Acore 10 mg film-coated tablets EFG
Spain
Table of Contents
Package Leaflet: Information for the User
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 leaflet carefully before you start taking this medicine, as 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 must not be given to other people, 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 adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Acore is and what it is used for
- What you need to know before taking Acore
- How to take Acore
- Possible side effects
- How to store Acore
- 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 to treat 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 you if you do not have erectile dysfunction. It is important to note that tadalafil is not effective in the absence of 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.
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 type of 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 may pose 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.
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 total or partial removal of the prostate with cutting of the nerves supplying the prostate (radical prostatectomy without preservation of neurovascular bundles).
If you experience a 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 be affected by tadalafil or may 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 treating high blood pressure
- riociguat
- a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia)
- medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for treating 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 taken with caution.
Consult your doctor for further information.
Fertility
In treated dogs, a decrease in sperm production by the testes was observed. A reduction in sperm count has also been observed in some men. These effects are unlikely to cause 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 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 some water. The tablets may be taken with or without food.
The recommended starting dose is 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 to be used before anticipated sexual activity and is not recommended for continuous daily use.
It is important to inform you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should stimulate each other as you normally would if you were not taking a medicine for erectile dysfunction.
Alcohol consumption may affect your ability to achieve an erection and 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.
If you take more Acore than you should
Contact your doctor. You may experience adverse effects described in section 4.
If you have taken more tadalafil than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medicine and the amount taken.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 vision loss (rare frequency), distorted or dimmed vision, blurred central vision, or sudden decrease in vision (frequency not known).
Other adverse effects that have been reported:
Frequent (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, presence of blood in urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, tinnitus (ringing in the ears), 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 decrease or loss of hearing, urticaria (red, itchy welts on the skin), bleeding from the penis, presence of blood in 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, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeats, angina, and sudden cardiac death.
- distorted, dimmed, 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 diarrhoea.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 after “EXP.:”. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Acore
- The active substance is tadalafil.
Acore 10 mg: each tablet contains 10 mg of tadalafil.
Acore 20 mg: each tablet contains 20 mg of tadalafil.
- The other components are:
Tablet core: anhydrous lactose, sodium croscarmellose, sodium lauryl sulphate, hydroxypropylcellulose, polysorbate 80 and magnesium stearate.
Coating: hypromellose 2910 (E464), monohydrate lactose, 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 pack
Acore 10 mg: yellow, oblong, biconvex film-coated tablet, engraved with “T 10” on one side and smooth on the other.
Acore 20 mg: yellow, oblong, biconvex film-coated tablet, engraved with “T 20” on one side and smooth on the other.
PVC/PVDC/Aluminum blister.
Pack contents:
Acore 10 mg: 4 tablets.
Acore 20 mg: 4, 8 and 12 tablets.
Other pack sizes:
Acore 5 mg: packs of 28 tablets.
Marketing Authorization Holder
GP-Pharm, S.A.
Els Vinyets Industrial Estate – Els Fogars, sector 2
Comarcal Road 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 review of this leaflet: September 2023
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.es/.