Tadalafil Polpharma

Package Leaflet: Information for the Patient

Tadalafil Polpharma, 2.5 mg Film-Coated Tablets

Tadalafil

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 side effects
• 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 is a medicine used to treat adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil Polpharma has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity. Tadalafil Polpharma contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Polpharma works by helping the blood vessels in your penis to relax and increase blood flow into the penis. The result is improved erectile function. Tadalafil Polpharma will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Polpharma does not work if there is no sexual stimulation.

2. Important information before taking Tadalafil Polpharma

When not to take Tadalafil Polpharma

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). Tadalafil Polpharma has been shown to increase the effects of these medicines. If you are taking any of these medicines or are not sure, tell your doctor.
• if you have had a heart attack in the last 90 days.
• if you have had a stroke in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in one or both eyes.
• if you are taking riociguat. This is a medicine used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs due to blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as tadalafil, increase the effects of this medicine. If you are taking riociguat or are not sure, tell your doctor.

Warnings and precautions

Before taking Tadalafil Polpharma, you should carefully discuss your medical history with your doctor. You should be aware that sexual activity carries a risk for patients with heart disease because it puts extra strain on your heart. If you have a heart condition, tell your doctor. Before taking the medicine, tell your doctor if you have any of the following conditions:

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

It is not known if Tadalafil Polpharma is effective in patients who have:

• undergone pelvic surgery.
• had their prostate removed (radical prostatectomy).

If you experience sudden loss of vision or loss of vision in one eye, stop taking Tadalafil Polpharma and seek medical attention immediately. Some patients taking tadalafil have reported a sudden decrease or loss of hearing. Although it is not known if these events are directly related to tadalafil, if you experience a sudden decrease or loss of hearing, stop taking Tadalafil Polpharma and seek medical attention immediately. Tadalafil Polpharma is not intended for use by women.

Children and adolescents

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

Tadalafil Polpharma and other medicines

Inform your doctor about all the medicines you are taking, including those you have bought without a prescription. Do not take Tadalafil Polpharma if you are taking nitrates. Tadalafil Polpharma may interact with some medicines, including those used to treat high blood pressure, alpha-blockers (used to treat high blood pressure or prostate enlargement), riociguat, 5-alpha reductase inhibitors (used to treat benign prostatic hyperplasia), ketoconazole (an antifungal), itraconazole, erythromycin, clarithromycin, phenobarbital, phenytoin, carbamazepine, rifampicin, and other treatments for erectile dysfunction.

Tadalafil Polpharma with food and drink

Information about the effect of alcohol is in section 3. Grapefruit juice may affect the efficacy of Tadalafil Polpharma, and you should be cautious when taking it. For more information, ask your doctor.

Fertility

When tadalafil was given to rats, there was a decrease in sperm production in the testes. A decrease in sperm concentration was observed in some men. It is unlikely to cause infertility.

Driving and using machines

Some men taking Tadalafil Polpharma have reported dizziness. You should be aware of how you react to the tablets before driving or operating machinery.

Tadalafil Polpharma contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially sodium-free.

3. How to take Tadalafil Polpharma

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Tadalafil Polpharma film-coated tablets are for oral use in men only. Swallow the tablet whole with a small amount of water. You can take the tablets with or without food. The recommended doseis one 5 mg tablet taken once a day, at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Polpharma. Do not take Tadalafil Polpharma more than once a day. Taking Tadalafil Polpharma once a day may be useful for men who anticipate having sexual activity twice a week or more. Taking Tadalafil Polpharma once a day allows you to achieve an erection at any time during the 24-hour period. It is important to note that Tadalafil Polpharma does not work without sexual stimulation. You and your partner should engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. Drinking too much alcohol can reduce your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Polpharma, do not drink too much alcohol (blood alcohol level of 0.08% or greater), as this may increase the risk of dizziness when standing up.

What to do if you take more Tadalafil Polpharma than you should

Inform your doctor. You may experience side effects described in section 4.

What to do if you forget to take Tadalafil Polpharma

Take a dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet. Do not take more than one dose of Tadalafil Polpharma per day. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tadalafil Polpharma can cause side effects, although not everybody gets them. These effects are normally mild to moderate.

If you experience any of the following side effects, stop taking Tadalafil Polpharma and contact a doctor immediately:

• allergic reactions, including skin rash (uncommon).
• chest pain - do not take nitrates, seek medical attention immediately (uncommon).
• priapism - prolonged and possibly painful erections after taking Tadalafil Polpharma (rare). If you have an erection that lasts more than 4 hours, seek medical attention immediately.
• sudden loss of vision (rare).

Other reported side effects include:

Common(seen in 1 to 10 in every 100 patients)

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

Uncommon(seen in 1 to 10 in every 1,000 patients)

• dizziness, stomach ache, feeling sick, being sick, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet or ankles, and feeling tired.

Rare(seen in 1 to 10 in every 10,000 patients)

• fainting, seizures, and temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), bleeding from the penis, blood in semen, and increased sweating.

Heart attack and stroke have been reported rarely in men taking tadalafil. Most of these men had pre-existing heart disease. There have been rare reports of partial, sudden, or permanent loss of vision in one or both eyes. Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include:

• migraine, face swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders of the blood vessels in the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.

Dizziness was reported more frequently in men over 75 years old taking tadalafil. Diarrhea was reported more frequently in men over 65 years old taking tadalafil.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Polpharma

There are no special storage instructions for this medicine. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. The packaging is labeled with the batch number and expiry date after LOT/EXP. Medicines should 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 K30, poloxamer 188, sodium lauryl sulfate, croscarmellose sodium, 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 film-coated tablets, 4.9-5.3 mm in diameter. Tadalafil Polpharma is available in blisters of PVC/PVDC/Aluminum in a cardboard box. Pack sizes: 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the package leaflet: