Package leaflet: Information for the patient

Profitadal, 5 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

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

Leaflet contents

What Profitadal is and what it is used for
What you should know 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 contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Profitadal 5 mg is used in 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 obtain an erection sufficient for sexual intercourse. Following sexual stimulation, Profitadal helps widen the blood vessels of the penis, allowing blood to flow into the penis. As a result, erection improves. Profitadal does not help patients who do not have erectile dysfunction. It is important to understand that Profitadal does not work without 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.
with urinary symptoms caused by a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, feeling of incomplete bladder emptying, and need to urinate more frequently, even at night. Profitadal improves blood flow and causes relaxation of the muscles of the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that Profitadal alleviates these urinary symptoms within 1–2 weeks after starting treatment.

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 to treat angina (chest pain). It has been shown that Profitadal intensifies 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 (heart attack) 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), known 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 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 to take Profitadal, discuss it with your doctor or pharmacist.
Please remember that sexual activity involves some risk for patients with heart conditions, as it places additional strain on the heart. If you have any heart problems, inform your doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms, therefore the doctor will perform tests to rule out prostate cancer before starting treatment with Profitadal for symptoms of benign prostatic hyperplasia. Profitadal is not used to treat prostate cancer.
Before taking the medicine, the patient should inform their doctor if any of the following conditions 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 complete or partial removal of the prostate gland with cutting of the nerves supplying the prostate (nerve-sparing radical prostatectomy).

If sudden vision deterioration or sudden vision loss occurs during tadalafil use, or if vision becomes distorted, blurred, or dimmed, stop taking tadalafil and contact a doctor immediately.
In some patients taking tadalafil, hearing deterioration or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to tadalafil use, if hearing deterioration or sudden hearing loss 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 you are currently taking, have recently taken, or plan 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. Inform your doctor or pharmacist if you are taking any of the following medicines:

alpha-blockers (used to treat high blood pressure or urinary symptoms caused by 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 oral ketoconazole (used to treat fungal infections) and protease inhibitors used in the treatment of AIDS or HIV infection;
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
rifampicin, erythromycin, clarithromycin, or itraconazole;
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, and therefore 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 using machines
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 contact their doctor before taking the medicine.
Sodium
The medicine contains 0.605 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 Profitadal

This medicine should always be taken as directed by a physician or pharmacist. In case of
doubt, consult a physician or pharmacist.
Profitadal tablets are intended for oral use only in men. The tablets should be swallowed whole,
with a small amount of water. Profitadal tablets may be taken regardless of meals.
Alcohol consumption may cause a temporary decrease in blood pressure. If a patient has taken
Profitadal or plans to take it, large amounts of alcohol (blood alcohol concentration of 0.08% or
higher) should be avoided, as this may increase the risk of experiencing dizziness upon standing.

Treatment of erectile dysfunction
Recommended dose: one 5 mg tablet taken once daily, approximately at the same time each
day. The physician may adjust the dose to 2.5 mg depending on the patient's response to
Profitadal. In such case, the 2.5 mg tablet should be used.
Profitadal should not be taken more frequently than once a day.
Taking Profitadal once daily allows achieving an erection following sexual stimulation at any
time within 24 hours. Daily administration of Profitadal may be beneficial for men who plan to
engage in sexual activity two or more times per week.
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.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of signs and symptoms of benign prostatic hyperplasia
Recommended dose: one 5 mg tablet taken once daily, approximately at the same time each
day. If a patient has benign prostatic hyperplasia and erectile dysfunction, the dose remains
unchanged at one 5 mg tablet once daily.
Profitadal must not be taken more than once a day.

Overdose of Profitadal
Inform a physician immediately. Adverse effects described in section 4 may occur.

Missed dose of Profitadal
Take the missed dose as soon as remembered, but do not take a double dose to make up for a
missed tablet. Do not take Profitadal more than once a day.
If there are any further doubts regarding the use of this medicine, consult a physician or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
These effects are usually mild or moderate.
If any of the adverse effects listed below occur, stop taking 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 worsening of vision (frequency unknown).

Other reported adverse effects:
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, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling tired.

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 swellings), bleeding from the penis, 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 loss of vision in one or both eyes.
In men taking tadalafil, several additional rare adverse effects
have been reported that were not observed during clinical trials. These include:

migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, disorders manifesting as ocular hyperaemia, irregular heartbeat, angina pectoris, and sudden cardiac death;
distorted, blurred, or impaired central vision, or sudden worsening of vision (frequency unknown).

Adverse effect: 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects 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 required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Profitadal contains

The active substance is tadalafil in a dose of 5 mg.
The other ingredients are: lactose, sodium croscarmellose, sodium lauryl sulfate, 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, biconvex film-coated tablet with "T 5" engraved on one side.
Profitadal is packed in blisters. One pack contains 28 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