TADALAFIL SANDOZ 10 mg FILM-COATED TABLETS

2. What you need to know before you take Tadalafil Sandoz

Do not take Tadalafil Sandoz:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6),
• if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.
• if you have a severe heart or liver problem,
• if you have recently had a heart attack (within the last 90 days),
• if you have had a stroke (within the last 6 months),
• if you have low blood pressure or uncontrolled high blood pressure,
• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION),
• 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 due to blood clots). PDE5 inhibitors, such as tadalafil, have shown an increase in the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking Tadalafil Sandoz.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on your heart. If you have a heart problem, tell your doctor.

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

• sickle cell anaemia (a disease of the red blood cells),
• multiple myeloma (cancer of the bone marrow),
• leukaemia (cancer of the blood cells),
• any deformation of your penis,
• a severe liver or kidney problem.

It is not known if tadalafil is effective in patients who have:

• undergone pelvic surgery,
• prostate surgery (removal of the prostate gland).

If you experience sudden decrease or loss of vision or hearing, stop taking tadalafil and contact your doctor immediately.

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

Tadalafil is not intended for use by women.

Children and adolescents

Tadalafil should not be used in children and adolescents under 18 years of age.

Other medicines and Tadalafil Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken or might 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 will work. Tell 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 for high blood pressure,
• riociguat,
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia),
• medicines such as ketoconazole tablets (for fungal infections) and protease inhibitors for the treatment of AIDS or HIV,
• phenobarbital, phenytoin, and carbamazepine (medicines for epilepsy),
• rifampicin, erythromycin, clarithromycin, or itraconazole,
• other treatments for erectile dysfunction.

Taking Tadalafil Sandoz with food and drink

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

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm count has been observed in some men. These effects are unlikely to lead to infertility.

Driving and using machines

Some men taking tadalafil during clinical studies had dizziness. Check carefully how you react to the tablets before driving or using machines.

Tadalafil Sandoz contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 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

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Tadalafil tablets are for oral use in men only. Swallow the tablet whole with some water. The 10 mg and 20 mg tablets can be split.

The tablets can be taken with or without food.

For the treatment of erectile dysfunction

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

The recommended starting 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. Tadalafil tablets are taken by mouth.

You should take a tablet at least 30 minutes before you plan to have sex. Tadalafil may still be effective up to 36 hours after taking the tablet. Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and is 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. You and your partner will still need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Consuming alcohol 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 drinking of alcohol (blood alcohol level of 0.08% or greater), as this may increase the risk of dizziness when standing up.

If you take more Tadalafil Sandoz than you should

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

If you have taken more Tadalafil Sandoz than you should, contact your doctor, pharmacist, or call the national poison control center, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Tadalafil Sandoz

If you have a once daily dosing regimen, take your dose as soon as you remember, but do not take a double dose to make up for a forgotten dose. Do not take more than one dose of tadalafil per day.

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

4. Possible side effects

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

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

• allergic reactions including skin rash (uncommon, may affect up to 1 in 100 people),
• chest pain - do not use nitrates, but seek medical help immediately (uncommon, may affect up to 1 in 100 people),
• prolonged and possibly painful erections (rare, may affect up to 1 in 1,000 people). If you have an erection that lasts for more than 4 hours, contact a doctor immediately,
• sudden loss of vision (rare, may affect up to 1 in 1,000 people), distorted vision, blurred vision, or loss of vision (frequency not known).

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach discomfort, 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(may affect up to 1 in 1,000 people)

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

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems.

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

Additional rare side effects have been reportedin men taking tadalafil that were not observed in clinical trials. These include:

• migraine, swelling of the face, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death,
• distorted, blurred, or loss of vision (frequency not known).

In men over 75 years of age, the most common side effect reported was dizziness. In men over 65 years of age, the most common side effect reported was diarrhea.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are: lactose monohydrate, sodium lauryl sulfate, povidone K-12, crospovidone (type B), sodium stearyl fumarate, and sodium in the core; polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc, yellow iron oxide (E172) in the coating.

Appearance and packaging of the product

Tadalafil Sandoz 10 mg

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

Tadalafil Sandoz 20 mg

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

The film-coated tablets are packaged in aluminum/OPA/aluminum/PVC blisters, PVC/ACLAR/PVC-aluminum blisters, or PVC/ACLAR/PVdC/PVC/aluminum blisters and are placed in a cardboard box.

Package 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.

Not all 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 medicine is authorized in the Member States of the European Economic Area 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

Slovakia: Tadalafil Sandoz 20 mg

Date of last revision of this package leaflet: June 2024

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