Package leaflet: Information for the patient

INVENTUM 100, 100 mg, chewable and suckable tablets
Sildenafilum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Inventum 100 is and what it is used for
Important information before taking Inventum 100
How to take Inventum 100
Possible side effects
How to store Inventum 100
Contents of the pack and other information

1. What Inventum 100 is and what it is 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 the blood vessels in the penis to relax, thereby increasing blood flow into the penis during sexual stimulation. Inventum 100 helps achieve an erection only if sexual stimulation occurs beforehand.
Inventum 100 is used to treat erectile dysfunction in adult men, i.e. impotence defined as the inability to obtain or maintain a penile erection sufficient for sexual intercourse.

2. Important information before using 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 concomitant use may lead to a dangerous decrease in blood pressure. The patient should inform the doctor if they are taking any medicines from this group – these medicines are often used to relieve symptoms of angina (chest pain). If in doubt, consult a doctor or pharmacist.
If the patient is taking nitric oxide-releasing drugs (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 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 100 have been shown to 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, or has low blood pressure.
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 100, the patient should discuss this with their doctor or pharmacist:

if the patient has sickle cell anaemia (an abnormality of red blood cells), leukaemia (a blood cancer), or multiple myeloma (a bone marrow cancer);
if the patient has anatomical deformity of the penis or Peyronie's disease;
if the patient has heart problems – in this case, the doctor should assess whether the heart muscle condition allows for the additional strain associated with sexual activity;
if the patient has peptic ulcer disease or bleeding disorders (such as haemophilia);
if the patient experiences sudden worsening of vision or sudden vision loss – in such case, the patient should stop taking Inventum 100 and contact a doctor immediately.

Inventum 100 must not be used simultaneously with other oral or topical treatments for erectile dysfunction.
Inventum 100 must not be used simultaneously with pulmonary arterial hypertension (PAH) therapies containing sildenafil or other PDE5 inhibitors.
Inventum 100 should not be taken if erectile dysfunction has not been diagnosed.
Inventum 100 is not a medicine intended for use in women.

Use of Inventum 100 in patients with kidney or liver function disorders
Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to prescribe a lower dose of Inventum 100.

Children and adolescents
Inventum 100 must not be used in individuals 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, have recently taken, or plan to take.
Inventum 100 may interact with certain medicines, especially those used to treat chest pain. If the patient's health deteriorates and immediate medical assistance is required, they must inform the doctor, pharmacist, or nurse about having taken Inventum 100 and the time of intake. The patient must not take Inventum 100 together with other medicines without a doctor's recommendation.
Do not take Inventum 100 if the patient is taking nitrates, because their concomitant use may cause dangerous lowering of blood pressure. The patient must always inform the doctor, pharmacist, or nurse if they are taking nitrates, which are used to treat angina (chest pain).
Do not take Inventum 100 if the patient is taking nitric oxide-releasing drugs (such as amyl nitrite), because their concomitant use may cause dangerous lowering of blood pressure.
If the patient is already taking riociguat, they should inform their doctor or pharmacist.
When taking protease inhibitors used in the treatment of HIV infection, it is recommended to start treatment with the lowest dose (25 mg) of Inventum 100.
Some patients taking α-adrenergic blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, 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 Inventum 100 together with α-adrenergic blockers. These symptoms are most likely to occur within 4 hours after taking Inventum 100. To reduce the risk of such symptoms, the patient should be on a stable dose regimen of their α-adrenergic blocker before starting Inventum 100. The doctor may decide to initiate treatment with a lower starting dose (25 mg) of Inventum 100.
If the patient is taking medicines containing sacubitril with valsartan, used in the treatment of heart failure, they should inform their doctor or pharmacist.

Taking Inventum 100 with food, drink, and alcohol
Inventum 100 can be taken with or without food. However, taking Inventum 100 with a heavy meal may delay the onset of the medicine's effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic effect of Inventum 100, significant amounts of alcohol should not be consumed before taking the medicine.

Pregnancy, breastfeeding, and fertility
Inventum 100 is not intended for use in women.

Driving and operating machinery
Inventum 100 may cause dizziness and visual disturbances. Patients should determine how they react to Inventum 100 before driving or operating machinery.

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

Monohydrate lactose
The medicine contains 281.83 mg of monohydrate lactose in each 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 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 impaired 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, meaning 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, meaning the medicine is considered "sodium-free".

3. How to take Inventum 100

This medicine should always be taken as directed by a doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended starting dose is 50 mg.
Inventum 100 must not be taken more than once a day.
Inventum 100 should be taken approximately one hour before planned sexual activity.
The tablet should be chewed and dissolved in the mouth.
If you feel that the effect of Inventum 100 is too strong or too weak, consult your doctor or pharmacist.
Inventum 100 enables an erection only in the presence of sexual stimulation. The time required for
Inventum 100 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.
Consult your doctor if, after taking Inventum 100, an erection does not occur or if the duration of
erection is insufficient for sexual intercourse.
Taking a higher than recommended dose of Inventum 100
Patients may experience adverse effects more frequently and with greater intensity.
Taking a dose higher than 100 mg does not increase the effectiveness of the medicine.
Do not take more tablets than prescribed by your doctor.
Contact your doctor if you have taken more tablets than recommended.
If you have any further questions regarding the use of this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions reported with the use of Inventum 100 are generally mild
or moderately severe and transient.
If any of the following adverse reactions occur, stop taking Inventum 100 and seek immediate medical help:

Allergic reaction – occurs not very often (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 not very often. If it occurs during or after sexual intercourse:
- adopt a semi-sitting position and try to relax,
- do not take nitrates to relieve chest pain.

Prolonged and sometimes painful erections – occur rarely (may occur in 1 in
1000 patients).
If an erection lasts longer than 4 hours, contact a doctor immediately.
Sudden worsening or loss of vision – occurs rarely.

Severe skin reactions – occur rarely. Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, on genital organs, and around the eyes, fever;
seizures or convulsions – occur rarely.

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 colored halos, blurred vision, visual disturbances,
stuffy nose, dizziness.
Not very common (may affect up to 1 in 100 patients): vomiting, skin rash, eye irritation,
eye congestion, eye pain, seeing flashes of light, bright vision, light sensitivity,
watery eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain,
drowsiness, reduced sense of touch, dizziness, tinnitus, dry mouth,
blocked or stuffy sinuses, nasal mucositis (symptoms include runny nose, sneezing,
and blocked nose), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn),
blood in urine, pain in hands or feet, nosebleeds, feeling of warmth, feeling of fatigue,
haematuria.
Rarely (may affect up to 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat,
transient reduction in blood flow to part of the brain, feeling of throat tightness,
numbness of the lips, bleeding into the back of the eye, double vision, decreased 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
coloration of the white part of the eye; bleeding from the penis, presence of blood in semen, dry nose, swelling
inside the nose, feeling of irritation, and sudden weakness or hearing loss.
Since the introduction of the medicine to the market, cases of unstable angina (heart disease)
and sudden death have been rarely reported. It is important to note that in most, but not all, men
who experienced these adverse reactions, heart function disorders were present prior to taking Inventum 100.
It is not possible to determine whether these adverse reactions were related to the use of Inventum 100.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Inventum 100

Keep this 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.

6. Contents of the packaging and other information

What Inventum 100 contains

The active substance is sildenafil.
Each tablet contains 100 mg of sildenafil formed in situ from 140.48 mg of sildenafil citrate.
The other ingredients are: potassium polycryllin, purified water, magnesium stearate, colloidal anhydrous silica, aspartame, sodium carmellose, peppermint flavor, lactose monohydrate, povidone K-30.

What Inventum 100 looks like and contents of the pack
Inventum 100 is a white, triangular, biconvex tablet.
The Inventum 100 tablet is imprinted with the number "100" on one side.
The tablets are packed in blisters of 2, 4, 8 or 12 tablets. Not all pack sizes are available on the market.
Marketing Authorisation 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