Package leaflet: Information for the patient

MAXON, 100 mg, coated tablets
Sildenafilum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What MAXON is and what it is used for

MAXON contains the active substance sildenafil, which belongs to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax blood vessels
in the penis, thereby increasing blood flow to the penis during sexual stimulation.
MAXON helps achieve an erection only if sexual stimulation occurs beforehand.
MAXON is used to treat erectile dysfunction in adult men, i.e. impotence defined as the
inability to achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using MAXON

When not to use MAXON

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 (i.e. "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 concurrent 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, 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, discuss with a doctor, pharmacist, or nurse if the patient:

Has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a bone marrow cancer).
Has a penile anatomical deformation or Peyronie's disease.
Has heart problems. In such cases, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity.
Has peptic ulcers or bleeding disorders (such as hemophilia).
Experiences sudden worsening of vision or sudden vision loss, in which case the use of MAXON should be stopped immediately and the patient should contact a doctor without delay.

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

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to prescribe a lower dose of MAXON.

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

MAXON and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
MAXON may interact with certain medicines, particularly those used to treat chest pain. If the patient's health deteriorates and immediate medical assistance is required, inform the doctor, pharmacist, or nurse about the intake of MAXON and the time it was taken. MAXON must not be taken together with other medicines without a doctor's recommendation.
Do not take MAXON if the patient is using nitrates, as their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates used to treat angina (i.e. "chest pain").
Do not take MAXON if the patient is using 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, inform the doctor or pharmacist.
For patients taking protease inhibitors used in the treatment of HIV infection, it is recommended to start treatment with a lower dose (25 mg) of MAXON.
Some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting. Such symptoms have occurred in some patients taking sildenafil and alpha-blockers concomitantly. These symptoms are most likely to occur within 4 hours after taking MAXON. To reduce the likelihood of such symptoms, the patient should be on a stable dose regimen of their alpha-blocker before starting MAXON. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of MAXON.
If the patient is taking medicines containing sacubitril with valsartan (used in the treatment of heart failure), they should inform their doctor or pharmacist.

Taking MAXON with food, drink, and alcohol
MAXON can be taken with or without food. However, taking MAXON 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 benefit of MAXON, significant alcohol intake should be avoided before taking the medicine.

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

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

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

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

3. How to use MAXON

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist. The recommended starting dose is 50 mg.
MAXON must not be taken more than once a day.
Do not take MAXON coated tablets simultaneously with other medicines containing
sildenafil (e.g. Viagra).
MAXON should be taken approximately one hour before planned sexual activity.
Swallow the tablet whole with a glass of water.
If you feel that the effect of MAXON is too strong or too weak, consult your
doctor or pharmacist.
MAXON enables an erection to occur only in the presence of sexual stimulation. The time
until MAXON takes effect varies between patients, usually ranging 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, an erection does not occur, or if the duration of the erection
is insufficient for sexual intercourse.
Taking a higher than recommended dose of MAXON
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 prescribed by your doctor.
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, pharmacist, or nurse.

4. Possible adverse reactions

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

Allergic reaction – occurs not commonly (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 not commonly. If chest pain occurs during or after sexual intercourse:
- adopt 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 in 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 skin peeling and swelling, formation of blisters in the mouth, genital area and around the eyes, fever.
Seizures or convulsions – occur rarely

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

Headache.

Common (may affect up to 1 in 10 patients):

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

Not common (may affect up to 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
Nausea
Dry mouth
Blocked or stuffy sinuses
Nasal mucositis (symptoms include runny nose, sneezing and blocked nose)
Upper abdominal pain
Gastroesophageal reflux disease (symptoms include heartburn)
Blood in urine
Pain in hands or feet
Nosebleeds
Sensation of warmth
Feeling of fatigue.

Rare (may affect up to 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
Double vision
Reduced visual acuity
Abnormal sensations inside the eye
Swelling of the eyes or eyelids
Small specks 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 semen
Dry nose
Swelling inside the nose
Irritability
Sudden hearing loss.

Since the introduction of the medicine 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 adverse reactions, cardiac disorders were present prior to taking MAXON.
It is not possible to determine whether these adverse reactions were related to the use of MAXON.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions,
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
2-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store MAXON medicine

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

6. Contents of the packaging and other information

What MAXON medicine contains

The active substance in MAXON is sildenafil. Each tablet contains 100 mg of sildenafil (as sildenafil citrate).
The other ingredients in the medicine are:
Tablet core: microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica.
Tablet coating: Opadry II 31F58914 white: hypromellose 15cP, lactose monohydrate, titanium dioxide (E171), polyethylene glycol 4000, disodium hydrogen citrate dihydrate.

What MAXON looks like and contents of the pack
MAXON 100 mg is a white, film-coated, capsule-shaped tablet, biconvex, with "100" embossed on one side.
MAXON is available in packs containing blisters of 1 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
GRAŻYNA ANNA
MARCINIAK