INVENTUM 25 mg Tablets

Contents of the leaflet

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

1. What is Inventum and what is it used for

Inventum 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 helps achieve an erection only if there is prior sexual stimulation.
Inventum is used in adult men to treat erectile dysfunction, defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Inventum

When not to take Inventum:

• 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) or medicines that release nitric oxide (e.g., molsidomine) or the anti-clotting medicine - nicorandil, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any of these medicines. These medicines are often used to alleviate symptoms of angina pectoris ("chest pain"). In case of doubt, the patient should consult their doctor or pharmacist;
• if the patient is taking amyl nitrite or amyl nitrate used as recreational drugs (so-called 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 Inventum, enhance the blood-pressure-lowering effect of this medicine. If the patient is unsure whether they are taking riociguat, they should inform their doctor or pharmacist;
• if the patient has severe heart diseases such as:
• unstable angina (manifested by chest pain when climbing the second floor within 10 seconds or dynamic walking for 20 minutes);
• ischemic heart disease (manifested by chest pain during sexual intercourse);
• congestive heart failure II, III, IV in the NYHA class (manifested by shortness of breath when climbing the second floor within 10 seconds or dynamic walking for 20 minutes);
• if the patient has other heart diseases such as moderate or severe valve disease, hypertrophic cardiomyopathy, or other;
• if the patient has severe liver failure;
• if the patient has had a heart attack, stroke, or life-threatening arrhythmias within the last 6 months;
• if the patient has low resting blood pressure below 90/50 mmHg;
• if the patient has high resting blood pressure above 170/100 mmHg;
• if the patient has been diagnosed with hereditary degenerative changes in the retina, such as retinitis pigmentosa;
• if the patient has ever experienced vision loss due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Inventum, the patient should discuss it with their doctor or pharmacist.

• If the patient has 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 the patient has anatomical deformation of the penis or Peyronie's disease (manifested by penis curvature);
• if the patient has heart problems - in this case, the doctor should assess whether the heart muscle condition allows for additional effort related to sexual activity;
• if the patient has stomach ulcers, duodenal ulcers, or bleeding disorders (such as hemophilia);
• if the patient has experienced sudden vision loss or sudden hearing loss - in this case, they should stop taking Inventum and immediately contact their doctor or pharmacist;
• if the patient has severe kidney problems and should not take a dose higher than 25 mg.

Inventum should not be used with other oral or topical treatments for erectile dysfunction.
Inventum should not be used with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.
Inventum should not be taken if erectile dysfunction has not been diagnosed.
Inventum is not intended for women.

Children and adolescents

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

Inventum 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.
Inventum may interact with some medicines, especially those used to treat chest pain. In case of a worsening condition requiring immediate medical attention, the patient should inform their doctor or pharmacist about taking Inventum and the time of its administration. Inventum should not be taken with other medicines without a doctor's recommendation.

Do not take Inventum if you are taking:

• nitrates (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate);
• medicines that release nitric oxide (e.g., molsidomine);
• the anti-clotting medicine - nicorandil, as their concurrent use may cause a dangerous decrease in blood pressure. These medicines are often used to alleviate symptoms of angina pectoris ("chest pain"). The patient should always inform their doctor or pharmacist if they are taking nitrates used to treat angina pectoris ("chest pain");
• amyl nitrite or amyl nitrate used as recreational drugs (so-called poppers), as their concurrent use may also cause a dangerous decrease in blood pressure.

If the patient is already taking riociguat, they should inform their doctor or pharmacist.
Before taking Inventum, the patient should contact their doctor or pharmacist if they are taking:

• protease inhibitors used to treat HIV infections, such as ritonavir;
• alpha-adrenergic blockers used to treat high blood pressure or prostate enlargement, such as doxazosin, as they may cause dizziness or lightheadedness, which can be symptoms of low blood pressure, caused by a decrease in blood pressure when standing up or sitting quickly. Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours of taking Inventum. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Inventum;
• medicines containing sacubitril with valsartan, used to treat heart failure.

Taking Inventum with food, drink, and alcohol

Inventum can be taken with or without food. However, taking Inventum while eating a large 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 Inventum, the patient should not consume significant amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Inventum is not intended for use by women.

Driving and using machines

Inventum may cause dizziness and vision disturbances. Patients should be aware of how they react to Inventum before driving or operating machines.

Inventum contains lactose monohydrate, aspartame, potassium, and sodium

Lactose monohydrate

The medicine contains 70.46 mg of lactose in each tablet.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Aspartame

The medicine contains 2.15 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 6.611 mg of potassium in each tablet.
The medicine contains less than 1 mmol (39 mg) of potassium per tablet, which means it is considered "potassium-free".

Sodium

The medicine contains 0.424 mg of sodium in each tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Inventum

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended dose

1 tablet (25 mg) per day - taken as needed - about an hour before planned sexual activity.
After consulting a doctor and depending on the response to the medicine, the dose may be increased.
The tablet should be chewed and dissolved, without swallowing.
Inventum should not be taken more than once a day.
Inventum allows for an erection only if there is prior sexual stimulation. The time after which the effect of Inventum 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 large meal.
The patient should contact their doctor if, after taking Inventum, they 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 occur again, the patient should contact their doctor to determine the cause and further action.
If the patient feels that the effect of Inventum is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Inventum 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 an increase in the medicine's effectiveness.
The patient should contact their doctor or pharmacist if they have taken more tablets than the recommended dose.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately inform their doctor or go to the nearest hospital if they experience the following symptoms after taking Inventum:

• sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat;
• if during sexual intercourse or after it the patient experiences chest pain, they should take a half-sitting position and try to relax;
• do not take nitratesto alleviate chest pain;
• prolonged and sometimes painful erection - lasting more than 4 hours;
• sudden vision loss or hearing loss;
• 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 patients):
headache.
Common(may affect up to 1 in 10 patients):
nausea, sudden flushing, hot flashes (symptoms include a feeling of heat in the upper body), indigestion, colored vision, blurred vision, vision disturbances, stuffy nose, dizziness.
Uncommon(may affect up to 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctivitis, eye pain, flashes of light, bright vision, sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, decreased sensation, dizziness, ringing in the ears, dry mouth, stuffy or congested nose, sinusitis (manifested by runny nose, sneezing, and stuffy nose), stomach pain, gastroesophageal reflux disease (manifested by heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of heat, and feeling of fatigue.
Rare(may affect up to 1 in 1,000 patients):
fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to a part of the brain, feeling of compression in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensations in the eye, swelling of the eyes or eyelids, small particles or spots 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, nasal congestion, feeling of irritability, and sudden hearing loss 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 essential to note that in most, but not all, men who experienced these side effects, heart function disorders occurred before taking Inventum.
It is not possible to determine whether these side effects were related to the use of Inventum.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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, more information can be collected on the safety of the medicine.

5. How to store Inventum

The 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. 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 Inventum contains

• The active substance of Inventum is sildenafil. Each tablet contains 25 mg of sildenafil formed in situ from 35.12 mg of sildenafil citrate.
• Other ingredients are: polacrilin potassium, purified water, magnesium stearate, anhydrous colloidal silica, aspartame, sodium croscarmellose, peppermint flavor, lactose monohydrate, povidone K-30.

What Inventum looks like and what the pack contains

Inventum is a white, triangular, biconvex tablet.
The Inventum tablet has the number "25" embossed on one side.
The packaging of Inventum is: 2, 4, or 8 tablets.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
Genepharm S.A.
18th km Marathonos Avenue
15351 Pallini Attiki
Greece
or
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
or
Rontis Hellas Medical and Pharmaceutical Products S.A.,
P.O. Box 3012 Larisa Industrial Area,
Larisa, 41004, Greece

Date of last revision of the leaflet: