Maxigra Go

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

Maxigra Go contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. The medication works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Sildenafil helps achieve an erection only if there is prior sexual stimulation.

Maxigra Go is used to treat erectile dysfunction in adult men, i.e., impotence. It is the inability to achieve or maintain an erection sufficient for sexual intercourse.

Maxigra Go should not be used by patients who do not have erectile dysfunction.

Maxigra Go is not intended for women.

If the patient does not experience improvement or feels worse after taking the medication, they should contact their doctor.

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Before taking the medication, please read the leaflet carefully and familiarize yourself with the "Patient Information" included in the packaging. To ensure safe use of the medication, please answer all questions contained in the information.

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 medication (listed in section 6).
• If the patient is taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medications from this group. The nitrate group includes:
• 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"). In case of doubt, the patient should consult a doctor or pharmacist.
• If the patient is taking medications or other agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concurrent use may also cause a dangerous decrease in blood pressure.
• If the patient is taking riociguat (e.g., Adempas). This medication 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 inhibitors (PDE5), such as Maxigra Go, enhance the blood pressure-lowering effect of this medication. 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 in the past few months, or in cases of low blood pressure.
• If the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa (retinitis pigmentosa).
• If the patient has ever experienced vision loss due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Maxigra Go, the patient should discuss it with their doctor or pharmacist in the following cases:

• sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), multiple myeloma (a bone marrow cancer);
• penile deformity or Peyronie's disease;
• heart problems. In this case, the doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity;
• peptic ulcer disease;
• bleeding disorders (such as hemophilia).

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If the patient experiences sudden vision loss or sudden blindness, they should stop taking Maxigra Go and immediately consult a doctor.

Maxigra Go should not be used concurrently with other oral or topical erectile dysfunction therapies.

Maxigra Go should not be used concurrently with pulmonary arterial hypertension therapies (PAH) using sildenafil or other phosphodiesterase type 5 inhibitors (e.g., tadalafil).

Special considerations for patients with renal or hepatic impairment

Patients with renal or hepatic impairment should consult their doctor before taking the medication.

Children and adolescents

Maxigra Go should not be used in individuals under 18 years of age.

Maxigra Go and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

The following medications may be marketed under different trade names. Therefore, the patient should carefully check the packaging and leaflet of the medication they are taking to determine the active substance.

Maxigra Go may interact with certain medications, especially those used to treat chest pain. In case of a worsening condition requiring immediate medical attention, the patient should inform their doctor about taking Maxigra Go and the time of administration. The patient should not take Maxigra Go concurrently with other medications without their doctor's recommendation.

The patient should not use Maxigra Go if they are taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure.

The nitrate group includes:

• 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 patient should always inform their doctor or pharmacist if they are taking nitrates used to treat angina pectoris ("chest pain").

The patient should not use Maxigra Go if they are taking medications or agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concurrent use may lead to a dangerous decrease in blood pressure.

If the patient is taking riociguat, they should inform their doctor or pharmacist.

In the case of taking protease inhibitors (e.g., ritonavir, saquinavir) used to treat HIV infections, the patient should consult their doctor before taking Maxigra Go.

In the case of taking alpha-adrenergic blockers before taking Maxigra Go, the patient should consult their doctor. In some patients taking alpha-adrenergic blockers (e.g., doxazosin, prazosin, terazosin) for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of low blood pressure caused by a drop in blood pressure when standing up or sitting down quickly.

Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking Maxigra Go. To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blockers before starting to take Maxigra Go. 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, taking fresh air, or crossing their legs may also help. The patient should avoid standing up or sitting down quickly.

If the patient is taking sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

Maxigra Go with food, drink, and alcohol

Maxigra Go can be taken with or without food. However, taking Maxigra Go while consuming large meals may prolong the time needed for the medication to start working.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Maxigra Go, the patient should not consume large amounts of alcohol before taking the medication.

Pregnancy, breastfeeding, and fertility

Maxigra Go is not intended for use by women.

Driving and using machines

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

Maxigra Go contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Maxigra Go

This medication should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

The recommended dose of the medication is 25 mg (1 tablet).

The doctor may recommend a different dosage after consultation.

Maxigra Go should not be taken more than once a day.

Taking a dose greater than 100 mg does not increase the medication's effectiveness.

The patient should not take Maxigra Go concurrently with other medications containing sildenafil (e.g., Maxigra, Sildenafil Medana, Viagra).

Administration

Maxigra Go should be taken approximately 1 hour before planned sexual activity.

The tablet should be swallowed whole, with a glass of water.

If the patient feels that the effect of Maxigra Go is too strong or too weak, they should consult their doctor or pharmacist.

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Maxigra Go allows for an erection only if there is prior sexual stimulation.

The time it takes for the medication to start working varies among patients, usually ranging from half an hour to one hour. The effect may occur later if the medication is taken after a large meal.

The patient should consult their doctor if they do not experience an erection after taking Maxigra Go or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Maxigra Go than recommended

The patient may experience more frequent or severe side effects.

Taking a dose greater than 100 mg does not increase the medication's effectiveness.

The patient should not take more tablets than indicated in the patient leaflet.

The patient should consult their doctor if they have taken more tablets than recommended.

In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Maxigra Go can cause side effects, although not everyone will experience them.

Side effects reported in connection with the use of Maxigra Go are usually mild or moderate and short-term.

In case of any of the following side effects, the patient should stop taking Maxigra Go and seek immediate medical attention:

• Allergic reaction - occurs uncommonly(may occur in less than 1 in 100 patients). Symptoms: sudden, wheezing breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonly. If it occurs during or after sexual intercourse:
• the patient should sit half-up and try to relax,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in less than 1 in 1,000 patients). If the erection lasts for more than 4 hours, the patient should immediately consult their doctor.
• Sudden vision loss or blindness - occur rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur rarely.

Other side effects:

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,
• flushing (symptoms include a feeling of heat in the upper body),
• indigestion,
• visual disturbances, blurred vision, color tinge to vision,
• stuffy nose, dizziness.

Uncommon(may occur in less than 1 in 100 patients):

• vomiting, skin rash,
• eye irritation, conjunctivitis, eye pain, flashes of light, blurred vision, sensitivity to light, tearing,
• palpitations, rapid heartbeat, high blood pressure, low blood pressure,
• muscle pain, drowsiness, decreased sensitivity to touch, dizziness of labyrinthine origin, ringing in the ears,
• dry mouth, stuffy or blocked sinuses, rhinitis (symptoms include runny nose, sneezing, and stuffy nose),
• upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn),
• blood in urine, pain in arms or legs, nosebleeds, feeling of heat, and feeling of fatigue.

Rare(may occur in less than 1 in 1,000 patients):

• fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain,
• feeling of pressure in the throat, numbness of the lips,
• bleeding in the back of the eye,
• double vision, reduced visual acuity,
• abnormal sensations in the eye, swelling of the eyes or eyelids,
• small particles or spots in the field of vision, seeing halos around light sources,
• pupil dilation, abnormal discoloration of the white of the eye,
• penile bleeding, presence of blood in semen,
• dry nose, swelling inside the nose,
• irritability, sudden weakness or loss of hearing.

After the medication was introduced to the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is essential to note that in most, but not all, men who experienced these side effects, heart problems existed before taking sildenafil. It is not possible to determine whether these side effects were related to the use of the medication containing sildenafil.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.

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By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Maxigra Go

The medication should be stored out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister. The expiration date refers to the last day of the month.

There are no special precautions for storing the medication.

Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Maxigra Go contains

• The active substance of the medication is sildenafil. Each tablet contains 25 mg of sildenafil (in the form of citrate).
• Other ingredients are:
• Core: mannitol, crospovidone type A, povidone K-30, colloidal silica, cornstarch, magnesium stearate, sodium lauryl sulfate.
• Coating: polyvinyl alcohol; titanium dioxide (E171); macrogol (MW350); talc; indigo carmine, lake (E132).

What Maxigra Go looks like and what the pack contains

Round, biconvex, film-coated tablets of light blue to blue color, with a diameter of 6.0 - 6.4 mm.

Maxigra Go is available in Aluminum/PVC/PCTFE blisters containing 1, 2, 4, or 8 film-coated tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: ---------------------------------------------------------------------------------------------------------------------------

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