Tadalafil Sandoz 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Tadalafilo Sandoz 10 mg film-coated tablets EFG

Tadalafilo Sandoz 20 mg film-coated tablets EFG

Tadalafil

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Tadalafilo Sandoz is and what it is used for
2. What you need to know before taking Tadalafilo Sandoz
3. How to take Tadalafilo Sandoz
4. Possible side effects
5. How to store Tadalafilo Sandoz
6. Contents of the pack and other information

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

Tadalafilo Sandoz contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil is used to treat adult men with:

• Erectile dysfunction.

This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity.

Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow into it. The result is improved erectile function.

Tadalafil will not help you if you do not have erectile dysfunction. It is important to warn you that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Tadalafilo Sandoz

Do not take Tadalafilo Sandoz:

• if you are allergic to tadalafil or to any of the other ingredients of this medicine (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 medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, inform your doctor,
• if you have a severe heart disease or have recently had a heart attack within the last 90 days,
• if you have recently had a stroke within the last 6 months,
• if you have low blood pressure or uncontrolled high blood pressure,
• if you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”,
• if you are taking riociguat. This medicine 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 blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Tadalafilo Sandoz.

Be aware that sexual activity carries a potential risk for patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

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

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

It is not known whether tadalafil is effective in patients who have undergone:

• pelvic surgery,
• surgical procedures involving complete or partial removal of the prostate with nerve-sparing not preserved (radical prostatectomy without neurovascular bundle preservation).

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

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

Tadalafilo Sandoz is not intended for use in women.

Children and adolescents

Tadalafil must not be used in children or adolescents under 18 years of age.

Other medicines and Tadalafilo Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take tadalafil if you are taking nitrates.

Some medicines may be affected by tadalafil or may affect how well tadalafil works. 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 medicines to treat high blood pressure,
• riociguat,
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia),
• medicines such as ketoconazole tablets (for treatment of fungal infections) and protease inhibitors for treatment of AIDS or HIV infection,
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines),
• rifampicin, erythromycin, clarithromycin, or itraconazole,
• other treatments for erectile dysfunction.

Taking Tadalafilo Sandoz with food and alcohol

Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect how well tadalafil works and should be taken with caution. Consult your doctor for further information.

Fertility

In dogs treated with tadalafil, a reduction in sperm production by the testes was observed. In some men, a reduction in sperm count has been observed. These effects are unlikely to result in infertility.

Driving and use of machines

Some men who took tadalafil during clinical studies experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafilo Sandoz contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Tadalafil Sandoz

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Tadalafil tablets are for oral use only in men. Swallow the tablet whole with some water. The 10 mg and 20 mg tadalafil tablets may be divided into equal doses.

Tadalafil tablets may be taken with or without food.

For the treatment of erectile dysfunction

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

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

Take the tadalafil tablet at least 30 minutes before sexual activity. Tadalafil may remain effective for up to 36 hours after taking the tablet. Tadalafil 10 mg and 20 mg are intended for use prior to anticipated sexual activity and are not recommended for continuous daily use.

Do not take tadalafil more than once a day.

It is important to note that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, 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 Tadalafil Sandoz than you should

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

If you have taken more Tadalafil Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tadalafil Sandoz

If you are on a once-daily tadalafil regimen, take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. You must not take tadalafil more than once a day.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. These effects are generally mild to moderate in intensity.

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

• allergic reactions including rashes (uncommon, may affect up to 1 in 100 people),
• chest pain – do not use nitrates but seek immediate medical help (uncommon, 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 continuously for more than 4 hours, you must contact a doctor immediately,
• sudden vision loss (rare, may affect up to 1 in 1,000 people), distorted, dimmed, blurred central vision or sudden decrease in vision (frequency not known).

Other adverse effects that have been reported:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy welts on the skin), bleeding from the penis, blood in semen, and increased sweating.

Rare cases of heart attack and stroke have also been reported in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medicine.

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

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

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death,
• distorted, dimmed, blurred central vision or sudden decrease in vision (frequency not known).

In men over 75 years of age receiving tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect was diarrhoea.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Sandoz

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

Do not use this medicine after the expiry date stated on the packaging and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Sandoz

• The active substance is tadalafil.

Tadalafil Sandoz 10 mg: each tablet contains 10 mg of tadalafil.

Tadalafil Sandoz 20 mg: each tablet contains 20 mg of tadalafil.

• The other components are: monohydrate lactose, sodium lauryl sulfate, povidone K-12, crospovidone (type B), stearoyl 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 pack

Tadalafil Sandoz 10 mg

Film-coated tablet, oval, yellowish to yellow in colour, approximately 11 x 6 mm. Marked on one side with a “10” and smooth on the other side.

Tadalafil Sandoz 20 mg

Film-coated tablet, oval, yellowish to yellow in colour, approximately 15 x 9 mm. Marked on one side with “20”. The other side of the tablet has two score lines. The tablet can be divided into equal halves and/or quarters.

Film-coated tablets are packed in Al/OPA/Al/PVC blisters, PVC/ACLAR/PVC/Aluminium blisters, PVC/ACLAR/PVdC/PVC-Aluminium blisters or PVC/PVdC-Aluminium blisters, and placed in a cardboard box.

Pack sizes:

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 medicinal product is authorized in the European Economic Area member states under 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

Date of the most recent review of this package leaflet: June 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.