ACORE 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Acore 5 mg Film-Coated Tablets EFG

Tadalafil

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Acore is and what it is used for
2. What you need to know before taking Acore
3. How to take Acore
4. Possible side effects
5. Storage of Acore
6. Package Contents and Additional Information

1. What Acore is and what it is used for

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

Tadalafil is used to treat adult men with:

• Erectile Dysfunction. This occurs when a man cannot obtain or maintain a firm erection, suitable for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to obtain a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, tadalafil acts by helping to relax the blood vessels in your penis, allowing blood flow to the penis. The result is an improvement in erectile function. Tadalafil will not help if you do not have erectile dysfunction. It is essential to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medication for erectile dysfunction.

• Urinary Symptoms Associated with Benign Prostatic Hyperplasia. This occurs when the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, feeling that the bladder has not been completely emptied, needing to urinate more frequently, even at night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms in as little as 1-2 weeks after starting treatment.

2. What you need to know before taking Acore

Do not take Acore

• If you are allergic to tadalafil or any of the other ingredients 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"). It has been seen that tadalafil increases the effects of these medications. If you are taking any type of nitrate or are unsure, tell your doctor.
• If you have severe heart disease or have had a heart attack recently, in the last 90 days.
• If you have had a stroke recently, in the last 6 months.
• If you have low blood pressure or uncontrolled high blood pressure.
• If you have ever had a loss of vision 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 blood clots). Phosphodiesterase type 5 inhibitors, such as tadalafil, have been 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 carries a possible risk in patients with heart problems, due to the additional effort it entails for 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 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 (a red blood cell abnormality)
• multiple myeloma (bone marrow cancer)
• leukemia (blood cell cancer)
• any penile deformation
• a severe liver problem
• a severe kidney problem.

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

• surgery in the pelvic area
• a surgical intervention in which the prostate was partially or totally removed and the prostate nerves were cut (radical prostatectomy without preservation of neurovascular bundles).

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

A 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 a 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 should not be used in children or adolescents under 18 years of age.

Other Medications and Acore

Inform your doctor or pharmacist if you are taking, have recently taken, 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 for 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 AIDS or HIV infection
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications)
• rifampicin, erythromycin, clarithromycin, or itraconazole
• other treatments for erectile dysfunction.

Taking Acore with Drinks 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 with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and Using Machines

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

Acore Contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Acore

Follow your doctor's instructions for taking this medication exactly. 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.

Consuming alcohol 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.

For the Treatment of Erectile Dysfunction

The recommended dose is one 5 mg tablet once a day, approximately at the same time every day. Your doctor may adjust your dose to 2.5 mg based on your response to tadalafil. You will be prescribed a 2.5 mg tablet.

When taking tadalafil daily, it allows you to obtain an erection at any time during the 24 hours of the day, provided there is sexual stimulation. Tadalafil taken daily may be useful in men who anticipate having sexual activity two or more times a week.

Do not take tadalafil more than once a day.

It is essential to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medication for erectile dysfunction.

Alcohol consumption may affect your ability to have an erection.

For the Treatment of Benign Prostatic Hyperplasia

The dose is one 5 mg tablet once a day, approximately at the same time every day.

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

Do not take tadalafil more than once a day.

If You Take More Acore Than You Should

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

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

If You Forget to Take Acore

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. These effects are generally mild to moderate.

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

• allergic reactions, including rash (uncommon)
• chest pain - do not use nitrates, but seek medical help immediately (uncommon)
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare). If you experience this type of erection, which can last continuously for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, dimmed, central blurred vision, or sudden decrease in vision (frequency not known).

Other side effects that have been reported:

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

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

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

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

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

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, hives (red itchy patches on the skin surface), bleeding in the penis, presence of blood in the semen, and increased sweating.

Myocardial infarction and stroke have also been reported rarely in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medication.

Rarely, cases of decreased or lost vision, partial, transient, or permanent in one or both eyes have been reported.

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

• migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rash, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.
• distorted, dimmed, central blurred vision, or sudden decrease in vision (frequency not known).

In men over 75 years of age treated with tadalafil, the most frequently reported side effect was dizziness. In men over 65 years of age treated with tadalafil, the most frequently reported side effect was diarrhea.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Acore

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister after "EXP.". 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 via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Acore Composition

• The active ingredient is tadalafil.

Acore 5 mg: each tablet contains 5 mg of tadalafil.

• The other ingredients are:

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

Coating: hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Acore 5 mg is a yellow, oblong, biconvex film-coated tablet, engraved with "T 5" on one side and smooth on the other.

PVC/PVDC/Aluminum blister.

Package Contents: 28 tablets.

Other Presentations

Acore 10 mg: packages of 4 tablets.

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

Marketing Authorization Holder

GP-Pharm, S.A.

Polígono Industrial Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C-244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona)

Spain

Manufacturer

Genepharm S.A.

18th km Marathonos Avenue,

153 51 Pallini Attiki

Greece

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

Date of the Last Revision of this Package Leaflet: September 2023

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