Tadalafil Apteo Med

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

Leaflet attached to the packaging: information for the user

Tadalafil APTEO MED, 10 mg, film-coated tablets

Tadalafilum

You should carefully read the contents of the leaflet before taking 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If the patient's condition does not improve or worsens after taking the medicine, they should consult a doctor.

Table of contents of the leaflet

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

Tadalafil APTEO MED is used to treat adult men with erectile dysfunction. This is a condition where a man cannot achieve or maintain an erection sufficient for sexual intercourse. It has been shown that tadalafil significantly improves the ability to achieve an erection sufficient for sexual intercourse.
Tadalafil APTEO MED contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil APTEO MED helps to widen the blood vessels in the penis, allowing blood to flow into the penis, leading to an erection. As a result, there is an improvement in erection. Tadalafil APTEO MED does not help patients who do not have erectile dysfunction.
It is important to be aware that Tadalafil APTEO MED does not work in the absence of sexual stimulation. The patient and his partner should arrange foreplay, just as if the patient were not taking erectile dysfunction medication.

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 is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that tadalafil enhances the effect 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 in the last 90 days;
• if the patient has had a stroke in 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 had a loss of vision 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 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 to take Tadalafil APTEO MED, the patient should use the diagnostic tool (questionnaire) attached to the packaging. In case of any doubts, they should discuss this with their doctor or pharmacist.
The patient should remember that sexual activity is associated with a risk for patients with heart disease, as it puts an additional strain on the heart. If the patient has heart problems, they should inform their doctor or pharmacist.
Before taking the medicine, the patient should inform their doctor or pharmacist if they 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 penile deformity;
• severe liver disease;
• severe kidney disease.

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

• after pelvic surgery;
• after total or partial removal of the prostate gland, during which the prostate nerves are cut (radical prostatectomy without nerve sparing).

If the patient experiences sudden worsening of vision or sudden loss of vision or distorted vision while taking tadalafil, they should stop taking Tadalafil APTEO MED and contact their doctor immediately.
In some patients taking tadalafil, a worsening or sudden loss of hearing has been observed. Although it is not known if this event is directly related to the use of tadalafil, if the patient experiences a worsening or sudden loss of hearing, they should stop taking Tadalafil APTEO MED and contact their doctor immediately.
Tadalafil APTEO MED should not be taken with other oral or topical medicines used to treat erectile dysfunction.
Tadalafil APTEO MED should not be taken with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadalafil APTEO MED, the patient should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
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 taking Tadalafil APTEO MED, the patient should use the diagnostic tool (questionnaire). In case of any doubts, they should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tadalafil APTEO MED should not be taken if the patient is taking nitrates.
Tadalafil APTEO MED may affect the action of some medicines or other medicines may affect the action of Tadalafil APTEO MED.
The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• alpha-adrenergic receptor blockers (used to treat high blood pressure or symptoms of 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 in tablets (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, and carbamazepine (antiepileptic medicines);
• rifampicin, erythromycin, clarithromycin (antibiotics) or itraconazole (antifungal medicine);
• other methods of treating erectile dysfunction.

In some patients who take blood pressure-lowering medicines, a decrease in blood pressure may occur, especially when standing up or sitting down quickly. If the patient experiences symptoms of low blood pressure (dizziness, fainting, feeling of impending faint), they should lie down or sit down and wait for the symptoms to pass, drinking water may also help, as well as getting some fresh air, tensing abdominal muscles, or crossing legs. The patient should avoid standing up or sitting down quickly.

Tadalafil APTEO MED with food and alcohol

Information on the effect of alcohol is given in section 3. Grapefruit juice may affect the efficacy of Tadalafil APTEO MED, and therefore, it should be consumed with caution. For more information, the patient should consult their doctor or pharmacist.

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 the patient should be aware of their reaction to the tablets before driving or operating machinery.

Tadalafil APTEO MED contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Tadalafil APTEO MED contains sodium

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

3. How to take Tadalafil APTEO MED

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.
Tadalafil APTEO MED tablets are intended 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.
Recommended doseis one 10 mg tablet, taken before planned sexual activity. If the patient feels that the effect of Tadalafil APTEO MED is too strong or too weak, they should consult their doctor or pharmacist. The doctor may recommend a different dosing regimen after consultation. Tadalafil APTEO MED tablets are intended for oral use.
The tablet can be taken at least 30 minutes before planned sexual activity.
Tadalafil APTEO MED may be effective for up to 36 hours after taking the tablet.
Tadalafil APTEO MED is intended for use before planned sexual activity.
The medicine should be used as needed. Do not use more than once a week. Do not take more than one tablet.
Tadalafil APTEO MED should not be taken with other oral or topical medicines used to treat erectile dysfunction.
Tadalafil APTEO MED should not be taken with pulmonary arterial hypertension therapies (PAH) using sildenafil or other PDE5 inhibitors.
For 48 hours after taking Tadalafil APTEO MED, the patient should not take medicines containing sildenafil used to treat erectile dysfunction or pulmonary hypertension.
Tadalafil APTEO MED should not be taken if erectile dysfunction has not been diagnosed.
It is important to be aware that Tadalafil APTEO MED does not work in the absence of sexual stimulation. The patient and his partner should arrange foreplay, just as if the patient were not taking erectile dysfunction medication.
Consuming alcohol may cause a temporary decrease in blood pressure. If the patient has taken Tadalafil APTEO MED or plans to take it, they should not consume large amounts of alcohol (blood alcohol concentration 0.08% or higher), as this may increase the risk of dizziness when standing up.

Taking more than the recommended dose of Tadalafil APTEO MED

The patient should inform their doctor. Adverse reactions described in section 4 may occur. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following side effects, they should stop taking the medicine and contact their doctor immediately:

• allergic reactions, including rash (not very common);
• chest pain - the patient should not take nitrates, and they should seek medical help immediately (not very common);
• 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, the patient should contact their doctor immediately;
• sudden loss of vision (rare), distorted, blurred, or impaired 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, eyelid swelling, eye redness, sudden worsening or loss of hearing, hives (itchy, red bumps on the skin), penile bleeding, 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 starting to take this medicine.
There have been reports of rare cases of partial, transient, or permanent loss of vision or loss of vision in one or both eyes.
In men taking tadalafil, several additional rare side effects have been reported, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing facial and throat swelling, severe skin rashes, disorders characterized by blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death.
• distorted, blurred, or impaired vision or sudden worsening 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tadalafil APTEO MED

The medicine should be stored out of 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 the month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil APTEO MED contains

• The active substance of the medicine is tadalafil. Each tablet contains 10 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 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, film-coated tablets in the shape of an almond, with the inscription "L 63" on one side and smooth on the other ( dimensions 10.1 mm ± 0.3 mm x 6.1 mm ± 0.3 mm).
Available pack sizes: 2 and 4 tablets.
Not all pack sizes may be marketed.

Marketing authorization 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
Date of last revision of the leaflet:April 2024