Tadalafil maxon

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

Package leaflet: information for the patient

TADALAFIL MAXON, 10 mg, coated tablets
Tadalafil
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed
by the physician or pharmacist.

• Keep this leaflet, so that it can be read again if necessary.
• If advice or additional information is needed, please contact the pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the physician or pharmacist. See section 4.
• If there is no improvement after using the medicine, or if the patient feels worse, contact the physician.

Table of contents

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

TADALAFIL MAXON is a medicine intended for adult men with erectile dysfunction,
i.e. the inability to achieve or maintain a penile erection sufficient for satisfactory
sexual intercourse. Tadalafil has been shown to significantly improve 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 (PDE5) inhibitors". During sexual stimulation, TADALAFIL MAXON
helps dilate the blood vessels of the penis, allowing blood flow and resulting in
an erection. TADALAFIL MAXON does not benefit patients who do not have erectile dysfunction.
For TADALAFIL MAXON to be effective, sexual stimulation is required.
The patient and his partner should remember the need for sexual stimulation, just as they would
when the patient is not taking medication for erectile dysfunction.

2. Important information before using the medicine TADALAFIL MAXON

When not to use 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 (chest pain). It has been shown that tadalafil 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 doctor has advised the patient to avoid sexual activity.
• 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, or uncontrolled heart rhythm disorders.
• 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 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, use the diagnostic tool (questionnaire) included in the packaging. If there are any doubts, discuss them with a doctor or pharmacist.
It should be remembered that sexual activity involves some risk, as it places additional strain on the heart. If, based on the results of the diagnostic tool (questionnaire), TADALAFIL MAXON cannot 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 any of the following conditions apply:

• sickle cell anemia (abnormal shape of 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 MAXON is effective in patients:

• after pelvic surgery.
• after complete or partial removal of the prostate gland, during which nerves to the prostate are severed (non-nerve-sparing radical prostatectomy).

If sudden worsening of vision, sudden vision loss, or distorted, blurred vision occurs during treatment with tadalafil, treatment with TADALAFIL MAXON should be stopped immediately and the patient should 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 the use of tadalafil, if hearing deterioration or sudden hearing loss occurs, treatment with TADALAFIL MAXON should be stopped and the patient should contact a doctor without delay.
TADALAFIL MAXON should not be used together with other oral or topical medicines used to treat erectile dysfunction.
TADALAFIL MAXON should not be used together with arterial pulmonary hypertension (PAH) therapies using sildenafil or other PDE5 inhibitors.
For 48 hours after taking TADALAFIL MAXON, medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension must not be taken.
TADALAFIL MAXON should not be taken if erectile dysfunction has not been diagnosed.
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 using TADALAFIL MAXON, use the diagnostic tool (questionnaire). If in doubt, inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not take TADALAFIL MAXON if taking nitrates.
TADALAFIL MAXON may affect the action of certain medicines or other medicines may affect the action of TADALAFIL MAXON. Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• 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 ketoconazole tablets (used to treat fungal infections) and protease inhibitors (e.g. ritonavir, saquinavir) used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin (antibiotics), or itraconazole (an antifungal medicine).
• other treatments for erectile dysfunction.

In some patients taking blood pressure-lowering medicines, blood pressure may drop, especially when standing up or sitting down quickly. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit and wait for symptoms to subside. Drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided.

TADALAFIL MAXON with alcohol and grapefruit juice
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of TADALAFIL MAXON, and therefore caution should be exercised when consuming it. For further information, consult a doctor or pharmacist.

Fertility
When the medicine was given to dogs, a reduction in sperm production in the testes was observed. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.

Driving and operating machinery
In clinical trials, some men taking tadalafil reported dizziness. Therefore, patients should understand their individual response to the tablets before deciding to drive or operate machinery.

TADALAFIL MAXON contains lactose
If the patient has previously been diagnosed with intolerance to certain 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, meaning the medicine is considered "sodium-free".

3. How to use TADALAFIL MAXON

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your 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. TADALAFIL MAXON tablets may be taken with or without food.

Recommended dose: One 10 mg tablet taken prior to anticipated sexual activity.
If you feel the effect of TADALAFIL MAXON is too strong or too weak, consult your doctor or pharmacist. After consultation, your doctor may recommend a different dosing regimen.
TADALAFIL MAXON tablets are intended for oral administration.

TADALAFIL MAXON may be taken at least 30 minutes before anticipated sexual activity. TADALAFIL MAXON may remain effective for up to 36 hours after tablet intake.

TADALAFIL MAXON is intended to be used prior to anticipated sexual activity. The medicine should be taken on an as-needed basis. Do not take more than once a week.

TADALAFIL MAXON must not be used together with other oral or topical treatments for erectile dysfunction.

TADALAFIL MAXON must not be used concomitantly with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.

For 48 hours after taking TADALAFIL MAXON, do not take any medicines containing sildenafil used for the treatment of erectile dysfunction or pulmonary hypertension.

TADALAFIL MAXON should not be taken if erectile dysfunction has not been diagnosed.

It is important to be aware that TADALAFIL MAXON requires sexual stimulation to be effective. The patient and his partner should remember to engage in sexual stimulation, just as they would when the patient is not taking medication for erectile dysfunction.

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 MAXON, he should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.

The score line on the tablet is not intended for breaking the tablet.

Use of a higher than recommended dose of TADALAFIL MAXON
Inform your doctor if this occurs. Adverse effects described in section 4 may occur.
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 will experience them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop using the
medicine and seek immediate medical advice:

• allergic reactions, including rash (occur less frequently than in 1 out of 100 patients – uncommon).
• chest pain – do not use nitrates, but seek immediate medical help (occurs uncommonly).
• priapism, a prolonged and possibly painful erection after taking tadalafil (occurs less frequently than in 1 out of 1,000 patients – rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately.
• sudden vision loss (occurs rarely), distorted, blurred, or dim central vision, or sudden worsening of vision (frequency unknown).

Other reported adverse reactions:
Common (occur less frequently than in 1 out of 10 patients)

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

Uncommon (occur less frequently than in 1 out of 100 patients)

• dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, sensation of palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (occur less frequently than in 1 out of 1,000 patients)

• fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin swellings), rectal bleeding, presence of 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 problems before starting treatment with this medicine.
There have been reports of rare cases of partial, transient or permanent visual impairment or vision loss in one or both eyes.
In men taking tadalafil, a few 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 blood congestion in the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, dim central vision or sudden worsening of vision (frequency unknown).

The adverse reaction: dizziness has been reported more frequently in men over 75 years of age
taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the 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 MAXON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month. The batch number is indicated after: Lot.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater 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 packaging and other information

What TADALAFIL MAXON contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredients are: Tablet core: monohydrate lactose (see 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 break line on one side.
TADALAFIL MAXON tablets are available in blisters containing 2 or 4 tablets.

Marketing Authorisation 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

Zakłady Farmaceutyczne POLPHARMA SA
(Pharmaceutical Works POLPHARMA SA)
ul. Pelplińska 19
83-200 Starogard Gdański
Poland

Zakłady Farmaceutyczne POLPHARMA SA
(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

Zakłady Farmaceutyczne POLPHARMA SA
(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

Zakłady Farmaceutyczne POLPHARMA SA
(Pharmaceutical Works POLPHARMA SA)
ul. Metalowca 2
39-460 Nowa Dęba
Poland