Maxon forte

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Leaflet attached to the packaging: patient information

MAXON FORTE, 50 mg, 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 tell 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 FORTE and what is it 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 is MAXON FORTE and what is it used for

MAXON FORTE 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 the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. MAXON FORTE helps achieve an erection only if there is prior sexual stimulation. MAXON FORTE is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking MAXON FORTE

When not to take 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 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, also known as "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 FORTE, 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 retinal disorders, such as retinitis pigmentosa.
• If the patient has ever experienced loss of vision due to non-inflammatory ischemic optic neuropathy.

Warnings and precautions

Before starting to take MAXON FORTE, the patient should discuss this with their doctor or pharmacist in the following cases:

• Sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or 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 strain associated with sexual activity.
• Ulcer or bleeding disorders (such as hemophilia).
• If the patient experiences sudden vision loss or sudden blindness, they should stop taking MAXON FORTE and immediately consult their doctor.

MAXON FORTE should not be taken concurrently with other oral or topical treatments for erectile dysfunction. MAXON FORTE should not be taken concurrently with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors. MAXON FORTE should not be taken if the patient has not been diagnosed with erectile dysfunction. MAXON FORTE is not intended for women. Special considerations for patients with renal or hepatic impairmentPatients with renal or hepatic impairment should inform their doctor. Patients with renal or hepatic impairment should not take a dose of MAXON FORTE higher than 25 mg.

Children and adolescents

MAXON FORTE should not be taken by individuals under the age of 18.

MAXON FORTE 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 FORTE 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 FORTE and the time of taking it. The patient should not take MAXON FORTE concurrently with other medicines without their doctor's advice. The patient should not take MAXON FORTE if they are 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"). The patient should not take MAXON FORTE if they are taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent use may also lead to 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 FORTE. 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 have occurred in some patients taking MAXON FORTE and alpha-adrenergic blockers concurrently. Their occurrence is most likely within 4 hours of taking MAXON FORTE. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take MAXON FORTE. The doctor may decide to use a lower initial dose (25 mg) of MAXON FORTE. 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.

MAXON FORTE with food, drink, and alcohol

MAXON FORTE can be taken with or without food. Although taking MAXON FORTE during a heavy 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 FORTE, the patient should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

MAXON FORTE is not intended for use by women.

Driving and using machines

MAXON FORTE may cause dizziness and vision 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 previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

MAXON FORTE 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 FORTE

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If the patient has previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, MAXON FORTE in a dose of 50 mg should only be taken if the patient did not experience the desired effect after taking sildenafil in a dose of 25 mg (i.e., they did not achieve an erection sufficient for sexual intercourse). If taking a lower dose of sildenafil (25 mg) allowed the patient to achieve an erection sufficient for sexual intercourse, they should not take a dose of 50 mg. MAXON FORTE should not be taken more than once a day.The patient should not take MAXON FORTE concurrently with other medicines containing sildenafil (e.g., Viagra). MAXON FORTE should be taken approximately one 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 FORTE is too strong or too weak, they should consult their doctor or pharmacist. MAXON FORTE allows for an erection only if there is prior sexual stimulation. The time after which the effect of MAXON FORTE occurs varies among patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal. The patient should consult their doctor if they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse after taking MAXON FORTE.

Taking a higher dose of MAXON FORTE 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 increase the efficacy 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. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

In case of any of the following side effects, the patient should stop taking MAXON FORTE and immediately seek 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 uncommonlyIf 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 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 - occur rarely
• Severe skin reactions - occur rarelySymptoms 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 up to 1 in 10 patients):

• Nausea
• Sudden flushing
• Hot flashes (symptoms include a feeling of heat in the upper body)
• Indigestion
• Visual disturbances, blurred vision, color tinge to vision
• Nasal congestion
• Dizziness.

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

• Vomiting
• Rash
• Eye irritation
• Conjunctivitis
• Eye pain
• Flashes of light
• Increased sensitivity to light
• Excessive tearing
• Pounding heart
• Fast heartbeat
• Hypertension
• Hypotension
• Muscle pain
• Somnolence
• Impaired sense of touch
• Dizziness
• Ringing in the ears
• Dry mouth
• Blocked or stuffy sinuses
• Nasal inflammation (symptoms include runny nose, sneezing, and stuffy nose)
• Upper abdominal pain
• Gastroesophageal reflux disease (symptoms include heartburn)
• Blood in urine
• Pain in 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
• Transient reduction in blood flow to part of the brain
• Feeling of tightness in the throat
• Numbness of the lips
• Bleeding at 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 field of vision
• Seeing halos around light sources
• Pupil dilation
• Abnormal discoloration of the white of the eye
• Bleeding from the penis
• Presence of blood in semen
• Nasal dryness
• Nasal swelling
• Feeling of irritability
• Sudden hearing loss.

After the medicine was placed on 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 problems existed before taking MAXON FORTE. It is not possible to determine whether these side effects were related to the use of MAXON FORTE.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw tel.: 22 49-21-301 fax: 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 FORTE

The medicine should be stored out of sight and reach of children. There are no special precautions for storing the medicine. The patient should not use this medicine 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 FORTE contains

• The active substance of MAXON FORTE is sildenafil. Each tablet contains 50 mg of sildenafil (as sildenafil citrate).
• The other ingredients of the medicine are: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, magnesium stearate, 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, convex on both sides, with the inscription "50" on one side. MAXON FORTE is available in packs containing blisters of 1, 2, or 4 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: