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 use by women.

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

Before taking the medication, read the leaflet carefully and familiarize yourself with the "Patient Information" attached to 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 dangerous lowering of 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 dangerous lowering of 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 recent months, as well as in cases of low blood pressure.
• If the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If the patient has ever experienced vision loss due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before starting 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 anatomical deformation 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).

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

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

Maxigra Go should not be used concurrently with treatments for pulmonary arterial hypertension (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 Maxigra Go.

Children and adolescents

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

Maxigra Go and other medications

The patient should inform 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 medications listed below may be available 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 chewable tablets may interact with certain medications, especially those used to treat chest pain. In case of a worsening condition that requires 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 dangerous lowering of 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 dangerous lowering of 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 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 occurred in some patients taking sildenafil and alpha-adrenergic blockers concurrently. 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 Maxigra Go. The patient should consult their doctor before taking the medication. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling of impending fainting), the patient should lie down or sit and wait for the symptoms to pass; drinking water or getting some fresh air 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 during a heavy meal may prolong the time it takes 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 vision disturbances. Patients should be aware of how they react to Maxigra Go before driving or operating machinery.

Maxigra Go contains aspartame, lactose, and sodium

The medication contains 2.15 mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

The medication contains lactose. 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 tablet, which means it is considered "sodium-free".

3. How to take Maxigra Go

This medication should always be taken exactly as described in the 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 Maxigra Go is 25 mg. The doctor may recommend a different dosing regimen 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).

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

The tablet should be chewed completely and then swallowed.

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

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

The time it takes for Maxigra Go 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 heavy meal.

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

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-lived.

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

• Allergic reaction - occurs uncommonly(may occur in less than 1 in 100 patients). Symptoms: sudden, wheezing breath, 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 an erection lasts more than 4 hours, the patient should consult their doctor immediately.
• Sudden vision loss or deterioration - occurs 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.

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, changes in color 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, dazzled vision,
• light sensitivity, tearing,
• palpitations, rapid heartbeat,
• hypertension, hypotension,
• muscle pain,
• drowsiness,
• reduced sense of touch,
• vertigo, ringing in the ears,
• dry mouth,
• stuffy or congested sinuses,
• nasal congestion (symptoms include runny nose, sneezing, and stuffy nose),
• upper abdominal pain,
• gastroesophageal reflux disease (symptoms include heartburn),
• blood in urine,
• arm or leg pain,
• nasal bleeding,
• 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,
• eye or eyelid swelling,
• small particles or spots in the visual field, 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 hearing loss or impairment.

After the medication was placed on 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 function disorders 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 those 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

Tel.: +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 will help gather more information on the safety of the medication.

5. How to store Maxigra Go

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

There are no special storage temperature recommendations; the medication should be stored in its original packaging to protect it from light.

The medication should not be used after the expiration date stated on the box and blister pack. The expiration date refers to the last day of the specified month.

Medications should not be disposed of in 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 packaging and other information

What Maxigra Go contains

• The active substance of the medication is sildenafil. Each chewable tablet contains 25 mg of sildenafil formed in situ from 35.12 mg of sildenafil citrate.
• Other ingredients are: potassium polacrylate, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E951), sodium croscarmellose, peppermint flavor (containing maltodextrin, modified corn starch (E1450), and peppermint oil), magnesium stearate, potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment).

What Maxigra Go looks like and contents of the pack

White, triangular, biconvex tablets with "25" embossed on one side.

Maxigra Go is available in blisters of 1, 2, 4, or 8 chewable tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

Genepharm S.A.

18th km Marathon Avenue

15351 Pallini Attiki

Greece

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. BOX 3012 Larisa Industrial Area

Larisa, 41004

Greece

Date of last revision of the leaflet:July 2022

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