TADALAFIL STADAGEN 10 mg FILM-COATED TABLETS

2. What you need to know before taking Tadalafil Stadagen

Do not take Tadalafil Stadagen if:

• you are allergic to tadalafil 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"). It has been seen that tadalafil increases the effects of these medications. If you are taking any type of nitrate or are unsure, tell your doctor.

• you have a severe heart disease or have recently suffered a heart attack, in the last 90 days.

• you have recently suffered a stroke, in the last 6 months.

• you have low blood pressure or uncontrolled high blood pressure.

• you have ever experienced 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 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 before starting to take tadalafil.

Be aware that sexual activity carries a possible risk in patients with heart problems, due to the additional effort it entails for the heart. If you have a heart problem, consult your doctor.

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

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformation.
• a severe liver problem.
• a severe 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 completely or partially 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 the event 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 Stadagen

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

Do not take tadalafil if you are already using nitrates.

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

• an alpha-blocker (used to treat high blood pressure or symptoms associated with benign prostatic hyperplasia).
• other medications for 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 Stadagen 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 Stadagen contains Lactose

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

Tadalafil Stadagen contains Sodium

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

3. How to take Tadalafil Stadagen

Follow your doctor's instructions for taking this medication exactly. In case of doubt, consult your doctor or pharmacist again.

Dose

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.

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

Method of Administration

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.

The tablet can be divided into equal doses.

When taking tadalafil, you can initiate sexual activity at least 30 minutes after taking it. Tadalafil may still be effective up to 36 hours after taking the tablet.

Do not take tadalafil 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.

Keep in mind that

It is essential 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.

Alcohol consumption may 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 (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 Tadalafil Stadagen than you should

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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)
• chest pain - do not use nitrates, but seek medical help immediately (uncommon)
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare). 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), distorted, blurred, 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
• flushing
• nasal congestion
• 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 heartbeat
• high blood pressure
• low blood pressure
• nasal bleeding
• ringing in the ears
• swelling of the hands, feet, or ankles
• feeling of fatigue

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

• fainting
• seizures
• temporary memory loss
• swelling of the eyelids
• red eyes
• sudden decrease or loss of hearing
• urticaria (red itchy rashes on the skin surface)
• bleeding in the penis
• blood in the semen
• 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 decreased or lost vision, partial, transient, or permanent in one or both eyes have been reported.

Some additional rare side effectshave been reported in men taking tadalafil that were not observed 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
• sudden cardiac death
• distorted, blurred, 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 Medication Surveillance System for Human Use: 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 Stadagen

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box and blister pack after "EXP.". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Any divided part of the remaining tablet should be discarded after 4 weeks.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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 Stadagen

• The active substanceis tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
• The other components are: Tablet core: Lactose monohydrate, sodium croscarmellose, sodium lauryl sulfate (E487), hydroxypropylcellulose, polysorbate, microcrystalline cellulose, magnesium stearate.

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

Appearance of the Product and Package Contents

Tadalafil Stadagen 10 mg is a yellow, round, scored film-coated tablet, biconvex, with a diameter of 8.1 ± 0.2 mm. The tablets can be divided into equal doses.

Tadalafil Stadagen 10 mg is available in blister packs containing 4, 8, 12, 16, 20, 24, 28, 30, 36, 48, and 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

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

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medication is authorized in the Member States of the European Economic Area under the following names:

Austria: Tadalafil STADA 10 mg Filmtabletten

Belgium: Tadalfil EG 10 mg filmomhulde tabletten

France: TADALAFIL EG LABO 10 mg comprimé pelliculé

Germany: Tadalafil STADA 10 mg Filmtabletten

Ireland: Tadalafil Clonmel 10 mg film-coated tablets

Netherlands: Tadalafil STADA 10 mg filmomhulde tabletten

Luxembourg: Tadalfil EG 10 mg comprimé pelliculé

Spain: Tadalafilo Stadagen 10 mg comprimidos recubiertos con película EFG

Date of the last revision of this package leaflet:December 2023

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