Leaflet: information for the patient

Tadalafilo Accord 20 mg film-coated tablets EFG

tadalafilo

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Tadalafilo Accord

3. How to take Tadalafilo Accord

4. Possible side effects

5. Storage of Tadalafilo Accord

6. Contents of the pack and additional informationadditional information

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

Tadalafilo Accord is used to treat:

• Erectile dysfunction in adult men:

This occurs when a man is unable to obtain or maintain a firm, adequate erection for satisfactory sexual activity. Tadalafilo has demonstrated a significant improvement in the ability to obtain a lasting erection of the penis suitable for sexual activity. After sexual stimulation, tadalafilo 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 tadalafilo is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication for erectile dysfunction.

• Pulmonary arterial hypertension in adults
  Its action consists of helping the blood vessels around the lungs to relax, improving blood flow to the lungs. The result of this is an increased ability to engage in physical activity.

Do not take Tadalafilo Accord if you:

• are allergic to tadalafil or any of the other components of this medication (listed in section 6).
• 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 (chest pain). Tadalafilo Accord has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.
• have a serious heart condition or have had a heart attack recently, within the last 90 days.
• have had a recent stroke, within the last 6 months.
• have low or uncontrolled high blood pressure.
• have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "eye infarction".
• are taking riociguat. This medication is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as Tadalafilo Accord, 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 or pharmacist before starting to take Tadalafilo Accord.

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

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

- any heart condition other than pulmonary hypertension

- blood pressure problems

- any hereditary eye disease

- sickle cell anemia (a blood disorder)

- multiple myeloma (bone marrow cancer)

- leukemia (blood cell cancer)

- any penile deformity,

- severe liver disease

- severe kidney disease

Tadalafilo Accord is not known to be effective in patients who have undergone:

- pelvic surgery

- a surgical procedure in which the prostate has been completely or partially removed and the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation)

If you experience a sudden decrease or loss of visionor your vision is distorted, blurred while taking tadalafil, stop taking Tadalafilo Accord and immediately contact your doctor.

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 sudden decrease or loss of hearing, stop taking tadalafil and immediately contact your doctor.

Tadalafilo Accord should not be used as a treatment for erectile dysfunction in women due to these being specific men's health issues.

Children and adolescents

Tadalafilo Accord should not be used in children or adolescents under 18 years old

Other medications and Tadalafilo Accord

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

Do not take Tadalafilo Accord if you are already using nitrates.

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

• bosentan (another treatment for pulmonary hypertension)
• nitrates (for chest pain)
• 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
• an inhibitor of 5-alpha reductase (used to treat benign prostatic hyperplasia)
• medications such as ketoconazole tablets (for 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 Accord 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 Accord and should be taken with caution. Consult your doctor for more information.

Pregnancy, lactation, and fertility

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take tadalafil while pregnant, unless it is strictly necessary and you have previously discussed it with your doctor.

Lactation

Do not take tadalafil if you are breastfeeding, as it is unknown if this medication may pass through breast milk. Ask your doctor or pharmacist before starting any medication if you are pregnant or breastfeeding.

Fertility

In dogs treated, 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 machinery

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

Tadalafilo Accord contains lactose:

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

Tadalafilo Accord contains sodium:

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

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

Swallow the whole tablets with a little water. The tablets can be taken with or without food.

Treating erectile dysfunction

The recommended starting doseis one 10 mg tablet before sexual activity. However, if you have received a 20 mg dose, it is because your doctor has decided that the recommended dose of 10 mg is too low.

You must take the Tadalafilo Accord tablet at least 30 minutes before sexual activity.

Tadalafilo may be effective for up to 36 hours after taking the tablet.

Do not take Tadalafilo Accord more than once a day. Tadalafilo 10 mg and 20 mg is indicated for use before planned sexual activity and is not recommended for continuous daily use.

It is essential to inform you thattadalafilois 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.

The consumption of alcohol may affect your ability to have an erection and may temporarily lower your blood pressure. If you have taken or are planning to takeTadalafilo Accord, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

Pulmonary arterial hypertension
Tadalafilo is administered in 20 mg tablets. The usual dose is two 20 mg tablets once a day. You must take the two tablets at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take one 20 mg tablet per day.

If you take more Tadalafilo Accord than you should

If you or anyone else takes more tablets than you should, consult your doctor or go to the hospital immediately, bringing the medication with you. You may experience adverse effects described in section 4.

If you forgot to take Tadalafilo Accord

Take your dose as soon as you remember, but do not take a double dose to compensate for the missed doses. Do not take Tadalafilo Accord more than once a day.

If you stop taking Tadalafilo Accord
For the treatment of pulmonary arterial hypertensiondo not stop taking the tablets, unless your doctor tells you to.

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.

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

-allergic reactions including rashes (infrequent)

-chest pain - do not use nitrates but seek medical help immediately (infrequent)

-priapism, a prolonged and possibly painful erection after taking Tadalafilo Accord (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 have been reported, which are listed below, separated by indication:

Side effects in erectile dysfunction

Frequent(may affect up to 1 in 10 patients)

-headache, back pain, muscle pain, pain in the arms and legs,

flushing of the face, nasal congestion and indigestion.

Infrequent(may affect up to 1 in 100 patients)

-dizziness, stomach pain,feeling sick, being sick (vomiting), reflux,blurred vision, eye pain, difficulty breathing, presence of blood in 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(may affect up to 1 in 1000 patients)

-loss of consciousness, convulsions and temporary loss of memory, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin's surface), bleeding in the penis, presence of blood in semen and increased sweating.

Also, rare cases of heart attack and stroke have been reported in men taking tadalafilo. Most of these men had some heart problem before taking this medicine.

Rarely, cases of partial or

permanent loss of vision in one or both eyes have been reported.

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

-migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin eruptions, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.

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

In men over 75 years old taking tadalafilo, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafilo, the most frequently reported side effect was diarrhea.

Side effects in pulmonary arterial hypertension

Frequent(may affect more than 1 in 10 people)
?headache, flushing, nasal congestion and paranasal sinus congestion (stuffy nose), nausea, indigestion (including abdominal pain or discomfort), muscle pain, back pain and limb pain (including extremity discomfort)

Infrequent(may affect up to 1 in 10 people)
?blurred vision, low blood pressure, nasal bleeding, vomiting, abnormal uterine bleeding, facial swelling, acid reflux, migraine, irregular heartbeat and fainting.

Infrequent(may affect up to 1 in 100 people)
?convulsions, temporary loss of memory, urticaria, excessive sweating, bleeding in the penis, presence of blood in semen and/or urine, high blood pressure, rapid heartbeat, sudden cardiac death and ringing in the ears.

Most, but not all, men who reported rapid heartbeat, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafilo. It is not possible to determine if these events were directly related to tadalafilo.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, 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:http://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 packaging after EXP/CAD. 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 trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tadalafilo Accord

• Theactive ingredientis tadalafilo
• Each film-coated tablet contains 20 mg of Tadalafilo
• Theother componentsare:

Core of the tablet:

Lactose monohydrate, sodium croscarmellose, hypromellose, microcrystalline cellulose, sorbitan stearate, magnesium stearate

Film coating:

Lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, talc, and yellow iron oxide (E172)

Appearance of the product and contents of the package:

Yellow, capsule-shaped, approximately 14.3 mm in length and 7 mm in width, biconvex, beveled edges, film-coated tablet, with “T 20” on one side and smooth on the other side.

Tadalafilo Accord is available in a transparent blister pack of Aluminio PVC/PE/PVdC.

Available package sizes:2, 4, 8, 12, 14, 28, 30, 56, or 60 tablets

Only some package sizes may be available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 – Barcelona

Responsible Manufacturers

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

Or

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50

95-200 Pabianice

Poland

Or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, 32009,

Greece

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last revision date of this leaflet:March 2024

Other sources of information

The detailed 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/).