Maxigra max

The medicine Maxigra Max 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 become familiar with the
"Patient Information Leaflet" enclosed in the packaging. To ensure safe use of the medicine, please answer all the questions contained in the questionnaire.
Package leaflet: information for the patient
Maxigra Max, 50 mg, film-coated tablets
Sildenafilum
Please read the 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 the 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, including any adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement after using the medicine, or if the patient feels worse, contact a physician.

Leaflet contents

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

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

Maxigra Max contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by promoting relaxation of blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation. Maxigra Max helps achieve an erection only if sexual stimulation is present.
Maxigra Max is used for the treatment of erectile dysfunction in adult men, i.e. impotence, which is the inability to achieve or maintain a penile erection sufficient for sexual intercourse.
Maxigra Max should not be used in patients who do not have erectile dysfunction.
Maxigra Max is not a medicine intended for use in women.
If there is no improvement after using the medicine, or if the patient feels worse, contact a physician.
Before using the medicine, carefully read the package leaflet and become familiar with the "Patient Information Leaflet" enclosed in the packaging. To ensure safe use of the medicine, please answer all the questions contained in the questionnaire.

2. Important information before using Maxigra Max

When not to use Maxigra Max

• If the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking medicines containing nitrates, because 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-containing 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). 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"), because their concomitant use may also cause dangerous lowering of blood pressure.
• 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 lung pressure caused by blood clots). It has been shown that phosphodiesterase type 5 (PDE5) inhibitors, such as Maxigra Max, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.
• If the patient has severe heart or liver disease.
• If the patient has had a stroke or heart attack within the past few months, or has low blood pressure.
• If the patient has inherited degenerative retinal disorders, such as retinitis pigmentosa (retinitis pigmentosa).
• If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting Maxigra Max, discuss this with your doctor or pharmacist if you have:

• Sickle cell anemia (an abnormality affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow);
• Anatomical penile deformity or Peyronie's disease;
• Heart conditions. In such cases, the doctor should assess whether the heart muscle can tolerate the additional strain associated with sexual activity;
• Peptic ulcer disease;
• Bleeding disorders (such as hemophilia).

If sudden vision worsening or sudden vision loss occurs, stop taking Maxigra Max immediately and contact a doctor without delay.
Maxigra Max must not be used concurrently with other oral or topical treatments for erectile dysfunction.
Maxigra Max must not be used concurrently with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other phosphodiesterase type 5 (PDE5) inhibitors (e.g. tadalafil).

Special considerations for patients with kidney or liver impairment
Patients with impaired kidney or liver function should inform their doctor. Patients with impaired kidney or liver function should not take a dose higher than 25 mg without first consulting a doctor.

Children and adolescents
Maxigra Max must not be used in individuals under 18 years of age.

Maxigra Max and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
The medicines listed below may be marketed under various brand names. Therefore, carefully check the packaging and the patient leaflet of any medicine you are taking to identify its active ingredient.
Maxigra Max, film-coated tablets, may interact with certain medicines, especially those used to treat chest pain. If your health deteriorates and requires immediate medical attention, inform the doctor that you have taken Maxigra Max and when it was taken. Do not take Maxigra Max with other medicines unless advised by a doctor.
Do not take Maxigra Max if you are using nitrate-containing medicines, because their concomitant use may lead to a dangerous drop in blood pressure. Nitrate-containing 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.

Always inform your doctor or pharmacist if you are taking nitrates used to treat angina (chest pain).
Do not take Maxigra Max if you are using medicines or agents that release nitric oxide (such as amyl nitrite, so-called poppers), because their concomitant use may lead to a dangerous drop in blood pressure.
If you are taking riociguat, inform your doctor or pharmacist.
If you are taking protease inhibitors (e.g. ritonavir, saquinavir) used in the treatment of HIV infection, consult your doctor before taking Maxigra Max.
If you are taking alpha-blockers, consult your doctor before taking Maxigra Max. 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 upon rapid standing or sitting. These symptoms have been reported in some patients taking sildenafil and alpha-blockers simultaneously. They are most likely to occur within 4 hours after taking Maxigra Max. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting Maxigra Max. The doctor may also decide to initiate treatment with a lower starting dose of sildenafil (25 mg). If symptoms of low blood pressure (dizziness, lightheadedness, feeling faint) occur, the patient should lie down or sit and wait until symptoms resolve. Drinking water, breathing fresh air, and crossing the legs may also help. Avoid rapid standing or sitting.
If you are taking ketoconazole, erythromycin, or cimetidine, consult your doctor before taking Maxigra Max.
If you are taking medicines containing sacubitril with valsartan, used in the treatment of heart failure, inform your doctor or pharmacist.

Maxigra Max with food, drink, and alcohol
Maxigra Max can be taken with or without food. However, taking Maxigra Max with a heavy meal may delay the onset of the medicine's effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic benefit of Maxigra Max, significant alcohol intake should be avoided before taking the medicine.

Pregnancy, breastfeeding, and fertility
Maxigra Max is not intended for use in women.

Driving and operating machinery
Maxigra Max may cause dizziness and visual disturbances. Patients should assess how they react to Maxigra Max before driving or operating machinery.

Maxigra Max contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Maxigra Max

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
If the patient has previously used medicines containing sildenafil at a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Maxigra Max 50 mg should only be used if the patient did not achieve a satisfactory effect (i.e. did not obtain an erection sufficient for sexual intercourse) after taking sildenafil 25 mg. The prerequisite is obtaining the result "I can use Maxigra Max containing sildenafil 50 mg" from the attached questionnaire.
There are patients for whom a dose of 25 mg is sufficient to achieve a satisfactory therapeutic effect. These patients should continue using the 25 mg dose, taken as needed approximately one hour before planned sexual activity.
Your doctor may recommend a different dosing regimen after consultation.
Maxigra Max must not be taken more than once in a 24-hour period.
Do not take Maxigra Max together with other medicines containing sildenafil (e.g. Maxigra Go, Sildenafil Medana, Viagra).
Maxigra Max should be taken approximately one hour before planned sexual activity. The tablet should be swallowed whole with a glass of water.
If you feel that the effect of Maxigra Max is too strong or too weak, consult your doctor or pharmacist.
Maxigra Max enables an erection to be achieved only in the presence of sexual stimulation. The time to onset of effect of Maxigra Max varies between patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal.
Contact your doctor if, after taking Maxigra Max, an erection is not achieved or if the duration of erection is insufficient for sexual intercourse.
Taking more than the recommended dose of Maxigra Max
Adverse effects may occur more frequently and may be more severe. Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than indicated in the patient leaflet.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts regarding 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.
Adverse reactions reported with the use of Maxigra Max are usually mild or moderate and transient.
If any of the following adverse reactions occur, stop taking Maxigra Max immediately and seek medical help:

• Allergic reaction – uncommon (may occur in less than 1 in 100 patients). Symptoms: rapid, wheezing breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – uncommon. If chest pain occurs during or after sexual intercourse:
  • adopt a semi-sitting position and try to relax,
  • do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – rare (may occur in less than 1 in 1000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden worsening or loss of vision – rare.
• Severe skin reactions – rare. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, genital area and around the eyes, fever.
• Seizures or fits – rare.

Other adverse reactions:
Very common (may affect more than 1 in 10 patients):

• headache.

Common (may affect up to 1 in 10 patients):

• nausea, sudden flushing of the face, hot flushes (symptoms include a feeling of warmth in the upper body), indigestion,
• seeing coloured halos, blurred vision, visual disturbances,
• stuffy nose, dizziness.

Uncommon (may affect up to 1 in 100 patients):

• vomiting, skin rash,
• eye irritation, eye redness, eye pain, seeing flashes of light, bright vision, light sensitivity, watery eyes,
• palpitations, rapid heartbeat, hypertension, hypotension,
• muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus,
• dry mouth, blocked or stuffy sinuses, nasal mucositis (symptoms include runny nose, sneezing and blocked nose),
• upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn),
• blood in urine, pain in hands or feet, nosebleeds, feeling of warmth and feeling of fatigue.

Rare (may affect up to 1 in 1000 patients):

• fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain,
• sensation of throat tightness, lip numbness,
• bleeding in the back of the eye, double vision,
• decreased visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids,
• small specks or spots in the field of vision, seeing halos around light sources,
• pupil dilation, abnormal discoloration of the sclera,
• rectal bleeding, blood in semen, dry nose, nasal swelling,
• feeling of irritability, sudden weakness or hearing loss.

After the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important to note that in most, but not all, men who experienced these adverse reactions, cardiac disorders were present prior to taking sildenafil. It is not possible to determine whether these adverse reactions were related to the use of the medicine containing sildenafil.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 provide more information on the safety of this medicine.

5. How to store Maxigra Max

Keep this medicine out of sight and reach of children.
No special storage conditions apply for this medicine.
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 no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Maxigra Max contains

• The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).
• The other ingredients are:
• Tablet core: mannitol (E421), crospovidone (type A), povidone (K30), colloidal anhydrous silica, maize starch, magnesium stearate, sodium lauryl sulfate.
• Coating: hypromellose, macrogol 6000, titanium dioxide, talc, indigo carmine (E132).

What Maxigra Max looks like and contents of the pack
The coated tablets are round, biconvex, and blue in colour.
The pack contains 1, 2 or 4 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01