Package leaflet: Information for the patient

Profitadal, 20 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Contents of the leaflet

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

1. What Profitadal is and what it is used for

Profitadal is a medicine intended for adult men with erectile dysfunction. This is a condition
in which a man cannot achieve or maintain an erection sufficient for sexual intercourse.
Profitadal has been shown to significantly improve the ability to achieve an erection sufficient for sexual intercourse.
Profitadal contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Profitadal helps widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, erection is improved.
Profitadal does not help patients who do not have erectile dysfunction.
It is important to be aware that Profitadal does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.

2. Important information before taking Profitadal

When not to take Profitadal:

if the patient is allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);
if the patient is taking organic nitrates in any form or other nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris (chest pain). It has been shown that Profitadal enhances the effect of these medicines. If the patient is taking nitrates in any form or is unsure, they should inform their doctor;
if the patient has severe heart disease or has had a myocardial infarction within the last 90 days;
if the patient has had a stroke within the last 6 months;
if the patient has low blood pressure or uncontrolled high blood pressure;
if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to as "eye stroke";
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). It has been shown that PDE5 inhibitors, such as Profitadal, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting Profitadal, discuss it with your doctor or pharmacist.
Please remember that sexual activity involves some risk in patients with heart disease, as it places additional strain on the heart. If there are any heart problems, inform your doctor.
Before taking the medicine, the patient should inform the doctor if any of the following apply:

sickle cell anemia (abnormal shape of red blood cells);
multiple myeloma (a bone marrow cancer);
leukemia (a blood cell cancer);
any deformity of the penis;
severe liver disease;
severe kidney disease.

It is not known whether Profitadal is effective in patients:

after pelvic surgery;
after total or partial removal of the prostate gland, during which the nerves to the prostate are cut (non-nerve-sparing radical prostatectomy).

If sudden vision loss or sudden decrease in vision occurs during tadalafil use, or if vision becomes distorted or blurred, stop taking tadalafil and contact a doctor immediately.
In some patients taking tadalafil, worsening or sudden loss of hearing has been observed.
Although it is not known whether this event is directly related to tadalafil use, if hearing loss or sudden decrease in hearing occurs, stop taking Profitadal and contact a doctor immediately.
Profitadal is not intended for use in women.
Children and adolescents
Profitadal is not intended for use in children and adolescents under 18 years of age.
Profitadal and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Profitadal if you are using nitrates.
Profitadal may affect the action of certain medicines, or other medicines may affect the action of Profitadal. Tell your doctor or pharmacist if you are taking the following medicines:

alpha-adrenergic receptor blockers (used to treat high blood pressure or urinary symptoms due to benign prostatic hyperplasia);
other medicines used to treat high blood pressure;
riociguat;
5-alpha-reductase inhibitors (used to treat benign prostatic hyperplasia);
medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used in the treatment of AIDS or HIV infection;
phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines);
rifampicin, erythromycin, clarithromycin, or itraconazol;
other treatments for erectile dysfunction.

Taking Profitadal with food and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Profitadal, so caution should be exercised when consuming it. For more information, consult your doctor.
Effect on fertility
When administered to dogs, the medicine caused reduced sperm production in the testes. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
In clinical trials, some men taking Profitadal reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.
Profitadal contains lactose and sodium
Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
Sodium
The medicine contains 2.419 mg of sodium in each tablet.
The medicinal product contains less than 1 mmol (23 mg) of sodium per 1 tablet, meaning the medicine is considered "sodium-free".

3. How to take Profitadal

This medicine should always be taken according to the instructions of your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Profitadal tablets are intended for oral use only in men. The tablets should be swallowed whole with
a small amount of water. The tablets may be taken regardless of meals.
Recommended starting dose is one 10 mg tablet taken prior to planned sexual activity. If your doctor
determines that the recommended 10 mg dose is insufficient, then one 20 mg tablet should be taken
as directed by your doctor.
Profitadal may be taken at least 30 minutes before planned sexual activity. Profitadal may remain
effective for up to 36 hours after taking the tablet.
Do not take Profitadal more than once a day. The 20 mg Profitadal tablet is intended for use prior to
planned sexual activity. Regular, daily use of the medicine is not recommended.
It is important to be aware that Profitadal does not work without sexual stimulation. The patient and
his partner should engage in foreplay, just as when the patient is not taking medicines for erectile
dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection and may cause transient
lowering of blood pressure. If the patient has taken or plans to take Profitadal, he should not consume
large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the
risk of dizziness upon standing.
Taking more than the recommended dose of Profitadal
Inform your doctor immediately. Adverse effects described in section 4 may occur.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop using the
medicine and seek immediate medical advice:

allergic reactions, including rash (uncommon);
chest pain – do not take nitrates, but seek immediate medical help (uncommon);
priapism, a prolonged and possibly painful erection after taking Profitadal (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately;
sudden loss of vision (rare), distorted, blurred or impaired central vision, or sudden decrease in vision (frequency unknown).

Other reported adverse reactions:
Common (occur in 1 to 10 out of 100 people)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (occur in 1 to 10 out of 1,000 people)

dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (occur in 1 to 10 out of 10,000 people)

fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden worsening or loss of hearing, urticaria (itchy, red skin eruptions), bleeding from the penis, presence of blood in semen, and increased sweating.

Myocardial infarction and stroke have been rarely reported in men taking tadalafil.
Most of these men had pre-existing heart problems before starting treatment with this medicine.
There have been reports of rare cases of partial, transient or permanent
visual impairment or vision loss in one or both eyes.
In men taking tadalafil, several additional rare adverse reactions
have been reported that were not observed during clinical trials. These include:

migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders characterized by increased blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death;
distorted, blurred, impaired central vision or sudden decrease in vision (frequency unknown).

Adverse reaction: dizziness has been reported more frequently in men over 75 years of age
taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age
taking tadalafil.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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 Profitadal

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
LOT - batch number
EXP - expiry date
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Profitadal contains

The active substance is tadalafil in a dose of 20 mg.
The other ingredients are: lactose, sodium croscarmellose, sodium lauryl sulphate, hydroxypropylcellulose, polysorbate 80, magnesium stearate, tablet coating: hypromellose 2910, monohydrate lactose, titanium dioxide (E171), triacetin, talc, yellow iron oxide (E172).

What Profitadal looks like and contents of the pack
Profitadal is a yellow, oval, film-coated tablet, biconvex on both sides, with the imprint "T 20" on one side.
Profitadal is packed in blisters. One package contains 2 film-coated tablets or 4 film-coated tablets in a cardboard box.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. (42) 22-53-100
Importer/Manufacturer
Genepharm S.A.
18th km Marathonos Avenue
Pallini Attiki, 15351
Greece
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA3000
Malta
PharmaPath S.A.
28is Oktovriou 1
Agia Varvara, 123 51
Greece