Tadalafil Stadagen 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Stadagen 5 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects 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 adverse 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 in 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 blood to flow into the penis. The result is improved erectile function. Tadalafil will not help if you do not have erectile dysfunction.

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

• Urinary symptoms associated with a common condition called benign prostatic hyperplasia.

This occurs when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, a sensation that the bladder has not emptied completely, and a need to urinate more frequently, even during the night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within as little as 1–2 weeks after starting treatment.

2. What you need to know before taking Tadalafilo Stadagen

Do not take Tadalafilo Stadagen if:

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

• you are taking any organic nitrates or nitric oxide donors such as amyl nitrite. This group of medicines (“nitrates”) is 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 “eye stroke”.

• 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 tadalafil.

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

Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform a prostate cancer screening before starting treatment with tadalafil for benign prostatic hyperplasia. Tadalafil does not treat prostate cancer.

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

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

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

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

If you experience 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 Tadalafilo Stadagen

Tell 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 interact with tadalafil or 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 for 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 Tadalafilo Stadagen with drinks and alcohol

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

Fertility

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

Driving and using machines

Some men taking tadalafil during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafilo Stadagen contains lactose

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

Tadalafilo 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 Tadalafilo Stadagen

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

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.

Do not take tadalafil more than once a day.

Alcohol consumption 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.

For the treatment of erectile dysfunction

Dosage

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

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

Please note that

Daily administration of tadalafil allows you to achieve an erection at any time during the 24-hour day, provided that sexual stimulation is present. Daily tadalafil may be beneficial for men who anticipate having sexual activity two or more times per week.

It is important to inform you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia

Dosage

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

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

You must not take this medicine 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, contact the Toxicology Information Service at phone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Tadalafilo Stadagen

Take your dose as soon as you remember, but do not take a double dose to make up for missed doses. You must not take tadalafil more than once a day.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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 loss of vision (rare frequency), distorted, dimmed, blurred vision or sudden decrease in vision (frequency not known)

Other adverse effects that have been reported

Frequent (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 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
• eyelid swelling
• red eyes
• sudden partial or complete decrease or loss of hearing
• hives (red, itchy welts on the skin surface)
• penile bleeding
• presence of blood in semen
• increased sweating

Rare cases of myocardial infarction and stroke have also been reported in men taking tadalafil. Most of these men had 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
• sudden cardiac death
• distorted, dimmed, blurred central 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 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers 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 5 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

Tadalafilo Stadagen 5 mg is a light yellow, round, biconvex, film-coated tablet with a diameter of 6.1 ± 0.2 mm.

Tadalafilo Stadagen 5 mg is available in blister packs containing 14, 16, 28, 30, 56, 84, 98 and 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio 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 medicinal product is authorized in the European Economic Area member states under 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

Date of most recent review of this leaflet: December 2023

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