Tadalafil Maxon

PATIENT INFORMATION LEAFLET

Before taking the medicine, use the attached diagnostic tool (questionnaire)!

Leaflet attached to the packaging: patient information

TADALAFIL MAXON, 10 mg, film-coated tablets

Tadalafil

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If the patient does not improve or feels worse after taking the medicine, they should contact their doctor.

Table of contents of the leaflet

• 1. What is TADALAFIL MAXON and what is it used for
• 2. Important information before taking TADALAFIL MAXON
• 3. How to take TADALAFIL MAXON
• 4. Possible side effects
• 5. How to store TADALAFIL MAXON
• 6. Contents of the pack and other information

1. What is TADALAFIL MAXON and what is it used for

TADALAFIL MAXON is a medicine for adult men with erectile dysfunction, which is the inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse. It has been shown that tadalafil significantly improves the ability to achieve an erection suitable for sexual intercourse. TADALAFIL MAXON contains the active substance tadalafil, which belongs to a group of medicines called "phosphodiesterase type 5 inhibitors" (PDE5). After sexual stimulation, TADALAFIL MAXON helps to widen the blood vessels of the penis, allowing blood to flow and causing an erection. TADALAFIL MAXON does not help patients who do not have erectile dysfunction. The condition for the effectiveness of TADALAFIL MAXON is sexual stimulation. The patient and their partner should remember to stimulate sexually, just like when the patient is not taking erectile dysfunction medication.

2. Important information before taking TADALAFIL MAXON

When not to take TADALAFIL MAXON:

• 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 pectoris ("chest pain"). It has been shown that tadalafil enhances the effect of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor.
• if the doctor has advised the patient to avoid sexual activity.
• if the patient has severe heart disease or has had a heart attack in the last 90 days.
• if the patient has had a stroke in the last 6 months.
• if the patient has low blood pressure or uncontrolled high blood pressure, or uncontrolled heart rhythm disorders.
• if the patient has ever had loss of vision due to non-inflammatory 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). It has been shown that PDE5 inhibitors, such as tadalafil, 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 treatment with TADALAFIL MAXON, the patient should use the diagnostic tool (questionnaire) attached to the packaging. In case of any doubts, the patient should discuss them with their doctor or pharmacist. The patient should remember that sexual activity carries some risk, as it puts extra strain on the heart. If the diagnostic tool (questionnaire) indicates that TADALAFIL MAXON should not be used due to heart problems, the patient should inform their doctor or pharmacist. Before taking the medicine, the patient should inform their doctor or pharmacist if they have any of the following conditions:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformity.
• severe liver disease.
• severe kidney disease.

It is not known if TADALAFIL MAXON is effective in patients:

• after surgical procedures in the pelvic area.
• after total or partial removal of the prostate gland, during which the prostate nerves are cut (radical prostatectomy without nerve sparing).

If the patient experiences sudden vision loss or sudden loss of vision or distorted vision while taking tadalafil, they should stop taking TADALAFIL MAXON and seek medical attention immediately. Some patients taking tadalafil have reported a decrease in hearing or sudden hearing loss. Although it is not known if this event is directly related to the use of tadalafil, if the patient experiences a decrease in hearing or sudden hearing loss, they should stop taking TADALAFIL MAXON and seek medical attention immediately. TADALAFIL MAXON should not be taken with other oral or topical medicines used to treat erectile dysfunction. TADALAFIL MAXON should not be taken with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors. For 48 hours after taking TADALAFIL MAXON, the patient should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension. TADALAFIL MAXON should not be taken if the patient does not have erectile dysfunction. TADALAFIL MAXON is not intended for use in women.

Children and adolescents

TADALAFIL MAXON is not intended for use in children and adolescents under 18 years of age.

TADALAFIL MAXON and other medicines

Before taking TADALAFIL MAXON, the patient should use the diagnostic tool (questionnaire). In case of doubts, the patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. TADALAFIL MAXON should not be taken if the patient is taking nitrates. TADALAFIL MAXON may affect the action of some medicines or other medicines may affect the action of TADALAFIL MAXON. The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor 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 in tablets (used to treat fungal infections) and protease inhibitors (e.g., ritonavir, saquinavir) used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines).
• rifampicin, erythromycin, clarithromycin (antibiotics) or itraconazole (antifungal medicine).
• other methods of treating erectile dysfunction.

In some patients taking blood pressure-lowering medicines, a decrease in blood pressure may occur, especially when standing up quickly or sitting down. If the patient experiences symptoms of low blood pressure (dizziness, fainting, feeling of impending fainting), they should first lie down or sit down and wait for the symptoms to pass, drinking water and taking fresh air may also help, and they should avoid standing up quickly or sitting down. The dividing line on the tablet is not intended for breaking the tablet.

TADALAFIL MAXON with food and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of TADALAFIL MAXON, and therefore, it should be consumed with caution. For more information, the patient should consult their doctor or pharmacist.

Fertility

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

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness, so the patient should be aware of their reaction to the tablets before driving a car or operating machines.

TADALAFIL MAXON contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

TADALAFIL MAXON contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take TADALAFIL MAXON

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. TADALAFIL MAXON tablets are intended 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. Recommended doseis one 10 mg tablet, taken before planned sexual activity. If the patient feels that the effect of TADALAFIL MAXON is too strong or too weak, they should consult their doctor or pharmacist. The doctor may recommend a different dosage after consultation. TADALAFIL MAXON tablets are intended for oral use. TADALAFIL MAXON can be taken at least 30 minutes before planned sexual activity. TADALAFIL MAXON may still be effective up to 36 hours after taking the tablet. TADALAFIL MAXON is intended for use before planned sexual activity. The medicine should be used as needed. Do not take more than once a week. TADALAFIL MAXON should not be taken with other oral or topical medicines used to treat erectile dysfunction. TADALAFIL MAXON should not be taken with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors. For 48 hours after taking TADALAFIL MAXON, the patient should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension. TADALAFIL MAXON should not be taken if the patient does not have erectile dysfunction. It is essential to be aware that the condition for the effectiveness of TADALAFIL MAXON is sexual stimulation. The patient and their partner should remember to stimulate sexually, just like when the patient is not taking erectile dysfunction medication. Consuming alcohol may affect the patient's ability to achieve an erection and may cause a temporary decrease in blood pressure. If the patient has taken TADALAFIL MAXON or plans to take it, they should not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of dizziness when standing up. The dividing line on the tablet is not intended for breaking the tablet.

Taking a higher dose of TADALAFIL MAXON than recommended

The patient should inform their doctor. Side effects described in section 4 may occur. In case of any further doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are usually mild or moderate.

If any of the following side effects occur, the patient should stop taking the medicine and seek medical attention immediately:

• allergic reactions, including rash (occurring in less than 1 in 100 patients - uncommon).
• chest pain - the patient should not take nitrates, but seek medical attention immediately (occurring in less than 1 in 100 patients - uncommon).
• priapism, prolonged and possibly painful erection after taking tadalafil (occurring in less than 1 in 1,000 patients - rare). If such an erection occurs and lasts continuously for more than 4 hours, the patient should seek medical attention immediately.
• sudden vision loss (occurring in less than 1 in 1,000 patients - rare), distorted, blurred, or impaired vision, or sudden worsening of vision (frequency not known).

Other reported side effects:
Common(occurring in less than 1 in 10 patients)

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

Uncommon(occurring in less than 1 in 100 patients)

• dizziness, abdominal pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(occurring in less than 1 in 1,000 patients)

• fainting, seizures, and transient memory loss, swelling of the eyelids, redness of the eyes, sudden worsening or loss of hearing, hives (itchy, red bumps on the skin), bleeding from the penis, blood in semen, and increased sweating.

Myocardial infarction and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before starting treatment with this medicine. There have been reports of rare cases of partial, transient, or permanent vision loss or blindness in one or both eyes. Men taking tadalafil have reported a few additional rare side effects, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac deaths
• distorted, blurred, or impaired vision, or sudden worsening of vision (frequency not known).

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 side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 The side effect can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store TADALAFIL MAXON

The medicine should be stored out of sight and reach of children. This medicine should not be taken after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month. The batch number is stated after Lot. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What TADALAFIL MAXON contains

• The active substance of the medicine is tadalafil. Each tablet of the medicine contains 10 mg of tadalafil.
• The other ingredients are: Core:lactose monohydrate (see the end of section 2), microcrystalline cellulose, povidone K 30, poloxamer type 188, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate. Coating:polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What TADALAFIL MAXON looks like and contents of the pack

TADALAFIL MAXON is a light orange, elongated, biconvex, film-coated tablet, approximately 11 mm x 6 mm with a dividing line on one side. TADALAFIL MAXON tablets are available in blisters containing 2 or 4 tablets.

Marketing authorization holder

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów Poland tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów Poland Pharmaceutical Works POLPHARMA SA ul. Pelplińska 19 83-200 Starogard Gdański Poland Pharmaceutical Works POLPHARMA SA ul. Metalowca 2 39-460 Nowa Dęba Poland

Importer

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów Poland Pharmaceutical Works POLPHARMA SA ul. Pelplińska 19 83-200 Starogard Gdański Poland Pharmacare Premium Ltd. HHF003 Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Pharmaceutical Works POLPHARMA SA ul. Metalowca 2 39-460 Nowa Dęba Poland

Date of last revision of the leaflet: