Package leaflet: information for the patient

MAXON ACTIVE, 25 mg, film-coated tablets
Sildenafilum
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after using the medicine, or if you feel worse, contact your doctor.

Table of contents of the leaflet:

What MAXON ACTIVE is and what it is used for
Important information before taking MAXON ACTIVE
How to take MAXON ACTIVE
Possible side effects
How to store MAXON ACTIVE
Contents of the pack and other information

1. What MAXON ACTIVE is and what it is 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 blood vessels in the penis, thereby increasing blood flow to the penis during sexual stimulation.
MAXON ACTIVE helps achieve an erection only if sexual stimulation occurs beforehand.
MAXON ACTIVE 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.

2. Important information before using MAXON ACTIVE

When not to use 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 concomitant use may lead to a dangerous decrease in blood pressure. The patient should inform the doctor if taking any medicines from this group – these medicines are often used to relieve symptoms of angina (chest pain). In case of doubt, consult a doctor or pharmacist.
If the patient is taking medicines that release nitric oxide (such as amyl nitrite, so-called "poppers"), because their concomitant use may also lead to a dangerous decrease in blood pressure.
If the patient is taking riociguat. This is a medicine 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). PDE5 inhibitors such as MAXON ACTIVE have been shown to 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, or has low blood pressure.
If the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa.
If the patient has ever experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting treatment with MAXON ACTIVE, discuss this with a doctor or pharmacist if:

The patient has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
The patient has anatomical deformity of the penis or Peyronie's disease.
The patient has heart problems. In such cases, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity.
The patient has peptic ulcer disease or bleeding disorders (such as hemophilia).
If sudden worsening of vision or sudden vision loss occurs, the patient should stop taking MAXON ACTIVE and contact a doctor immediately.

MAXON ACTIVE must not be used simultaneously with other oral or topical treatments for erectile dysfunction.
MAXON ACTIVE must not be used together with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
MAXON ACTIVE should not be taken if erectile dysfunction has not been diagnosed.
MAXON ACTIVE is not a medicine intended for women.

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. Patients with impaired kidney or liver function should not take a dose of MAXON ACTIVE higher than 25 mg.

Children and adolescents
MAXON ACTIVE must not be used in individuals under 18 years of age.

MAXON ACTIVE and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
MAXON ACTIVE may interact with certain medicines, especially those used to treat chest pain. If the patient's condition worsens and requires immediate medical attention, inform the doctor, pharmacist, or nurse about taking MAXON ACTIVE and the time of its administration. Do not take MAXON ACTIVE together with other medicines without medical advice.
Do not use MAXON ACTIVE if the patient is taking nitrates, as their concomitant use may lead to a dangerous decrease in blood pressure. Always inform the doctor or pharmacist if the patient is taking nitrates used in the treatment of angina (chest pain).
Do not use MAXON ACTIVE if the patient is taking medicines that release nitric oxide (such as amyl nitrite), as their concomitant use may also cause a dangerous drop in blood pressure.
If the patient is already taking riociguat, inform the doctor or pharmacist.
When taking protease inhibitors used in the treatment of HIV infection, it is recommended to start treatment with a lower dose (25 mg) of MAXON ACTIVE.
In some patients taking alpha-blockers 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. Such symptoms have been reported in some patients taking MAXON ACTIVE together with alpha-blockers. They are most likely to occur within 4 hours after taking MAXON ACTIVE. To reduce the likelihood of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting MAXON ACTIVE. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of MAXON ACTIVE. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit until symptoms subside. Drinking water, getting fresh air, tensing abdominal muscles, 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 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. However, taking MAXON ACTIVE with a heavy meal may delay the time needed for the medicine to take effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of MAXON ACTIVE, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
MAXON ACTIVE is not intended for use by women.

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

MAXON ACTIVE contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

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

3. How to use MAXON ACTIVE

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 25 mg. Your doctor may, after consultation, recommend a different dosing regimen.
MAXON ACTIVE must not be taken more than once a day.
Do not take MAXON ACTIVE coated tablets simultaneously with orally disintegrating Viagra tablets.
MAXON ACTIVE should be taken approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water.
If you feel the effect of MAXON ACTIVE is too strong or too weak, consult your doctor or pharmacist.
MAXON ACTIVE enables an erection to occur only in the presence of sexual stimulation. The time to onset of effect of MAXON ACTIVE varies between patients, but usually ranges 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 MAXON ACTIVE, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of MAXON ACTIVE
Adverse reactions may occur more frequently and may be more severe.
Taking a dose higher than 100 mg does not result in increased 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 about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects reported with the use of MAXON ACTIVE are usually mild or moderate in intensity and transient.
If any of the following adverse effects occur, discontinue taking MAXON ACTIVE and seek immediate medical help:

Allergic reaction – occurs uncommonly (may occur in 1 out of 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:
- assume 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 1 out of 1000 patients). If an erection lasts longer than 4 hours, contact a doctor immediately.
Sudden worsening 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, genital area, and around the eyes, fever.
Seizures or convulsions – occur rarely

Other adverse effects:
Very commonly (may affect more than 1 in 10 patients):

Headache.

Commonly (may affect 1 in 10 patients):

Nausea,
Sudden flushing of the face,
Hot flushes (symptoms include a feeling of warmth in the upper body),
Indigestion,
Visual disturbances (seeing colored halos, light sensitivity, blurred vision or reduced visual acuity),
Nasal congestion,
Dizziness.

Uncommonly (may affect 1 in 100 patients):

Vomiting,
Skin rash,
Eye irritation,
Eye redness,
Eye pain,
Seeing flashes of light,
Bright vision,
Light sensitivity,
Eye tearing,
Palpitations,
Rapid heartbeat,
Hypertension,
Hypotension,
Muscle pain,
Drowsiness,
Reduced sense of touch,
Dizziness,
Tinnitus,
Dry mouth,
Blocked or stuffy sinuses,
Nasal mucositis (symptoms include runny nose, sneezing, and nasal congestion),
Upper abdominal pain,
Gastroesophageal reflux disease (symptoms include heartburn),
Blood in urine,
Pain in hands or feet,
Nosebleeds,
Feeling of warmth,
Feeling of fatigue.

Rarely (may affect 1 in 1000 patients):

Fainting,
Stroke,
Heart attack,
Irregular heartbeat,
Transient reduction in blood flow to part of the brain,
Throat tightness,
Numbness of the lips,
Bleeding into the back of the eye or eyelids,
Small particles or spots in the visual field,
Seeing halos around light sources,
Pupil dilation,
Abnormal coloring of the white part of the eye,
Bleeding from the penis,
Presence of blood in semen,
Dry nose,
Swelling inside the nose,
Irritability,
Sudden hearing loss or hearing impairment.

After sildenafil-containing medicines were introduced into 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 effects, heart problems were already present before taking sildenafil-containing medicines. It is not possible to determine whether these adverse effects were related to the use of MAXON ACTIVE.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store MAXON ACTIVE

Keep the medicine out of sight and reach of children.
There are no special storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the blister and the outer cardboard
package following EXP:.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What MAXON ACTIVE contains

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

Coating composition: Opadry II 31F58914 white: hypromellose 15cP, monohydrate lactose, 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, biconvex, with the imprint “25” on one side.
MAXON ACTIVE is available in packages containing blisters of 1, 2, 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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