Tadaxin

Package leaflet: Information for the user

Tadaxin, 20 mg, coated tablets
Tadalafilum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 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 obtain an erection adequate for sexual intercourse.
Tadaxin contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadaxin helps widen the blood vessels of the penis, allowing increased blood flow into the penis. This results in improved erection. Tadaxin does not help patients who do not have erectile dysfunction.
It is important to be aware that Tadaxin 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.

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 pectoris (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 medicine is 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). 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 disease, as it places additional strain on the heart. If there are any heart problems, inform your doctor.
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:

• after pelvic surgery;
• after total or partial removal of the prostate gland with cutting of the nerves supplying the prostate (nerve-sparing radical prostatectomy).

If sudden worsening of vision or sudden vision loss occurs while using tadalafil, or if images appear blurred, distorted, or dimmed, stop taking Tadaxin and contact a 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 worsens or sudden hearing loss occurs, stop taking Tadaxin and contact a 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 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 ketoconazole tablets (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 caution should be exercised when consuming it. For more information, consult your doctor.
Fertility
When Tadaxin was administered to dogs, reduced sperm production in the testes was observed.
Reduced 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 was reported. Therefore, patients should understand their individual response 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
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Tadaxin

This medicine should always be taken as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Tadaxin tablets are intended for oral use only in men. The tablets should be swallowed whole, with a small amount of water. Tadaxin tablets may be taken regardless of meals.
The recommended starting dose is one 10 mg tablet taken prior to planned sexual activity. If this dose is not sufficient, the doctor may increase the dose to 20 mg.
The tablet may be taken at least 30 minutes before planned sexual activity.
Tadaxin may remain effective for up to 36 hours after taking the tablet.
Tadaxin should not be taken more than once a day. Tadaxin 10 mg and 20 mg is intended for use prior to planned sexual activity and is not recommended for regular, daily use.
It is important to be aware that Tadaxin does 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 erectile dysfunction medications.
Alcohol consumption may cause transient lowering of blood pressure. If the patient has taken or plans to take Tadaxin, 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 a higher than recommended dose of Tadaxin
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 they do not occur in everyone.
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 vision loss (rare), distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

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, breathing difficulties, 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 (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
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 blood congestion in the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, dimmed, blurred central vision or sudden worsening of vision (frequency unknown).

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 reactions occur, including any adverse reactions 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 responsible entity.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Tadaxin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "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. This will help protect the environment.

6. Contents of the pack and other information

What Tadaxin contains

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• Other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, povidone K-29-32, sodium citrate, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate.
  Tablet coating: 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 marking "L 64" on one side and smooth on the other side (measuring 14.1 ± 0.3 mm x 8.1 ± 0.3 mm).
Pack sizes available: 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.
ul. Krakowiaków 65
02-255 Warsaw
Manufacturer/Importer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz