MAXON FORTE

Before taking the medication, use the diagnostic tool (questionnaire) provided!

Package leaflet: information for the patient

MAXON FORTE, 50 mg, coated tablets
Sildenafilum
Please read the entire leaflet carefully before using the medication, as it contains
important information for the patient.
This medication should always be used exactly as described in the patient leaflet or according to
the instructions provided by the doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after using the medication, or if the patient feels worse, medical advice should be sought.

Table of contents of the leaflet:

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

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

MAXON FORTE contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The drug works by promoting relaxation of blood vessels in the penis, thereby increasing blood flow into the penis during sexual stimulation.
MAXON FORTE helps achieve an erection only if preceded by sexual stimulation.
MAXON FORTE is used to treat erectile dysfunction in adult men, that is, impotence defined as the inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using MAXON FORTE

When not to use MAXON FORTE

• 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 they are taking any medicines from this group—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 that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concomitant 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). PDE5 inhibitors, such as MAXON FORTE, 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Before starting to take MAXON FORTE, 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 been diagnosed with anatomical penile deformity 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 ulcers or bleeding disorders (such as hemophilia).
• If sudden worsening of vision or sudden vision loss occurs, the patient should stop taking MAXON FORTE and contact a doctor immediately.

MAXON FORTE should not be used concurrently with other oral or topical treatments for erectile dysfunction.
MAXON FORTE should not be used together with arterial pulmonary hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
MAXON FORTE should not be taken if erectile dysfunction has not been diagnosed.
MAXON FORTE 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 FORTE higher than 25 mg.

Children and adolescents
MAXON FORTE should not be used in individuals under 18 years of age.

MAXON FORTE and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
MAXON FORTE may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and immediate medical assistance is required, the doctor, pharmacist, or nurse should be informed that MAXON FORTE was taken and at what time. MAXON FORTE should not be taken with other medicines unless directed by a doctor.
Do not take MAXON FORTE 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, which are used to treat angina (chest pain).
Do not take MAXON FORTE 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, they should inform their 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 FORTE.
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 up. These symptoms have been observed in some patients taking MAXON FORTE together with alpha-blockers. They are most likely to occur within 4 hours after taking MAXON FORTE. To reduce the risk of such symptoms, the patient should be on a stable dose regimen of their alpha-blocker before starting MAXON FORTE. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of MAXON FORTE. 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 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), they should inform their doctor or pharmacist.

MAXON FORTE with food, drink, and alcohol
MAXON FORTE can be taken with or without food. However, taking MAXON FORTE 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 potential of MAXON FORTE, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
MAXON FORTE is not intended for use in women.

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

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

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

3. How to use MAXON FORTE

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
If the patient has previously used medicines containing sildenafil at a dose of 50 mg or higher, the
recommended dose is 50 mg. Otherwise, MAXON FORTE at a dose of 50 mg should be used only
if the patient did not achieve the desired effect (i.e. did not obtain an erection sufficient for sexual
intercourse) after taking sildenafil at a dose of 25 mg.
If treatment with a lower dose of sildenafil (25 mg) enabled an erection sufficient for sexual
intercourse, a 50 mg dose should not be used.
MAXON FORTE must not be taken more than once a day.
Do not take MAXON FORTE coated tablets together with other medicines containing sildenafil (e.g. Viagra).
MAXON FORTE should be taken approximately one hour before planned sexual activity. Swallow the tablet whole with a glass of water.
If the effect of MAXON FORTE seems too strong or too weak, consult a doctor or pharmacist.
MAXON FORTE enables an erection only in the presence of sexual stimulation.
The time to onset of action of MAXON FORTE 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 a doctor if no erection occurs after taking MAXON FORTE, or if the duration of erection is insufficient for sexual intercourse.
Taking more than the recommended dose of MAXON FORTE
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 leaflet.
Contact a doctor if more tablets have been taken than recommended.
If there are any further doubts regarding the use of this medicine, consult a 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 FORTE are usually mild or moderate in severity and transient.
If any of the following adverse effects occur, discontinue taking MAXON FORTE 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:
  • sit in a semi-upright 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 decrease or loss of vision – occurs rarely
• Severe skin reactions – occur rarely. Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area and around the eyes, fever.
• Seizures or convulsions – occur rarely

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

• Headache.

Common (may affect 1 in 10 patients):

• Nausea
• Sudden flushing of the face
• Hot flushes (symptoms include feeling of warmth in the upper body)
• Indigestion
• Seeing coloured halos, blurred vision, visual disturbances
• Nasal congestion
• Dizziness.

Uncommon (may affect 1 in 100 patients):

• Vomiting
• Skin rash
• Eye irritation
• Eye hyperaemia
• 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
• Dryness of the 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.

Rare (may affect 1 in 1000 patients):

• Fainting
• Stroke
• Myocardial infarction
• 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
• Double vision
• Decreased visual acuity
• Abnormal sensations inside the eye
• Swelling of the eyes or eyelids
• Small specks or spots in the visual field
• Seeing halos around light sources
• Pupil dilation
• Abnormal discoloration of the white part of the eye
• Bleeding from the penis
• Blood in semen
• Dry nose
• Swelling inside the nose
• Irritability
• Sudden hearing loss or hearing impairment.

Since the medicine has been marketed, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important to note that most, but not all, of the men who experienced these adverse effects had pre-existing heart conditions before taking MAXON FORTE. It is not possible to determine whether these adverse effects were related to the use of MAXON FORTE.

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
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store MAXON FORTE

Keep this medicine out of sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the blister and the outer carton 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 in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What MAXON FORTE contains

• The active substance in MAXON FORTE is sildenafil. Each tablet contains 50 mg of sildenafil (as sildenafil citrate).
• Other components of the medicine are:
  Tablet core: microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silicon dioxide.
  Tablet coating Opadry II 31F58914 white: hypromellose 15cP, lactose monohydrate, titanium dioxide (E171), macrogol 4000, sodium citrate dihydrate.

What MAXON FORTE looks like and contents of the pack
MAXON FORTE 50 mg is a white, round, film-coated tablet, biconvex, with the imprint "50" on one side.
MAXON FORTE is available in packages containing blisters with 1, 2 or 4 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