TADALAFIL ACCORD 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tadalafil Accord 20 mg Film-Coated Tablets EFG

tadalafil

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Tadalafil Accord is used for the treatment of:

• Erectile dysfunction in adult men:

This occurs when a man cannot get or maintain a hard erection that is sufficient for satisfactory sexual activity. Tadalafil has been shown to significantly improve the ability to get and maintain an erection sufficient for satisfactory sexual activity. After sexual stimulation, tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is an improvement in erectile function. Tadalafil will not help you if you do not have erectile dysfunction. It is important to note that tadalafil is not effective if there is no sexual stimulation.

• Pulmonary arterial hypertension in adultsIts action is to help the blood vessels around the lungs relax, improve blood flow to the lungs. The result of this is a greater ability to perform physical activity.

2. What you need to know before you take Tadalafil Accord

Do not take Tadalafil Accord if you:

• are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that Tadalafil Accord increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• have a severe heart disease or have had a heart attack in the last 90 days.
• have had a stroke in the last 6 months.
• have low blood pressure or uncontrolled high blood pressure.
• have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "eye stroke".
• 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 Accord, have shown that they 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 taking Tadalafil Accord.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, consult your doctor.

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

• any other heart problem
• blood pressure problems
• any inherited eye disease
• sickle cell anaemia (a disease of the red blood cells)
• multiple myeloma (cancer of the bone marrow)
• leukaemia (cancer of the blood cells)
• any deformation of the penis
• a severe liver problem
• a severe kidney problem

It is not known if Tadalafil Accord is effective in patients who have:

• had surgery in the pelvic area
• had a surgical procedure in which the prostate was partially or totally removed and the nerves of the prostate were cut (radical prostatectomy without preservation of neurovascular bundles)

If you experience a sudden decrease or loss of vision or your vision is distorted, dimmed while taking tadalafil, stop taking Tadalafil Accord 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 Accord should not be used as a treatment for erectile dysfunction in women because these are specific male health issues.

Children and adolescents

Tadalafil Accord should not be used in children and adolescents under 18 years of age.

Other medicines and Tadalafil Accord

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

Do not take Tadalafil Accord if you are already taking nitrates.

Some medicines may be affected by Tadalafil Accord or may affect the way Tadalafil Accord works. Tell your doctor or pharmacist if you are using:

• bosentan (another treatment for pulmonary arterial hypertension)
• nitrates (for chest pain)
• an alpha-blocker (used to treat high blood pressure or symptoms of an enlarged prostate)
• other medicines for high blood pressure
• riociguat
• a 5-alpha reductase inhibitor (used to treat an enlarged prostate)
• medicines such as ketoconazole tablets (for fungal infections) and protease inhibitors for the treatment of HIV or AIDS
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines)
• rifampicin, erythromycin, clarithromycin, or itraconazole
• other treatments for erectile dysfunction

Taking Tadalafil Accord with drinks and alcohol

Information about the effect of alcohol is in section 3. Grapefruit juice may affect the way Tadalafil Accord works and should be taken with caution. Consult your doctor for more 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 if you are pregnant unless it is strictly necessary and you have discussed it with your doctor.

Breastfeeding

Do not take tadalafil if you are breastfeeding, as it is not known if this medicine can pass into breast milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.

Fertility

In dogs treated with tadalafil, a decrease in sperm production 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 you take the tablets before driving or using machines.

Tadalafil Accord contains lactose:

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Tadalafil Accord contains sodium:

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

3. How to take Tadalafil Accord

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

For erectile dysfunction

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

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

Tadalafil can be effective for 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 intended for use before anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that tadalafil is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medicine for erectile dysfunction.

Consuming alcohol may affect your ability to get 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 it may increase the risk of dizziness when standing up.

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

If you take more Tadalafil Accord than you should

If you or anyone else takes more tablets than they should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. You may experience side 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 forgotten doses. Do not take Tadalafil Accord more than once a day.

If you stop taking Tadalafil AccordFor the treatment of pulmonary arterial hypertensiondo not stop taking the tablets unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop using the medicine 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 Accord (rare) If you experience this type of erection, which can last for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare) distorted, dimmed, central blurred vision, or sudden loss of vision (frequency not known).

Other side effects have been reported, which are listed below, separated by indication:

Side effects in erectile dysfunction

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in arms and legs,

flushing, nasal congestion, and indigestion.

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach pain, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty breathing, presence of blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

Rare(may affect up to 1 in 1,000 people)

• fainting, seizures, and transient memory loss, swelling of the eyelids, red eyes, sudden loss of hearing, hives (red itchy patches on the skin that sting), bleeding from the penis, presence of blood in semen, and/or urine, high blood pressure, rapid heartbeat, and excessive 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 medicine.

Rarely, cases of partial, temporary, or permanent loss of vision have been reported.

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

• migraine, swelling of the face, 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, and sudden cardiac death.

• distorted, dimmed, central blurred vision, or sudden loss of 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.

Side effects in pulmonary arterial hypertensionVery common(may affect more than 1 in 10 people)? headache, flushing, nasal congestion, and indigestion (including stomach pain or discomfort).

Common(may affect up to 1 in 10 people)? blurred vision, low blood pressure, nosebleeds, vomiting, abnormal uterine bleeding, swelling of the face, acid reflux, migraine, irregular heartbeat, and fainting.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: http://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP/CAD. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Tadalafilo Accord

• The active ingredientis tadalafil
• Each film-coated tablet contains 20 mg of Tadalafilo
• The other componentsare:

Core of the tablet:

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 package contents

Yellow, capsule-shaped, approximately 14.3 mm in length and 7 mm in width, biconvex, beveled edges, film-coated tablet, with "T 20" on one face and smooth on the other side.

Tadalafilo Accord is available in a transparent aluminum PVC/PE/PVdC blister pack.

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

Only some package sizes may be available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 – Barcelona

Manufacturers

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

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 authorized in the Member States of the European Economic Area 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/).