Tadalafil apteo med

Before taking the medicine, use the diagnostic tool (questionnaire) provided!

Package leaflet: Information for the user

Tadalafil APTEO MED, 10 mg, coated tablets
Tadalafilum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

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

Table of contents

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

1. What Tadalafil APTEO MED is and what it is used for

Tadalafil APTEO MED is used to treat 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 adequate for sexual intercourse.
Tadalafil APTEO MED contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil APTEO MED helps widen the blood vessels of the penis, allowing increased blood flow into the penis and resulting in an erection. As a result, erectile function improves. Tadalafil APTEO MED does not benefit men who do not have erectile dysfunction.
It is important to understand that Tadalafil APTEO MED does not work in the absence of 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 Tadalafil APTEO MED

When not to take Tadalafil APTEO MED:

• 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 group of medicines ("nitrates") is 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 doctor has advised the patient to avoid sexual activity;
• 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, or uncontrolled heart rhythm disorders;
• 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). It has been shown that PDE5 inhibitors, such as Tadalafil APTEO MED, 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 treatment with Tadalafil APTEO MED, patients should use the diagnostic tool (questionnaire) included in the packaging. If any doubts arise, they should discuss them with their doctor or pharmacist.
It should be remembered that sexual activity involves some risk in patients with heart disease, as it places additional strain on the heart. If heart problems exist, the patient should inform their doctor or pharmacist.
Before taking the medicine, the patient should inform their doctor or pharmacist if any of the following conditions apply:

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

It is not known whether Tadalafil APTEO MED is effective in patients:

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

If sudden vision deterioration or sudden vision loss occurs during treatment with tadalafil, or if vision becomes distorted or blurred, treatment with Tadalafil APTEO MED should be stopped immediately and the patient should contact their doctor without delay.
In some patients taking tadalafil, hearing deterioration 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 deterioration or sudden hearing loss occurs, treatment with Tadalafil APTEO MED should be stopped and the patient should contact their doctor immediately.
Tadalafil APTEO MED should not be used together with other oral or topical medicines used to treat erectile dysfunction.
Tadalafil APTEO MED should not be used together with arterial pulmonary hypertension (PAH) therapies using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadalafil APTEO MED, medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension must not be taken.
Tadalafil APTEO MED should not be taken if erectile dysfunction has not been diagnosed.
Tadalafil APTEO MED is not intended for use in women.

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

Tadalafil APTEO MED and other medicines
Before using Tadalafil APTEO MED, patients should use the diagnostic tool (questionnaire). If in doubt, patients should inform their doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines they plan to take.
Tadalafil APTEO MED must not be taken if nitrates are being used.
Tadalafil APTEO MED may affect the action of certain medicines or other medicines may affect the action of Tadalafil APTEO MED.
Patients should inform their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor 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 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 (antibiotics), or itraconazole (antifungal medicine);
• other treatments for erectile dysfunction.

In some patients taking blood pressure-lowering medicines, blood pressure may drop, especially when standing up or sitting down quickly. If symptoms of low blood pressure occur (dizziness, lightheadedness, feeling faint), the patient should lie down or sit until symptoms subside. Drinking water, breathing fresh air, tensing abdominal muscles, or crossing legs may also help. Rapid standing or sitting should be avoided.

Tadalafil APTEO MED, food, and alcohol
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil APTEO MED, and therefore caution should be exercised when consuming it. For further information, patients should consult their doctor or pharmacist.

Fertility
When administered to dogs, a reduction in 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 clinical trials, some men taking tadalafil reported dizziness. Therefore, patients should understand their individual response to the tablets before deciding to drive or operate machinery.

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

Tadalafil APTEO MED 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 Tadalafil APTEO MED

This medicine should always be taken exactly as described in this patient information leaflet, or as
directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Tadalafil APTEO MED tablets are intended for oral use only in men.
Swallow the tablet whole with a small amount of water. The tablets may be taken regardless of
meals.
Recommended dose: One 10 mg tablet taken prior to planned sexual activity. If you feel that the
effect of Tadalafil APTEO MED is too strong or insufficient, consult your doctor or pharmacist.
After consultation, your doctor may recommend a different dosing regimen. Tadalafil APTEO MED
tablets are intended for oral administration.
The tablet may be taken at least 30 minutes before planned sexual activity.
Tadalafil APTEO MED may remain effective for up to 36 hours after taking the tablet.
Tadalafil APTEO MED is intended to be used prior to planned sexual activity.
The medicine should be taken on an as-needed basis. Do not use more than once a week. Do not
take more than one tablet.
Tadalafil APTEO MED must not be used simultaneously with other oral or topical medicines used
in the treatment of erectile dysfunction.
Tadalafil APTEO MED must not be used concomitantly with arterial pulmonary hypertension (PAH)
therapy using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadalafil APTEO MED, do not take any medicines containing sildenafil
used in the treatment of erectile dysfunction or pulmonary hypertension.
Tadalafil APTEO MED should not be taken if erectile dysfunction has not been diagnosed.
It is important to understand that Tadalafil APTEO MED does not work in the absence of 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.
Alcohol consumption may cause transient lowering of blood pressure. If the patient has taken or
plans to take Tadalafil APTEO MED, 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.
Taking a higher than recommended dose of Tadalafil APTEO MED
Inform your doctor immediately. Adverse effects described in section 4 may occur.
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 will experience them.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop using the
medicine and seek immediate medical advice:

• 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 APTEO MED (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 dim 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, 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 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, a few 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 ocular hyperaemia, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, dim 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department for 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tadalafil APTEO MED

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. These measures will help protect the environment.

6. Contents of the packaging and other information

What Tadalafil APTEO MED contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• Other components 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 Tadalafil APTEO MED looks like and contents of the pack
Yellow, biconvex, almond-shaped coated tablets with the imprint
"L 63" on one side and smooth on the other side (measuring 10.1 mm ± 0.3 mm x 6.1 mm ± 0.3 mm).
Pack sizes available: 2 and 4 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel.: 22 32 16 240
Manufacturer/Importer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz