Inventum

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

Package leaflet: information for the patient

INVENTUM, 25 mg, chewable tablets
Sildenafilum
Please read this leaflet carefully before taking this medicine because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult your pharmacist.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if the patient feels worse, contact the doctor.

Contents of the leaflet

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

1. What Inventum is and what it is used for

Inventum 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. Inventum helps achieve an erection only if the patient is sexually stimulated.
Inventum is used in adult men for the treatment of erectile dysfunction, defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. 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 drugs that release nitric oxide (e.g. molsidomine), or the anti-anginal drug nicorandil, as concomitant use may lead to dangerous lowering of blood pressure. The doctor should be informed if the patient is taking any of these drugs. These medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult a doctor or pharmacist;
• if the patient is using amyl nitrite or amyl nitrate used as recreational drugs (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 medicine 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). PDE5 inhibitors such as Inventum have been shown to 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 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 classification (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 disorders, hypertrophic cardiomyopathy, or others;
• if the patient has severe liver impairment;
• if the patient has had a myocardial infarction, stroke, or life-threatening cardiac 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 inherited degenerative retinal disorders such as retinitis pigmentosa;
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy.

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

• If the patient has conditions increasing the risk of priapism (prolonged, painful erection), such as: sickle cell anemia (an abnormality of red blood cells), multiple myeloma (a bone marrow cancer), or leukemia (a blood cancer);
• if the patient has anatomical penile deformity or Peyronie's disease (manifesting as penile curvature);
• if the patient has heart problems – in this case, the doctor should assess whether the cardiac condition allows for the additional strain associated with sexual activity;
• if the patient has peptic ulcer disease or coagulation disorders (such as hemophilia);
• if the patient experiences sudden worsening of vision or sudden vision loss – in such case, Inventum should be discontinued immediately and the patient should contact a doctor or pharmacist without delay;
• if the patient has severe renal impairment, the dose should not exceed 25 mg.

Inventum must not be used concurrently with other oral or topical treatments for erectile dysfunction.
Inventum must not be used concurrently with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Inventum should not be taken if erectile dysfunction has not been diagnosed.
Inventum is not intended for use in women.
Children and adolescents
Inventum must not be used in individuals under 18 years of age.

Inventum 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.
Inventum may interact with certain medicines, especially those used to treat chest pain. In case of worsening health requiring immediate medical attention, inform the doctor or pharmacist about taking Inventum and the time of its administration. Do not take Inventum together with other medicines without medical advice.

Do not take Inventum if the patient is using:

• nitrates (e.g. nitroglycerin, isosorbide mononitrate, isosorbide dinitrate);
• 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 (chest pain). Always inform the doctor or pharmacist if the patient is taking nitrates used to treat angina (chest pain);
• amyl nitrite or amyl nitrate used as recreational drugs (so-called poppers), because their concomitant use may also cause dangerous lowering of blood pressure.

If the patient is already taking riociguat, inform the doctor or pharmacist.
Contact a doctor or pharmacist before taking Inventum if the patient is using:

• protease inhibitors used in the treatment of HIV infection, such as ritonavir;
• α-adrenolytic drugs used to treat high blood pressure or benign prostatic hyperplasia, such as doxazosin, 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 been reported in some patients taking sildenafil and α-adrenolytic drugs concomitantly. These are most likely to occur within 4 hours after taking Inventum. To reduce the likelihood of such symptoms, the patient should be on a stable dose regimen of their α-adrenolytic medicine before starting Inventum;
• medicines containing sacubitril with valsartan, used in the treatment of heart failure.

Use of Inventum with food, drink, and alcohol
Inventum may be taken with or without food. However, taking Inventum with a heavy meal may delay the onset of its action.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of Inventum, significant amounts of alcohol should not be consumed before taking the medicine.
Pregnancy, breastfeeding, and effects on fertility
Inventum is not intended for use in women.

Driving and using machines
Inventum may cause dizziness and visual disturbances. Patients should assess how they react to Inventum before driving or operating machinery.
Inventum contains lactose monohydrate, aspartame, potassium, and sodium
Lactose monohydrate
The medicine contains 70.46 mg of lactose per tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Aspartame
The medicine contains 2.15 mg of aspartame per 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 impaired excretion.
Potassium
The medicine contains 6.611 mg of potassium per 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 0.424 mg of sodium per 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

This medicine should always be taken exactly as described in this patient leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose
1 tablet (25 mg) per day – taken as needed, approximately one hour before planned sexual activity.
After consultation with a doctor and depending on the response to the medicine, the dose may be increased.
The tablet should be chewed and dissolved in the mouth; it does not require to be taken with water.

Inventum must not be taken more than once a day.

Inventum enables an erection only if there is sexual stimulation. The time it takes for Inventum to work varies between patients, but usually ranges 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 Inventum, an erection is not achieved, or if the duration of erection is insufficient for sexual intercourse.

If difficulties in achieving and (or) maintaining an erection recur, contact your doctor to determine the cause and further management.

If you feel that the effect of Inventum is too strong or too weak, consult your doctor or pharmacist.

Taking more Inventum than recommended
If an overdose is taken, side 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.
Contact your doctor or pharmacist if you have taken more tablets than recommended.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported with the use of Inventum are usually mild or
moderately severe and short-lived.

You should immediately inform a doctor or go to the nearest hospital if
the patient experiences any of the following symptoms after taking Inventum:

• sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat;
• if during or after sexual intercourse the patient experiences chest pain, they should assume a semi-sitting position and try to relax;
• do not take nitrates to relieve chest pain;
• abnormally prolonged and sometimes painful erection – lasting more than 4 hours;
• sudden decrease or loss of vision;
• severe skin reactions characterized by severe skin peeling and swelling, formation of blisters in the mouth, genital areas and around the eyes, fever;
• seizures or convulsions.

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 feeling of warmth in the upper
part of the body), indigestion, seeing coloured tinge, blurred vision, visual disturbances,
stuffy nose, dizziness.
Uncommon (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,
tearing, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain,
drowsiness, reduced sense of touch, dizziness, ringing in the ears, dry mouth,
blocked or stuffy sinuses, inflammation of the nasal mucosa (characterized by runny nose, sneezing
and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (characterized by
heartburn), blood in urine, pain in hands or legs, nosebleeds, feeling of warmth and 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, sensation of tightness in the throat, 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 particles or spots in the visual field, seeing halos around light sources,
pupil dilation, abnormal discoloration of the white part of the eye; rectal bleeding, presence of blood
in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden hearing loss.
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, heart problems were already present before taking Inventum.
It is not possible to determine whether these adverse reactions were related to the use of Inventum.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should 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 may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Inventum

Keep this medicine out of the 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 stated month.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Inventum contains

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

What Inventum looks like and contents of the pack
Inventum is a white, triangular, biconvex tablet.
The Inventum tablet is engraved with the number "25" on one side.
Pack sizes: 2, 4 or 8 tablets.
Marketing Authorization Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel.: (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