Maxon Active

Before taking the medicine, use the attached diagnostic tool!

Leaflet attached to the packaging: patient information

MAXON ACTIVE, 25 mg, film-coated tablets

Sildenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If the patient's condition does not improve or worsens after taking the medicine, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is MAXON ACTIVE and what is it used for

MAXON ACTIVE contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. The medicine works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. MAXON ACTIVE helps achieve an erection only if there is prior sexual stimulation. MAXON ACTIVE is used to treat erectile dysfunction in adult men, which is the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking MAXON ACTIVE

When not to take MAXON ACTIVE

• 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 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 medicines from this group - these medicines are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, the patient should consult their doctor or pharmacist.
• If the patient is taking medicines that release nitric oxide (such as amyl nitrite, so-called poppers), as their concurrent use may also lead to a dangerous decrease in blood pressure.
• If the patient is taking riociguat. 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). It has been shown that PDE5 inhibitors, such as MAXON ACTIVE, 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 recently had a stroke or heart attack, as well as in cases of low blood pressure.
• If the patient has hereditary degenerative changes in the retina, such as retinitis pigmentosa.
• If the patient has ever lost vision due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take MAXON ACTIVE, 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).
• If the patient has anatomical deformation of the penis or Peyronie's disease.
• Heart problems. In this case, the doctor should assess whether the patient's heart condition allows for the additional effort associated with sexual activity.
• Ulcer disease or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden blindness, they should stop taking MAXON ACTIVE and immediately consult their doctor.

MAXON ACTIVE should not be taken with other oral or topical treatments for erectile dysfunction. MAXON ACTIVE should not be taken with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. MAXON ACTIVE should not be taken if erectile dysfunction has not been diagnosed. MAXON ACTIVE is not intended for women. Special considerations for patients with kidney or liver function disordersPatients with kidney or liver function disorders should inform their doctor. Patients with kidney or liver function disorders should not take a dose of MAXON ACTIVE higher than 25 mg.

Children and adolescents

MAXON ACTIVE should not be taken by persons under 18 years of age.

MAXON ACTIVE and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. MAXON ACTIVE may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens, requiring immediate medical attention, they should inform their doctor, pharmacist, or nurse about taking MAXON ACTIVE and the time of its administration. MAXON ACTIVE should not be taken with other medicines without a doctor's recommendation. MAXON ACTIVE should not be taken if the patient is taking nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should always inform their doctor or pharmacist if they are taking nitrates, which are used to treat angina pectoris ("chest pain"). MAXON ACTIVE should not be taken if the patient is taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent use may also cause a dangerous decrease in blood pressure. If the patient is already taking riociguat, they should inform their doctor or pharmacist. When taking protease inhibitors used to treat HIV infection, it is recommended to start treatment with a lower dose (25 mg) of MAXON ACTIVE. In some patients taking alpha-adrenergic blockers 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 MAXON ACTIVE and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking MAXON ACTIVE. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take MAXON ACTIVE. The doctor may decide to use a lower initial dose (25 mg) of MAXON ACTIVE. If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint) occur, the patient should first lie down or sit and wait for the symptoms to pass; drinking water, taking fresh air, tensing abdominal muscles, or crossing legs may also help. The patient should avoid standing up or sitting down quickly. If the patient is taking medicines containing sacubitril with valsartan (used to treat heart failure), they should inform their doctor or pharmacist.

Taking MAXON ACTIVE with food, drink, and alcohol

MAXON ACTIVE can be taken with or without food. Although taking MAXON ACTIVE while eating a large meal may prolong the time needed for the medicine to start working. The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of MAXON ACTIVE, the patient should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

MAXON ACTIVE is not intended for use by women.

Driving and using machines

MAXON ACTIVE may cause dizziness and vision disturbances. Patients should find out how they react to MAXON ACTIVE before driving vehicles or operating machines.

MAXON ACTIVE contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

MAXON ACTIVE contains sodium

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

3. How to take MAXON ACTIVE

This medicine 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 the medicine is 25 mg. The doctor may, after consultation, recommend a different dosing regimen. MAXON ACTIVE should not be taken more than once a day.MAXON ACTIVE film-coated tablets should not be taken at the same time as VIAGRA tablets that dissolve in the mouth. MAXON ACTIVE should be taken about an hour before planned sexual activity. The tablet should be swallowed whole, with a glass of water. If the patient feels that the effect of MAXON ACTIVE is too strong or too weak, they should consult their doctor or pharmacist. MAXON ACTIVE allows for an erection only if there is prior sexual stimulation. The time after which the effect of MAXON ACTIVE occurs varies from patient to patient, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a large meal. The patient should consult their doctor if, after taking MAXON ACTIVE, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of MAXON ACTIVE than recommended

The patient may experience more frequent side effects, and they may be more severe. Taking a dose higher than 100 mg does not mean an increase in the effectiveness of the medicine. 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 medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, MAXON ACTIVE can cause side effects, although not everybody gets them. The side effects reported in connection with the use of MAXON ACTIVE are usually mild or moderate and short-lived.

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

• Allergic reaction - occurs uncommonly(may occur in 1 in 100 patients) Symptoms: sudden wheezing, 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,
• they should not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely (may occur in 1 in 1000 patients).If the erection lasts for more than 4 hours, the patient should immediately consult their doctor.
• Sudden vision loss or blindness - occurs rarely
• Severe skin reactions - occur rarelySymptoms may include severe peeling and swelling of the skin, 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 up to 1 in 10 patients) :

• Nausea,
• Sudden flushing of the face,
• Hot flushes (symptoms include a feeling of heat in the upper part of the body),
• Indigestion,
• Visual disturbances (seeing with a colored aura, sensitivity to light, blurred vision, or decreased sharpness of vision),
• Stuffy nose,
• Dizziness.

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

• Vomiting,
• Rash,
• Irritation of the eye,
• Redness of the eye,
• Eye pain,
• Seeing flashes of light,
• Increased brightness of vision,
• Sensitivity to light,
• Excessive tearing,
• Pounding heart,
• Fast heartbeat,
• High blood pressure,
• Low blood pressure,
• Muscle pain,
• Sleepiness,
• Decreased sense of touch,
• Dizziness,
• Ringing in the ears,
• Dry mouth,
• Stuffy or congested sinuses,
• Inflammation of the nasal mucosa (symptoms include runny nose, sneezing, and stuffy nose),
• Pain in the upper abdomen,
• Gastroesophageal reflux disease (symptoms include heartburn),
• Blood in the urine,
• Pain in the arms or legs,
• Nosebleeds,
• Feeling of heat,
• Feeling of fatigue.

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

• Fainting,
• Stroke,
• Heart attack,
• Irregular heartbeat,
• Temporary reduction of blood flow to part of the brain,
• Feeling of constriction in the throat,
• Numbness of the lips,
• Bleeding into the back of the eye 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,
• Bleeding from the penis,
• Blood in the semen,
• Dry nose,
• Swelling inside the nose,
• Feeling of irritability,
• Sudden loss of hearing.

After the introduction of sildenafil-containing medicines to 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 side effects, heart function disorders occurred before taking the sildenafil-containing medicine. It is not possible to determine whether these side effects were related to the use of MAXON ACTIVE.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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 PL-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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store MAXON ACTIVE

The medicine should be stored out of sight and reach of children. There are no special recommendations for storing the medicine. The medicine should not be taken after the expiry date stated on the blister pack and carton after EXP:. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What MAXON ACTIVE contains

• The active substance of MAXON ACTIVE is sildenafil. Each tablet contains 25 mg of sildenafil (as sildenafil citrate).
• The other ingredients of the medicine are: Excipients: microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate.

Coating: Opadry II 31F58914 white: hypromellose 15cP, lactose monohydrate, titanium dioxide (E171), macrogol 4000, sodium citrate dihydrate.

What MAXON ACTIVE looks like and contents of the pack

MAXON ACTIVE 25 mg is a white, round, film-coated tablet, convex on both sides, with the inscription "25" on one side. MAXON ACTIVE is available in packs containing blisters of 1, 2, 4, or 8 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów tel. 22 732 77 00

Manufacturer

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów

Date of last revision of the leaflet: