TADALAFIL SANDOZ 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tadalafil Sandoz 10 mg Film-Coated Tablets EFG

Tadalafil Sandoz 20 mg Film-Coated Tablets EFG

Tadalafil

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

• Keep this package leaflet, as 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Tadalafil 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 is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

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

Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that tadalafil is not effective if there is no 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.

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 condition called 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 caused by blood clots). Phosphodiesterase 5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effects 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 an 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 anemia (a disorder of the red blood cells),
• multiple myeloma (cancer of the bone marrow),
• leukemia (cancer of the blood cells),
• any deformation of your penis,
• a severe liver problem,
• a severe kidney problem.

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

• undergone pelvic surgery,
• had a surgical procedure in which the prostate gland was removed (prostatectomy).

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

A decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known if this condition is directly related to tadalafil, if you experience a decrease 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 works. 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 the treatment of fungal infections) and protease inhibitors for the treatment of HIV or AIDS,
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines),
• rifampicin, erythromycin, clarithromycin, or itraconazole,
• other treatments for erectile dysfunction.

Taking Tadalafil Sandoz with Food and Alcohol

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 produce infertility.

Driving and Using Machines

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

Tadalafil Sandoz contains Lactose and Sodium

If your doctor has told you that you have an intolerance to some sugars, consult 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

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

The tablets can be taken with or without food.

For the Treatment of Erectile Dysfunction

• Flexible dose, as needed, 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. Tadalafil tablets are taken by mouth.

You should take a tadalafil tablet at least 30 minutes before sexual activity. Tadalafil may still be effective up to 36 hours after taking the tablet. Tadalafil 10 and 20 mg is intended for use before 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 if there is no 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 large amounts of alcohol may decrease 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

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 Toxicological Information Service, 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 tadalafil more than once a 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),
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare, may affect up to 1 in 1,000 people). If you have an erection that lasts more than 4 hours, you should contact a doctor immediately,
• sudden loss of vision (rare, may affect up to 1 in 1,000 people), distorted vision, blurred vision, or sudden 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, 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 urine, prolonged erection, 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 (red itchy patches on 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 decrease or loss of vision in one or both eyes have been reported.

Some additional rare side effects have been reportedin men taking tadalafil that were not observed in clinical trials, including:

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

In men over 75 years of age treated with tadalafil, the most frequently reported adverse event was dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported adverse event was diarrhea.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: 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 packaging and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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

Appearance of the Product and Contents of the Pack

Tadalafil Sandoz 10 mg

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

Tadalafil Sandoz 20 mg

Film-coated tablet, oval, yellow to ochre in color, approximately 15 x 9 mm in size. Marked with a “20” on one side and has two score lines on the other side. 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, PVC/ACLAR/PVdC/PVC-aluminum blisters, or PVC/PVdC-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 Healthcare Products (AEMPS) http://www.aemps.gob.es/.