Tadalafil teva

Package leaflet: Information for the user

Tadalafil Teva,
20 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Tadalafil Teva is and what it is 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 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 of the penis, allowing blood to flow into it. This results in improved erection.
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 a medicine 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, such as 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), also known 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 for patients with heart disease, as it places additional strain on the heart. If there are any heart problems, inform the 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 bone marrow cancer).
• leukemia (a blood cell cancer).
• 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 total or partial removal of the prostate gland with nerve-sparing techniques (nerve-sparing radical prostatectomy).

If during treatment with tadalafil there is sudden worsening of vision or sudden vision loss, or if vision becomes blurred or distorted, STOP using Tadalafil Teva and 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 the use of tadalafil, 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 your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do NOT take Tadalafil Teva if you are taking 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 in the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Teva with alcohol
Information regarding the effect of 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, reduced 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; therefore, 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 in doubt, consult your
doctor or pharmacist.
Tadalafil Teva tablets are intended for oral use only in men.

Once-daily dosing
The recommended dose is 5 mg (corresponding to one quarter of a 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, a 2.5 mg tablet should be used.
Do not take Tadalafil Teva more often than once daily.
Taking Tadalafil Teva once daily may be beneficial for men who plan to engage in sexual activity
twice a week or more. Taking Tadalafil Teva once daily allows achieving an erection following
sexual stimulation at any time within 24 hours.

Initial (on-demand) dosing
The recommended initial dose is 10 mg (corresponding to half a tablet), taken before planned
sexual activity. If this dose is not sufficient, your doctor may increase the dose to 20 mg
(corresponding to one tablet).
This dose may be taken at least 30 minutes before planned sexual activity. Tadalafil Teva may be
effective for up to 36 hours after taking the dose.
Do not take the 10 mg or 20 mg doses more often than once per day. These doses are intended for
use before planned sexual activity and are not recommended for continuous daily use.

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 if the patient were not
taking erectile dysfunction medication.

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.

Method of administration
Depending on the dosing regimen ( once daily or on-demand ), tablets may be divided into four
parts ( once daily ) or into halves ( on-demand ).
Tadalafil Teva is intended for oral administration and may be taken with or without food.
Swallow the tablet or portion of the tablet with a small amount of water.

Dividing the tablet into four equal parts (for use of tadalafil 5 mg dose once daily)

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

Splitting the tablet in half (using tadalafil at a dose of 10 mg as needed)

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

Use of a higher than recommended dose of Tadalafil Teva
You should inform your doctor. Adverse reactions described in section 4 may occur.
Missed dose of Tadalafil Teva
If you are taking the medicine once daily and you miss a dose, take it as soon as you remember,
but do not take a double dose to make up for the missed dose.
DO NOT take Tadalafil Teva more often than once a day.
If you have any further doubts regarding the use of the medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
These reactions are usually mild or moderate.
IF ANY OF THE FOLLOWING ADVERSE REACTIONS OCCUR, DISCONTINUE
THE USE OF THE MEDICINE AND IMMEDIATELY CONTACT A DOCTOR:

• Allergic reactions, including rashes (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 vision loss (rare), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency not known).

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 mucosa 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,
• Difficulty breathing,
• Presence of blood in urine,
• Prolonged erection,
• Palpitations, rapid heartbeat, high blood pressure, low blood pressure,
• Nosebleeds and tinnitus,
• Swelling of hands, feet or ankles, and feeling of fatigue.

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 skin swellings),
• 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 reactions
have been reported, which were not observed during clinical trials. These include:

• Migraine,
• Facial swelling,
• Severe allergic reactions causing facial and throat swelling,
• Severe skin rashes,
• Disorders manifesting as blood flow to the eyes,
• Irregular heartbeat,
• Angina pectoris,
• Sudden cardiac death,
• Distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known).

The adverse reaction of dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Teva. Diarrhoea has been reported more frequently in men over 65 years of age 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 4921301
Fax: +48 22 4921309
e-mail: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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 stated month.
This medicinal product does not require any special storage conditions.
Medicines must not be disposed of via the sewage system 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 20 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 20 mg are oval, film-coated tablets, ochre to yellow in colour, with two break lines on one side and the engraved mark “20” on the other side. Tablet dimensions: length 15.0 mm; width 9.0 mm.
The tablet may be divided into two or four equal doses.
The tablets are available in blister packs containing 2, 4, 5, 8, 10, 12, 15, 18, 24, 28, 36, 48 or 56 film-coated tablets, or in perforated blister strips containing 2x1, 4x1, 8x1, 12x1, 24x1 or 36x1 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.
Emilii Plater 53 Street
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.
Mogilska 80 Street
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