TADALAFIL FORTIS

The medicine Tadalafil Fortis is used in men aged ≥18 years with erectile dysfunction (impotence), i.e. the inability to achieve or maintain an erection of the penis sufficient for sexual intercourse.
Before using the medicine, carefully read the package leaflet and the “Patient Information Leaflet” included in the package. To use the medicine safely, please answer all the questions contained in the questionnaire.
Package leaflet: information for the patient
Tadalafil Fortis
10 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after taking the medicine, or if you feel worse, contact your doctor.

Contents of the leaflet

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

1. What Tadalafil Fortis is and what it is used for

Tadalafil Fortis 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. It has been shown that Tadalafil Fortis significantly improves the ability to achieve an erection adequate for sexual intercourse.
Tadalafil Fortis contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. During sexual stimulation, Tadalafil Fortis helps widen the blood vessels in the penis, allowing increased blood flow into the penis. As a result, erection improves. Tadalafil Fortis does not benefit patients who do not have erectile dysfunction.
It is important to understand that Tadalafil Fortis does not work without sexual stimulation. Foreplay remains essential, just as it is when the patient is not taking medication for erectile dysfunction.
Tadalafil Fortis is not intended for use in women.
If there is no improvement after taking the medicine, or if you feel worse, contact your doctor.
Before using the medicine, carefully read the package leaflet and the “Patient Information Leaflet” included in the package. To use the medicine safely, please answer all the questions contained in the questionnaire.

2. Important information before using Tadalafil Fortis

When not to use Tadalafil Fortis

• 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 medicines containing nitrates, as their concomitant use may lead to a dangerous decrease in blood pressure. The doctor should be informed if the patient is taking any medicines from this group. Nitrate-containing medicines include:
• nitroglycerin (Glyceroli trinitras) – e.g. Nitrocard, Nitromint, Sustonit, Nitroderm, Minitran
• isosorbide mononitrate (Isosorbidi mononitras) – e.g. Effox, Isosorbide mononitrate Vitabalans, Isosorbidi mononitras Accord, Mono Mack, Mononit, Monosan, Olicard retard
• isosorbide dinitrate (Isosorbidi dinitras) – e.g. Sorbonit
• pentaerythritol tetranitrate (Pentaerythrityli tetranitras) – e.g. Galpent, Pentaerythritol compositum. These medicines are often used to relieve symptoms of angina (chest pain). It has been shown that Tadalafil Fortis enhances the effects of these medicines. If in doubt, consult a doctor or pharmacist.
• if the patient is taking medicines or other agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concomitant use may also cause dangerous lowering of blood pressure.
• if the patient has severe heart disease or has had a 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), also known as "eye stroke".
• if the patient is taking riociguat (e.g. Adempas). This medicine is used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high lung pressure caused by blood clots). Phosphodiesterase type 5 (PDE5) inhibitors such as Tadalafil Fortis have been shown to enhance the blood pressure-lowering effect of riociguat. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting treatment with Tadalafil Fortis, the patient should complete the questionnaire provided in the package. If any doubts arise, the patient should discuss them with a doctor.

It should be remembered that sexual activity involves some risk for patients with heart disease, as it places additional strain on the heart. If the patient has heart problems (including those identified from the questionnaire indicating that Tadalafil Fortis should not be used due to heart conditions), they should inform their doctor. Before taking the medicine, the patient should inform the doctor if any of the following conditions apply:

• sickle cell anemia (abnormal shape of red blood cells)
• abnormal blood pressure
• any inherited eye diseases
• multiple myeloma (a bone marrow cancer)
• leukemia (a blood cell cancer)
• any penile deformity or unwanted or prolonged erections lasting longer than 4 hours
• severe liver disease
• severe kidney disease

It is not known whether Tadalafil Fortis is effective in patients:

• after pelvic surgery
• after total or partial removal of the prostate gland with nerve-sparing techniques (radical prostatectomy without nerve-sparing)

If sudden worsening of vision, sudden vision loss, or distorted, dimmed vision occurs during treatment with Tadalafil Fortis, the patient should stop taking the medicine immediately and contact a doctor without delay.
In some patients taking tadalafil, hearing loss or sudden hearing decrease has been observed. Although it is not known whether this event is directly related to tadalafil use, if hearing loss or sudden hearing decrease occurs, the patient should stop taking Tadalafil Fortis and contact a doctor immediately.
Tadalafil Fortis should not be used together with other oral or topical medicines used to treat erectile dysfunction.
Tadalafil Fortis should not be used concomitantly with arterial pulmonary hypertension (PAH) therapies using sildenafil or other PDE5 inhibitors.
Other medicines for erectile dysfunction or pulmonary hypertension containing sildenafil (e.g. Maxigra Go, Maxigra Max, Sildenafil Medana, Viagra) must not be taken within 48 hours of taking Tadalafil Fortis.
Tadalafil Fortis should not be taken if erectile dysfunction has not been diagnosed.
In some patients taking alpha-blockers (e.g. doxazosin, prazosin, terazosin) for high blood pressure or benign prostatic hyperplasia, dizziness or lightheadedness may occur, which may be symptoms of low blood pressure caused by a drop in blood pressure upon rapid standing or sitting. To reduce the risk of these symptoms, the patient should be on a stable dose of their alpha-blocker before starting Tadalafil Fortis.
If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should:

• lie down or sit until symptoms subside
• drinking water, getting fresh air, or crossing the legs may also help. Rapid standing or sitting should be avoided. Additionally, if the patient is taking blood pressure-lowering medicines, they should consult their doctor before using Tadalafil Fortis.

Children and adolescents
Tadalafil Fortis is not intended for use in children and adolescents under 18 years of age.

Interaction of Tadalafil Fortis with other medicines
Before using Tadalafil Fortis, the patient should complete the questionnaire provided in the package. If in doubt, the patient should inform the doctor about all medicines currently or recently used, as well as any medicines they plan to use.
The following medicines may be available under various brand names. Therefore, the patient should carefully check the packaging and patient leaflet of any medicine they are taking to identify its active ingredient.
Tadalafil Fortis may interact with certain medicines, especially those used to treat chest pain. If the patient's condition worsens and requires immediate medical attention, they must inform the doctor about taking Tadalafil Fortis and the time of administration. This is very important due to the long duration of action of this medicine. Tadalafil Fortis should not be taken with other medicines without a doctor's recommendation.
Do not use Tadalafil Fortis if the patient is taking nitrates, as their concomitant use may lead to dangerous lowering of blood pressure. Nitrate-containing medicines include:

• nitroglycerin (Glyceroli trinitras) – e.g. Nitrocard, Nitromint, Sustonit, Nitroderm, Minitran
• isosorbide mononitrate (Isosorbidi mononitras) – e.g. Effox, Isosorbide mononitrate Vitabalans, Isosorbidi mononitras Accord, Mono Mack, Mononit, Monosan, Olicard retard
• isosorbide dinitrate (Isosorbidi dinitras) – e.g. Sorbonit
• pentaerythritol tetranitrate (Pentaerythrityli tetranitras) – e.g. Galpent, Pentaerythritol compositum. The patient should always inform the doctor or pharmacist if they are taking nitrates used to treat angina (chest pain). Do not use Tadalafil Fortis if the patient is taking medicines or agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concomitant use may lead to dangerous lowering of blood pressure.

Tadalafil Fortis may affect the action of certain medicines, or other medicines may affect the action of Tadalafil Fortis. Before taking Tadalafil Fortis, the patient should consult a doctor if they are taking:

• alpha-adrenergic receptor blockers (e.g. doxazosin, prazosin, terazosin) used to treat high blood pressure or urinary symptoms due to benign prostatic hyperplasia
• other medicines used to treat high blood pressure
• riociguat (used to treat pulmonary hypertension)
• 5-alpha-reductase inhibitors (e.g. dutasteride, finasteride) used to treat benign prostatic hyperplasia
• ketoconazole tablets (used to treat fungal infections)
• protease inhibitors (e.g. ritonavir, saquinavir) used to treat AIDS or HIV infection
• phenobarbital, phenytoin, and carbamazepine (anticonvulsants)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• itraconazole (used to treat fungal infections)
• other treatments for erectile dysfunction

Tadalafil Fortis, food, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Fortis, and therefore caution should be exercised when consuming it.

Pregnancy, breastfeeding, and fertility
Tadalafil Fortis is not intended for use in women.
Fertility
When administered to dogs, the medicine caused a reduction in 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 Tadalafil Fortis reported dizziness. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.

Tadalafil Fortis contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Fortis

This medicine should always be taken exactly as described in this patient information leaflet or
as advised by your doctor or pharmacist. If in doubt, consult your doctor or
pharmacist.
Tadalafil Fortis tablets are intended for oral use only in men.
Swallow the tablet whole with a glass of water. The tablet can be taken with or without food.
The recommended dose is one 10 mg tablet taken prior to planned sexual activity.
Take the medicine at least 30 minutes before planned sexual activity. The medicine may be
effective for up to 36 hours after taking the tablet.
This is an on-demand medicine, taken as needed.
Do not take more than one tablet. Do not take the medicine more than once a week.
It is important to be aware that Tadalafil Fortis does not work in the absence of sexual stimulation.
Foreplay remains important, just as it is when a patient is not taking medicines for erectile dysfunction.
Do not take Tadalafil Fortis together with other oral or topical medicines used to treat erectile dysfunction.
Do not take Tadalafil Fortis together with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or other PDE5 inhibitors.
Do not take other medicines for erectile dysfunction, such as those containing sildenafil (e.g.,
Maxigra Go, Maxigra Max, Sildenafil Medana, Viagra), within 48 hours of taking Tadalafil Fortis.
Do not take Tadalafil Fortis if erectile dysfunction has not been diagnosed.
Drinking alcohol 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 Tadalafil Fortis, 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.
Contact your doctor if, after taking Tadalafil Fortis, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking more than the recommended dose of Tadalafil Fortis
Inform your doctor immediately. Adverse effects described in section 4 may occur.
Missing a dose of Tadalafil Fortis
Do not take a double dose to make up for a missed tablet. Do not take Tadalafil Fortis more than once a week.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them. These effects are usually mild or moderate.
If any of the adverse effects listed below occur, stop taking the medicine and consult a doctor immediately:

• allergic reactions, including rash (uncommon).
• chest pain – do not take nitrates; seek immediate medical help (uncommon).
• priapism – prolonged and possibly painful erection after taking Tadalafil Fortis (rare). If such an erection occurs and lasts continuously for more than 4 hours, contact a doctor immediately. Without immediate treatment, damage to penile tissue and permanent loss of potency may occur.
• sudden loss of vision (rare), distorted, blurred, or dim central vision, or sudden decrease in vision (frequency not known)

Other reported adverse effects:
Common (observed in less than 1 in 10 patients)

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

Uncommon (observed in less than 1 in 100 patients)

• dizziness, abdominal pain, nausea, vomiting, gastroesophageal reflux, 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 (observed in less than 1 in 1,000 patients)

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

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of these men had pre-existing heart conditions before starting tadalafil treatment.
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 effects have been reported, which 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 blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, dim, blurred central vision or sudden decrease in vision (frequency not known).

Adverse effect: dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhea was reported more frequently in men over 65 years of age taking tadalafil.
Reporting of adverse effects
If any adverse effects occur, including those 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
Phone: +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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Tadalafil Fortis

No special storage instructions are required for this medicinal product.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Tadalafil Fortis contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• Other components are: Core of the tablet: monohydrate lactose, crospovidone, pregelatinized starch, corn starch, magnesium stearate, sodium lauryl sulfate; Coating of the tablet: monohydrate lactose, hypromellose, titanium dioxide (E 171), triacetin, yellow iron oxide (E 172)

What Tadalafil Fortis looks like and contents of the pack
Yellow, elongated, biconvex coated tablets, 10 mm in length and 5.5 mm in height.
PVC/PCTFE/PVC/Aluminium blister in a cardboard box containing 4 coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fortis Pharmaceuticals Sp. z o.o.
ul. Adama Mickiewicza 29
40-085 Katowice
Poland
Tel: +48 786 280 118
e-mail: [email protected]
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº2, Abrunheira
2710-228 Sintra
Portugal