Inventum 100

1. What is Inventum 100 and what is it used for

Inventum 100 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. Inventum 100 helps to achieve an erection only if there is prior sexual stimulation.
Inventum 100 is used to treat erectile dysfunction in adult men, defined as the inability to achieve or maintain an erection sufficient for sexual intercourse.

2. Important information before taking Inventum 100

When not to take Inventum 100

• 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, consult a doctor or pharmacist.
• If the patient is taking medicines that release nitric oxide (such as amyl nitrite, 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 100, 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, and in cases of low blood pressure.
• 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 100, the patient should discuss it with their doctor or pharmacist.

• if the patient has sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow);
• if the patient has an anatomical deformation of the penis or Peyronie's disease;
• if the patient has heart problems - in this case, the doctor should assess whether the patient's heart condition allows for the additional strain associated with sexual activity;
• if the patient has stomach ulcers or bleeding disorders (such as hemophilia);
• if the patient has experienced sudden vision loss or sudden blindness - in this case, the patient should stop taking Inventum 100 and seek medical help immediately.

Inventum 100 should not be used at the same time as other oral or topical treatments for erectile dysfunction.
Inventum 100 should not be used at the same time as treatments for pulmonary arterial hypertension (PAH) using sildenafil or other PDE5 inhibitors.
Inventum 100 should not be taken if erectile dysfunction has not been diagnosed.
Inventum 100 is not intended for women.
Use of Inventum 100 in patients with kidney or liver function disorders
Patients with kidney or liver function disorders should inform their doctor. The doctor may decide to use a lower dose of Inventum 100.

Children and adolescents

Inventum 100 should not be used in persons under 18 years of age.

Inventum 100 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 100 may interact with some medicines, especially those used to treat chest pain. If the patient's condition worsens and requires immediate medical attention, they should inform their doctor, pharmacist, or nurse about taking Inventum 100 and the time of taking it. The patient should not take Inventum 100 with other medicines without their doctor's advice.
The patient should not use Inventum 100 if they are taking nitrate medicines, as their concurrent use may cause a dangerous decrease in blood pressure. The patient should always inform their doctor, pharmacist, or nurse if they are taking nitrates, which are used to treat angina pectoris (chest pain).
The patient should not use Inventum 100 if they are taking medicines that release nitric oxide (such as amyl nitrite), as their concurrent use may cause a dangerous decrease in blood pressure.
If the patient is already taking riociguat, they should inform their doctor or pharmacist.
If the patient is taking protease inhibitors used to treat HIV infections, it is recommended to start treatment with the lowest dose (25 mg) of Inventum 100.
In some patients who are 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 occurred in some patients taking Inventum 100 and alpha-adrenergic blockers. Their occurrence is most likely within 4 hours after taking Inventum 100. To reduce the possibility of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blocker before starting to take Inventum 100. The doctor may decide to use a lower initial dose (25 mg) of Inventum 100.
If the patient is taking medicines containing sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

Using Inventum 100 with food, drink, and alcohol

Inventum 100 can be taken with or without food.
Although taking Inventum 100 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 100, the patient should not consume large amounts of alcohol before taking the medicine.

Pregnancy, breastfeeding, and fertility

Inventum 100 is not intended for use by women.

Driving and using machines

Inventum 100 may cause dizziness and vision disturbances. Patients should be aware of how they react to Inventum 100 before driving or operating machinery.

Inventum 100 contains lactose monohydrate, aspartame, potassium, and sodium

Lactose monohydrate

The medicine contains 281.83 mg of lactose monohydrate 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 8.6 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 26.445 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 1.695 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 100

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended initial dose is 50 mg.
Inventum 100 should not be taken more than once a day.
Inventum 100 should be taken about an hour before planned sexual activity.
The tablet should be chewed and dissolved in the mouth.
If the patient feels that the effect of Inventum 100 is too strong or too weak, they should consult their doctor or pharmacist.
Inventum 100 allows for an erection only if there is prior sexual stimulation. The time after which the effect of Inventum 100 occurs varies from patient to patient, 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 consult their doctor if, after taking Inventum 100, they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse.

Taking a higher dose of Inventum 100 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 effectiveness of the medicine.
The patient should not take more tablets than prescribed by their doctor.
The patient should consult their doctor if they have taken more tablets than recommended.
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Inventum 100 can cause side effects, although not everybody gets them.
Side effects reported in connection with the use of Inventum 100 are usually mild or moderate and short-lived.

In case of any of the following side effects, the patient should stop taking Inventum 100 and seek medical help immediately:

• 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 seek medical help immediately.
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 1 in 10 patients):
nausea, sudden flushing, hot flashes (symptoms include a feeling of heat in the upper body), indigestion, seeing a colored glow, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommon(may occur in 1 in 100 patients): vomiting, skin rash, eye irritation, conjunctival hyperemia, eye pain, seeing flashes of light, bright vision, sensitivity to light, tearing, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, drowsiness, decreased touch sensation, dizziness, ringing in the ears, dry mouth, stuffy or blocked sinuses, nasal congestion (symptoms include runny nose, sneezing, and stuffy nose), stomach pain, gastroesophageal reflux disease (symptoms include heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling hot and feeling tired, hematuria.
Rare(may occur in 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, feeling of constriction in the throat, numbness of the lips, bleeding in the back of the eye, double vision, decreased visual acuity, abnormal sensations in the eye, eye or eyelid swelling, 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, nasal swelling, feeling irritable, and sudden hearing loss or deafness.
After the medicine was placed on 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 function disorders occurred before taking Inventum 100.
It is not possible to determine whether these side effects were related to the use of Inventum 100.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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
Tel.: + 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Inventum 100

Keep the medicine 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. Package contents and other information

What Inventum 100 contains

• The active substance of the medicine is sildenafil.
• Each tablet contains 100 mg of sildenafil formed in situ from 140.48 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 100 looks like and what the package contains

Inventum 100 is a white, triangular, biconvex tablet.
The Inventum 100 tablet has the number "100" embossed on one side.
The tablets are packaged in blisters of 2, 4, 8, or 12 tablets. Not all pack sizes are available on the market.

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
or
Genepharm S.A.
18th km Marathonos Avenue
15351 Pallini Attiki
Greece
or
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta

Date of last revision of the leaflet: