Maxigra go

The Maxigra Go medication 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 medication, carefully read the package leaflet and familiarize yourself with
the “Patient Information Leaflet” included in the package. For safe use of the medication,
please answer all questions contained in the information leaflet.
Package leaflet: information for the patient
Maxigra Go, 25 mg, coated tablets
Sildenafilum
Please read this leaflet carefully before taking the medication, as it contains important information for the patient.
This medication 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 you need advice or further information, consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after taking the medication or if you feel worse, contact your doctor.

Table of contents of the leaflet

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

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

Maxigra Go contains the active substance – sildenafil, which belongs to a group of medications known as phosphodiesterase type 5 inhibitors. The medication works by promoting relaxation of blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation. Sildenafil helps achieve an erection only if sexual stimulation is present.
Maxigra Go is used in the treatment of erectile dysfunction in adult men, i.e. impotence.
This refers to the inability to achieve or maintain a penile erection sufficient for sexual intercourse.
Maxigra Go should not be used in patients who do not have erectile dysfunction.
Maxigra Go is not a medication intended for use in women.
If there is no improvement after taking the medication or if you feel worse, contact your doctor.
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Before using the medication, carefully read the package leaflet and familiarize yourself with the “Patient Information Leaflet” included in the package. For safe use of the medication, please answer all questions contained in the information leaflet.

2. Important information before taking Maxigra Go

When not to take Maxigra Go

• 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, as their concomitant use may lead to a dangerous decrease in blood pressure. The doctor should be informed if the patient is 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 blood pressure in the lungs caused by blood clots). Phosphodiesterase type 5 (PDE5) inhibitors such as Maxigra Go have been shown to enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, the doctor should be informed.
• 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 treatment with Maxigra Go, the patient should discuss this with a doctor or pharmacist if:

• They have sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• They have anatomical penile deformity or Peyronie's disease.
• They have heart problems. In such cases, the doctor should assess whether the patient's cardiac condition can tolerate the additional strain associated with sexual activity.
• They have peptic ulcer disease.
• They have bleeding disorders (such as hemophilia).

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If sudden worsening of vision or sudden vision loss occurs, the patient should stop taking Maxigra Go and contact a doctor immediately.
Maxigra Go must not be used concurrently with other oral or topical treatments for erectile dysfunction.
Maxigra Go 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 renal or hepatic impairment
Patients with impaired kidney or liver function should consult a doctor before using Maxigra Go.

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

Maxigra Go and other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
The medicines listed below may be marketed under various brand names. Therefore, carefully check the active ingredient of any medicine on its packaging and in the leaflet.
Maxigra Go may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and requires immediate medical attention, the doctor must be informed about taking Maxigra Go and the time of administration. Maxigra Go should not be taken with other medicines unless directed by a doctor.
Do not take Maxigra Go if the patient is using nitrate-containing medicines, as their concomitant use may lead to dangerous lowering of 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 the doctor or pharmacist if the patient is taking nitrates used to treat angina (chest pain).

Do not take Maxigra Go if the patient is using 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.
If the patient is taking riociguat, inform the doctor or pharmacist.
If the patient is taking protease inhibitors (e.g. ritonavir, saquinavir) used in the treatment of HIV infection, consult a doctor before taking Maxigra Go.
If the patient is taking alpha-blockers, consult a doctor before taking Maxigra Go. 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 standing up or sitting down quickly.
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Such symptoms have occurred in some patients taking sildenafil and alpha-blockers concomitantly. They are most likely to occur within 4 hours after taking Maxigra Go. To reduce the risk of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting Maxigra Go. If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending fainting) occur, the patient should lie down or sit down and wait until symptoms subside. Drinking water, breathing fresh air, or crossing the legs may also help. Rapid standing or sitting should be avoided.
If the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure, inform the doctor or pharmacist.

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

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

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

Maxigra Go 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 take Maxigra Go

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.
The recommended dose is 25 mg (1 tablet).
Your doctor may, after consultation, recommend a different dosing regimen.
Maxigra Go must not be taken more than once a day.
Taking a dose higher than 100 mg does not result in increased effectiveness of the medicine.
Do not take Maxigra Go together with other medicines containing sildenafil (e.g. Maxigra, Sildenafil Medana, Viagra).

Method of administration
Maxigra Go 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 Go is too strong or too weak, consult your doctor or pharmacist.
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Maxigra Go enables an erection only in the presence of sexual stimulation.
The time required for Maxigra Go to take effect 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 Go, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.

Taking a higher than recommended dose of Maxigra Go
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 information leaflet.
Contact your doctor if you have taken more tablets than recommended.
If you have any further doubts concerning 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 experiences them.
Adverse reactions reported with Maxigra Go are usually mild or
moderate in severity and transient.
If any of the following adverse reactions occur, stop taking Maxigra Go immediately and seek medical help:

• Allergic reaction – occurs uncommonly (may occur in less than 1 in 100 patients). Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs uncommonly. 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 – occur rarely (may occur in less than 1 in 1,000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
• Sudden decrease or loss of vision – occurs rarely.
• Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions – occur rarely.

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

• headache.

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Common (may occur in less than 1 in 10 patients):

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

Uncommon (may occur in less than 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 mucosal inflammation (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 occur in less than 1 in 1,000 patients):

• fainting, stroke, myocardial infarction, irregular heartbeat, transient reduction in blood flow to part of the brain,
• throat tightness, lip numbness,
• bleeding into the back of the eye,
• double vision, decreased visual acuity,
• abnormal sensations inside the eye, eye or eyelid swelling,
• small specks or dots in the field of vision, seeing halos around light sources,
• pupil dilation, abnormal discoloration of the white part of the eye,
• rectal bleeding, blood in semen,
• dry nose, nasal swelling,
• irritability, sudden weakness or hearing loss.

After marketing authorization, rare cases of unstable angina (heart disease) and sudden death have been reported.
It should be noted 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 at 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 to the marketing authorization holder.
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Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Maxigra Go

Keep this medicine out of sight and reach 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.
No special storage conditions are required 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 Maxigra Go contains

• The active substance is sildenafil. Each tablet contains 25 mg of sildenafil (as citrate).
• The other ingredients are:
• Tablet core: mannitol, crospovidone type A, povidone K-30, anhydrous colloidal silicon dioxide, maize starch, magnesium stearate, sodium lauryl sulfate.
• Coating: polyvinyl alcohol; titanium dioxide (E171); macrogol (MW 350); talc; indigo carmine, lake (E132).

What Maxigra Go looks like and contents of the pack
Round, biconvex, film-coated tablets, light blue to blue in colour,
with a diameter of 6.0 - 6.4 mm.
Maxigra Go is available in aluminium/PVC/PCTFE blisters containing 1, 2, 4 or 8 film-coated tablets per cardboard box.
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

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