Leaflet: information for the user

Tadalafilo Stadagen 5 mg film-coated tablets EFG

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 Stadagen is and what it is used for

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

3. How to take Tadalafilo Stadagen

4. Possible side effects

5. Storage of Tadalafilo Stadagen

6. Contents of thepack and additional information

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

Tadalafilo is indicated for the treatment in adult men with:

• erectile dysfunction.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 of 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 erectile dysfunction.

Tadalafilo will not help if you do not have erectile dysfunction. It is essential to inform you that tadalafilo is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medicine for erectile dysfunction.

• urinary symptoms associated with a common disease calledbenign prostatic hyperplasia.

This iswhen 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 Stadagen if:

• You are allergic to tadalafilo or any of the other components of this medication (listed in section 6).

• 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, tell your doctor.

• You have a serious heart disease or have had a heart attack recently, within the last 90 days.

• You have had a recent stroke, within the last 6 months.

• You have low or uncontrolled high blood pressure.

• You have ever presented vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”.

• 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 before starting to take tadalafilo.

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.

Since 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:

• Anemia falciforme (a red blood cell abnormality).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cell cancer).
• Any penile deformity.
• Severe liver disease.
• Severe kidney disease.

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

• Pelvic surgery.
• A 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 sudden decrease or loss of visionor your vision is distorted, blurred while taking tadalafilo,stop taking tadalafilo and contact your doctor immediately.

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

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 Stadagen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to use any other medication.

Do not take tadalafilo if you are already using nitrates.

Some medications may be affected by tadalafilo or may affect the proper functioning of tadalafilo. Inform your doctor or pharmacist if you are using:

• 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 Stadagen with beverages and alcohol

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

Fertility

In treated dogs, 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 Stadagen contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Tadalafilo Stadagen contains sodium

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

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

Administration Form

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

Do not take tadalafil more than once a day.

Consuming alcohol may temporarily lower your blood pressure. If you have taken or are planning to take tadalafil, avoid excessive alcohol consumption (e.g. more than 900 ml of beer or 350 ml of wine), as it may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction

Dose

The recommended dose is one 5 mg tablet once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be done by taking one 2.5 mg tablet.

Not all recommended doses are possible using 5 mg tablets. Tadalafil may also be available in 2.5, 10, and 20 mg tablets. Not all doses may be marketed.

Take note that

Daily tadalafil administration allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Daily tadalafil administration may be useful for men who anticipate engaging in sexual activity two or more times a week.

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 you would without taking a medication for erectile dysfunction.

Alcohol consumption may affect your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia

Dose

The dose is one 5 mg tablet once a day, approximately at the same time.

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet once a day.

Do not take this medication more than once a day.

If you take more Tadalafilo Stadagen than you should

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service, Tel. 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Tadalafilo Stadagen

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)
• chest pain - do not use nitrates but seek medical help immediately (rare)
• prolonged and possibly painful erection after taking tadalafil (rare). If you experience this type of erection, which can last for more than 4 hours, you must contact a doctor immediately
• sudden loss of vision (rare), distorted, blurred, or reduced central vision (unknown frequency).

Other side effects reported

Common(may affect up to 1 in 10 people)

• headache
• back pain
• muscle pain
• arm and leg pain
• flushing of the face
• nasal congestion
• 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
• nosebleed
• tinnitus
• swelling of the hands, feet, or ankles
• sense of fatigue

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

• syncope
• seizures
• transient loss of memory
• swelling of the eyelids,
• red eyes
• sudden loss or decrease in hearing
• urticaria (hives)
• bleeding in the penis
• blood in the semen
• increased sweating

Infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had some pre-existing heart condition before taking this medicine.

Rare cases of partial or permanent loss of vision in one or both eyes have also been reported.

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

• migraine
• swelling of the face
• severe allergic reaction causing swelling of the face or throat
• severe skin rashes
• certain disorders affecting blood flow to the eyes
• irregular heartbeat
• angina pectoris
• sudden cardiac death
• distorted, blurred, or reduced central vision (unknown frequency).

In men over 75 years old taking tadalafil, the most commonly reported side effect was dizziness. In men over 65 years old taking tadalafil, the most commonly 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 the Spanish 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 use this medication after the expiration date that appears on the box and the blister pack after “CAD.:”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not dispose of medications through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofTadalafil Stadagen

• Theactive ingredientis tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• Theother componentsare:Core of the tablet: Lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate (E487), hydroxypropyl cellulose, polysorbate, microcrystalline cellulose, magnesium stearate

Coating:hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin, yellow iron oxide (E172), talc.

Appearance of the product and contents of the package

Tadalafil Stadagen5 mg is a yellowish clear, round, biconvex, film-coated tablet, with a diameter of6.1±0.2mm.

Tadalafil Stadagen5 mg is available in blister packs containing 14, 16, 28, 30, 56, 84, 98, and 100 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Tadalafil STADA 5 mg Filmtabletten

Belgium:Tadalfil EG 5 mg filmomhulde tabletten

France:TADALAFIL EG LABO 5 mg comprimé pelliculé

Germany:Tadalafil STADA 5 mg Filmtabletten

Netherlands:Tadalafil STADA 5 mg filmomhulde tabletten

Luxembourg:Tadalfil EG 5 mg comprimé pelliculé

Spain:Tadalafilo Stadagen 5 mg comprimidos recubiertos con película EFG

Last review date of this leaflet:December 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/