Prospect: information for the patient

Tadalafilo Sandoz 10 mg film-coated tablets

Tadalafilo Sandoz 20 mg film-coated tablets

Tadalafilo

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What Tadalafilo Sandoz is and for what it is used

2. What you need to know before starting to take Tadalafilo Sandoz

3. How to take Tadalafilo Sandoz

4. Possible adverse effects

5. Storage of Tadalafilo Sandoz

6. Contents of the pack and additional information

Tadalafilo Sandoz contains the active ingredient tadalafilo which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafilo is used to treat adult men with:

• Erectile dysfunction.

This occurs when a man is unable to obtain or maintain a firm erection, adequate for a satisfactory sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis, adequate for sexual activity.

After sexual stimulation, tadalafilo acts by helping to relax the blood vessels of your penis, allowing blood to flow into the penis. The result is an improvement in erectile function.

Tadalafilo will not help if you do not have erectile dysfunction. It is essential to inform you that tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way you would without taking a medication for erectile dysfunction.

Do not take Tadalafilo Sandoz:

• if you are allergic to tadalafil or any of the other ingredients of this medication (listed in section 6),
• if you are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medications (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, inform your doctor,
• if you have a serious heart disease or have had a heart attack recently in the last 90 days,
• if you have had a recent stroke, in the last 6 months,
• if you have low or uncontrolled high blood pressure,
• if you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”,
• if you are taking riociguat. This medication is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by clots). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tadalafilo Sandoz.

Be aware that sexual intercourse carries a possible risk in patients with heart problems, due to the additional effort it imposes on the heart. If you have a heart problem, consult your doctor.

Before taking the tablets, inform your doctor if you have:

• sickle cell anemia (a disorder of red blood cells),
• multiple myeloma (bone marrow cancer),
• leukemia (blood cancer),
• any deformity of the penis,
• serious liver disease,
• serious kidney disease.

Tadalafil is not known to be effective in patients who have undergone:

• pelvic surgery,
• surgeries in which the prostate has been completely or partially removed and the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a decrease or sudden loss of vision or your vision is distorted, while taking tadalafil, stop taking tadalafil and immediately contact your doctor.

A decrease or sudden loss of hearing has been observed in some patients taking tadalafil. Although, it is not known if this reaction is directly related to tadalafil, if you experience a decrease or sudden loss of hearing, stop taking tadalafil and immediately contact your doctor.

Tadalafil is not intended for use in women.

Children and adolescents

Tadalafil should not be used in children or adolescents under 18 years old.

Other medications and Tadalafilo Sandoz

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication.

Do not take tadalafil if you are taking nitrates.

Some medications may be affected by tadalafil or may affect the proper functioning of tadalafil. Inform your doctor or pharmacist if you are taking:

• an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia),
• other medications to treat high blood pressure,
• riociguat,
• an inhibitor of 5-alpha reductase (used to treat benign prostatic hyperplasia),
• medications such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV/AIDS or HIV infection,
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications),
• rifampicin, erythromycin, clarithromycin, or itraconazole,
• other treatments for erectile dysfunction.

Taking Tadalafilo Sandoz with beverages and alcohol

The information about the effect of alcohol is found in section 3. Grapefruit juice may affect the proper functioning of tadalafil and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machinery

Some men who took tadalafil during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machinery.

Tadalafilo Sandoz contains lactose and sodium

If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Tadalafilo tablets are for oral administration only in men. Swallow the tablet whole with a little water. Tadalafilo tablets of 10 mg and 20 mg can be divided into equal doses.

Tadalafilo tablets can be taken with or without food.

For the treatment of erectile dysfunction

• Flexible dose, on demand, using 10 or 20 mg tablets:

The recommended initial dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafilo tablets are administered orally.

You should take the tadalafilo tablet at least 30 minutes before sexual activity. Tadalafilo may remain effective for up to 36 hours after taking the tablet. Tadalafilo 10 and 20 mg is intended for use before a planned sexual activity and is not recommended for continuous daily use.

Do not take tadalafilo more than once a day.

It is essential to inform you that tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to achieve an erection and may temporarily lower your blood pressure. If you have taken or plan to take tadalafilo, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

If you take more Tadalafilo Sandoz than you should

Consult your doctor. You may experience adverse effects described in section 4.

If you have taken more Tadalafilo Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Tadalafilo Sandoz

If you have a once-daily dose of tadalafilo, take your dose as soon as you remember, but do not take a double dose to compensate for the missed dose. Do not take tadalafilo more than once a day.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.These side effects are generally mild to moderate in intensity.

If you experience any of the following side effects, stop using the medicine and seek medical help immediately:

• allergic reactions including rashes (rare, may affect up to 1 in 100 people),
• chest pain - do not use nitrates but seek medical help immediately (rare, may affect up to 1 in 100 people),
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare, may affect up to 1 in 1,000 people). If you experience this type of erection, which may last for more than 4 hours, you must contact a doctor immediately,
• sudden loss of vision (rare, may affect up to 1 in 1,000 people), distorted, blurred, central vision blurred or sudden loss of vision (frequency unknown).

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion and indigestion.

Rare(may affect up to 1 in 100 people)

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

Rare(may affect up to 1 in 1,000 people)

• loss of consciousness, seizures and temporary loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin's surface), bleeding in the penis, blood in the semen and increased sweating.

Also, rare cases of heart attack and stroke have been reported in men taking tadalafil. Most of these men had some heart problem before taking this medicine.

Rarely, cases of partial or permanent loss of vision, temporary or permanent, in one or both eyes have been reported.

Some rare additional side effects have been reported in men taking tadalafil that were not reported during clinical trials. These include:

• migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death,
• distorted, blurred, central vision blurred or sudden loss of vision (frequency unknown).

In men over 75 years old taking tadalafil, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafil, the most frequently reported side effect was diarrhea.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the envelopeand blisterafter CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tadalafilo Sandoz

• The active ingredient is tadalafilo.

Tadalafilo Sandoz 10 mg: each tablet contains 10 mg of tadalafilo.

Tadalafilo Sandoz 20 mg: each tablet contains 20 mg of tadalafilo.

• The other components are: lactose monohydrate, sodium laurilsulfate, povidone K-12, crospovidone (type B), stearate fumarate and sodium in the core; polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc, yellow iron oxide (E172) in the coating.

Appearance of the product and contents of the package

Tadalafilo Sandoz 10 mg

Film-coated tablet, oval, yellow to brown color, approximately 11 x 6 mm. Marked on one side with a "10" and smooth on the other side.

Tadalafilo Sandoz 20 mg

Film-coated tablet, oval, yellow to brown color, approximately 15 x 9 mm. One side marked with "20". The other side of the tablet has two grooves. The tablet can be divided into equal halves and/or quarters.

Film-coated tablets are packaged in aluminum/OPA/aluminum/PVC blisters, PVC/ACLAR/PVC-aluminum blisters, PVC/ACLAR/PVdC/PVC/aluminum blisters, or PVC/PVdC-aluminum blisters and are introduced into a cardboard box.

Packaging sizes:

Tadalafilo Sandoz 10 mg : 4, 12, 24, 36, 48 tablets.

Tadalafilo Sandoz 20 mg : 2, 4, 5, 8, 10, 12, 24, 36, 48, 56 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.,

Verovškova ulica 57,

1526 Ljubljana, Slovenia

or

TEVA Pharma, S.L.U.

Polígono Industrial Malpica,

C/C, nº4, 50016

Zaragoza, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Tadalafil 1A Pharma 10 mg – Filmtabletten

Tadalafil 1A Pharma 20 mg – Filmtabletten

Austria: Tadalafil 1A Pharma 10 mg – Filmtabletten

Tadalafil 1A Pharma 20 mg – Filmtabletten

France: TADALAFIL SANDOZ 10 mg, comprimé pelliculé

TADALAFIL SANDOZ 20 mg, comprimé pelliculé

Malta: Tadalafil – 1 A Pharma 10 mg Film-coated Tablet

Tadalafil – 1 A Pharma 20 mg Film-coated Tablet

Netherlands: Tadalafil 1A Pharma 10 mg, filmomhulde tabletten

Tadalafil 1A Pharma 20 mg, filmomhulde tabletten

Czech Republic: Tadalafil Sandoz 20 mg

Slovak Republic: Tadalafil Sandoz 20 mg

Last review date of this prospectus: June 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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