Tadalafil Polpharma

Package Leaflet: Information for the Patient

Tadalafil Polpharma, 5 mg Film-Coated Tablets

Tadalafilum

Read the Package Leaflet Carefully Before Taking the Medication, 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 contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Polpharma 5 mg is 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. After sexual stimulation, Tadalafil Polpharma works by helping the blood vessels in your penis to relax and widen, allowing more blood to flow into your penis. As a result, this helps to improve your erection. Tadalafil Polpharma does not work if you do not have erectile dysfunction. It is important to note that Tadalafil Polpharma does not work without sexual stimulation.
• with symptoms of benign prostatic hyperplasia (a non-cancerous enlargement of the prostate gland). This is when the prostate gland gets bigger with age. Symptoms include: difficulty starting to pass urine, feeling like you need to pass urine often, or feeling like you need to pass urine more often during the night. Tadalafil Polpharma improves blood flow and helps the muscles in the prostate and bladder to relax, which can help to improve these symptoms. Tadalafil Polpharma has been shown to improve these symptoms after 1-2 weeks of treatment.

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 nitrates or are unsure, tell your doctor.
• if you have severe heart disease or have had a heart attack within the last 90 days.
• if you have had a stroke within 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 due to blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as tadalafil, increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, tell your doctor.

Warnings and Precautions

Before taking Tadalafil Polpharma, you should discuss this with your doctor.
Remember that sexual activity carries a risk for patients with heart disease, because it puts extra strain on your heart. If you have heart problems, tell your doctor.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so your doctor will check you for prostate cancer before you start taking Tadalafil Polpharma to treat benign prostatic hyperplasia. Tadalafil Polpharma is not for the treatment of prostate cancer.
Before taking Tadalafil Polpharma, tell your doctor if you have:

• sickle cell anaemia (a disease of the red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukaemia (a cancer of the blood cells).
• 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 during treatment with Tadalafil Polpharma, 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 if these events are directly related to tadalafil, if you experience a sudden decrease or loss of hearing, 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.

Tadalafil Polpharma and Other Medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and those you plan to take.
Do 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. Tell your doctor or pharmacist if you are taking:

• alpha-blockers (used to treat high blood pressure or symptoms of 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 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 Alcohol

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

Fertility

When given to dogs, a decrease in sperm production was observed. A decrease in sperm concentration was observed in some men. It is unlikely to affect fertility.

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 you drive or use machines.

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

This medicine should always be taken exactly as directed by your doctor. If you are not sure, ask your doctor or pharmacist.
Tadalafil Polpharma tablets are for oral use only in men.
Swallow the tablet whole with a small amount of water. The tablets can be taken with or without food.
Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken Tadalafil Polpharma or plan to take it, you should avoid excessive drinking of alcohol (blood alcohol level of 0.08% or greater), as this may increase the risk of dizziness when standing up.

Treatment of Erectile Dysfunction

Recommended doseis one 5 mg tablet per day, taken at approximately the same time every day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Polpharma. You should take one 2.5 mg tablet.
Do not take Tadalafil Polpharma more than once per day.
Taking Tadalafil Polpharma once per day allows you to get an erection at any time during the 24-hour period. Taking Tadalafil Polpharma once per day may be more suitable for you if you plan to have sexual activity twice a week or more frequently.
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.
Drinking alcohol may affect your ability to get an erection.

Treatment of Symptoms of Benign Prostatic Hyperplasia

Doseis one 5 mg tablet per day, taken at approximately the same time every day.
If you have both erectile dysfunction and benign prostatic hyperplasia, the dose remains one 5 mg tablet per day.
Do not take Tadalafil Polpharma more than once per day.

Taking More Than the Recommended Dose of Tadalafil Polpharma

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

Forgetting a Dose of 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 Tadalafil Polpharma more than once 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 to moderate.

If You Experience Any of the Following Side Effects, Stop Taking Tadalafil Polpharma and Contact Your Doctor Immediately:

• allergic reactions, including rashes (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 have an erection that lasts more than 4 hours, seek medical help 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, 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 temporary 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 reported rarely 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 eye.
Men taking tadalafil have reported the following additional rare side effects, which were not observed in clinical trials:

• migraine, swelling of the face, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders of the eye, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, or 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 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 expiration date and batch number.
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 5 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 brown, elongated, biconvex film-coated tablets; length 7.9-8.3 mm, width 3.9-4.3 mm.
Tadalafil Polpharma is available in PVC/PVDC/Aluminium blisters in a carton box.
Available pack sizes: 14, 28, 56, or 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer/Importer

Polpharma S.A.
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
Metalowca 2, 39-460 Nowa Dęba

Date of Last Revision of the Leaflet: