Tadalafil Accord: detailed information

Package leaflet: Information for the user

Tadalafil Accord 2.5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tadalafil Accord is and what it is used for
What you need to know before taking Tadalafil Accord
How to take Tadalafil Accord
Possible side effects
How to store Tadalafil Accord
Contents of the pack and other information

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

Tadalafil Accord contains the active substance tadalafil, which belongs to a class of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Accord is a treatment for adult men with:
Erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Accord has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse. Following sexual stimulation, Tadalafil Accord helps relax the blood vessels in the penis, allowing blood flow into the penis. The result is improved erectile function. Tadalafil Accord will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Accord has no effect in the absence of sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.

2. What you should know before taking Tadalafil Accord

Do not take Tadalafil Accord if:

you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). It has been shown that Tadalafil Accord enhances the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
you have a severe heart disease or have had a heart attack in the last 90 days.
you have had a stroke within the last 6 months.
you have low blood pressure or uncontrolled high blood pressure.
you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
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 secondary to blood clots). PDE5 inhibitors such as tadalafil have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tadalafil Accord.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts additional strain on the heart. If you have a heart condition, inform your doctor.
Before taking the tablets, inform your doctor if you have:

sickle cell anemia (an abnormality of red blood cells).
multiple myeloma (a malignant tumor of the bone marrow).
leukemia (a malignant tumor of blood cells).
any deformity of the penis.
a serious liver problem.
a serious kidney problem.

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

pelvic surgery
removal of all or part of the prostate gland where the nerves to the prostate have been cut (non-nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Accord and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed.
Although it is not known whether this event is directly related to tadalafil, if you experience sudden reduction or loss of hearing, stop taking Tadalafil Accord and contact your doctor immediately.
Tadalafil Accord must not be used in the treatment of erectile dysfunction in women, as this is a health issue specific to men.
Children and adolescents
Tadalafil Accord is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Accord
Inform your doctor 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 themselves affect how Tadalafil Accord works. Inform your doctor or pharmacist if you are already taking:

an alpha-blocker (used to treat high blood pressure or urinary problems 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 fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadalafil Accord with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Accord works and should be consumed with caution. Consult your doctor for further information.
Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine. Do not take tadalafil unless strictly necessary and after discussing it with your doctor.
Breastfeeding
Do not breastfeed while taking these tablets, as it is not known whether this medicine passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
Fertility
In treated dogs, a reduction in sperm development in the testes has been observed. In some men, a reduction in sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Accord in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
Tadalafil Accord contains lactose:
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Tadalafil Accord

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Swallow the tablet whole with water. Tablets may be taken regardless of food intake.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust your dose to 2.5 mg based on your response to Tadalafil Accord. This dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Accord more than once a day.
Taking Tadalafil Accord once daily may be beneficial for men who anticipate engaging in sexual activity two or more times per week.
When taken once daily, Tadalafil Accord 5 mg enables you to achieve an erection, if there is sexual stimulation, at any time during the 24-hour period.
It is important to note that Tadalafil Accord does not work without sexual stimulation. You and your partner will need to engage in foreplay, as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a drop in your blood pressure. If you have taken or plan to take Tadalafil Accord, avoid excessive alcohol consumption (blood alcohol levels of 0.08% or higher), as this may increase the risk of dizziness when standing up.

If you take more Tadalafil Accord than you should
If you or anyone else takes more tablets than prescribed, contact your doctor or go to the hospital immediately, taking the medicine or its packaging with you. You may experience the 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 the missed tablet. You must not take Tadalafil Accord more than once a day.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These side effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop using the medicine and seek
immediate medical attention:

allergic reactions, including skin rash (uncommon frequency).
chest pain – do not use nitrates but seek immediate medical attention (uncommon frequency).
priapism, a prolonged and possibly painful erection after taking Tadalafil Accord (rare frequency). If you have an erection of this type lasting more than 4 consecutive hours, you must contact a doctor immediately.
sudden loss of vision (rare frequency).

Other side effects reported:

Common (may affect up to 1 in 10 people)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and digestive disturbances.

Uncommon (may affect up to 1 in 100 people)

dizziness, stomach ache, nausea, vomiting, reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus (ringing in the ears), swelling of the hands, feet or ankles, and feeling of fatigue.

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

fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (itchy red patches on the skin), penile bleeding, blood in semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking tadalafil. Most of these individuals already had heart problems before taking the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking tadalafil. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death. The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton and blister after "Exp". The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Accord contains

The active substance is tadalafil.
Each film-coated tablet contains 2.5 mg of tadalafil.
The other components are:
Tablet core: monohydrate lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, sorbitan stearate, and magnesium stearate.
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, and talc.

Description of the appearance of Tadalafil Accord and package contents
Tadalafil Accord 2.5 mg is a white, round, film-coated tablet approximately 5.5 mm in diameter with beveled edges, biconvex, marked with "T" on one side and "25" on the other.
Tadalafil Accord 2.5 mg is available in PVC/PE/PVdC and clear aluminum blisters in a pack containing 28 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers:
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF,
United Kingdom
Wessling Hungary Kft
Fòti ùt 56., Budapest 1047,
Hungary
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

| Member States | Proposed medicinal product name | |---------------|----------------------------------| | UK | Tadalafil 2.5/5/10/20 mg Film-coated Tablets | | AT | Tadalafil Accord 5/10/20 mg Filmtabletten | | BG | Tadalafil Акорд 2.5/5/10/20 мг филмирани таблетки | | CY | Tadalafil Accord 5/20 mg Film-coated Tablets | | CZ | Tadalafil Accord 5/20 mg potahované tablety | | DE | Tadalafil Accord 5/20 mg Filmtabletten | | DK | Tadalafil Accord | | EE | Tadalafil Accord | | | Tadalafil Accord 2.5/5/10/20 mg tabletti | | FI | kalvopäällysteinen/filmdragerad tablet | | FR | TADALAFIL ACCORD 2,5 mg, comprimé pelliculé
TADALAFIL ACCORD 5 mg, comprimé pelliculé
TADALAFIL ACCORD 10 mg, comprimé pelliculé
TADALAFIL ACCORD 20 mg, comprimé pelliculé | | IT | Tadalafil Accord | | LT | Tadalafil 5/10/20 mg Film-coated Tablets | | LV | Tadalafil Accord 5/10/20 mg plėvele dengtos tabletės | | NL | Tadalafil Accord 20 mg apvalkotās tabletes | | NO | Tadalafil Accord 5/10/20 mg, filmomhulde tabletten | | PL | Tadalafil Accord | | SE | Tadalafil Accord | | SK | Tadalafil Accord 2.5/5/10/20 mg filmdragerad tablet |

Package leaflet: information for the user

Tadalafil Accord 5 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine as it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tadalafil Accord is and what it is used for
What you need to know before taking Tadalafil Accord
How to take Tadalafil Accord
Possible side effects
How to store Tadalafil Accord
Contents of the pack and other information

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

Tadalafil Accord contains the active substance tadalafil, which belongs to a class of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Accord is a treatment for adult men with:

Erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Accord has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse. Following sexual stimulation, Tadalafil Accord helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil Accord will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Accord has no effect in the absence of sexual stimulation. You and your partner will need to engage in foreplay, 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 condition occurs when the prostate gland enlarges with age. Symptoms include difficulty starting urination, a sensation of not completely emptying the bladder, and a more frequent need to urinate, including during the night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms associated with benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Accord

Do not take Tadalafil Accord if:

you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). It has been shown that Tadalafil Accord increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
you have a severe heart disease or have recently had a heart attack within the last 90 days.
you have had a stroke within the last 6 months.
you have low blood pressure or uncontrolled high blood pressure.
you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
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 secondary to blood clots). PDE5 inhibitors such as tadalafil have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

sickle cell anemia (an abnormality of red blood cells).
multiple myeloma (a malignant tumor of the bone marrow).
leukemia (a malignant tumor of blood cells).
any deformity of the penis.
a serious liver problem.
a serious kidney problem.

Since benign prostatic hyperplasia and prostate cancer may have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Tadalafil Accord for benign prostatic hyperplasia.
Tadalafil Accord does not treat prostate cancer.
It is not known whether Tadalafil Accord is effective in patients who have undergone:

pelvic surgery
removal of all or part of the prostate gland where the nerves to the prostate were cut (nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Accord and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed.
Although it is not known whether the event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking Tadalafil Accord and contact your doctor immediately.
Tadalafil Accord must not be used in the treatment of erectile dysfunction or benign prostatic hyperplasia in women, as these are health conditions specific to men.
Children and adolescents
Tadalafil Accord is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Accord
Inform your doctor 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 themselves affect how Tadalafil Accord works. Inform your doctor or pharmacist if you are taking:

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

Tadalafil Accord with food, beverages, and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Accord works and should be consumed with caution. Consult your doctor for further information.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding with breast milk, ask your doctor for advice before taking this medicine. Do not take tadalafil if you are pregnant, unless strictly necessary and after discussing it with your doctor.
Breastfeeding
Do not breastfeed while taking these tablets, as it is not known whether this medicine passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy and breastfeeding.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. It is unlikely that these effects would cause infertility.
Driving and using machines
Some men taking Tadalafil Accord in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Accord contains lactose:
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Tadalafil Accord

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the tablet whole with water. The tablets may be taken regardless of food intake.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Accord. This dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Accord more than once a day.

When taken once daily, Tadalafil Accord allows you to achieve an erection, if there is sexual stimulation, at any time during the 24 hours following administration. Daily administration of Tadalafil Accord may benefit men who anticipate having sexual activity two or more times per week.

It is important to note that Tadalafil Accord does not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a reduction in blood pressure. If you have taken or plan to take Tadalafil Accord, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

For the treatment of benign prostatic hyperplasia
The dose is one 5 mg tablet taken once daily at approximately the same time each day.

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

If you forget to take Tadalafil Accord
Take your missed dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. Do not take Tadalafil Accord more than once a day.

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

4. Possible side effects

allergic reactions, including skin rash (uncommon frequency).
chest pain – do not use nitrates, but seek immediate medical help (uncommon frequency).
priapism, a prolonged and possibly painful erection after taking Tadalafil Accord (rare frequency). If you have an erection lasting more than 4 hours, you must contact a doctor immediately.
sudden loss of vision (rare frequency).

Other side effects have been reported:
Common (may affect up to 1 in 10 people)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and digestive disturbances.

Uncommon (may affect up to 1 in 100 people)

dizziness, stomach discomfort, nausea, vomiting, reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, increased heart rate,

high blood pressure, low blood pressure, nosebleeds, tinnitus,
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, eyelid swelling, red eyes, sudden decrease or loss of hearing, and urticaria (red, itchy patches on the skin), penile bleeding, blood in semen, and increased sweating. Rarely, heart attacks and strokes have been reported in men taking tadalafil. Most of these individuals already had heart problems before taking the medicine.

Rare cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.
Some additional rare side effects, not observed during clinical studies, have been reported in men taking tadalafil. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.

The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 and blister after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Accord contains

The active substance is tadalafil.
Each film-coated tablet contains 5 mg of tadalafil.
The other components are:
Tablet core: monohydrate lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, sorbitan stearate, and magnesium stearate.
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, talc, and iron oxide yellow (E172).

Description of the appearance of Tadalafil Accord and package contents
Tadalafil Accord 5 mg is a light yellow, capsule-shaped, film-coated tablet, approximately 8.6 mm long and 4.8 mm thick, with beveled edges and biconvex shape, marked with "T5" on one side and plain on the other side.
Tadalafil Accord 5 mg is available in PVC/PE/PVdC and clear aluminum blisters in pack sizes of 14, 28, 30, 84, or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers:
Accord Healthcare Limited
Sage house, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF,
United Kingdom
Wessling Hungary Kft
Fòti ùt 56., Budapest 1047,
Hungary
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

	Member States		Proposed name of the medicinal product
UK		Tadalafil 2.5/5/10/20 mg Film-coated Tablets
AT		Tadalafil Accord 5/10/20 mg Filmtabletten
BG		Tadalafil Accord 2.5/5/10/20 mg film-coated tablets
CY		Tadalafil Accord 5/20 mg Film-coated Tablets
CZ		Tadalafil Accord 5/20 mg potahované tablety
DE		Tadalafil Accord 5/20 mg Filmtabletten
DK		Tadalafil Accord
EE		Tadalafil Accord
FI		Tadalafil Accord 2.5/5/10/20 mg tabletti kalvopäällysteinen/filmdragerad tablet
FR		TADALAFIL ACCORD 2.5 mg, comprimé pelliculé TADALAFIL ACCORD 5 mg, comprimé pelliculé TADALAFIL ACCORD 10 mg, comprimé pelliculé TADALAFIL ACCORD 20 mg, comprimé pelliculé

IT	Tadalafil Accord
LT	Tadalafil 5/10/20 mg Film-coated Tablets
LV	Tadalafil Accord 5/10/20 mg film-coated tablets
NL	Tadalafil Accord 20 mg filmomhulde tabletten
NO	Tadalafil Accord 5/10/20 mg, filmomhulde tabletter
PL	Tadalafil Accord
SE	Tadalafil Accord
SK	Tadalafil Accord 2.5/5/10/20 mg filmomhulde tabletter

Package leaflet: information for the user

Tadalafil Accord 10 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tadalafil Accord is and what it is used for
What you need to know before taking Tadalafil Accord
How to take Tadalafil Accord
Possible side effects
How to store Tadalafil Accord
Package contents and other information

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

Tadalafil Accord contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Accord is a treatment for adult men with:
Erectile dysfunction. This condition occurs when a man is unable to achieve or maintain
an erection sufficient for sexual intercourse. Tadalafil Accord has been shown to significantly improve
the ability to obtain an erection sufficient for sexual intercourse. Following sexual stimulation, Tadalafil
Accord helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved
erectile function. Tadalafil Accord will not help you if you do not have erectile dysfunction. It is
important to note that Tadalafil Accord has no effect in the absence of sexual stimulation. You and your partner
will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking Tadalafil Accord

Do not take Tadalafil Accord if:

you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
you 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 (or "chest pain"). It has been shown that Tadalafil Accord increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
you have a serious heart condition or have had a heart attack in the last 90 days.
you have had a stroke in the last 6 months.
you have low blood pressure or uncontrolled high blood pressure.
you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
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 secondary to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tadalafil Accord.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart condition, inform your doctor.
Before taking the tablets, inform your doctor if you have:

sickle cell anemia (an abnormality of red blood cells).
multiple myeloma (a malignant tumor of the bone marrow).
leukemia (a malignant tumor of blood cells).
any penile deformity or have involuntary or persistent erections lasting more than 4 hours.
severe liver problems.
severe kidney problems.

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

pelvic surgery
removal of all or part of the prostate gland where nerves to the prostate were severed (nerve-sparing radical prostatectomy).

If you experience sudden decrease or loss of vision, stop taking Tadalafil Accord and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed.
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 Accord and contact your doctor immediately.
Tadalafil Accord must not be used in the treatment of erectile dysfunction in women, as this is a condition specific to men.
Children and adolescents
Tadalafil Accord is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Accord
Inform your doctor 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 themselves affect how Tadalafil Accord works. Inform your doctor or pharmacist if you are taking:

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

Tadalafil Accord with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Accord works and should be consumed with caution. Consult your doctor for further information.
Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine. Do not take tadalafil unless strictly necessary and after discussing it with your doctor.
Breastfeeding
Do not breastfeed while taking these tablets, as it is not known whether this medicine passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
Fertility
In dogs treated with tadalafil, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. It is unlikely that these effects would lead to infertility.
Driving and using machines
Some men taking Tadalafil Accord in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Accord contains lactose:
If you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Tadalafil Accord

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Swallow the tablet whole with water. The tablets can be taken regardless of food intake.

For the treatment of erectile dysfunction
The recommended starting dose is one 10 mg tablet taken prior to sexual activity. If this dose is not effective enough, your doctor may increase the dose to 20 mg. Tadalafil Accord tablets are for oral use.
You should take the Tadalafil Accord tablet at least 30 minutes before sexual activity.
Tadalafil Accord may still 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 intended for use prior to anticipated sexual activity and is not recommended for daily continuous use.

It is important to note that Tadalafil Accord will not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.

Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a lowering of your blood pressure. If you have taken or plan to take Tadalafil Accord, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

If you take more Tadalafil Accord than you should
If you or anyone else takes more tablets than prescribed, contact your doctor or go to hospital immediately. Take the medicine or the packaging with you. The side effects described in section 4 may occur.

If you have any questions about 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 everyone gets them. These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop using this medicine and seek
immediate medical help:

allergic reactions, including skin rash (uncommon frequency).
chest pain – do not use nitrates but seek immediate medical help (uncommon frequency).
priapism, a prolonged and possibly painful erection after taking Tadalafil Accord (rare frequency). If you have an erection of this type lasting more than 4 hours, you must contact a doctor immediately.
sudden loss of vision (rare frequency). Other side effects reported include:

Common (may affect up to 1 in 10 people)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and digestive disturbances.
Uncommon (may affect up to 1 in 100 people)
dizziness, stomach ache, nausea, vomiting, reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, increased heart rate, 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 1,000 people)

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

Rarely, heart attacks and strokes have been reported in men taking tadalafil. Most of these men already had heart problems before taking the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.
Some additional rare side effects, not observed during clinical studies, have been reported in men taking tadalafil. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, serious skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death. The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.

5. How to store 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 carton and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Accord contains

The active substance is tadalafil.
Each film-coated tablet contains 10 mg of tadalafil.
The other components are:
Tablet core: monohydrate lactose, sodium croscarmellose, hypromellose, microcrystalline cellulose, sorbitan stearate, and magnesium stearate.
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, talc, and yellow iron oxide (E172).

Description of the appearance of Tadalafil Accord and contents of the pack
Tadalafil Accord 10 mg is a yellow, film-coated capsule-shaped tablet approximately 11 mm long and 5.5 mm thick, with bevelled edges, biconvex, marked with "T10" on one side and plain on the other side.
Tadalafil Accord 10 mg is available in PVC/PE/PVdC and clear aluminium blisters containing 4 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:

| Member States | Proposed medicinal product name | |-------------------|-------------------------------------| | UK | Tadalafil 2.5/5/10/20 mg Film-coated Tablets | | AT | Tadalafil Accord 5/10/20 mg Filmtabletten | | BG | Tadalafil Акорд 2.5/5/10/20 мг филмирани таблетки | | CY | Tadalafil Accord 5/20 mg Film-coated Tablets | | CZ | Tadalafil Accord 5/20 mg potahované tablety | | DE | Tadalafil Accord 5/20 mg Filmtabletten | | DK | Tadalafil Accord | | EE | Tadalafil Accord | | FI | Tadalafil Accord 2.5/5/10/20 mg tabletti kalvopäällysteinen/filmdragerad tablet | | FR | TADALAFIL ACCORD 2,5 mg, comprimé pelliculé
TADALAFIL ACCORD 5 mg, comprimé pelliculé
TADALAFIL ACCORD 10 mg, comprimé pelliculé
TADALAFIL ACCORD 20 mg, comprimé pelliculé | | IT | Tadalafil Accord | | LT | Tadalafil 5/10/20 mg Film-coated Tablets | | LV | Tadalafil Accord 5/10/20 mg plēvele dengtas tabletēs | | NL | Tadalafil Accord 20 mg apvalkotās tabletes | | NO | Tadalafil Accord 5/10/20 mg, filmomhulde tabletten | | PL | Tadalafil Accord | | SE | Tadalafil Accord | | SK | Tadalafil Accord 2.5/5/10/20 mg filmdragerad tablet |

Package leaflet: Information for the user

Tadalafil Accord 20 mg film-coated tablets

Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tadalafil Accord is and what it is used for
What you need to know before taking Tadalafil Accord
How to take Tadalafil Accord
Possible side effects
How to store Tadalafil Accord
Contents of the pack and other information

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

Tadalafil Accord contains the active substance tadalafil, which belongs to a class of medicines known as
phosphodiesterase type 5 inhibitors.
Tadalafil Accord is indicated for the treatment of:

Erectile dysfunction in adult men. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Accord has been shown to significantly improve the ability to achieve an erection suitable for sexual activity. Following sexual stimulation, Tadalafil Accord helps relax the blood vessels in the penis, allowing blood flow into the penis. The result is improved erectile function. Tadalafil Accord will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Accord has no effect in the absence of sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.
Pulmonary arterial hypertension in adults: It works by helping to relax the blood vessels in the lungs, thereby improving blood flow to the lungs. The result is an improved ability to exercise.

2. What you need to know before taking Tadalafil Accord

Do not take Tadalafil Accord if:

you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). It has been shown that Tadalafil Accord enhances the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
you have a severe heart disease or have recently had a heart attack (within the last 90 days).
you have had a stroke within the last 6 months.
you have low blood pressure or uncontrolled high blood pressure.
you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
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 secondary to blood clots). PDE5 inhibitors, such as tadalafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tadalafil Accord.

Be aware that sexual activity involves a potential risk for patients with heart disease, as it places additional strain on the heart. If you have a heart condition, inform your doctor.

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

any heart problems other than high blood pressure.
problems with your blood pressure.
any hereditary eye diseases.
sickle cell anemia (an abnormality of red blood cells).
multiple myeloma (a malignant tumor of the bone marrow).
leukemia (a malignant tumor of blood cells).
any deformity of the penis.
severe liver problems.
severe kidney problems.

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

pelvic surgery
removal of all or part of the prostate gland where nerves to the prostate have been cut (nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Accord and contact your doctor immediately.

In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. 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 Accord and contact your doctor immediately.

Tadalafil Accord must not be used in the treatment of erectile dysfunction in women, as it is intended for male-specific health conditions.

Children and adolescents

Tadalafil Accord is not indicated for use in children and adolescents under 18 years of age.

Other medicines and Tadalafil Accord

Inform your doctor 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 themselves affect how Tadalafil 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 problems associated with benign prostatic hyperplasia)
other medicines for high blood pressure
riociguat
a 5-alpha reductase enzyme inhibitor (used to treat benign prostatic hyperplasia)
medicines such as ketoconazole tablets (for fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection
phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines)
rifampicin, erythromycin, clarithromycin, or itraconazole
other treatments for erectile dysfunction

Tadalafil Accord with food, beverages and alcohol

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

Pregnancy, breast-feeding and fertility

Pregnancy

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breast-feeding, ask your doctor for advice before taking this medicine. Do not take tadalafil unless strictly necessary and after discussing it with your doctor.

Breast-feeding

Do not breast-feed while taking these tablets, as it is not known whether this medicine passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breast-feeding.

Fertility

In dogs treated with tadalafil, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. It is unlikely that these effects would cause infertility.

Driving and using machines

Some men taking Tadalafil Accord in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.

Tadalafil Accord contains lactose:

If you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Tadalafil Accord

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Swallow the tablet whole with water. The tablets can be taken regardless of food intake.

For the treatment of erectile dysfunction

The recommended starting dose is one 10 mg tablet taken prior to sexual activity. However, your doctor has prescribed you a dose of one 20 mg tablet because they have determined 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 Accord may remain 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 indicated for use prior to anticipated sexual activity and is not recommended for daily continuous use.
It is important to note that Tadalafil Accord will not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to have an erection and may temporarily cause a reduction in your blood pressure. If you have taken or plan to take Tadalafil Accord, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

For the treatment of pulmonary arterial hypertension
Tadalafil is supplied as a 20 mg tablet. The usual dose is 2 tablets of 20 mg taken once daily. You should take both tablets at the same time, one after the other. If you have mild to 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, contact your doctor or go to the hospital immediately, taking the medicine or packaging with you. The side effects described in section 4 may occur.

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 tablets. 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 advised otherwise by your doctor.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop using the medicine and seek
immediate medical help:

allergic reactions, including skin rashes (uncommon frequency).
chest pain – do not use nitrates but seek immediate medical help (uncommon frequency).
priapism, a prolonged and possibly painful erection after taking Tadalafil Accord (rare frequency). If you have an erection of this type lasting more than 4 hours in succession, you must contact a doctor immediately.
sudden loss of vision (rare frequency).

Other side effects have been reported and are listed below, categorized by indication:
Side effects in erectile dysfunction
Common (may affect up to 1 in 10 people)

headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion, and digestive disturbances.

Uncommon (may affect up to 1 in 100 people)

dizziness, stomach ache, blurred vision, nausea, vomiting, acid reflux, eye irritation, breathing difficulties, blood in the urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of the hands, feet or ankles, and feeling tired.

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

fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (itchy red patches on the skin), penile bleeding, blood in the semen, and increased sweating.

Rarely, heart attacks and strokes have been reported in men taking tadalafil. Most of these individuals already had pre-existing heart conditions before taking the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been reported.
Some additional rare side effects not observed during clinical studies have been reported in men taking tadalafil. These include:

migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death. The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.

Side effects in pulmonary arterial hypertension
Very common (may affect more than 1 in 10 people)

headache, flushing, nasal and sinus congestion (stuffy nose), nausea, indigestion (including abdominal pain or discomfort), muscle pain, back pain, and pain in the extremities (including limb discomfort).

Common (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, penile bleeding, blood in the semen and/or urine, high blood pressure, rapid heartbeat, sudden cardiac death, and tinnitus. Most, but not all, men who experienced rapid heartbeat, irregular heartbeat, heart attack, stroke, or sudden cardiac death had known pre-existing heart conditions before taking tadalafil. It is not possible to determine whether these events were directly associated with tadalafil.

5. How to store 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 and blister after Exp. The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Accord contains

The active substance is tadalafil.
Each film-coated tablet contains 20 mg of tadalafil.
The other components are:
Tablet core: monohydrate lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, sorbitan stearate, and magnesium stearate.
Film coating: monohydrate lactose, hypromellose, titanium dioxide (E171), triacetin, talc, and yellow iron oxide (E172).

Description of the appearance of Tadalafil Accord and contents of the pack
Tadalafil Accord 20 mg is a yellow, film-coated capsule-shaped tablet approximately 14.3 mm in length and 7 mm in thickness, with bevelled edges, biconvex, marked with "T20" on one side and plain on the other.
Tadalafil Accord 20 mg is available in PVC/PE/PVdC and clear aluminium blisters in pack sizes of 2, 4, 8, 12, 56 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturers:
Accord Healthcare Limited
Sage house, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF,
United Kingdom
Wessling Hungary Kft
Fòti ùt 56., Budapest 1047,
Hungary
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area Member States under the following names:

| Member States | Proposed medicinal product name | |-------------------|-------------------------------------| | UK | Tadalafil 2.5/5/10/20 mg Film-coated Tablets | | AT | Tadalafil Accord 5/10/20 mg Filmtabletten | | BG | Tadalafil Акорд 2.5/5/10/20 мг филмирани таблетки | | CY | Tadalafil Accord 5/20 mg Film-coated Tablets | | CZ | Tadalafil Accord 5/20 mg potahované tablety | | DE | Tadalafil Accord 5/20 mg Filmtabletten | | DK | Tadalafil Accord | | EE | Tadalafil Accord | | FI | Tadalafil Accord 2.5/5/10/20 mg tabletti, kalvopäällysteinen/filmdragerad tablet | | FR | TADALAFIL ACCORD 2,5 mg, comprimé pelliculé
TADALAFIL ACCORD 5 mg, comprimé pelliculé
TADALAFIL ACCORD 10 mg, comprimé pelliculé
TADALAFIL ACCORD 20 mg, comprimé pelliculé | | IT | Tadalafil Accord | | LT | Tadalafil 5/10/20 mg Film-coated Tablets | | LV | Tadalafil Accord 5/10/20 mg plėvele dengtos tabletės | | NL | Tadalafil Accord 20 mg apvalkotās tabletes | | NO | Tadalafil Accord 5/10/20 mg, filmomhulde tabletten | | PL | Tadalafil Accord | | SE | Tadalafil Accord | | SK | Tadalafil Accord 2.5/5/10/20 mg filmdragerad tablet |