Leaflet: information for the patient

Tadalafilo Sandoz 5 mg film-coated tablets EFG

Tadalafilo

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

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

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

2. What you need to know before you start taking Tadalafilo Sandoz

3. How to take Tadalafilo Sandoz

4. Possible side effects

5. Storage of Tadalafilo Sandoz

6. Contents of the pack and additional information

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

Tadalafilo is used to treat adult men with:

• Impotence.

This is when a man cannot get or keep an erection firm enough for satisfying sexual activity. Tadalafilo has shown a significant improvement in the ability to get a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, tadalafilo 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.

Tadalafilo will not help if you do not have impotence. It is essential to inform you that tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medicine for impotence.

Tadalafilo5 mgis used to treat men with:

• Urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This is when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, feeling that the bladder is not fully emptied, needing to urinate more frequently, even at night. Tadalafilo improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

Do not take Tadalafilo Sandoz:

• if you are allergic to tadalafilo or any of the other components 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”). Tadalafilo has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, inform your doctor,
• if you have a severe heart disease or have had a heart attack recently in the last 90 days,
• if you have had a recent stroke, in the last 6 months,
• if you have low or high blood pressure that is not controlled,
• if you have ever had vision loss 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 hypertension (i.e., high blood pressure in the lungs) and chronic pulmonary thromboembolic hypertension (i.e., high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as tadalafilo, have shown to 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 Tadalafilo Sandoz.

Be aware that sexual intercourse carries a possible risk for patients with heart problems, due to the additional 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 tadalafilo 5 mg:5 mgsince benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer review before starting treatment with tadalafilo for benign prostatic hyperplasia. Tadalafilo does not treat prostate cancer.

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

• sickle cell anemia (a red blood cell alteration),
• multiple myeloma (bone marrow cancer),
• leukemia (blood cell cancer),
• any penile deformity,
• severe liver disease,
• severe kidney disease.

Tadalafilo is not known to be effective in patients who have undergone:

• pelvic surgery,
• any surgical intervention in which the prostate has been completely or partially removed and the prostate nerves have been cut (radical prostatectomy without neurovascular bundle preservation).

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

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

Tadalafilo is not intended for use in women.

Children and adolescents

Tadalafilo should not be used in children or adolescents under 18 years old.

Other medications and Tadalafilo Sandoz

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may have to take any other medication.

Do not take tadalafilo if you are taking nitrates.

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

Taking Tadalafilo Sandoz with beverages and alcohol

The information about the effect of alcohol is found in section 3. Grapefruit juice may affect the proper functioning of tadalafilo and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machines

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

Tadalafilo Sandoz contains lactose and sodium

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

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

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

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

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 of day. Your doctor may adjust your dose to 2.5 mg based on your response to tadalafil. You will be prescribed a 2.5 mg tablet.

Tadalafil taken daily allows you to get an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Daily tadalafil may be useful for men who plan to have sex two or more times a week.

Do not take tadalafil more than once a day.

It is essential to inform you that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication 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 plan 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.

Treatment of benign prostatic hyperplasia, using 5 mg tablets:

The dose is one 5 mg tablet once a day, approximately at the same time of 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 Tadalafilo Sandoz than you should

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

If you have taken more Tadalafilo Sandoz than you should, consult your doctor immediately, your pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Tadalafilo Sandoz

If you have a once-a-day tadalafil dosage, take your dose as soon as you remember, but do not take a double dose to compensate for the missed doses. Do 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.These side effects are generally mild to moderate in intensity.

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

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

Other side effects that have been reported:

Frequent(may affect up to 1 in 10 people)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion and indigestion.

Rare(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 heartbeat, high blood pressure, low blood pressure, nasal bleeding, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

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

• loss of consciousness, seizures and temporary loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin's surface), bleeding in the penis, blood in the semen and increased sweating.

Also, rare cases of heart attack and stroke have been reported in men taking tadalafil. Most of these men had some heart problem before taking this medicine.

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

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

• migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death,
• distorted, blurred, central vision blurred or sudden loss of vision (frequency unknown).

In men over 75 years old taking tadalafil, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafil, the most frequently reported side effect was diarrhea.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the envelopeand blisterafter 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 drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tadalafilo Sandoz

• The active ingredient is tadalafilo.

Tadalafilo Sandoz 5 mg: each tablet contains 5 mg of tadalafilo.

• The other components are: lactose monohydrate, sodium laurilsulfate, povidone K-12, crospovidone (type B), stearate 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 package

Tadalafilo Sandoz 5 mg

Film-coated tablet, oval, of ocre to yellow color, approximately 8 x 4 mm. Marked with “5” on one face and smooth on the other face.

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 introduced into a cardboard box.

Package sizes:

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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 with 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

Last review date of thisleaflet:June 2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.