Prospect: information for the patient

Acore 5 mg film-coated tablets EFG

Tadalafil

Read this prospect carefully before starting to take this medication, as 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 medication has been prescribed only to 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 known as phosphodiesterase type 5 inhibitors.

Tadalafilo is used to treat adult men with:

• Impotence. This 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, 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 impotence. 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 impotence.

• Urinary symptoms associated with a common disease calledbenign prostatic hyperplasia.This occurs when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate, feeling that the bladder has not been completely emptied, a need to urinate more frequently, even at night. Tadalafilo improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo has demonstrated an improvement in these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

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, in the last 90 days
• If you have had a recent stroke, in 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). PDE5 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 poses a possible risk for patients with heart problems, due to the additional strain 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 tadalafil for benign prostatic hyperplasia.Tadalafil does not treat prostate cancer.

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

• sickle cell anemia (an abnormality of red blood cells)
• multiple myeloma (bone marrow cancer)
• leukemia (blood cell cancer)
• any penile deformity
• serious liver disease
• serious kidney disease.

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

• pelvic surgery
• surgery 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 decrease or sudden loss of vision or your vision is distorted, blurred while taking tadalafil, stop taking tadalafil and contact your doctor immediately.

Decrease or sudden 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 decrease or sudden 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 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
• an inhibitor of 5-alpha reductase (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. 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 tadalafil during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating machines.

Acore contains lactose

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

Follow exactly the administration instructions of this medication 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.

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 tabletonce a day, approximately at the same time of day. Your doctor may adjust your dose to 2.5mg based on your response to tadalafil. You will be prescribed a 2.5mg tablet.

Taking tadalafil daily allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Daily tadalafil administration may be useful for men who anticipate engaging in sexual activity two or more times a week.

Do not take tadalafil more than once a day.

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 you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tabletonce a day, approximately at the same time of day.

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

Do not take tadalafil more than once a day.

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 immediately, your pharmacist, or call the Toxicological Information Service, Tfno. 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Acore

Take your dose as soon as you remember, but do not take a double dose to compensate for the 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.

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 in 1 to 10 of every 100 patients)

• headache, back pain, muscle pain, arm and leg pain, 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.

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.Reporting side effects can help provide more information about 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 drain or in the trash.Dispose of the containers and medications you no longer need at the SIGRE collection pointof your usual pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Acore

• The active ingredient is tadalafil.

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

• The other components are:

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

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

Appearance of the product and content of the packaging

Acore 5 mg is a yellow, oblong, biconvex tablet covered with a film, engraved with “T 5” on one face and smooth on the other.

PVC/PVDC/Aluminum blister.

Content of the packaging: 28 tablets.

Other presentations:

Acore 10 mg: packaging of 4 tablets.

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

Marketing authorization holder

GP-Pharm, S.A.

Industrial Park 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/.