Tadalafil Adamed

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Tadalafil Adamed, 10 mg, film-coated tablets

Tadalafil

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

• Keep this 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 leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tadalafil Adamed and what is it used for

Tadalafil Adamed is a medicine used for 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.
Tadalafil Adamed contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Adamed helps to widen the blood vessels in the penis, allowing blood to flow into the penis. As a result, the erection is improved. Tadalafil Adamed does not help patients who do not have erectile dysfunction.
It is important to note that Tadalafil Adamed 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 Tadalafil Adamed

When not to take Tadalafil Adamed:

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

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

It is not known whether Tadalafil Adamed is effective in patients:

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

If during treatment with tadalafil, sudden worsening of vision or sudden loss of vision or distorted vision occurs, the patient should stop taking Tadalafil Adamed and immediately contact a doctor.
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 a decrease in hearing or sudden hearing loss occurs, the patient should stop taking Tadalafil Adamed and immediately contact a doctor.
Tadalafil Adamed is not intended for use in women.

Children and adolescents

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

Tadalafil Adamed and other medicines

The patient should tell the doctor about all medicines being taken or recently taken, as well as any medicines planned to be taken.
It is not recommended to take Tadalafil Adamed if nitrates are being taken.
Tadalafil Adamed may affect the action of some medicines or other medicines may affect the action of Tadalafil Adamed. The patient should inform the doctor or pharmacist if any of the following medicines are being taken:

• 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, or itraconazole.
• other methods of treating erectile dysfunction.

Tadalafil Adamed with food and alcohol

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

Fertility

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

Driving and using machines

Some men taking tadalafil during clinical trials reported dizziness, so it is recommended to be aware of your reaction to the tablets before driving or operating machinery.

Tadalafil Adamed contains lactose:

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

Tadalafil Adamed 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 Adamed

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
Tadalafil Adamed 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 this dose is not sufficient, the doctor may increase the dose to 20 mg (two 10 mg tablets). Tadalafil Adamed tablets are intended for oral use.
Tadalafil Adamed can be taken at least 30 minutes before planned sexual activity.
Tadalafil Adamed may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Adamed more than once a day. Tadalafil Adamed 10 mg is intended for use before planned sexual activity. It is not recommended to take the medicine on a regular, daily basis. The score line on the tablet is not intended to break the tablet.
It is essential to remember that Tadalafil Adamed 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 affect the patient's ability to achieve an erection and may cause a temporary decrease in blood pressure. If the patient has taken Tadalafil Adamed 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 a higher dose of Tadalafil Adamed than recommended

The patient should inform their doctor. Side effects described in section 4 may occur.
If the patient has any further questions 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 any of the following side effects occur, the patient should stop taking the medicine and immediately consult a doctor:

• allergic reactions, including rash (not very common).
• chest pain - do not take nitrates, but seek medical help immediately (not very common).
• priapism, prolonged and possibly painful erections after taking tadalafil (rare). If such an erection occurs and lasts continuously for more than 4 hours, the patient should immediately consult a doctor.
• sudden loss of vision (rare), distorted, blurred, or unclear vision or sudden worsening of vision (frequency not known).

Other reported side effects:
Common(occurring in less than 1 in 10 patients)

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

Uncommon(occurring in less than 1 in 100 patients)

• dizziness, abdominal pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erections, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(occurring in less than 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.
Men taking tadalafil have reported several additional rare side effects, which 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 flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac deaths
• distorted, blurred, or unclear vision or sudden worsening of vision (frequency not known).

Dizziness was reported more frequently in men over 75 years of age taking tadalafil. Diarrhea was reported more frequently in men over 65 years of age taking tadalafil.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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 gather more information on the safety of this medicine.

5. How to store Tadalafil Adamed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry Date (EXP). The expiry date refers to the last day of the month stated.
Batch number is stated after: Batch Number (Lot).
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Adamed contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• Excipients: Lactose monohydrate, microcrystalline cellulose, povidone K 30, poloxamer type 188, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate

Coating of the tablet (Opadry II Orange 85F230012)

Polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron oxide, yellow (E 172), iron oxide, red (E 172)

What Tadalafil Adamed looks like and contents of the pack

Tadalafil Adamed 10 mg is a light orange, elongated, biconvex, film-coated tablet, approximately 11 mm x 6 mm with a score line on one side.
Tadalafil Adamed 10 mg tablets are available in Aluminum/PVC/PVDC blisters packed in a cardboard box. The pack contains 2, 4, 8, or 12 film-coated tablets.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Phone: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland
Zakłady Farmaceutyczne Polpharma S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Zakłady Farmaceutyczne Polpharma S.A.
ul. Metalowca 2
39-460 Nowa Dęba
Poland
Date of last revision of the leaflet:June 2025