Tadalafil Stadagen 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tadalafilo Stadagen 20 mg film-coated tablets EFG

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

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

Leaflet Contents

1. What Tadalafilo Stadagen is and what it is used for
2. What you need to know before taking Tadalafilo Stadagen
3. How to take Tadalafilo Stadagen
4. Possible side effects
5. How to store Tadalafilo Stadagen
6. Contents of the pack and other information

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

Tadalafilo Stadagen contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil is indicated for the treatment of adult men with:

• Erectile dysfunction. This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has demonstrated significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction.

Tadalafil will not help you if you do not have erectile dysfunction. It is important to inform you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner must engage in sexual stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Tadalafil Stadagen

Do not take Tadalafil Stadagen if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (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 medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.

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

• you have recently had a stroke, within 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 condition described as “stroke of the eye”.

• you are taking riociguat. This medicine 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). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to take tadalafil.

Be aware that sexual activity involves a possible risk for patients with heart problems due to the additional strain it places on the heart. If you have a heart condition, consult your doctor.

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

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of blood cells).
• any deformity of the penis.
• severe liver problems.
• severe kidney problems.

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

• pelvic surgery.
• a surgical procedure in which the prostate has been completely or partially removed and the nerves to the prostate have been severed (radical prostatectomy without neurovascular bundle preservation).

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

Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known whether this event is directly related to tadalafil, if you experience 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 must not be used in children or adolescents under 18 years of age.

Other medicines and Tadalafil Stadagen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take tadalafil if you are already using nitrates.

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

Taking Tadalafil Stadagen with food and alcohol

Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect how well tadalafil works and should be taken with caution. Consult your doctor for further information.

Fertility

In treated dogs, a reduction in sperm production by the testes was observed. A reduction in sperm has been observed in some men. These effects are unlikely to result in infertility.

Driving and using machines

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

Tadalafil Stadagen contains lactose

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

Tadalafil Stadagen contains sodium

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

3. How to take Tadalafil Stadagen

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Dosage

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

Not all recommended doses can be achieved using only 20 mg tablets. Tadalafil is also available in 2.5 mg, 5 mg, and 10 mg tablets. Not all strengths may be marketed.

Method of administration

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

The tablet can be divided into equal doses: place the tablet on a hard, flat surface and then split it by pressing down with a finger.

After taking tadalafil, you may initiate sexual activity at least 30 minutes later. Tadalafil may remain effective for up to 36 hours after taking the tablet.

Do not take tadalafil more than once a day. The 10 mg and 20 mg doses are to be taken prior to anticipated sexual activity and are not recommended for daily continuous use.

Please note that

It is important to be aware that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in the same level of sexual stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to get 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 this may increase the risk of dizziness when standing up.

If you take more Tadalafil Stadagen than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the packaging and the patient information leaflet to the healthcare professional.

4. Possible adverse effects

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

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

• allergic reactions including rashes (uncommon)
• chest pain – do not use nitrates but seek immediate medical help (uncommon)
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). If you experience this type of erection, which may last continuously for more than 4 hours, you must contact a doctor immediately
• sudden vision loss (rare frequency), distorted central vision, dimmed, blurred vision or sudden decrease in vision (frequency not known).

Other adverse effects that have been reported

Common (may affect up to 1 in 10 people)

• headache
• back pain
• muscle pain
• pain in arms and legs
• facial 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
• presence of 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
• feeling of tiredness

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

• fainting
• seizures
• transient memory loss
• swelling of the eyelids
• red eyes
• sudden decrease or loss of hearing
• urticaria (red, itchy welts on the skin surface)
• penile bleeding
• presence of blood in the semen
• increased sweating

Myocardial infarction and stroke have also been rarely reported in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medicine.

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

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

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

In men over 75 years of age receiving tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect was diarrhoea.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Stadagen

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

Do not use this medicine after the expiry date stated on the carton and blister after "EXP:". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Any remaining divided tablet must be discarded after 4 weeks.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Stadagen

• The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other components are:
  Tablet core: Monohydrate lactose, sodium croscarmellose, sodium lauryl sulfate (E487), hydroxypropylcellulose, polysorbate, microcrystalline cellulose, magnesium stearate.

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

Appearance of the product and contents of the container

Tadalafil Stadagen 20 mg is a yellow, round, biconvex tablet, film-coated, with a cross-score on one side, and a diameter of 10.1 ± 0.2 mm. The tablet can be divided into equal doses.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer Responsible

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 medicinal product is authorized in the European Economic Area (EEA) member states under 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

Date of the most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/