TADAXIN 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Tadaxin, 20 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Tadaxin and what is it used for
4. Important information before taking Tadaxin
   1. When not to take Tadaxin:
   2. Warnings and precautions
   3. Children and adolescents
   4. Tadaxin and other medicines
   5. Tadaxin with food and drink
   6. Fertility
   7. Driving and using machines
   8. Tadaxin contains lactose
   9. Tadaxin contains sodium
5. How to take Tadaxin
   1. Use of higher than recommended dose of Tadaxin
6. Possible side effects
   1. If you experience any of the following side effects, stop taking Tadaxin and contact your doctor immediately:
   2. Reporting side effects
7. How to store Tadaxin
8. Contents of the pack and other information
   1. What Tadaxin contains
   2. What Tadaxin looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. Date of last revision of the package leaflet: November 2023

Package Leaflet: Information for the User

Tadaxin, 20 mg, Film-Coated Tablets

Tadalafil

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

• Keep this package 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 those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Tadaxin and what is it 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 is Tadaxin and what is it used for

Tadaxin is used to treat adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for satisfactory sexual performance.
It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for satisfactory sexual performance.
Tadaxin contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadaxin helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, it helps to improve erectile function. Tadaxin does not help patients who do not have erectile dysfunction.
It is important to note 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 erectile dysfunction medication.

2. Important information before taking Tadaxin

When not to take Tadaxin:

• 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. 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 you are taking nitrates in any form or are unsure, you should inform your doctor;
• 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 a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), also known as "eye stroke";
• if you are 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 blood pressure in the lungs caused by blood clots). It has been shown that phosphodiesterase type 5 inhibitors, such as Tadaxin, enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or are unsure, you should inform your doctor.

Warnings and precautions

Before taking Tadaxin, you should discuss this with your doctor.
It should be remembered that sexual activity carries a risk for patients with heart disease, as it puts an extra strain on the heart. If you have heart problems, you should inform your doctor.
Before taking Tadaxin, you should inform your doctor if you have any of the following conditions:

• sickle cell anemia (abnormal shape of red blood cells);
• multiple myeloma (bone marrow cancer);
• leukemia (blood cell cancer);
• any deformation of the penis;
• severe liver disease;
• severe kidney disease.

It is not known whether Tadaxin is effective in patients who have:

• undergone pelvic surgery;
• had their prostate removed (prostatectomy) and the nerves in the prostate area have been cut (radical prostatectomy without nerve sparing).

If you experience sudden vision loss or sudden loss of vision, or if your vision is blurred, you should stop taking Tadaxin and contact your doctor immediately.
In some patients taking tadalafil, a decrease in hearing or sudden hearing loss has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if you experience a decrease in hearing or sudden hearing loss, you should 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

You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should not take Tadaxin if you are taking nitrates.
Tadaxin may affect the way some medicines work, or some medicines may affect the way Tadaxin works.
You should 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 an enlarged prostate);
• other medicines used to treat high blood pressure;
• riociguat;
• 5-alpha reductase inhibitors (used to treat an enlarged prostate);
• medicines such as ketoconazole in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (anti-epileptic medicines);
• rifampicin, erythromycin, clarithromycin, or itraconazole;
• other treatments for erectile dysfunction.

Tadaxin with food and drink

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

Fertility

When tadalafil was administered to dogs, a decrease in sperm production in the testes was observed.
A decrease in sperm count has been observed in some men. It is unlikely to lead to infertility.

Driving and using machines

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

Tadaxin contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking Tadaxin.

Tadaxin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Tadaxin

This medicine should always be taken exactly as your doctor has instructed you. If you are unsure, you should ask your doctor or pharmacist.
Tadaxin 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.
The recommended starting doseis one 10 mg tablet, taken before planned sexual activity. If this dose is not effective, your doctor may increase the dose to 20 mg.
The tablet can be taken at least 30 minutes before planned sexual activity.
Tadaxin may still be effective up to 36 hours after taking the tablet.
You should not take Tadaxin more than once a day. Tadaxin, 10 mg and 20 mg, is intended for use before planned sexual activity and is not recommended for continuous, daily use.
It is important to remember 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 erectile dysfunction medication.
Consuming alcohol may cause a temporary decrease in blood pressure. If you have taken Tadaxin or plan to take it, you should not consume large amounts of alcohol (blood alcohol level 0.08% or higher), as this may increase the risk of dizziness when standing up.

Use of higher than recommended dose of Tadaxin

You should inform your doctor. Side effects described in section 4 may occur.
If you have any further questions on the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tadaxin can cause side effects, although not everybody gets them.
These effects are usually mild or moderate.

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

• allergic reactions, including skin rash (uncommon);
• chest pain - do not take nitrates, seek medical help immediately (uncommon);
• priapism - prolonged and possibly painful erections after taking Tadaxin (rare). If you experience such an erection, and it lasts for more than 4 hours, you should seek medical help immediately;
• sudden vision loss (rare), blurred vision, or sudden loss of vision (frequency not known).

Other reported side effects:
Common(may affect up to 1 in 10 patients)

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

Uncommon(may affect up to 1 in 100 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, 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, swelling of the eyelids, redness of the eyes, sudden worsening or loss of hearing, hives (itchy, red bumps on the skin), bleeding from the penis, blood in semen, and increased sweating.

Heart attack and stroke have been rarely reported in men taking tadalafil. Most of them had heart problems before taking this medicine.
There have been reports of rare cases of partial, transient, or permanent loss of vision or blindness in one or both eyes.
In men taking tadalafil, several additional rare side effects have been reported, including:

• migraine, facial swelling, severe allergic reactions causing swelling of the face and throat, severe skin rashes, eye disorders, irregular heartbeat, angina pectoris, and sudden cardiac death.
• blurred vision, or sudden loss of vision (frequency not known).

Side effects such as dizziness and diarrhea have been reported more frequently in men over 75 years of age taking tadalafil. Diarrhea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 after "EXP".
The expiry date refers to the last day of that month.
Store in a temperature below 30°C.
Medicines should 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.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, povidone K-29-32, sodium citrate, sodium lauryl sulfate, croscarmellose sodium, colloidal silicon dioxide, sodium stearylfumarate. 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 tablets in the shape of an almond, with the marking "L 64" on one side and smooth on the other (dimensions 14.1 ± 0.3 mm x 8.1 ± 0.3 mm).
Available pack sizes: 2, 4, 8, 10, 12, 14, 28, 56, or 84 tablets.
Not all pack sizes may be marketed.

Marketing authorization 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

Date of last revision of the package leaflet: November 2023