effective for up to 36 hours after taking the tablet.
Do not take Tadalafil Teva more than once in 24 hours. Tadalafil Teva 10 mg and 20 mg are intended for use prior to planned sexual activity and are not recommended for regular, daily administration.
It is important to understand that Tadalafil Teva will 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 medicines for erectile dysfunction.
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.
Taking more than the recommended dose of Tadalafil Teva
You should inform your doctor. Adverse effects described in section 4 may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
These reactions are usually mild or moderate.
IF ANY OF THE ADVERSE REACTIONS LISTED BELOW OCCUR, DISCONTINUE
TREATMENT IMMEDIATELY AND CONTACT A DOCTOR:

Allergic reactions, including skin rash (uncommon).
Chest pain – do not use 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, contact a doctor immediately.
Sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency unknown).

Other reported adverse reactions:
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, 4
Vomiting,
Gastroesophageal reflux,
Blurred vision,
Eye pain,
Difficulty breathing,
Rectal bleeding,
Blood in urine,
Prolonged erection,
Palpitations, rapid heartbeat, high blood pressure, low blood pressure,
Nosebleeds 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 eyelids, eye redness, sudden worsening or loss of hearing and urticaria (itchy, red raised areas on the skin),
Rectal bleeding,
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 conditions before starting treatment.
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 reactions 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 blood flow to the eyes,
Irregular heartbeat,
Angina pectoris,
Sudden cardiac death,
Distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown). The adverse reaction dizziness was reported more frequently in men aged over 75 years taking Tadalafil Teva. Diarrhea was reported more frequently in men aged over 65 years taking Tadalafil Teva.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 after EXP. The expiry date refers to the last day of the specified month.
This medicinal product does not require any special storage conditions.
Medicines must 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 Teva contains
The active substance is tadalafil.
Each tablet contains 10 mg of tadalafil.
The other ingredients are:
Core of the tablet: monohydrate lactose, 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
Tadalafil Teva 10 mg are oval, film-coated tablets, ochre to yellow in colour, with the inscription "10" embossed on one side. The other side of the tablet is smooth. Tablet dimensions: length 11.1 mm; width 6.4 mm.
The tablets are available in blisters containing 4, 12, 18 or 28 film-coated tablets, or in perforated blisters containing 4x1 or 24x1 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