ACORE 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Acore 10 mg film-coated tablets EFG

Acore 20 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Acore and what is it 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 is Acore and what is it 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, adequate for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to achieve a lasting erection of the penis, adequate for sexual activity.

After sexual stimulation, tadalafil acts by helping to relax the blood vessels in the 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.

2. What you need to know before taking Acore

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"). 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 a severe heart condition or have recently had a heart attack, within the last 90 days.
• If you have recently had a stroke, within 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 condition 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 shown that they 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 requires for the heart. 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 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 procedure in which the prostate was completely or partially 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, blurred 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

Tell 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 is 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 the administration instructions of this medication exactly as indicated by your doctor. In case of 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 anticipated sexual activity and is not recommended for continuous daily use.

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 and may temporarily decrease 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.

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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not all people 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, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

Other side effects that have been reported:

Frequent(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, blood in the urine, prolonged erection, palpitations, rapid heartbeat, 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), bleeding from the penis, 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 swelling of the face or throat, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.
• distorted, blurred, 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 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 contribute to providing 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 through wastewater or household waste. Place the packaging and any unused medications in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Acore Composition

• The active ingredient is tadalafil.

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

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

• The other ingredients are:

Tablet Core: 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). Acore 10 mg also contains black iron oxide (E172).

Appearance of the Product and Package Contents

Acore 10 mg: is a yellow, oblong, biconvex film-coated tablet, engraved with "T 10" on one side and smooth on the other.

Acore 20 mg: is a yellow, oblong, biconvex film-coated tablet, engraved with "T 20" on one side and smooth on the other.

PVC/PVDC/Aluminum blister pack.

Package Contents:

Acore 10 mg: 4 tablets.

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

Other Presentations:

Acore 5 mg: packages of 28 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/.