Leaflet: information for the user

Tadalafilo Stadagen 20 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; do 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 starting to take 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.Erectile dysfunction is when a man cannot obtain or maintain a firm erection, adequate for a satisfactory sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis, adequate 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 you if you do not have erectile dysfunction.

Tadalafilo will not help you 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 you would if you were not taking a medicine for erectile dysfunction.

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 high blood pressure that is not controlled.

• You have ever had 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 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 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.

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

• Anemia falciforme (an abnormality of red blood cells).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cell cancer).
• Any deformity of the penis.
• A serious liver problem.
• A serious kidney problem.

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

• Surgery in the pelvic area.
• A surgical intervention in which the prostate has been completely or partially removed and the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

A 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 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 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.
• 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 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. Grapefruit 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 an intolerance to certain sugars, consult him before taking this medication.

Tadalafilo Stadagen contains sodium

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

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

Dose

The recommended initial dose is one 10 mg tablet before sexual activity. However, you have been given a dose of one 20 mg tablet because your doctor has decided that the recommended dose of 10 mg is too weak.

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

Administration Form

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

The tablet can be divided into equal doses: place the tablet on a hard, flat surface. Then, divide the tablet by pressing down with a finger.

You can initiate sexual activity at least 30 minutes after taking tadalafilo. Tadalafilo may still be effective up to 36 hours after taking the tablet.

You should not take tadalafilo more than once a day. The 10 and 20 mg doses will be used before expected sexual activity and are not recommended for continuous daily use.

Be Aware of the Following

It is essential to note that tadalafilo 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.

Consuming alcohol may affect your ability to achieve an erection and may temporarily lower your blood pressure. If you have taken or are planning to take tadalafilo, 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.

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, contact 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.

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

Frequent(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
• nasal bleeding
• tinnitus
• swelling of the hands, feet, or ankles
• feeling 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 heart problem before taking this medicine.

Rarely, cases of partial or permanent loss of vision 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
• 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 heartbeat
• angina pectoris
• sudden cardiac death
• distorted, blurred, or reduced central vision (unknown frequency).

In men over 75 years old taking tadalafil, the most common side effect reported was dizziness. In men over 65 years old taking tadalafil, the most common side effect reported 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 not listed 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.

Any remaining tablet fragments must be discarded after 4 weeks.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition ofTadalafilo Stadagen

• Theactive ingredientis tadalafilo. Each film-coated tablet contains 20 mg of tadalafilo.
• Theother componentsare:Tablet core: Lactose monohydrate, croscarmellose sodium, laurilsulfate of sodium (E487), hydroxypropylcellulose, polisorbate, microcrystalline cellulose, magnesium stearate

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

Appearance of the product and contents of the pack

Tadalafilo Stadagen20 mg is a yellow, round, biconvex,scored in the form of a cross,film-coated tablet, of a diameter of10.1±0.2mm. The tablet can be divided into equal doses.

Tadalafilo Stadagen20 mg is available in blister packs containing 4, 8, 12, 16, 20, 24, 28, 30, 36, 48, 56 and 60 tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

STADA, 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 medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria:Tadalafil STADA 20 mg Filmtabletten

Belgium:Tadalfil EG 20 mg filmomhulde tabletten

France:TADALAFIL EG LABO 20 mg comprimé pelliculé

Germany:Tadalafil STADA 20 mg Filmtabletten

Ireland:Tadalafil Clonmel 20 mg film-coated tablets

Netherlands:Tadalafil STADA 20 mg filmomhulde tabletten

Luxembourg:Tadalfil EG 20 mg comprimé pelliculé

Spain:Tadalafilo Stadagen 20 mg comprimidos recubiertos con película EFG

Last review date of this leaflet:September 2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/