Tadaxin

Patient Information Leaflet

Tadaxin, 5 mg, coated tablets
Tadalafilum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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

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

1. What Tadaxin is and what it is used for

Tadaxin contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Tadaxin 5 mg is used in the treatment of adult men with:

• Erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve an erection suitable for sexual activity. Following sexual stimulation, Tadaxin helps dilate the blood vessels in the penis, allowing increased blood flow into the penis. This results in improved erectile function. Tadaxin does not benefit men who do not have erectile dysfunction. It is important to understand that Tadaxin will 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.
• Urinary symptoms caused by a common condition known as benign prostatic hyperplasia (BPH). This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, sensation of incomplete bladder emptying, and increased frequency of urination, including during the night. Tadaxin improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms within 1–2 weeks after starting treatment.

2. Important information before taking Tadaxin

When not to take Tadaxin:

• 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 tadalafil enhances the effects 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 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), 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 pressure in the lungs caused by blood clots). PDE5 inhibitors, such as Tadaxin, 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.

Warnings and precautions
Before starting Tadaxin, discuss this with your doctor.
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 cause similar symptoms; therefore, the doctor will perform tests to rule out prostate cancer before starting Tadaxin for the treatment of symptoms of benign prostatic hyperplasia.
Tadaxin is not used in the treatment of prostate cancer.
Before taking Tadaxin, the patient should inform their 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 Tadaxin is effective in patients:

• who have undergone pelvic surgery;
• who have undergone total or partial removal of the prostate gland with nerve-sparing techniques (nerve-sparing radical prostatectomy).

If sudden vision loss, blurred vision, or distorted vision occurs during treatment with tadalafil, stop taking Tadaxin and contact your doctor immediately.
In some patients taking tadalafil, worsening or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing loss or sudden hearing deterioration occurs, stop taking Tadaxin and contact your doctor immediately.
Tadaxin is not intended for use in women.

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

Tadaxin and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Tadaxin if you are using nitrates.
Tadaxin may affect the action of certain medicines, or other medicines may affect the action of Tadaxin. Tell your doctor or pharmacist if you are taking any of the following medicines:

• alpha-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 oral ketoconazole (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines);
• rifampicin, erythromycin, clarithromycin, or itraconazole;
• other treatments for erectile dysfunction.

Tadaxin, food, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadaxin, and therefore caution should be exercised when consuming it. For more information, consult your doctor.

Fertility
When Tadaxin was administered to dogs, a reduction in sperm production in the testes was observed.
A reduction in sperm count has been observed in some men. It is unlikely that this would lead to infertility.

Driving and operating machinery
In some men taking tadalafil during clinical trials, dizziness has been reported. Therefore, patients should understand how they react to the tablets before deciding to drive or operate machinery.

Tadaxin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Tadaxin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Tadaxin

This medicine should always be taken according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
Tadaxin tablets are intended for oral use in men only. The tablets should be swallowed whole with a
small amount of water. Tadaxin tablets may be taken with or without food.
Alcohol consumption may cause a temporary decrease in blood pressure. If a patient has taken or
plans to take Tadaxin, he should avoid consuming large amounts of alcohol (blood alcohol
concentration of 0.08% or higher), as this may increase the risk of dizziness upon standing.

Treatment of erectile dysfunction
Recommended dose: One 5 mg tablet taken once daily at approximately the same time each day.
The doctor may adjust the dose to 2.5 mg depending on the patient's response to Tadaxin. In such a
case, the 2.5 mg tablet should be used.
Tadaxin should not be taken more than once a day.
Taking Tadaxin once daily allows the achievement of an erection following sexual stimulation at
any time within 24 hours. Daily administration of Tadaxin may be beneficial for men who plan to
engage in sexual activity twice a week or more frequently.
It is important to understand that Tadaxin will not work in the absence of sexual stimulation. The
patient and his partner should engage in foreplay, just as they would when the patient is 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 (BPH)
Dose: One 5 mg tablet taken once daily at approximately the same time each day. If a patient has
both benign prostatic hyperplasia and erectile dysfunction, the dose remains unchanged at one 5 mg
tablet once daily.
Tadaxin must not be taken more than once a day.

Taking more Tadaxin than prescribed
Inform your doctor immediately. Adverse effects described in section 4 may occur.

Missing a dose of Tadaxin
Take the missed dose as soon as remembered, but do not take a double dose to make up for the
missed tablet. Do not take Tadaxin more than once a day.
If you have any further questions about 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 everyone experiences them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the medicine
and seek immediate medical advice:

• allergic reactions, including rashes (uncommon);
• chest pain – do not take nitrates; seek immediate medical help (uncommon);
• priapism – prolonged and possibly painful erection after taking Tadaxin (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 not known).

Other reported adverse reactions:
Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

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

Rare (may affect up to 1 in 1,000 patients)

• fainting, seizures and 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 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 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 manifesting as blood congestion in the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, or impaired central vision or sudden worsening of vision (frequency not known).

Adverse reactions such as dizziness and diarrhoea have been reported more frequently in men
aged over 75 years taking tadalafil. Diarrhoea has been reported more frequently in men
aged over 65 years taking tadalafil.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, tell your doctor, pharmacist, or nurse. 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 authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Tadaxin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
Store below 30°C.
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 pack and other information

What Tadaxin contains

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredients are: Core of the tablet: monohydrate lactose, microcrystalline cellulose, povidone K-29-32, sodium citrate, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate. Coating of the tablet: hypromellose 6 cPs, triacetin, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Tadaxin looks like and contents of the pack
Yellow, biconvex, film-coated almond-shaped tablets, embossed with the code
"L 62" on one side and smooth on the other (measuring 8.6 ± 0.3 mm x 5.1 ± 0.3 mm).
Pack sizes: available in packs of 2, 4, 8, 10, 12, 14, 28, 56 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
Krakowiaków Street 65
02-255 Warsaw
Manufacturer/Importer
Synoptis Industrial Sp. z o.o.
Rabowicka Street 15
62-020 Swarzędz