Profitadal

Package Leaflet: Information for the Patient

Profitadal, 5 mg, Film-Coated Tablets

Tadalafil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Profitadal and what is it 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 to treat adult men with:

• erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Profitadal has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity. After sexual stimulation, Profitadal works by helping the blood vessels in your penis to relax and widen, allowing blood to flow into your penis. The result is an improved erection. Profitadal does not work if you do not have erectile dysfunction. It is important to note that Profitadal does not work without sexual stimulation.
• with symptoms of benign prostatic hyperplasia (enlarged prostate gland). This is when the prostate gland gets bigger with age. Symptoms include: difficulty starting to pass urine, a feeling of not completely emptying the bladder, and needing to pass urine more often, even at night. Profitadal improves blood flow and relaxes the muscles in the prostate and bladder, which may help to relieve the symptoms of benign prostatic hyperplasia. It has been shown that Profitadal can relieve these symptoms of benign prostatic hyperplasia after 1-2 weeks of treatment.

2. Important information before taking Profitadal

When not to take Profitadal:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6);
• if you are taking organic nitrates or other nitric oxide donors, such as amyl nitrite. These are medicines used to treat angina (chest pain). It has been shown that Profitadal increases the effects of these medicines. If you are taking any of these medicines, you should not take Profitadal;
• if you have severe heart disease or have had a heart attack in the last 90 days;
• if you have had a stroke in the last 6 months;
• if you have low blood pressure or uncontrolled high blood pressure;
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "stroke of the eye";
• if you are taking riociguat. This is a medicine used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs due to blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as Profitadal, increase the effects of this medicine. If you are taking riociguat or are unsure, you should tell your doctor.

Warnings and precautions

Before taking Profitadal, you should discuss this with your doctor or pharmacist.
Remember that sexual activity carries a risk for patients with heart disease, because it puts extra strain on your heart. If you have heart problems, you should tell your doctor.
Benign prostatic hyperplasia and prostate cancer can have the same symptoms, so your doctor will check you for prostate cancer before you start taking Profitadal to treat your benign prostatic hyperplasia symptoms. Profitadal is not for use in treating prostate cancer.
Before taking Profitadal, you should tell your doctor if you have:

• sickle cell anaemia (a disease of red blood cells);
• multiple myeloma (a cancer of the bone marrow);
• leukaemia (a cancer of the blood cells);
• any deformation of your penis;
• severe liver disease;
• severe kidney disease.

It is not known if Profitadal is effective in patients who have:

• had pelvic surgery;
• had prostate removal (prostatectomy) in which the nerves to the prostate are cut (radical prostatectomy without nerve sparing).

If you experience sudden loss of vision or loss of vision in one eye, or blurred vision, you should stop taking tadalafil and contact your doctor immediately.
Some patients taking tadalafil have reported a sudden decrease or loss of hearing. Although it is not known if these events are related to tadalafil, if you experience a sudden decrease or loss of hearing, you should stop taking Profitadal and contact your doctor immediately.
Profitadal is not intended for use by women.

Children and adolescents

Profitadal should not be used in children and adolescents under 18 years.

Profitadal and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and those you plan to take.
Do not take Profitadal if you are taking nitrates.
Profitadal may affect the way some other medicines work or other medicines may affect the way Profitadal works. Tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or symptoms of 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 (used to treat fungal infections) and protease inhibitors (used to treat AIDS or HIV infection);
• phenobarbital, phenytoin, and carbamazepine (medicines used to treat epilepsy);
• rifampicin, erythromycin, clarithromycin, or itraconazole;
• other treatments for erectile dysfunction.

Taking Profitadal with food and drink

Information about the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Profitadal, and therefore, caution should be exercised when consuming it. For more information, you should ask your doctor.

Fertility

When tadalafil was given to dogs, it caused a decrease in sperm production in the testes. A decrease in sperm concentration was observed in some men. It is unlikely to lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness. Therefore, you should be aware of how you react to the tablets before driving or operating machinery.

Profitadal contains lactose and sodium

Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Sodium

This medicine contains 0.605 mg sodium per tablet.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, which is essentially 'sodium-free'.

3. How to take Profitadal

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Profitadal tablets are for oral use only in men. The tablets should be swallowed whole with a small amount of water. The tablets can be taken with or without food.
Drinking alcohol may cause a temporary drop in blood pressure. If you have taken Profitadal or plan to take it, you should avoid drinking large amounts of alcohol (blood alcohol level of 0.08% or greater), as this may increase the risk of dizziness when standing up.

Treatment of erectile dysfunction

Recommended doseis one 5 mg tablet, taken once a day, at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg based on your response to Profitadal. You should take one 2.5 mg tablet.
Do not take Profitadal more than once a day.
Taking Profitadal once a day will enable you to achieve an erection, after sexual stimulation, at any time point during the 24 hours of the day. Taking Profitadal once a day may be useful for men who anticipate having sexual activity twice a week or more frequently.
It is important to note that Profitadal does not work without sexual stimulation. You and your partner should engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection.

Treatment of benign prostatic hyperplasia symptoms

Recommended doseis one 5 mg tablet, taken once a day, at approximately the same time each day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet per day.
Do not take Profitadal more than once a day.

Taking more Profitadal than you should

Inform your doctor. You may experience side effects described in section 4.

Forget to take Profitadal

Take a dose as soon as you remember, but do not take a double dose to make up for a forgotten tablet. Do not take more than one dose of Profitadal per day.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects are usually mild to moderate.

If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately:

• allergic reactions, including skin rash (uncommon);
• chest pain - do not take nitrates, but seek medical help immediately (uncommon);
• priapism, a prolonged erection after taking Profitadal (rare). If you experience this, seek medical help immediately;
• sudden loss of vision (rare), distorted vision, blurred vision, or loss of vision (frequency not known).

Other reported side effects include:
Common(affects 1 to 10 users in 100)

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

Uncommon(affects 1 to 10 users in 1,000)

• dizziness, stomach ache, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(affects 1 to 10 users in 10,000)

• fainting, seizures, and transient memory loss, swelling of the eyelids, eye redness, sudden loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, blood in semen, and increased sweating.

Myocardial infarction and stroke have been reported rarely in men taking tadalafil. Most of these men had pre-existing heart disease.
There have been reports of rare cases of partial, temporary, or permanent vision loss or blindness in one or both eyes.
Men taking tadalafil have reported the following additional rare side effects:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac deaths;
• distorted vision, blurred vision, or loss of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years old taking tadalafil. Diarrhea was reported more frequently in men over 65 years old taking tadalafil.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Profitadal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Lot - batch number
EXP - expiry date
There are no special storage instructions for this medicine.
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 pack and other information

What Profitadal contains

• The active substance is tadalafil, 5 mg.
• The other ingredients are: lactose, croscarmellose sodium, sodium lauryl sulfate, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, tablet coating: hypromellose 2910, lactose monohydrate, titanium dioxide (E171), triacetin, talc, yellow iron oxide (E172).

What Profitadal looks like and contents of the pack

Profitadal is yellow, biconvex, film-coated tablets with "T 5" embossed on one side.
Profitadal is packaged in blisters. One pack contains 28 film-coated tablets in a cardboard box.

Marketing Authorisation Holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
Phone: (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
Date of last revision of the leaflet:27.02.2024