Tadalafil Accord 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tadalafilo Accord 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 you should not give it to others, 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.

Leaflet Contents

1. What Tadalafilo Accord is and what it is used for
2. What you need to know before taking Tadalafilo Accord
3. How to take Tadalafilo Accord
4. Possible side effects
5. How to store Tadalafilo Accord
6. Contents of the pack and other information

1. What Tadalafilo Accord is and what it is used for

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

Tadalafilo Accord is used for the treatment of:

• Erectile dysfunction in adult men:

This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafil has demonstrated significant improvement in 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 in the absence of sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

• Pulmonary arterial hypertension in adults: Its action consists of helping the blood vessels around the lungs to relax, thereby improving blood flow to the lungs. The result is increased ability to perform physical activity.

2. What you need to know before taking Tadalafilo Accord

Do not take Tadalafilo Accord if you:

• are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• 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 pectoris ("chest pain"). Tadalafilo Accord has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.
• have severe heart disease or have recently had a heart attack within the last 90 days.
• have recently had a stroke within the last 6 months.
• have low blood pressure or uncontrolled high blood pressure.
• have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• 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 Tadalafilo Accord 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 or pharmacist before starting to take Tadalafilo Accord.

Be aware that sexual activity involves a possible 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:

• any heart problems other than pulmonary hypertension
• blood pressure problems
• any hereditary vision disorders
• 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 Tadalafilo Accord is effective in patients who have undergone:

• pelvic surgery
• surgical procedures involving total or partial removal of the prostate with nerve bundles severed (nerve-sparing radical prostatectomy not performed)

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking tadalafil, stop taking Tadalafilo Accord 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.

Tadalafilo Accord must not be used as a treatment for erectile dysfunction in women, as these are health issues specific to men.

Children and adolescents

Tadalafilo Accord must not be used in children or adolescents under 18 years of age.

Other medicines and Tadalafilo Accord

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

Do not take Tadalafilo Accord if you are already using nitrates.

Some medicines may be affected by Tadalafilo Accord or may affect how well Tadalafilo Accord works. Inform your doctor or pharmacist if you are taking:

• bosentan (another treatment for pulmonary arterial hypertension)
• nitrates (for chest pain)
• 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 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 Tadalafilo Accord with food and alcohol

Information about the effect of alcohol is provided in section 3. Grapefruit juice may affect how well Tadalafilo Accord works and should be used with caution. Consult your doctor for further information.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Do not take tadalafil during pregnancy unless strictly necessary and only after discussing it with your doctor.

Breastfeeding

Do not take tadalafil while breastfeeding, as it is unknown whether this medicine passes into breast milk. Ask your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.

Fertility

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

Driving and using 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.

Tadalafilo Accord contains lactose:

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

Tadalafilo Accord contains sodium:

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".

3. How to take Tadalafil Accord

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

Swallow the tablets whole with a little water. The tablets can be taken with or without food.

To treat erectile dysfunction

The recommended starting dose is one 10 mg tablet before sexual activity. However, if you have been prescribed the 20 mg dose, it is because your doctor has decided that the recommended 10 mg dose is too low for you.

You should take the Tadalafil Accord tablet at least 30 minutes before sexual activity.

Tadalafil may be effective up to 36 hours after taking the tablet.

Do not take Tadalafil Accord more than once a day. Tadalafil 10 mg and 20 mg is indicated for use before anticipated sexual activity and is not recommended for continuous daily use.

It is important to warn you that tadalafil is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in the same kind of stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to obtain an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Accord, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness upon standing.

Pulmonary arterial hypertension
Tadalafil is administered in 20 mg tablets. The usual dose is two 20 mg tablets once daily. You should take both tablets at the same time, one after the other. If you have mild or moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet per day.

If you take more Tadalafil Accord than you should

If you or anyone else takes more tablets than prescribed, consult your doctor or go to hospital immediately, taking the medicine with you. You may experience adverse effects described in section 4.

If you forget to take Tadalafil Accord

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

If you stop taking Tadalafil Accord
For the treatment of pulmonary arterial hypertension, do not stop taking the tablets unless your doctor tells you to.

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 can cause adverse effects, although not everybody will experience them.

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

• allergic reactions including rashes (uncommon)
• chest pain – do not use nitrates but seek medical help immediately (uncommon)
• priapism, a prolonged and possibly painful erection after taking Tadalafilo Accord (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, dimmed, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse effects have been reported, which are listed below, grouped by indication:

Adverse effects in erectile dysfunction

Frequent (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• dizziness, stomach pain, feeling sick, being sick (vomiting), heartburn, 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 (may affect up to 1 in 1000 patients)

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy welts on the skin surface), 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 problems before taking this medicine.

Rarely, cases of decreased or sudden loss of vision, partial, transient or permanent, 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 heartbeat, angina, and sudden cardiac death.

• distorted vision, dimmed vision, blurred central vision, or sudden decrease in vision (frequency not known).

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

Adverse effects in pulmonary arterial hypertension

Very frequent (may affect more than 1 in 10 people):
headache, flushing, nasal and paranasal sinus congestion (stuffy nose), nausea, indigestion (including abdominal pain or discomfort), muscle pain, back pain, and pain in the extremities (including limb discomfort)

Frequent (may affect up to 1 in 10 people):
blurred vision, low blood pressure, nosebleeds, vomiting, increased or abnormal uterine bleeding, facial swelling, acid reflux, migraine, irregular heartbeat, and fainting

Uncommon (may affect up to 1 in 100 people):
seizures, transient memory loss, urticaria, excessive sweating, bleeding from the penis, presence of blood in semen and/or urine, high blood pressure, rapid heart rate, sudden cardiac death, and tinnitus (ringing in the ears)

The majority, but not all, of the men who reported rapid heart rate, irregular heartbeat, myocardial infarction, stroke, and sudden cardiac death had known heart problems before taking tadalafil. It is not possible to determine whether these events were directly related to tadalafil.

Reporting of adverse effects

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

5. Storage of Tadalafil Accord

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

Do not use this medicine after the expiry date stated on the packaging after EXP/EXP. The expiry date is 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 packaging at a SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Accord

• The active substance is tadalafil
• Each film-coated tablet contains 20 mg of Tadalafil
• The other components are:

Tablet core:

Lactose monohydrate, sodium croscarmellose, hypromellose, microcrystalline cellulose, sorbitan stearate, magnesium stearate

Film coating:

lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, talc, and yellow iron oxide (E172)

Appearance of the product and contents of the container

Yellow, capsule-shaped, approximately 14.3 mm long and 7 mm wide, biconvex, bevelled edges, film-coated tablet, marked with "T 20" on one side and smooth on the other.

Tadalafil Accord is available in transparent PVC/PE/PVdC/Aluminium blisters.

Available pack sizes: 2, 4, 8, 12, 14, 28, 30, 56 or 60 tablets

Some pack sizes may not be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 – Barcelona, Spain

Manufacturers

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

Or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

Or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50

95-200 Pabianice

Poland

Or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, 32009,

Greece

This medicinal product is authorised in the European Economic Area member states under the following names:

Date of the last revision of this leaflet: March 2024

Other sources of information

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