Tadalafil Abdi 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tadalafilo Abdi 10 mg film-coated tablets EFG

Read the entire patient information 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, consult 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 effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Package leaflet

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

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

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

Tadalafilo Abdi is indicated for the treatment of erectile dysfunction in adult men. Erectile dysfunction occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity.

Following sexual stimulation, this medicine 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 if you do not have erectile dysfunction. It is important to warn you that this medicine is not effective in the absence of sexual stimulation. Therefore, you and your partner must engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before starting Tadalafil Abdi

Do not take Tadalafil Abdi if:

• you are allergic to tadalafil or to 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 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 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

Consult your doctor before starting to take tadalafil.

Be aware that sexual activity involves a potential 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 the same symptoms, your doctor will examine you for prostate cancer 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 the red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of the 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:

• surgery in the pelvic area.
• a surgical procedure in which the prostate has been totally or partially removed and the nerves of 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 diminished 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 Abdi

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 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 to treat high blood pressure.
• riociguat (a medicine used to treat high blood pressure in the lungs). See also “Do not take Tadalafil Abdi if:”
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (used to treat fungal infections) and protease inhibitors used to treat HIV/AIDS.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafil Abdi with food and alcohol

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

Fertility

In treated dogs, a decrease in sperm production by the testes has been observed. A reduction in sperm has been observed in some men. It is unlikely that these effects lead to infertility.

Driving and operating machinery

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

Tadalafil Abdi contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with your doctor before taking this medicine.

Tadalafil Abdi contains sodium

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

3. How to take Tadalafil Abdi

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

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

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 (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

The recommended starting dose is one 10 mg tablet taken prior to sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg.

When you take tadalafil, you may begin sexual activity at least 30 minutes after taking the tablet. Tadalafil may remain effective for up to 36 hours after taking the tablet.

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

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

If you take more Tadalafilo Abdi than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

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 may cause adverse effects, although not everyone experiences them. These effects are generally mild to moderate in intensity.

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

• 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, diminished, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse effects reported:

Common (observed in 1 to 10 out of every 100 patients)

• headache, back pain, muscle aches, arm and leg pain, facial flushing, nasal congestion, and indigestion.

Uncommon (observed in 1 to 10 out of every 1,000 patients)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (ringing in the ears), swelling of the hands, feet or ankles, and feeling tired.

Rare (observed in 1 to 10 out of every 10,000 patients)

• fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (red, itchy skin rash), bleeding from the penis, blood in semen, and increased sweating.
• heart attack and stroke. Most of these men had pre-existing heart conditions before taking this medication.
• decrease or sudden loss of vision, partial, temporary or permanent, in one or both eyes.

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

• migraine, facial swelling, severe allergic reaction causing facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death (heart attack).
• distorted, diminished, blurred central vision or sudden decrease in vision (frequency not known).

In men over 75 years of age receiving this medication, the most frequently reported adverse effect was dizziness.

In men over 65 years of age receiving this medication, the most frequently reported adverse effect was diarrhea.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Abdi

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 “CAD” and “EXP”, respectively. 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. If you are in doubt, 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 Tadalafilo Abdi

The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.

• Other components are:

Tablet core: sodium lauryl sulfate (E487), lactose monohydrate, hypromellose (EF) (E463), sodium croscarmellose (E468), microcrystalline cellulose (type 102) (E460), magnesium stearate (E572), purified water.

Film coating: hypromellose 5 cP (HPMC) (E464), titanium dioxide, talc, yellow iron oxide (E172), triacetin (E1518).

Appearance of the product and contents of the pack

The 5 mg tablets are film-coated, pale yellow, almond-shaped, biconvex tablets, approximately 7.6 mm in length, marked with a "5" on one side.

Pack contents:

Tadalafilo Abdi 5 mg is available in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturing Responsibility Holder

Marketing Authorization Holder:

Abdi Farma GmbH

Donnersbergstraße 4

64646 Heppenheim

Germany

Manufacturing Responsibility Holder:

Interpharma Services Ltd.

43A Cherni Vrach Blvd., Sofia 1407

Bulgaria

Or

Flavine Pharma France

3 Voie d’Allermagne, Vitrolles,

13127 France

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

XENTENEL PHARMA EUROPE, S.L.

Vallsolana Garden Business Park

Camí de Can Camps, 17-19 – Kibo Building

08174 Sant Cugat del Vallès

Spain

93 836 4600

[email protected]

Date of the most recent review of this leaflet: 11/2023

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/)