INVENTUM 50 mg Tablets

Contents of the leaflet

1. What is Inventum Max and what is it used for
2. Important information before taking Inventum Max
   1. When not to take Inventum Max
   2. Warnings and precautions
   3. Children and adolescents
   4. Inventum Max and other medicines
   5. You should not take Inventum Max if you are taking:
   6. Inventum Max with food, drinks, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Inventum Max contains lactose monohydrate, aspartame, potassium, and sodium
   10. Lactose monohydrate
   11. Aspartame
   12. Potassium
   13. Sodium
3. How to take Inventum Max
   1. You should not take Inventum Max more than once a day.
   2. Taking a higher dose of Inventum Max than recommended
   3. You should not take more tablets than indicated in the patient leaflet.
4. Possible side effects
   1. You should immediately inform your doctor or go to the nearest hospital and stop taking Inventum Max if you experience any of the following symptoms after taking this medicine:
   2. Other side effects:
   3. Reporting side effects
5. How to store Inventum Max
6. Contents of the pack and other information
   1. What Inventum Max contains
   2. What Inventum Max looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

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

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

2. Important information before taking Inventum Max

When not to take Inventum Max

• if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6);
• if you are taking nitrates(e.g. nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, pentaerythritol tetranitrate) or medicines that release nitric oxide (e.g. molsidomine) or anti-clotting medicine - nicorandil, as their concurrent use may lead to dangerous lowering of blood pressure. You should inform your doctor if you are taking any of these medicines. These medicines are often used to relieve symptoms of

angina pectoris („chest pain”). In case of doubt, you should consult your doctor or pharmacist;
if you are taking other medicines or agents that release nitric oxide (such as amyl nitrite, so-called poppers), as their concurrent use may also lead to dangerous lowering of blood pressure;

Warnings and precautions

Before starting to take Inventum Max, you should discuss it with your doctor or pharmacist.

• If you have diseases that increase the risk of priapism (prolonged, painful erection) such as sickle cell anemia (a disorder affecting red blood cells), multiple myeloma (a bone marrow cancer) or leukemia (a blood cancer);
• if you have anatomical deformation of the penis or Peyronie's disease (manifested by curvature of the penis);
• if you have heart problems - in this case, your doctor should assess whether your heart condition allows for the additional effort associated with sexual activity;
• if you have stomach or duodenal ulcers or bleeding disorders (such as hemophilia);
• if you have experienced sudden vision loss or sudden loss of vision - in this case, you should stop taking Inventum Max and immediately contact your doctor.

Inventum Max should not be used in combination with other oral or topical treatments for erectile dysfunction.
Inventum Max should not be used in combination with treatments for pulmonary arterial hypertension (PAH) using 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 women.
Special considerations for patients with renal impairment
Patients with renal impairment should inform their doctor. Patients with renal impairment should not take a dose of sildenafil higher than 25 mg.

Children and adolescents

Inventum Max should not be used in persons under 18 years of age.

Inventum Max and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The following medicines may be available under different trade names. Therefore, you should carefully check the packaging and leaflet of the medicine you are taking to see what the active substance is.
Inventum Max may interact with some medicines, especially those used to treat chest pain. In case of deterioration of your health requiring immediate medical attention, you should inform your doctor, pharmacist, or nurse about taking Inventum Max and the time of its intake. You should not take Inventum Max with other medicines without your doctor's advice.

You should not take Inventum Max if you are taking:

• nitrates (e.g. nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, pentaerythritol tetranitrate);
• medicines that release nitric oxide (e.g. molsidomine);
• anti-clotting medicine - nicorandil, as their concurrent use may cause dangerous lowering of blood pressure. These medicines are often used to relieve symptoms of angina pectoris („chest pain”). You should always inform your doctor or pharmacist if you are taking nitrates, which are used to treat angina pectoris („chest pain”);
• other medicines or agents that release nitric oxide (such as amyl nitrite, so-called poppers), as their concurrent use may also cause dangerous lowering of blood pressure.

If you are taking riociguat, you should inform your doctor or pharmacist.
Before taking Inventum Max, you should contact your doctor or pharmacist if you are taking:

• protease inhibitors (e.g. ritonavir) used to treat HIV infections; in this case, it is recommended to start treatment with a lower dose of sildenafil (25 mg);
• alpha-adrenergic blockers (e.g. doxazosin, tamsulosin, terazosin) used to treat high blood pressure or prostate enlargement, as dizziness or fainting may occur, which may be symptoms of low blood pressure, caused by a drop in blood pressure when standing up or sitting down quickly. Such symptoms occurred in some patients taking sildenafil and alpha-adrenergic blockers concurrently. Their occurrence is most likely within 4 hours of taking Inventum Max. To reduce the risk of these symptoms, you should regularly take your fixed dose of alpha-adrenergic blocker before starting to take Inventum Max. Your doctor may decide to use a lower initial dose (25 mg) of Inventum Max. If symptoms of low blood pressure (dizziness, fainting, feeling of impending fainting) occur, you should first lie down or sit and wait for the symptoms to pass, drinking water may also help, as well as taking fresh air, tensing abdominal muscles, crossing legs. You should avoid standing up or sitting down quickly;
• ketokonazole (an antifungal medicine), erythromycin (an antibiotic), cimetidine (a medicine for heartburn);
• medicines containing sacubitril with valsartan, used to treat heart failure.

Inventum Max with food, drinks, and alcohol

Inventum Max can be taken with or without food.
However, taking Inventum Max while eating large meals 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 effects of Inventum Max, you should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Inventum Max is not intended for use in women.

Driving and using machines

Inventum Max may cause dizziness and vision disturbances. Before driving or operating machines, you should find out how you react to Inventum Max.

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

Lactose monohydrate

The medicine contains 140.92 mg of lactose monohydrate in each tablet.
If you have been diagnosed with intolerance to some sugars, you should contact your 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 its 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, which means 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, which means 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 advised by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
If you have previously taken medicines containing sildenafil in a dose of 50 mg or higher, the recommended dose of the medicine is 50 mg. Otherwise, Inventum Max in a dose of 50 mg should only be used if you did not experience the desired effect after taking sildenafil in a dose of 25 mg (i.e. you did not achieve an erection sufficient for sexual intercourse).
If taking a lower dose of sildenafil (25 mg) allowed you to achieve an erection that enabled you to have sexual intercourse, you should not take the medicine in a dose of 50 mg.

You should not take Inventum Max more than once a day.

You should not take Inventum Max at the same time as other medicines containing sildenafil (e.g. Inventum, Viagra).
Inventum Max should be taken about an hour before planned sexual activity.
The Inventum Max tablet should be chewed and dissolved, the tablet does not require drinking.
Inventum Max allows you to achieve an erection only if there is prior sexual stimulation. The time after which the effect of Inventum Max occurs varies from person to person, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a large meal.
You should contact your doctor if, after taking Inventum Max, you do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.
If problems with achieving and/or maintaining an erection recur, you should contact your doctor to determine the cause and further action.
If you feel that the effect of Inventum Max is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Inventum Max 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 mean increased efficacy of the medicine.

You should not take more tablets than indicated in the patient leaflet.

You should contact your doctor or pharmacist if you have taken more tablets than recommended.
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

You should immediately inform your doctor or go to the nearest hospital and stop taking Inventum Max if you experience any of the following symptoms after taking this medicine:

• sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat;
• if during or after sexual intercourse you experience chest pain. You should then:
• take a semi-sitting position and try to relax;
• not take nitratesto relieve chest pain;
• prolonged and sometimes painful erection - lasting more than 4 hours;
• sudden vision loss or sudden loss of vision;
• severe skin reactions characterized by severe peeling and swelling of the skin, blistering in the mouth, on the genitals, and around the eyes, fever;
• seizures or convulsions.

Other side effects:

Very common(may affect more than 1 in 10 people):

• headache.

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

• nausea, sudden flushing of the face, hot flushes (symptoms include a feeling of heat in the upper part of the body), indigestion,
• seeing with a colored aura, blurred vision, vision disturbances,
• feeling of a blocked nose, dizziness.

Uncommon(may affect up to 1 in 100 people):

• vomiting, skin rash,
• eye irritation, conjunctivitis, eye pain, seeing flashes of light, dazzled vision, sensitivity to light, tearing of the eyes,
• palpitations, rapid heartbeat, high blood pressure, low blood pressure,
• muscle pain, drowsiness, decreased sensation of touch, dizziness of labyrinthine origin, ringing in the ears,
• dry mouth, blocked or stuffy sinuses, rhinitis (manifested by runny nose, sneezing, and stuffy nose),
• upper abdominal pain, gastroesophageal reflux disease (manifested by heartburn),
• arm or leg pain, nosebleeds, feeling of heat and feeling of fatigue, hematuria.

Rare(may affect up to 1 in 1,000 people):

• fainting, stroke, heart attack, irregular heartbeat, transient reduction of blood flow to part of the brain,
• feeling of pressure in the throat, numbness of the lips,
• bleeding in the back of the eye, double vision,
• reduced visual acuity, abnormal sensations in the eye, swelling of the eyes or eyelids,
• small particles or dots in the field of vision, seeing halos around light sources,
• pupil dilation, abnormal discoloration of the white of the eye,
• penile bleeding, presence of blood in semen, dry nose, swelling inside the nose,
• feeling of irritability and sudden weakness or loss of hearing.

After the introduction of sildenafil to the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important that in most, but not all men who experienced these side effects, heart disease was present before taking sildenafil. It is not possible to determine whether these side effects were related to the use of the medicine containing sildenafil.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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, you can help provide more information on the safety of this medicine.

5. How to store Inventum Max

Medicine should be stored out of sight and reach of children.
Store in the original packaging to protect 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Inventum Max contains

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

What Inventum Max looks like and contents of the pack

Inventum Max is a white, triangular, biconvex tablet.
The Inventum Max tablet has the number „50” embossed on one side.
The tablets are packaged 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.
Partyzancka 133/151
95-200 Pabianice
Phone: (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.
Szkolna 31
95-054 Ksawerów

Date of last revision of the leaflet: