Tadalafil zentiva

Package leaflet: Information for the patient

Tadalafil Zentiva, 10 mg, coated tablets
Tadalafilum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Leaflet contents

1. What Tadalafil Zentiva is and what it is used for
2. Important information before taking Tadalafil Zentiva
3. How to take Tadalafil Zentiva
4. Possible side effects
5. How to store Tadalafil Zentiva
6. Contents of the pack and other information

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

Tadalafil Zentiva is used in the treatment of 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 Zentiva has been shown to significantly improve the ability to achieve an erection adequate
for sexual intercourse.
Tadalafil Zentiva contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Zentiva helps widen the
blood vessels in the penis, allowing increased blood flow into the penis. This results in improved
erection. Tadalafil Zentiva does not benefit men who do not have erectile dysfunction.
It is important to understand that Tadalafil Zentiva 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.

2. Important information before using Tadalafil Zentiva

When not to use Tadalafil Zentiva

• 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. This is a group of medicines ("nitrates") used to treat angina (chest pain). It has been shown that Tadalafil Zentiva enhances the effects of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor.
• 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), 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). PDE5 inhibitors such as tadalafil 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 Zentiva, discuss this with your doctor.
Please remember that sexual activity involves a possible risk for patients with heart disease, as it places additional strain on the heart. If the patient has heart problems, they should inform their doctor.
Before taking this medicine, the patient should inform their doctor if any of the following apply:

• sickle cell anemia (abnormally shaped 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 Zentiva is effective in patients:

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

If sudden vision loss, blurred vision, or distorted vision occurs during treatment with Tadalafil Zentiva, the patient should stop taking Tadalafil Zentiva and contact their 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 hearing loss or sudden hearing deterioration occurs, the patient should stop taking Tadalafil Zentiva and contact their doctor immediately.
Tadalafil Zentiva is not intended for use in women.
Children and adolescents
Tadalafil Zentiva is not intended for use in children and adolescents under 18 years of age.
Tadalafil Zentiva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Tadalafil Zentiva if the patient is using nitrates.
Tadalafil Zentiva may affect the action of certain medicines or other medicines may affect the action of Tadalafil Zentiva. Inform your doctor or pharmacist if the patient is taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or urinary symptoms caused by 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.

Taking Tadalafil Zentiva with food, drink, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Zentiva, and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When administered to dogs, a reduction in sperm production in the testes was observed. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
During clinical trials, some men taking Tadalafil Zentiva reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.
Tadalafil Zentiva contains lactose and sodium
If the patient has an intolerance to certain sugars, they should consult their doctor before starting treatment.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Zentiva

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.
Tadalafil Zentiva tablets are intended for oral use in men only.
The tablets should be swallowed with a small amount of water. Tadalafil Zentiva tablets may be taken with or without food.
The recommended dose is one 10 mg tablet taken prior to planned sexual activity.
If this dose is not sufficient, your doctor may increase the dose to 20 mg.
Tadalafil Zentiva tablets are intended for oral administration.
Tadalafil Zentiva may be taken at least 30 minutes before planned sexual activity.
Tadalafil Zentiva may remain effective for up to 36 hours after taking the tablet.
Do not take Tadalafil Zentiva more than once a day. Tadalafil Zentiva 10 mg and 20 mg are intended to be taken as needed before planned sexual activity. Regular daily use is not recommended.
It is important to understand that Tadalafil Zentiva 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 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 Zentiva, he should avoid consuming large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Use of a higher than recommended dose of Tadalafil Zentiva
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, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below occur, stop taking the medicine
and seek immediate medical advice:

• allergic reactions, including rash (not uncommon).
• chest pain – do not use nitrates, but seek immediate medical help (not uncommon).
• priapism, a prolonged and possibly painful erection after taking Tadalafil Zentiva (rare). If such an erection occurs and persists continuously for more than 4 hours, seek immediate medical advice.
• sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
Common (affects 1 to 10 in 100 patients)

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

Not common (affects 1 to 10 in 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, tinnitus, swelling of hands, feet or ankles, and feeling tired.

Rare (affects 1 to 10 in 10,000 patients)

• fainting, convulsions and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), rectal bleeding, presence of blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these patients
had pre-existing heart conditions 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 the medicinal product Tadalafil Zentiva, 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 congestion in the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death
• distorted, dimmed, blurred central vision or sudden worsening of vision (frequency not known)

Adverse reaction: dizziness was reported more frequently in men over 75 years of age
taking the medicinal product Tadalafil Zentiva. Diarrhoea was reported more frequently in men
over 65 years of age taking the medicinal product Tadalafil Zentiva.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02 - 222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder or its representative
in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadalafil Zentiva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton
after: EXP. The expiry date refers to the last day of the stated month.
This medicine 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 help protect
the environment.

6. Contents of the package and other information

What Tadalafil Zentiva contains

• The active substance is tadalafil. Each coated tablet contains 10 mg of tadalafil.
• Other ingredients are:
  Tablet core: monohydrate lactose, pregelatinized starch (maize), colloidal anhydrous silica, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
  Coating: hypromellose 2910, monohydrate lactose, titanium dioxide (E 171), triacetin, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Tadalafil Zentiva looks like and contents of the pack
Light yellow, oval, film-coated tablets, marked with the imprint ‘10’ on one side and smooth on the other, approximately 11 mm x 7 mm in size.
Packaged in blisters made of PVC/Aclar (PCTFE)/aluminium, placed in a cardboard box.
Pack sizes: 2 and 4 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 (22) 375 92 00