TADALAFIL SANDOZ 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tadalafil Sandoz 5 mg Film-Coated Tablets EFG

Tadalafil

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are 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 taking Tadalafil Sandoz
3. How to take Tadalafil Sandoz
4. Possible side effects
5. Storage of Tadalafil Sandoz
6. Package Contents and Additional 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 occurs when a man cannot obtain or maintain a firm erection, suitable for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to obtain a lasting erection of the penis suitable for sexual activity.

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

Tadalafil will not help if you do not have erectile dysfunction. It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medication for erectile dysfunction.

Tadalafil 5 mgis used to treat men with:

• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, feeling that the bladder has not been fully emptied, needing to urinate more often, even at night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms in as little as 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Sandoz

Do not take Tadalafil 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"). It has been seen that tadalafil increases the effects of these medications. If you are taking any type of nitrate or are unsure, inform your doctor,
• if you have a severe heart condition or have had a heart attack recently, in the last 90 days,
• if you have had a stroke recently, in the last 6 months,
• if you have low blood pressure or uncontrolled high blood pressure,
• if you have ever had a loss of vision 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 blood clots). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown that they 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 Tadalafil Sandoz.

Be aware that sexual activity can carry a possible risk in patients with heart problems, due to the extra effort it puts on the heart. If you have a heart problem, consult your doctor.

If you are being treated for benign prostatic hyperplasia with tadalafil 5 mg: since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer screening 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 red blood cells),
• multiple myeloma (bone marrow cancer),
• leukemia (blood cell cancer),
• any penile deformation,
• a serious liver problem,
• a serious kidney problem.

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

• surgery in the pelvic area,
• a surgical intervention in which the prostate was partially or totally removed and the prostate nerves were cut (radical prostatectomy without preservation of neurovascular bundles).

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

A sudden decrease or 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 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 should not be used in children or adolescents under 18 years of age.

Other Medications and Tadalafil Sandoz

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

Taking Tadalafil Sandoz with Drinks and Alcohol

Information about the effect of alcohol can be 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 with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and Using Machines

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

Tadalafil Sandoz Contains Lactose and Sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

For the Treatment of Erectile Dysfunction

• Once a Day Using 2.5 or 5 mg Tablets:

The recommended dose is one 5 mg tablet once a day, approximately at the same time every day. Your doctor may adjust the dose to 2.5 mg based on the response to tadalafil. You will be prescribed a 2.5 mg tablet.

When taking tadalafil daily, it allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Tadalafil administered daily may be useful in men who anticipate having sexual activity two or more times a week.

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. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medication for erectile dysfunction.

Consuming alcohol can affect your ability to have 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.

For the Treatment of Benign Prostatic Hyperplasia, Using 5 mg Tablets:

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

Do not take tadalafil more than once a day.

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, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If You Forget to Take Tadalafil Sandoz

If you have a once-daily dosage of tadalafil, take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. You should not take tadalafil more than once a day.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them. These effects are generally mild to moderate.

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

• allergic reactions including 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 potentially painful erection after taking tadalafil (rare, may affect up to 1 in 1,000 people). If you experience this type of erection, which can last continuously for 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, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

Other side effects that have been reported:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, pain in the 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, 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, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (red itchy rashes on the skin surface), bleeding in 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 before taking this medication.

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

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

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

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tadalafil Sandoz

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

Do not use this medication after the expiration date stated on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tadalafil Sandoz

• The active substance is tadalafil.

Tadalafil Sandoz 5 mg: each tablet contains 5 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 of the Product and Package Contents

Tadalafil Sandoz 5 mg

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

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 5 mg: 14, 28, 84 tablets.

Not all package 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 medication 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 Last Revision of this Package Leaflet:June 2024

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