Package leaflet: Information for the patient

Tadalafil Polpharma, 2.5 mg film-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, 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 effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Tadalafil Polpharma is and what it is used for
Important information before taking Tadalafil Polpharma
How to take Tadalafil Polpharma
Possible side effects
How to store Tadalafil Polpharma
Contents of the package and other information

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

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

When not to take Tadalafil Polpharma

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. This is a group of medicines ("nitrates") used to treat angina (chest pain). It has been shown that Tadalafil Polpharma 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), 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 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 Polpharma, patients should discuss this with their doctor.
Patients should be aware that sexual activity involves some risk for patients with heart conditions, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Before taking the medicine, 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 Polpharma is effective in patients:

after pelvic surgery.
after total or partial removal of the prostate gland with nerve-sparing techniques (radical prostatectomy without nerve-sparing).

If sudden vision loss or sudden decrease in vision occurs, the patient should stop taking Tadalafil Polpharma and contact their doctor immediately.
In some patients taking tadalafil, hearing loss or sudden decrease in hearing has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing loss or sudden decrease in hearing occurs, the patient should stop taking Tadalafil Polpharma and contact their doctor immediately.
Tadalafil Polpharma is not intended for use in women.

Children and adolescents
Tadalafil Polpharma is not intended for use in children and adolescents under 18 years of age.

Tadalafil Polpharma and other medicines
The patient should tell their doctor about all medicines they are currently taking, have recently taken, or plan to take.
Tadalafil Polpharma must not be taken if the patient is using nitrates.
Tadalafil Polpharma may affect the action of certain medicines or other medicines may affect the action of Tadalafil Polpharma. The patient should inform their doctor or pharmacist if they are taking:

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 to treat AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadalafil Polpharma, alcohol and drinking
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Polpharma, and therefore caution should be exercised when consuming it. For further information, consult a doctor.

Fertility
When Tadalafil Polpharma was 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
In clinical trials, some men taking Tadalafil Polpharma reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.

Tadalafil Polpharma 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 coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Polpharma

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
consult your doctor or pharmacist.
Tadalafil Polpharma tablets are intended for oral use only in men.
The tablets should be swallowed whole with a small amount of water. Tadalafil Polpharma tablets
can be taken with or without food.
The recommended dose is one 5 mg tablet once daily, taken at approximately the same time
each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil
Polpharma. In such case, the 2.5 mg tablet should be used.
Do not take Tadalafil Polpharma more than once a day.
Taking Tadalafil Polpharma once daily may be beneficial for men who plan to engage in sexual
activity two or more times per week.
Taking Tadalafil Polpharma once daily allows achieving an erection following sexual
stimulation at any time within 24 hours.
It is important to understand that Tadalafil Polpharma 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
Polpharma, he should avoid consuming large amounts of alcohol (blood alcohol concentration
of 0.08% or higher), as this may increase the risk of experiencing dizziness upon standing.
Taking more Tadalafil Polpharma than recommended
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you forget to take Tadalafil Polpharma
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 Polpharma more than once a day.
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 not everyone will experience them. These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the medicine and seek immediate medical advice:

allergic reactions, including rash (uncommon).
chest pain – do not take nitrates; seek immediate medical help (uncommon).
priapism – prolonged and possibly painful erection after taking Tadalafil Polpharma (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
sudden loss of vision (rare).

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, vomiting, gastroesophageal reflux, blurred vision, eye pain, breathing difficulties, 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 (observed in 1 to 10 out of 10,000 patients)

fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin eruptions), 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 men had pre-existing heart conditions before starting tadalafil treatment.
There have been reports of rare cases of partial, transient or permanent vision loss or visual impairment in one or both eyes.
In men taking tadalafil, a few 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 into the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.

Adverse reaction: dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhea was reported more frequently in men over 65 years of age taking tadalafil.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: 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 Polpharma

No special storage instructions are required for this medicinal product.
Keep the 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.
The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP and the batch number after the abbreviation Lot/LOT.
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 Polpharma contains

The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate, povidone K 30, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate;
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

What Tadalafil Polpharma looks like and contents of the pack
White or almost white, round, biconvex coated tablets with a diameter of 4.9–5.3 mm.
The medicine is available in blisters made of PVC/PVDC/Aluminium, packed in a cardboard box.
Pack sizes:
28 coated tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer/Importer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Pharmacare Premium Ltd.,
HHF003 Hal Far Industrial Estate,
Birzebbugia, BBG3000, Malta
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba