Acore 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acore 5 mg film-coated tablets EFG

Tadalafil

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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. How to store Acore
6. Contents of the pack and other information

1. What Acore is and what it is used for

This medicine contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Tadalafil is used for the treatment of adult men with:

• Erectile dysfunction. This occurs when a man cannot achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity.

Following sexual stimulation, tadalafil works by helping to relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil will not help if you do not have erectile dysfunction. It is important to note that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should engage in sexual stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, a sensation that the bladder has not emptied completely, and the need to urinate more frequently, even during the night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within 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 to any of the other ingredients of this medicine (listed in section 6).
• If you are taking any organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina ("chest pain"). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.
• If you have severe heart disease 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 experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye"
• If you are taking riociguat. This medicine 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). PDE5 inhibitors such as tadalafil have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to take this medicine.

Be aware that sexual activity involves a potential risk for patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform a prostate cancer evaluation 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 (a cancer of the bone marrow)
• leukemia (a cancer of blood cells)
• any deformity of the penis
• severe liver problems
• severe kidney problems.

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

• pelvic surgery
• surgical procedures involving complete or partial removal of the prostate with nerve bundles severed (radical prostatectomy without neurovascular bundle preservation).

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

Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known whether this event is directly related to tadalafil, if you experience 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 must not be used in children or adolescents under 18 years of age.

Other medicines and Acore

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take tadalafil if you are already using nitrates.

Some medicines may interact with tadalafil or affect how well tadalafil works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia)
• other medicines for high blood pressure
• riociguat
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia)
• medicines such as ketoconazole tablets (for treatment of fungal infections) and protease inhibitors for treatment of AIDS or HIV infection
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines)
• rifampicin, erythromycin, clarithromycin, or itraconazole
• other treatments for erectile dysfunction.

Taking Acore with food and alcohol

Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect how well tadalafil works and should be used with caution.

Consult your doctor for further information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testes was observed. Some men have shown reduced sperm counts. These effects are unlikely to result in infertility.

Driving and use of machines

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

Acore contains lactose

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

3. How to take Acore

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Alcohol consumption 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 daily, taken at approximately the same time each day. Your doctor may adjust your dose to 2.5 mg depending on your response to tadalafil. A 2.5 mg tablet will be prescribed for you.

When tadalafil is taken daily, it allows you to achieve an erection at any time during the day, over a 24-hour period, provided that sexual stimulation occurs. Daily tadalafil administration may be beneficial for men who expect to have sexual activity two or more times per week.

Do not take tadalafil more than once a day.

It is important to note that tadalafil is not effective without sexual stimulation. Therefore, you and your partner should engage in the same level of stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet once daily, taken at approximately the same time each day.

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

You must 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, contact your doctor, pharmacist immediately, or call the Toxicology Information Service, Tel. 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Acore

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. These effects are generally mild to moderate in intensity.

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

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

Other adverse effects that have been reported:

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

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

Uncommon (observed in 1 to 10 out 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 pulse, high blood pressure, low blood pressure, nosebleeds, ringing in the ears (tinnitus), swelling of the hands, feet or ankles, and feeling tired.

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

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden partial or complete hearing loss, urticaria (red, itchy skin rashes), bleeding from the penis, blood in the semen, and increased sweating.

Rare cases of heart attack and stroke have also been reported in men taking tadalafil. Most of these men had pre-existing heart conditions before taking this medicine.

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

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

• migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, serious skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.
• distorted, dimmed vision, blurred central vision, or sudden decrease in vision (frequency not known).

In men over 75 years of age receiving tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect was diarrhea.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acore

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

Do not use this medicine after the expiry date stated on the carton and blister pack following “EXP.”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your usual pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acore

• The active substance 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, hydroxypropylcellulose, polysorbate 80, and magnesium stearate.

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

Appearance of the product and contents of the pack

Acore 5 mg is a yellow, oblong, biconvex film-coated tablet, marked “T 5” on one side and smooth on the other.

PVC/PVDC/Aluminum blister.

Contents of the pack: 28 tablets.

Other pack sizes:

Acore 10 mg: packs of 4 tablets.

Acore 20 mg: packs 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 most recent revision of this leaflet: September 2023

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