Tadalafil Maxigra

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

Tadalafil Maxigra is a medication intended for adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that Tadalafil Maxigra significantly improves the ability to achieve an erection sufficient for sexual intercourse.
Tadalafil Maxigra contains the active substance tadalafil, which belongs to a group of medications called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Maxigra helps to widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, there is an improvement in erection. Tadalafil Maxigra does not help patients who do not have erectile dysfunction.
It is important to note that Tadalafil Maxigra does not work in the absence of sexual stimulation.
It is also important to arrange foreplay, just like when the patient is not taking medications for erectile dysfunction.
Tadalafil Maxigra is not intended for use in women.
If there is no improvement after taking the medication or the patient feels worse, they should contact their doctor.

Before taking the medication, it is necessary to carefully read the leaflet and familiarize yourself with the "Patient Information" attached to the packaging. To ensure safe use of the medication, please answer all questions in the questionnaire.

2. Important information before taking Tadalafil Maxigra

When not to take Tadalafil Maxigra

• nitroglycerin (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 medications are often used to relieve symptoms of angina pectoris ("chest pain"). It has been shown that Tadalafil Maxigra enhances the effect of these medications. In case of doubt, the doctor or pharmacist should be consulted.

Warnings and precautions

Before starting to take Tadalafil Maxigra, the patient should use the questionnaire attached to the packaging. In case of any doubts, the doctor or pharmacist should be consulted.
It should be remembered that sexual activity is associated with a certain risk in patients with heart disease, as it puts an additional strain on the heart. If there are heart problems (including those resulting from the questionnaire that Tadalafil Maxigra should not be used due to heart problems), the doctor or pharmacist should be informed.
The patient should inform their doctor before taking the medication 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 deformation of the penis.
• severe liver disease.
• severe kidney disease.

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

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

If during the use of Tadalafil Maxigra there is a sudden worsening of vision or sudden loss of vision, or the image is distorted, blurred, the use of Tadalafil Maxigra should be stopped and the doctor should be consulted immediately.
In some patients taking tadalafil, a worsening or sudden loss of hearing has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if there is a worsening or sudden loss of hearing, the use of Tadalafil Maxigra should be stopped and the doctor should be consulted immediately.
Tadalafil Maxigra should not be used concurrently with other oral or topical medications used to treat erectile dysfunction.
Tadalafil Maxigra should not be used concurrently with therapies for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.
Other medications for erectile dysfunction, e.g., containing sildenafil (including Maxigra Go, Maxigra Max, Sildenafil PPH, Viagra), should not be taken within 48 hours of taking Tadalafil Maxigra.
Tadalafil Maxigra should not be taken if erectile dysfunction has not been diagnosed.
Consuming alcohol may affect the patient's ability to achieve an erection and may cause a transient decrease in blood pressure. If the patient has taken Tadalafil Maxigra 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 doctor should be consulted if, after taking Tadalafil Maxigra, there is no erection or the duration of the erection is not sufficient for sexual intercourse.

• if the patient is taking alpha-adrenergic blocking agents (e.g., doxazosin, prazosin, terazosin) for high blood pressure or symptoms of benign prostatic hyperplasia, they may experience dizziness or lightheadedness, which can be symptoms of low blood pressure, caused by a drop in blood pressure when standing up quickly or sitting down. To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocking agents before starting to take Tadalafil Maxigra.
• if the patient experiences symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint), they should:

lie down or sit and wait for the symptoms to pass,

• drinking water, getting fresh air, crossing legs may also help. It is recommended to avoid standing up or sitting down quickly. Additionally, if the patient is taking blood pressure-lowering medications, they should discuss this with their doctor before taking Tadalafil Maxigra.

Children and adolescents

Tadalafil Maxigra is not intended for use in children and adolescents under the age of 18.

Tadalafil Maxigra and other medications

Before taking Tadalafil Maxigra, the patient should use the questionnaire attached to the packaging. In case of any doubts, the doctor or pharmacist should be consulted.
The medications listed below may be available under different trade names. Therefore, it is necessary to carefully check the packaging and patient leaflet of the medication being taken to determine the active substance of the medication.
Tadalafil Maxigra may interact with some medications, especially those used to treat angina pectoris. If the patient's condition worsens and requires immediate medical attention, they should inform their doctor about taking Tadalafil Maxigra and the time of its administration. This is very important due to the long duration of action of this medication. Tadalafil Maxigra should not be taken concurrently with other medications without the doctor's recommendation.
It is not recommendedto take Tadalafil Maxigra if the patient is taking medications from the nitrate group, as their concurrent use may lead to dangerous lowering of blood pressure.
The group of nitrates includes the following medications:

• nitroglycerin (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 doctor or pharmacist should always be informed if the patient is taking nitrates used to treat angina pectoris ("chest pain").

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

• alpha-adrenergic blocking agents (e.g., doxazosin, prazosin, terazosin) used to treat high blood pressure or symptoms of benign prostatic hyperplasia,
• other medications 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 in tablets (used to treat fungal infections),
• protease inhibitors (e.g., ritonavir, saquinavir) used to treat AIDS or HIV infection,
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medications),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• itraconazole (used to treat fungal infections),
• other methods of treating erectile dysfunction.

Tadalafil Maxigra with drinking and alcohol

Information on the effect of alcohol is provided in section 3. Grapefruit juice may affect the efficacy of Tadalafil Maxigra, and therefore, it should be consumed with caution.

Pregnancy, breastfeeding, and fertility

Tadalafil Maxigra is not intended for use in women.
Fertility
When administered to dogs, a decrease in sperm production in the testes was observed. A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and operating machinery

In some men taking tadalafil during clinical trials, dizziness was reported, so it is necessary to know one's reaction to the tablets before making a decision to drive or operate machinery.

Tadalafil Maxigra contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.
The medication contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medication is considered "sodium-free".

3. How to take Tadalafil Maxigra

This medication should always be taken exactly as described in this patient leaflet or according to the doctor's or pharmacist's recommendations. In case of any doubts, the doctor or pharmacist should be consulted.
Tadalafil Maxigra 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 regardless of meals.

Recommended dose of Tadalafil Maxigra is one 10 mg tablet, taken before planned sexual activity.

The medication should be taken at least 30 minutes before planned sexual activity. The medication may be effective for up to 36 hours after taking the tablet.
The medication is for occasional use, as needed.

Do not take more than once a week. Do not take more than one tablet.

It is important to note that Tadalafil Maxigra does not work in the absence of sexual stimulation.
It is also important to arrange foreplay, just like when the patient is not taking medications for erectile dysfunction.
Tadalafil Maxigra should not be used concurrently with other oral or topical medications used to treat erectile dysfunction.
Tadalafil Maxigra should not be used concurrently with therapies for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.
Other medications for erectile dysfunction, e.g., containing sildenafil (including Maxigra Go, Maxigra Max, Sildenafil PPH, Viagra), should not be taken within 48 hours of taking Tadalafil Maxigra.
Tadalafil Maxigra should not be taken if erectile dysfunction has not been diagnosed.
Consuming alcohol may affect the patient's ability to achieve an erection and may cause a transient decrease in blood pressure. If the patient has taken Tadalafil Maxigra 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 doctor should be consulted if, after taking Tadalafil Maxigra, there is no erection or the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Tadalafil Maxigra than recommended

The doctor should be informed about this. Side effects described in section 4 may occur.

Missing a dose of Tadalafil Maxigra

A double dose should not be taken to make up for a missed tablet. Tadalafil Maxigra should not be taken more than once a week.
In case of any further doubts about the use of this medication, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. These effects are usually mild or moderate.

If any of the following side effects occur, the use of Tadalafil Maxigra should be stopped and the doctor should be consulted immediately:

• allergic reactions, including rash (not very common).
• chest pain - nitrates should not be used, and immediate medical attention should be sought (not very common).
• priapism - prolonged and potentially painful erection after taking Tadalafil Maxigra (rare). If such an erection occurs and lasts continuously for more than 4 hours, the doctor should be consulted immediately. If immediate treatment is not provided, it may lead to tissue damage and permanent loss of potency.
• sudden loss of vision (rare), distorted, blurred, or unclear vision (frequency unknown).

Other side effects have been reported:

Common(observed in less than 1 in 10 patients)

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

Uncommon(observed 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 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, hives (itchy, red swellings on the skin surface), bleeding from the penis, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before starting to take tadalafil.
There have been reports of rare cases of partial, transient, or permanent vision loss or blindness in one or both eyes.
In men taking tadalafil, several additional rare side effectshave been reported, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, disorders characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac deaths.
• distorted, blurred, or unclear vision or sudden worsening of vision (frequency unknown).

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 side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medication.

5. How to store Tadalafil Maxigra

There are no special recommendations for storing the medication.
The medication should be stored out of sight and reach of children.
The medication should not be used after the expiration date stated on the packaging and blister.
The expiration date refers to the last day of the specified month.
Medications should not be disposed of in sewage or household waste containers. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Contents of the packaging and other information

What Tadalafil Maxigra contains

• The active substance of the medication is tadalafil. Each tablet of the medication contains 10 mg of tadalafil.
• Other ingredients are: Tablet core: lactose monohydrate, povidone K 30, poloxamer type 188, sodium lauryl sulfate, croscarmellose sodium, colloidal silicon dioxide, 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 what the packaging contains

Light orange, elongated, biconvex, coated tablets with a dividing line on one side; length 10.9-11.4 mm, width 5.4-5.9 mm. The dividing line on the tablet is not intended for breaking the tablet.
The medication is available in PVC/PVDC/Aluminum blisters in a cardboard box containing 2 or 4 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +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 Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Date of the last update of the leaflet: ---------------------------------------------------------------------------------------------------------------------------