Tadalafil Sandoz 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tadalafilo Sandoz 5 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, and you should not give it 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 cannot 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.

After 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 stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

Tadalafil 5 mg is used to treat men with:

• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland increases in size over the years. Symptoms include difficulty starting to urinate, a sensation that the bladder has not emptied completely, and a need to urinate more frequently, even during the night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within as short a time as 1–2 weeks after starting treatment.

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 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 taking Tadalafilo Sandoz.

Be aware that sexual activity involves 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.

If you are being treated for benign prostatic hyperplasia with tadalafil 5 mg: since benign prostatic hyperplasia and prostate cancer may have similar symptoms, your doctor will perform a prostate cancer evaluation before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

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

• sickle cell anemia (a disorder of the red blood cells),
• multiple myeloma (cancer of the bone marrow),
• leukemia (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,
• a surgical procedure in which the prostate has been partially or completely removed and the nerves of the prostate have been severed (radical prostatectomy without neurovascular bundle preservation).

If you experience 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.

Tadalafil 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

Inform 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 drinks and alcohol

Information about the effect of alcohol is found 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 treated dogs, a decrease in sperm production by the testes was observed. In some men, a reduction in sperm 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 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 you are unsure, consult your doctor or pharmacist again.

Tadalafil tablets are for oral use only in men. Swallow the tablet whole with a little water. The tablets may be taken with or without food.

For the treatment of erectile dysfunction

• Once daily using 2.5 mg or 5 mg tablets:

The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust your dose to 2.5 mg based on your response to tadalafil. A 2.5 mg tablet may be prescribed for you.

When taken daily, tadalafil allows you to achieve an erection at any time during the 24-hour day, provided that sexual stimulation occurs. Daily tadalafil may be beneficial for men who expect to have sexual activity two or more times per week.

Do not take tadalafil more than once a day.

It is important to inform 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.

Alcohol consumption may affect your ability to obtain 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 upon standing.

For the treatment of benign prostatic hyperplasia, using 5 mg tablets:

The dose is one 5 mg tablet once daily, taken at approximately the same time each day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once daily.

Do not take tadalafil more than once a day.

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 immediately at telephone number: 91 562 04 20, indicating the medication and 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 can cause adverse effects, although not everyone will experience 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, blood in the urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (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 in the penis, blood in the 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 decreased or lost vision, partial, transient or permanent, 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 Medicinal Products: 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after 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. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging that 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 5 mg: each tablet contains 5 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 5 mg

Film-coated tablet, oval, yellowish to yellow in colour, approximately 8 x 4 mm. Marked with "5" on one side and smooth on the other side.

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

Pack sizes:

Tadalafil Sandoz 5 mg: 14, 28, 84 tablets.

Only some 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 Member States of the European Economic Area under the following names:

Germany: Tadalafil 1A Pharma 5 mg – Filmtabletten

Austria: Tadalafil 1A Pharma 5 mg – Filmtabletten

France: TADALAFIL SANDOZ 5 mg, comprimé pelliculé

Malta: Tadalafil – 1 A Pharma 5 mg Film-coated Tablet

Netherlands: Tadalafil 1A Pharma 5mg, filmomhulde tabletten

Czech Republic: Tadalafil Sandoz 5 mg

Sweden: Tadalafil Sandoz 5 mg filmdragerade tabletter

Date of the most recent revision of this 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/.