Prospect: information for the patient

Acore 10 mg film-coated tablets

Acore 20 mg film-coated tablets

Tadalafil

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

• Keep this prospect, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others, 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.

1. What is Acore and for what it is used

2. What you need to know before starting to take Acore

3. How to take Acore

4. Possible adverse effects

5. Storage of Acore

6. Contents of the package and additional information

This medication contains the active ingredient tadalafilo, which belongs to a group of medications called phosphodiesterase type 5 inhibitors.

Tadalafilo is used to treat adult men with:

• Erectile dysfunction. 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, penile erection suitable for sexual activity.

After sexual stimulation, tadalafilo acts by helping to relax the blood vessels in your 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 you would without taking a medication for erectile dysfunction.

Do not take Acore

• If you are allergic to tadalafil or any of the other components of this medication (listed in section 6).
• If 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"). Tadalafil has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.
• If you have a serious heart disease or have had a recent heart attack, within the last 90 days.
• If you have had a recent stroke, within the last 6 months.
• If you have low or uncontrolled high blood pressure.
• If you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as "eye infarction".
• If you are taking riociguat. This medication 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 clots). Phosphodiesterase type 5 inhibitors, such as tadalafil, 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 this medication.

Be aware that sexual activity may pose a possible risk for patients with heart problems, due to the additional effort it requires. If you have a heart problem, consult your doctor.

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

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

It is not known if 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 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 or blurred while taking tadalafil, stop taking tadalafil and immediately contact your doctor.

There have been reports of sudden hearing loss in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience sudden hearing loss, stop taking tadalafil and immediately contact your doctor.

Tadalafil is not intended for use in women.

Children and adolescents

Tadalafil should not be used in children or adolescents under 18 years old.

Other medications and Acore

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

Do not take tadalafil if you are already using nitrates.

Some medications may be affected by tadalafil or may affect the proper functioning of tadalafil. 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
• 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 Acore with beverages and alcohol

Information about the effect of alcohol can be found in section 3. Grapefruit juice may affect the proper functioning of tadalafil and should be taken with caution.

Consult your doctor for more information.

Fertility

In dogs treated, a decrease in sperm production by the testicles was observed. Some men have experienced a reduction in sperm count. 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.

Acore contains lactose

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

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

The tablets of this medication are for oral administration only in men. Swallow the tablet whole with a little water. The tablets can be taken with or without food.

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. Tadalafil tablets are administered orally.

You should take the tadalafil tablet at least 30 minutes before sexual activity. Tadalafil may remain effective for up to 36 hours after taking the tablet.

Do not take tadalafil more than once a day. Tadalafil 10 and 20 mg is intended for use before a planned sexual activity and is not recommended for continuous daily use.

It is essential to inform you that tadalafil 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.

Consuming alcohol may affect your ability to achieve an erection and may temporarily lower your blood pressure. If you have taken or plan 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.

If you take more Acore than you should

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

If you have taken more tadalafil than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, Tel. 91 562 04 20, indicating the medication and the amount taken.

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 (frequency unknown).

Other side effects that have been reported:

Frequent(observed between 1 and 10 in every 100 patients)

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

Rare(observed between 1 and 10 in 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 between 1 and 10 in 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.

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

Rarely, cases of partial or permanent loss of vision, temporary or permanent, in one or both eyes have been reported.

Some rare additional side effects have been reported in men taking tadalafil that were not reported 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.
• distorted, blurred, central vision blurred or sudden decrease in vision (frequency unknown).

In men over 75 years old taking tadalafil, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafil, 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 prospectus.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.:”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection point of your usual 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.

Composition of Acore

• The active ingredient is tadalafilo.

Acore 10 mg: each tablet contains 10 mg of tadalafilo.

Acore 20 mg: each tablet contains 20 mg of tadalafilo.

• The other components are:

Tablet core: anhydrous lactose, sodium croscarmellose, sodium lauryl sulfate, hydroxypropyl cellulose, polysorbate 80, and magnesium stearate.

Covering: hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), and yellow iron oxide (E172). Acore 10 mg also contains black iron oxide (E172).

Appearance of the product and contents of the packaging

Acore 10 mg: it is a yellow, oblong, biconvex tablet covered with a film, engraved with “T 10” on one face and smooth on the other.

Acore 20 mg: it is a yellow, oblong, biconvex tablet covered with a film, engraved with “T 20” on one face and smooth on the other.

PVC/PVDC/Aluminum blister.

Contents of the packaging:

Acore 10 mg: 4 tablets.

Acore 20 mg: 4, 8, and 12 tablets.

Other presentations:

Acore 5 mg: packaging of 28 tablets.

Marketing authorization holder

GP-Pharm, S.A.

Industrial Estate Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C-244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona)

Spain

Responsible for manufacturing

Genepharm S.A.

18th km Marathonos Avenue,

153 51 Pallini Attiki

Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

Last review date of this leaflet: September 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/.