Inventum max

Before taking the medication, read the package leaflet and complete the diagnostic TEST.
Inventum Max is intended for use in men aged ≥ 18 years with erectile dysfunction,
i.e. the inability to achieve or maintain penile erection sufficient for sexual intercourse.

Package leaflet: information for the patient

Inventum Max, 50 mg, chewable tablets
Sildenafilum
Please read the entire leaflet carefully before taking this medication, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a physician or pharmacist.

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

Table of contents of the leaflet

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

1. What Inventum Max is and what it is used for

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

2. Important information before taking Inventum Max

When not to take Inventum Max

• 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 (e.g. nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, pentaerythritol tetranitrate) or drugs releasing nitric oxide (e.g. molsidomine) or the anti-anginal drug nicorandil, because their concomitant use may lead to a dangerous decrease in blood pressure. The doctor should be informed if the patient is taking any of these drugs. These drugs are often used to relieve symptoms of

angina pectoris ("chest pain"). In case of doubt, consult a doctor or
pharmacist;

• if the patient is taking other drugs or agents releasing nitric oxide (such as amyl nitrite, so-called poppers), because their concomitant use may also lead to dangerous lowering of blood pressure;
• if the patient is taking riociguat. This is a drug used in the treatment of 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 Inventum Max, enhance the blood pressure-lowering effect of this drug. If the patient is taking riociguat or is unsure about it, the doctor or pharmacist should be informed;
• if the patient has severe heart diseases such as:
• unstable coronary artery disease (manifesting as chest pain after climbing two flights of stairs within 10 seconds or during brisk walking for 20 minutes);
• ischemic heart disease (manifesting as chest pain during sexual intercourse);
• congestive heart failure class II, III, IV according to NYHA (manifesting as shortness of breath after climbing two flights of stairs within 10 seconds or during brisk walking for 20 minutes);
• if the patient has other heart diseases such as: moderate or severe heart valve disease, hypertrophic cardiomyopathy or others;
• if the patient has severe liver impairment;
• if the patient has had myocardial infarction, stroke, or life-threatening cardiac arrhythmias within the last 6 months;
• if the patient has low blood pressure (at rest below 90/50 mmHg);
• if the patient has high blood pressure (at rest above 160/100 mmHg);
• if the patient has been diagnosed with hereditary degenerative retinal disorders such as retinitis pigmentosa (retinitis pigmentosa);
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy.

Warnings and precautions
Before starting to take Inventum Max, discuss this with your doctor or pharmacist.

• If the patient has diseases increasing the risk of priapism (prolonged, painful erection), such as: sickle cell anemia (an abnormality affecting red blood cells), multiple myeloma (a bone marrow cancer), or leukemia (a blood cancer);
• if the patient has anatomical deformity of the penis or Peyronie's disease (manifesting as penile curvature);
• if the patient has heart conditions – in this case, the doctor should assess whether the condition of the heart muscle allows for the additional strain associated with sexual activity;
• if the patient has peptic ulcer disease of the stomach or duodenum or bleeding disorders (such as hemophilia);
• if the patient experiences sudden worsening of vision or sudden vision loss – in such case, treatment with Inventum Max should be discontinued and the patient should immediately contact a doctor.

Inventum Max should not be used simultaneously with other oral or topical therapies for erectile dysfunction.
Inventum Max should not be used simultaneously with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Inventum Max should not be taken by patients who do not have erectile dysfunction.
Inventum Max is not intended for use by women.

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

Children and adolescents
Inventum Max should not be used in individuals under 18 years of age.

Inventum Max and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The medicines listed below may be marketed under various brand names. Therefore, carefully check the package and leaflet of the medicine being taken to identify its active substance.
Inventum Max may interact with certain medicines, especially those used to treat chest pain. In case of worsening health requiring immediate medical attention, inform the doctor, pharmacist, or nurse about taking Inventum Max and the time of its administration. Do not take Inventum Max together with other medicines without medical advice.

Do not take Inventum Max if the patient is taking:

• nitrates (e.g. nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, pentaerythritol tetranitrate);
• drugs releasing nitric oxide (e.g. molsidomine);
• the anti-anginal drug nicorandil, because their concomitant use may cause dangerous lowering of blood pressure. These drugs are often used to relieve symptoms of angina pectoris ("chest pain"). Always inform the doctor or pharmacist if the patient is taking nitrates used to treat angina pectoris ("chest pain");
• other drugs or agents releasing nitric oxide (such as amyl nitrite, so-called poppers), because their concomitant use may also cause dangerous lowering of blood pressure.

If the patient is taking riociguat, inform the doctor or pharmacist.
Before taking Inventum Max, contact your doctor or pharmacist if the patient is taking:

• protease inhibitors (e.g. ritonavir) used in the treatment of HIV infection; in such cases, initiating treatment with a lower dose of sildenafil (25 mg) is recommended;
• alpha-blockers (e.g. doxazosin, tamsulosin, terazosin) used to treat high blood pressure or benign prostatic hyperplasia, because 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 occurred in some patients taking sildenafil together with alpha-blockers. They are most likely to occur within 4 hours after taking Inventum Max. To reduce the risk of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting Inventum Max. The doctor may decide to use a lower initial dose (25 mg) of Inventum Max. If symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending fainting) occur, the patient should lie down or sit and wait until symptoms subside; drinking water, getting fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided;
• ketoconazole (a drug used to treat fungal infections), erythromycin (an antibiotic), cimetidine (a drug for heartburn);
• drugs containing sacubitril with valsartan, used in the treatment of heart failure.

Inventum Max with food, drink, and alcohol
Inventum Max can be taken with or without food.
However, taking Inventum Max with a heavy meal may prolong the time needed for the drug to start working.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximally benefit from the therapeutic effects of Inventum Max, significant amounts of alcohol should not be consumed before taking the drug.

Pregnancy, breastfeeding, and effects on fertility
Inventum Max is not intended for use by women.

Driving and operating machinery
Inventum Max may cause dizziness and visual disturbances. Patients should determine how they react to Inventum Max before driving or operating machinery.

Inventum Max contains monohydrate lactose, aspartame, potassium, and sodium

Monohydrate lactose
The medicine contains 140.92 mg of monohydrate lactose in each tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

Aspartame
The medicine contains 4.3 mg of aspartame in each tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria.
This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

Potassium
The medicine contains 13.223 mg of potassium in each tablet.
The medicine contains less than 1 mmol (39 mg) of potassium per tablet, meaning the medicine is considered "potassium-free".

Sodium
The medicine contains 0.848 mg of sodium in each tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Inventum Max

This medicine should always be taken exactly as described in this 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 of this medicine is 50 mg. Otherwise, Inventum Max at a dose of 50 mg should only be used if the patient did not achieve the desired effect (i.e. did not achieve an erection sufficient for sexual intercourse) after taking sildenafil at a dose of 25 mg.
If taking a medicine containing sildenafil at a lower dose (25 mg) enabled an erection sufficient for sexual intercourse, the 50 mg dose of the medicine should not be used.
Inventum Max should not be taken more than once a day.
Do not take Inventum Max together with other medicines containing sildenafil (e.g. Inventum, Viagra).
Inventum Max should be taken approximately one hour before planned sexual activity.
The Inventum Max tablet should be chewed and dissolved in the mouth; the tablet does not need to be swallowed with liquid.
Inventum Max enables the achievement of an erection only in the presence of sexual stimulation. The time it takes for Inventum Max to take 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 a doctor if, after taking Inventum Max, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
If difficulties in achieving and (or) maintaining an erection recur, contact a doctor to determine the cause and further management.
If the effect of Inventum Max seems too strong or too weak, consult a doctor or pharmacist.
Taking a higher than recommended dose of Inventum Max
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 or pharmacist 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported with the use of Inventum Max are usually mild
or moderate in intensity and short-lived.
Immediately inform a doctor or go to the nearest hospital and discontinue
the use of Inventum Max if the patient experiences any of the following symptoms after taking this medicine:

• sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat;
• chest pain during or after sexual intercourse. In such case, the patient should:
• assume a semi-sitting position and try to relax;
• not take nitrates to relieve chest pain;
• abnormally prolonged and sometimes painful erection – lasting more than 4 hours;
• sudden worsening or loss of vision;
• severe skin reactions manifesting as severe peeling and swelling of the skin, formation of blisters in the mouth, genital organs, and around the eyes, fever;
• epileptic seizures or convulsions.

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

• headache.

Common (may occur in less than 1 in 10 patients):

• nausea, sudden facial redness, hot flushes (symptoms include a feeling of warmth in the upper body), indigestion,
• seeing colored halos, blurred vision, visual disturbances,
• stuffy nose, dizziness.

Uncommon (may occur in less than 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, arterial hypertension, arterial hypotension,
• muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus,
• dry mouth, stuffy or blocked sinuses, nasal mucositis (characterized by runny nose, sneezing, and nasal congestion),
• upper abdominal pain, gastroesophageal reflux disease (manifesting as heartburn),
• pain in hands or feet, nosebleeds, feeling of warmth, and feeling of fatigue, haematuria.

Rare (may occur in less than 1 in 1,000 patients):

• fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain,
• sensation of throat tightness, numbness of the lips,
• bleeding into the posterior part of the eye, double vision,
• decreased visual acuity, abnormal sensations inside the eye, eye or eyelid swelling,
• small particles or spots in the visual field, seeing halos around light sources,
• pupil dilation, abnormal discoloration of the sclera,
• rectal bleeding, presence of blood in semen, nasal dryness, nasal swelling,
• feeling of irritability, sudden weakness or loss of hearing.

Since sildenafil has been marketed, 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
sildenafil. It is not possible to determine whether these adverse reactions were related to the use of
a medicine containing sildenafil.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 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 collect further information on the safety of the medicine.

5. How to store Inventum Max

Keep the medicine out of the sight and reach of children.
Store in the original packaging, protected from light.
Do not use this medicine after the expiry date stated on the carton.
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. This will help protect the environment.

6. Contents of the pack and other information

What Inventum Max contains

• The active substance is sildenafil.
• Each tablet contains 50 mg of sildenafil, derived in situ from 70.24 mg of sildenafil citrate.
• Other ingredients are: povidone K-30, purified water, magnesium stearate, colloidal anhydrous silica, aspartame, sodium croscarmellose, peppermint flavor, lactose monohydrate, potassium polacrilin.

What Inventum Max looks like and contents of the pack
Inventum Max is a white, triangular, biconvex tablet.
The Inventum Max tablet is imprinted with the number "50" on one side.
Tablets are packed in blisters containing 1, 2, or 4 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel.: (42) 22-53-100
Manufacturer
Genepharm S.A.
18th km Marathonos Avenue
15351 Pallini Attiki
Greece
or
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
or
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów