Tadalafil Polpharma

Package Leaflet: Information for the Patient

Tadalafil Polpharma, 20 mg Film-Coated Tablets

Tadalafil

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

• 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 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 for the treatment of adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual performance. It has been shown that Tadalafil Polpharma significantly improves the ability to achieve an erection sufficient for satisfactory sexual performance. Tadalafil Polpharma contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Polpharma helps to relax the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection is improved. Tadalafil Polpharma does not help patients who do not have erectile dysfunction.

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 organic nitrates or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris (chest pain). It has been shown that Tadalafil Polpharma enhances the effect of these medicines. If you are taking nitrates in any form or are unsure, you should inform your doctor.
• if you have severe heart disease or 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 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). It has been shown that phosphodiesterase type 5 inhibitors, such as tadalafil, potentiate the blood pressure lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.

Warnings and precautions

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

• sickle cell anemia (abnormal shape of 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 whether Tadalafil Polpharma is effective in patients who have:

• undergone pelvic surgery.
• had their prostate removed (radical prostatectomy without nerve sparing).

If you experience sudden loss of vision or hearing, or if your vision is distorted, you should stop taking Tadalafil Polpharma and contact your doctor immediately. Some patients taking tadalafil have reported a sudden decrease or loss of hearing. Although it is not known whether this event is directly related to the use of tadalafil, if you experience a decrease or loss of hearing, you should stop taking Tadalafil Polpharma and contact your doctor 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

You should tell your doctor about all the medicines you are taking, or have recently taken, and about any medicines you plan to take. You should not take Tadalafil Polpharma if you are taking nitrates. Tadalafil Polpharma may affect the way some medicines work, or some medicines may affect the way Tadalafil Polpharma works. You should tell your doctor or pharmacist if you are taking:

• alpha-blockers (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha reductase inhibitors (used to treat an enlarged prostate).
• medicines such as ketoconazole (used to treat fungal infections) and protease inhibitors (used to treat AIDS or HIV infection).
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Polpharma with food and drink

Information about the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil Polpharma, and therefore, caution should be exercised when consuming grapefruit juice. For more information, you should consult your doctor.

Fertility

When tadalafil was administered to dogs, a decrease in sperm production was observed in the testes. A decrease in sperm concentration was observed in some men. It is unlikely that this will lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials 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, you should consult 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

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. Tadalafil Polpharma film-coated tablets are for oral use only in men. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food. The recommended starting dose is one 10 mg tablet, taken before planned sexual activity. In patients who do not respond to the 10 mg dose, your doctor may increase the dose to 20 mg. You should take the medicine at least 30 minutes before planned sexual activity. The medicine may still be effective up to 36 hours after taking the tablet. The maximum frequency of taking the medicine is once a day. Tadalafil Polpharma 10 mg and 20 mg is intended for use before planned sexual activity. It is not recommended to take the medicine on a continuous, daily basis. It is important to remember 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. Consuming large amounts of alcohol may decrease your ability to achieve an erection and may also temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Polpharma, you should not drink large amounts of alcohol (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

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

You should inform your doctor. You may experience side effects, as described in section 4.

What to do if you miss a dose of Tadalafil Polpharma

Take the 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 usually mild or moderate.

If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately:

• allergic reactions, including skin rash (not very common).
• chest pain - do not take nitrates, and seek medical help immediately (not very common).
• priapism - prolonged and possibly painful erections after taking Tadalafil Polpharma (rare). If you experience such an erection, which lasts continuously for more than 4 hours, you should contact your doctor immediately.
• sudden loss of vision (rare), distorted vision, blurred vision, or sudden loss of vision (frequency not known).

Other side effects have been reported:

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

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

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

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, 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 transient memory loss, swelling of the eyelids, redness of the eyes, sudden loss of hearing, hives (itchy, red welts on the skin), bleeding from the penis, 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 disease. There have been reports of rare cases of partial, temporary, or permanent loss of vision in one or both eyes. In men taking tadalafil, several additional rare side effects have been reported, including:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted vision, blurred vision, or sudden loss of vision (frequency not known).

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 experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. 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 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. The expiry date refers to the last day of the month. The packaging is marked with "EXP" (expiry date) and "Lot/LOT" (batch number). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Polpharma contains

• The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other ingredients are: Tablet core: lactose monohydrate, povidone K 30, poloxamer type 188, sodium lauryl sulfate, croscarmellose sodium, 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 pink, elongated, biconvex film-coated tablets with a line on one side; length 14.9-15.4 mm, width 7.1-7.6 mm. The line on the tablet is not intended for breaking the tablet. The medicine is available in PVC/PVDC/Aluminum blisters in a cardboard box. The pack sizes are: 2, 4, 8, or 12 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Polpharma S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer/Importer

Polpharma S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Pharmacare Premium Ltd, HHF003 Hal Far Industrial Estate, Birzebbugia, BBG3000, Malta, Polpharma S.A., Production Plant in Nowa Dęba, ul. Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: