Prospecto: information for the user

Tadalafilo Abdi 10 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect

1. What Tadalafilo Abdi is and for what it is used
2. What you need to know before starting to take Tadalafilo Abdi
3. How to take Tadalafilo Abdi
4. Possible adverse effects
5. Storage of Tadalafilo Abdi
6. Contents of the package and additional information

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

Tadalafilo is indicated for the treatment of erectile dysfunction in adult men. This condition occurs when a man is unable to 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, this medication acts by helping to relax the blood vessels of the penis, allowing blood to flow into the penis. The result is an improvement in erectile function.

Tadalafilo will not help if you do not have erectile dysfunction. It is essential to inform you that this medication 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.

Do not take Tadalafilo Abdi if:

• You are allergic to tadalafilo or to 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 uncontrolled high blood pressure.
• You have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarct”.
• You are taking riociguat. This medication is used to treat pulmonary 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.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform a prostate cancer review before starting treatment with tadalafilo for benign prostatic hyperplasia. Tadalafilo does not treat prostate cancer.

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

• Thalassemia (an abnormality of red blood cells).
• Multiple myeloma (bone marrow cancer).
• Leukemia (blood cell cancer).
• Any penile deformity.
• Severe liver disease.
• Severe kidney disease.

The effectiveness of tadalafilo is not known in patients who have undergone:

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

If you experience a sudden decrease or loss of vision or your vision is distorted, blurred 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.

Other medications and Tadalafilo Abdi

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take tadalafilo if you are already taking 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(medication used to treat high blood pressure in the lungs). See also “Do not take Tadalafilo Abdi if:”
• 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 Abdi 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 Abdi contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medication.

Tadalafilo Abdi contains sodium

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

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

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.

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

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. Tadalafilo 10 and 20 mg will be used before expected sexual activity and are not recommended for continuous daily use.

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 as you would without taking a medication 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

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).
• priapism, a 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, central vision blurred or sudden decrease in vision (unknown frequency).

Other side effects that have been reported:

Frequent(observed in 1 to 10 of every 100 patients)

-headache, back pain, muscle pain, pain in the arms and legs, facial flushing, nasal congestion and indigestion.

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

• 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 and feeling tired.

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

• syncope, seizures and transient loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin's surface), bleeding in the penis, blood in the semen and increased sweating.
• heart attack and stroke. Most of these men had some heart problem before taking this medicine.
• partial or permanent loss of vision, temporary or permanent in one or both eyes.

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

• migraine, facial swelling, severe allergic reaction that causes 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, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

In men over 75 years old taking this medicine, the most frequently reported side effect was dizziness.

In men over 65 years old taking this medicine, the most frequently reported side effect 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 that does not appear 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” and “EXP” respectively. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Tadalafilo Abdi Composition

The active ingredient is tadalafilo. Each tablet contains 5 mg of tadalafilo.

• The other components are:

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

Coating: hydroxypropylmethylcellulose (HPMC) 5cP (E464), titanium dioxide, talc, yellow iron oxide (E172), triacetin (E1518).

Appearance of the product and content of the packaging

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

Content of packaging:

Tadalafilo Abdi 5 mg is available in blister packaging with 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Abdi Farma GmbH

Donnersbergstraße 4

64646 Heppenheim

Germany

Responsible manufacturer:

Interpharma Services Ltd.

43A Cherni Vrach Blvd. Sofia 1407

Bulgaria

Or

Flavine Pharma France

3 Voie d’Allermagne, Vitrolles,

13127 France

For more information about this medication, 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]

Last review date of this leaflet: 11/2023

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