Tadalafil polpharma

Package leaflet: Information for the patient

Tadalafil Polpharma, 5 mg coated tablets
Tadalafilum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Tadalafil Polpharma contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Polpharma 5 mg is used in the treatment of adult men:

• with erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Polpharma has been shown to significantly improve the ability to achieve an erection sufficient for sexual intercourse. Following sexual stimulation, Tadalafil Polpharma helps widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, erection is improved. Tadalafil Polpharma does not help 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.
• with urinary symptoms caused by a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, sensation of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadalafil Polpharma improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that Tadalafil Polpharma alleviates these urinary symptoms as early as 1–2 weeks after starting treatment.

2. Important information before using Tadalafil Polpharma

When not to use 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, such as 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 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, discuss this with your doctor.
Please remember that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has any heart problems, they should inform their doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform an examination to rule out prostate cancer before starting Tadalafil Polpharma for the treatment of symptoms of benign prostatic hyperplasia. Tadalafil Polpharma is not used to treat prostate cancer.
Before taking the medicine, the patient should inform the doctor if any of the following conditions 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 Polpharma is effective in patients:

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

If sudden worsening of vision, sudden vision loss, or distorted, dimmed vision occurs during treatment with Tadalafil Polpharma, stop taking Tadalafil Polpharma immediately and contact a doctor without delay.
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 hearing loss or worsening of hearing occurs, stop taking Tadalafil Polpharma and contact a 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
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Tadalafil Polpharma if you are using nitrates.
Tadalafil Polpharma may affect the action of certain medicines, or other medicines may affect the action of Tadalafil Polpharma. Tell your doctor or pharmacist if you 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 in the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Polpharma, alcohol, and grapefruit juice
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the efficacy of Tadalafil Polpharma and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When administered to dogs, the medicine caused a reduction in sperm production in the testes. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In some men taking tadalafil during clinical trials, dizziness was reported. Therefore, patients should understand their individual response to the tablets before deciding to drive or operate machinery.
Tadalafil Polpharma contains lactose and sodium
If the patient has previously been diagnosed with an 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 take Tadalafil Polpharma

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Tadalafil Polpharma tablets are intended for oral use only in men.
The tablet should be swallowed whole with a small amount of water. Tadalafil Polpharma 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 Polpharma,
he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher),
as this may increase the risk of experiencing dizziness upon standing.

Treatment of erectile dysfunction
Recommended dose: one 5 mg tablet once daily, taken at approximately the same time each day.
The doctor may adjust the dose to 2.5 mg depending on the patient's response to Tadalafil Polpharma.
In such case, the 2.5 mg tablet should be used.
Tadalafil Polpharma should not be taken more than once a day.
Taking Tadalafil Polpharma once daily enables achieving an erection following sexual stimulation
at any time within 24 hours. Daily administration of Tadalafil Polpharma may be beneficial for men
who plan to engage in sexual activity two or more times per week.
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.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of signs and symptoms of benign prostatic hyperplasia
Dose: one 5 mg tablet once daily, taken at approximately the same time each day.
If the patient has both benign prostatic hyperplasia and erectile dysfunction, the dose remains
unchanged at one 5 mg tablet once daily.
Tadalafil Polpharma must not be taken more than once a day.

Taking more than the recommended dose of Tadalafil Polpharma
Inform your doctor immediately. Adverse effects described in section 4 may occur.

Missed dose of 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 experiences them. These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the medicine and contact a doctor immediately:

• 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), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency unknown).

Other adverse reactions reported:
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, difficulty breathing, presence of blood in urine, prolonged duration of erection, sensation of heart palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

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.

Myocardial infarction 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 decrease in vision or loss of vision in one or both eyes.
In men taking tadalafil, several additional rare adverse reactions have been reported that 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 rush of blood to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

Adverse reaction: dizziness was reported more frequently in men aged over 75 years taking tadalafil. Diarrhea was reported more frequently in men aged over 65 years taking tadalafil.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. 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
Phone: +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 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 requirements apply for this medicinal product.
Keep the medicine out of 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 marking on the packaging following EXP indicates the expiry date, and following Lot/LOT indicates the batch number.
Medicines must not be disposed of via the sewage 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 Polpharma contains

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• Other ingredients are:
  Tablet core: monohydrate lactose, 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, yellow iron oxide (E172), red iron oxide (E172).

What Tadalafil Polpharma looks like and contents of the pack
Light brown, elongated, biconvex coated tablets; length 7.9–8.3 mm, width 3.9–4.3 mm.
The medicine is available in PVC/PVDC/Aluminium blisters packed in a cardboard box.
Pack sizes:
14, 28, 56 or 84 coated tablets.
Not all pack sizes may be marketed.

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