Tadalafil maxigra

The medicinal product Tadalafil Maxigra is used in men aged ≥18 years with erectile dysfunction (impotence), i.e. the inability to achieve or maintain a penile erection sufficient for sexual intercourse.
Before using the medicine, carefully read the package leaflet and review the "Patient Information" leaflet included in the packaging. For safe use of the medicine, please answer all questions contained in the questionnaire.
Package leaflet: information for the patient
Tadalafil Maxigra
10 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before using 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 physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or additional information is needed, consult a physician or pharmacist.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement after taking the medicine, or if the patient feels worse, contact a physician.

Contents of the leaflet

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

1. What Tadalafil Maxigra is and what it is used for

Tadalafil Maxigra is a medicine intended for adult men with erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection adequate for sexual intercourse. Tadalafil Maxigra has been shown to significantly improve the ability to achieve an erection suitable for sexual intercourse.
Tadalafil Maxigra contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Maxigra helps dilate the blood vessels of the penis, allowing increased blood flow into the penis. This results in improved erection. Tadalafil Maxigra does not benefit patients who do not have erectile dysfunction.
It is important to be aware that Tadalafil Maxigra does not work in the absence of sexual stimulation. Adequate foreplay remains essential, just as when the patient is not taking medication for erectile dysfunction.
Tadalafil Maxigra is not intended for use in women.
If no improvement occurs after using the medicine, or if the patient feels worse, contact a physician.
Before using the medicine, carefully read the package leaflet and review the "Patient Information" leaflet included in the packaging. For safe use of the medicine, please answer all questions contained in the questionnaire.

2. Important information before using Tadalafil Maxigra

When not to use Tadalafil Maxigra

• 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 medicines containing nitrates, as their concomitant use may lead to a dangerous decrease in blood pressure. The patient should inform the doctor if they are taking any medicines from this group. Nitrate medicines include:
• glyceryl trinitrate (Glyceroli trinitras) – e.g. Nitrocard, Nitromint, Sustonit, Nitroderm, Minitran
• isosorbide mononitrate (Isosorbidi mononitras) – e.g. Effox, Isosorbide mononitrate Vitabalans, Isosorbidi mononitras Accord, Mono Mack, Mononit, Monosan, Olicard retard
• isosorbide dinitrate (Isosorbidi dinitras) – e.g. Sorbonit
• pentaerythritol tetranitrate (Pentaerythrityli tetranitras) – e.g. Galpent, Pentaerythritol compositum. These medicines are often used to relieve symptoms of angina (chest pain). It has been shown that Tadalafil Maxigra enhances the effects of these medicines. If in doubt, consult a doctor or pharmacist.
• if the patient is taking medicines or other agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concomitant use may also cause dangerous lowering of blood pressure.
• 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.
• 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 (e.g. Adempas). This medicine is 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 (PDE5) inhibitors, such as Tadalafil Maxigra, 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 Maxigra, the patient should complete the questionnaire provided in the package. If any doubts arise, they should discuss them with a doctor or pharmacist.
It should be remembered that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has heart problems (including those identified in the questionnaire indicating that Tadalafil Maxigra should not be used due to heart conditions), they should inform their doctor or pharmacist.
Before taking the medicine, the patient should inform the doctor if any of the following conditions apply:

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

It is not known whether Tadalafil Maxigra is effective in patients:

• after pelvic surgery.
• after complete or partial removal of the prostate gland with cutting of the nerves supplying the prostate (non-nerve-sparing radical prostatectomy).

If sudden worsening of vision or sudden vision loss occurs during treatment with Tadalafil Maxigra, or if vision becomes blurred or distorted, the patient should stop taking Tadalafil Maxigra and contact a doctor immediately.
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 tadalafil use, if hearing loss or worsening of hearing occurs, the patient should stop taking Tadalafil Maxigra and contact a doctor immediately.
Tadalafil Maxigra must not be used together with other oral or topical medicines used to treat erectile dysfunction.
Tadalafil Maxigra must not be used concomitantly with arterial pulmonary hypertension (PAH) therapies using sildenafil or other PDE5 inhibitors.
Other medicines for erectile dysfunction or pulmonary hypertension containing sildenafil (e.g. Maxigra Go, Maxigra Max, Sildenafil PPH, Viagra) must not be taken within 48 hours of taking Tadalafil Maxigra.
Tadalafil Maxigra should not be taken if erectile dysfunction has not been diagnosed.
In some patients taking alpha-blockers (e.g. doxazosin, prazosin, terazosin) for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure caused by a drop in blood pressure when standing up or sitting down quickly. To reduce the risk of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting Tadalafil Maxigra.
If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should:

• lie down or sit until symptoms subside,
• drinking water, getting fresh air, or crossing the legs may also help. The patient should avoid standing up or sitting down quickly. Additionally, if the patient is taking blood pressure-lowering medicines, they should discuss this with their doctor before using Tadalafil Maxigra.

Children and adolescents
Tadalafil Maxigra is not intended for use in children and adolescents under 18 years of age.
Tadalafil Maxigra and other medicines
Before using Tadalafil Maxigra, the patient should complete the questionnaire provided in the package. If in doubt, the patient should inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines they plan to take.
The medicines listed below may be marketed under various brand names. Therefore, the patient should carefully check the packaging and patient leaflet of any medicine they are taking to identify its active substance.
Tadalafil Maxigra may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and immediate medical assistance is required, they should inform the doctor that they have taken Tadalafil Maxigra and the time of intake. This is very important due to the long duration of action of this medicine. Tadalafil Maxigra must not be taken with other medicines without medical advice.
Do not use Tadalafil Maxigra if the patient is taking nitrates, as their concomitant use may lead to dangerous lowering of blood pressure. Nitrate medicines include:

• glyceryl trinitrate (Glyceroli trinitras) – e.g. Nitrocard, Nitromint, Sustonit, Nitroderm, Minitran
• isosorbide mononitrate (Isosorbidi mononitras) – e.g. Effox, Isosorbide mononitrate Vitabalans, Isosorbidi mononitras Accord, Mono Mack, Mononit, Monosan, Olicard retard
• isosorbide dinitrate (Isosorbidi dinitras) – e.g. Sorbonit
• pentaerythritol tetranitrate (Pentaerythrityli tetranitras) – e.g. Galpent, Pentaerythritol compositum. The patient should always inform the doctor or pharmacist if they are taking nitrates used to treat angina (chest pain).

Do not use Tadalafil Maxigra if the patient is taking medicines or agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concomitant use may lead to dangerous lowering of blood pressure.
Tadalafil Maxigra may affect the action of certain medicines, or other medicines may affect the action of Tadalafil Maxigra. Before taking Tadalafil Maxigra, the patient should consult a doctor or pharmacist if they are taking:

• alpha-adrenergic blocking agents (e.g. doxazosin, prazosin, terazosin) used to treat high blood pressure or urinary symptoms due to benign prostatic hyperplasia,
• other medicines used to treat high blood pressure,
• riociguat (used to treat pulmonary hypertension),
• 5-alpha-reductase inhibitors (e.g. dutasteride, finasteride) used to treat benign prostatic hyperplasia,
• ketoconazole tablets (used to treat fungal infections),
• protease inhibitors (e.g. ritonavir, saquinavir) used to treat AIDS or HIV infection,
• phenobarbital, phenytoin, and carbamazepine (anticonvulsants),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• itraconazole (used to treat fungal infections),
• other treatments for erectile dysfunction.

Tadalafil Maxigra, alcohol, and grapefruit juice
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the efficacy of Tadalafil Maxigra and therefore caution should be exercised when consuming it.
Pregnancy, breastfeeding, and fertility
Tadalafil Maxigra is not intended for use in women.
Fertility
When administered to dogs, the medicine caused a reduction in sperm production in the testes. 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 Maxigra contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Maxigra

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 Maxigra tablets are intended for oral use only in men.
The tablet should be swallowed whole with a small amount of water. Tablets may be taken
regardless of meals.
The recommended dose of Tadalafil Maxigra is one 10 mg tablet taken prior to planned
sexual activity.
Take the medicine at least 30 minutes before planned sexual activity. The medicine may be
effective for up to 36 hours after taking the tablet.
This is an on-demand medicine, taken as needed.
Do not use more than once a week. Do not take more than 1 tablet.
It is important to be aware that Tadalafil Maxigra does not work in the absence of sexual
stimulation. Adequate foreplay is essential, just as when the patient is not taking
erectile dysfunction medicines.
Tadalafil Maxigra must not be used simultaneously with other oral or topical medicines used
in the treatment of erectile dysfunction.
Tadalafil Maxigra must not be used together with arterial pulmonary hypertension (APH)
therapy involving sildenafil or other PDE5 inhibitors.
Do not take other erectile dysfunction medicines, e.g. those containing sildenafil (including
Maxigra Go, Maxigra Max, Sildenafil PPH, Viagra), within 48 hours after taking Tadalafil
Maxigra.
Tadalafil Maxigra should not be taken if erectile dysfunction has not been diagnosed.
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 Maxigra,
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.
Contact your doctor if, after taking Tadalafil Maxigra, an erection does not occur or if the duration
of erection is insufficient for sexual intercourse.
Use of a higher than recommended dose of Tadalafil Maxigra
Inform your doctor. Adverse effects described in section 4 may occur.
Missed dose of Tadalafil Maxigra
Do not take a double dose to make up for a missed tablet. Do not take Tadalafil Maxigra more
frequently than once a week.
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 taking the medicine and seek immediate medical advice:

• Allergic reactions, including rash (uncommon).
• Chest pain – do not take nitrates; seek immediate medical help (uncommon).
• Priapism – prolonged and possibly painful erection after taking Tadalafil Maxigra (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately. Without prompt treatment, damage to penile tissue and permanent loss of potency may occur.
• Sudden loss of vision (rare), distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency unknown).

Other adverse reactions reported:
Common (observed in less than 1 in 10 patients)

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

Uncommon (observed in less than 1 in 100 patients)

• Dizziness, abdominal pain, nausea, vomiting, gastroesophageal reflux, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

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

• Fainting, seizures, and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin eruptions), bleeding from the penis, 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 conditions before starting tadalafil.
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, which 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 rush to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• Distorted, dimmed, blurred central vision, or sudden worsening of vision (frequency unknown).

Adverse reaction: dizziness was reported more frequently in men aged over 75 years taking tadalafil. Diarrhea was reported more frequently in men aged over 65 years taking tadalafil.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Tadalafil Maxigra

There are no special storage instructions for this medicinal product.
The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Tadalafil Maxigra contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• Other ingredients are:
  Tablet core: monohydrate lactose, povidone K 30, poloxamer 188, sodium lauryl sulfate, sodium croscarmellose, 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 Maxigra looks like and contents of the packaging
Light orange, elongated, biconvex coated tablets with a division line on one side; length 10.9–11.4 mm, width 5.4–5.9 mm. The division line on the tablet is not intended for breaking the tablet.
The medicine is available in PVC/PVDC/aluminum blisters, packed in cardboard boxes containing 2 or 4 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 Branch in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba