TADALAFIL 2.5 mg Film-coated tablets

Зміст інструкції

1. Tadalafil Accord 2,5 mg film-coated tablets
   1. What is Tadalafil Accord and what it is used for
   2. What you need to know before taking Tadalafil Accord
   3. How to take Tadalafil Accord
   4. Possible side effects
   5. How to store Tadalafil Accord
   6. Package Contents and Other Information
2. Tadalafil Accord 5 mg film-coated tablets
   1. What is Tadalafil Accord and what it is used for
   2. What you need to know before taking Tadalafil Accord
   3. How to take Tadalafil Accord
   4. Possible side effects
   5. How to store Tadalafil Accord
   6. Package contents and other information
3. Tadalafil Accord 10 mg film-coated tablets
   1. What is Tadalafil Accord and what it is used for
   2. What you need to know before taking Tadalafil Accord
   3. How to take Tadalafil Accord
   4. Possible side effects
   5. How to store Tadalafil Accord
   6. Package Contents and Other Information
4. Tadalafil Accord 20 mg film-coated tablets
   1. What is Tadalafil Accord and what it is used for
   2. What you need to know before taking Tadalafil Accord
   3. How to take Tadalafil Accord
   4. Possible side effects
   5. How to store Tadalafil Accord
   6. Package Contents and Other Information

Tadalafil Accord 2,5 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tadalafil Accord contains the active substance tadalafil which belongs to the 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 cannot achieve or maintain
an erection adequate for sexual intercourse. Tadalafil Accord has been shown to significantly improve
the ability to achieve an erection adequate for sexual intercourse. After sexual stimulation Tadalafil
Accord helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result is a
better erectile function. Tadalafil Accord will not be helpful if you do not have erectile dysfunction. It is
important to note that Tadalafil Accord has no effect if there is no 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 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 for the treatment of 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, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, within 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 had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• 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). It has been shown that PDE5 inhibitors, such as tadalafil, increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, tell 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 a heart condition, because it puts extra strain on the heart. If you have a heart problem, tell your doctor.
Before taking the tablets, tell 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 the 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 of the prostate have been cut (radical prostatectomy without nerve sparing).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Accord and contact your doctor immediately.
A decrease or sudden loss of hearing has been observed in some patients taking tadalafil.
Although it is not known whether the event is directly related to tadalafil, if you experience a decrease or loss of hearing, stop taking Tadalafil Accord and contact your doctor immediately.

Tadalafil Accord should not be used in the treatment of erectile dysfunction by women, because these are health problems specific to men.
Children and adolescents
Tadalafil Accord is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Tadalafil Accord
Tell 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 can be affected by Tadalafil Accord or they themselves can affect how Tadalafil Accord works. Tell 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 to treat high blood pressure.
• riociguat.
• a 5 alpha-reductase enzyme inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (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 drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect how Tadalafil Accord works and should be taken with caution. Ask your doctor for further information.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, 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 because 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 dogs treated with it, a reduction in sperm development in the testicles has been observed. A decrease in sperm count has been observed in some men. These effects are unlikely to cause infertility.

Driving and operating machinery
Some men taking Tadalafil Accord during clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or operating machinery.

Tadalafil Accord contains lactose:
If you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Tadalafil Accord

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Swallow the tablet whole with water. The tablets can be taken independently
of food intake.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet to be taken once a day at approximately the same time
of day. Your doctor may adjust the 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.
Daily administration of Tadalafil Accord may be useful for men who plan to
have sexual activity two or more times a week.
When taken once a day, Tadalafil Accord 5 mg allows you to achieve an erection, if there is
sexual stimulation, at any time of the day within 24 hours.
It is important to note that Tadalafil Accord does not work if there is no sexual stimulation. You and your partner
will need to engage in foreplay, as you would if you were not taking medication for
erectile dysfunction.
Drinking alcoholic beverages may interfere with your ability to achieve an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend 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 you stand up.

If you take more Tadalafil Accord than you should
If you or anyone else takes more tablets than you should, contact your doctor or go immediately
to the hospital, bringing the medicine or the packaging with you. 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 compensate for forgetting
the tablet. You should not take Tadalafil Accord more than once a day.
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 everybody gets them.
These effects are normally mild to moderate in severity.

If any of the following side effects occur, stop using the medicine and seek
immediate medical assistance:

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain - do not use nitrates but seek immediate medical assistance (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking Tadalafil Accord (rare frequency). If you have an erection of this type that lasts for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare frequency). Other side effects that have been reported include:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in the arms and legs, flushing of the face, nasal congestion and digestive disorders. Uncommon(may affect up to 1 in 100 people)
• dizziness, stomach discomfort, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, 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, convulsions and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and hives (itchy red patches on the skin surface), bleeding of the penis, blood in the semen and increased sweating.

Rarely, in men taking tadalafil, heart attacks and strokes have been reported. Most of these subjects
had heart problems already before using the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been
reported.

Some further rare side effectsthat had not been observed during clinical trials 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, some disorders that change blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death. Dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 package and on the blister after Exp. The
expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water 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 substanceis tadalafil.
• Each film-coated tablet contains 2.5 mg of tadalafil.
• The other ingredientsare: Tablet Core:lactose monohydrate, sodium croscarmellose, hypromellose, microcrystalline cellulose, sorbitan stearate and magnesium stearate. Film Coating:lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin and talc.

Description of the appearance of Tadalafil Accord and package contents
Tadalafil Accord 2.5 mg is a film-coated tablet, white in colour, round, approximately 5.5 mm in
diameter with a bevelled edge, biconvex with “T” imprinted on one side and “25” on the other side.
Tadalafil Accord 2.5 mg is available in PVC/PE/PVdC and clear Aluminium blisters in packs of 28
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
Manufacturer:
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 with the
following denominations:
Member StatesProposed 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
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
FR

Tadalafil Accord 5 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tadalafil Accord contains the active ingredient tadalafil which belongs to the 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 cannot achieve or maintain an erection adequate for sexual intercourse. Tadalafil Accord has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse. After sexual stimulation Tadalafil Accord helps to relax the blood vessels in the penis, allowing blood flow to 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 if there is no sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking 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 emptying the bladder completely, and a more frequent need to urinate, even at night. Tadalafil improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms associated with benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within 1-2 weeks of starting treatment.

2. What you need to know before taking 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).
• you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used for the treatment of angina pectoris (or “chest pain”). Tadalafil Accord has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, 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 had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “an eye stroke”.
• 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, tell 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 a heart condition, because it puts extra strain on the heart. If you have a heart problem, tell your doctor.
Before taking the tablets, tell your doctor if you have:

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

Because benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will
perform checks for prostate cancer before starting treatment with Tadalafil Accord for
benign prostatic hyperplasia.
Tadalafil Accord does not cure 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 of the prostate have been cut (radical prostatectomy without nerve sparing).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Accord and contact
your doctor immediately.
A decrease or sudden loss of hearing has been observed in some patients taking tadalafil.
Although it is not known whether the event is directly related to tadalafil, if you experience a reduction
or sudden loss of hearing, stop taking Tadalafil Accord and contact your doctor immediately.

Tadalafil Accord should not be used in the treatment of erectile dysfunction or benign prostatic hyperplasia
by women, because these are health problems specific to men.
Children and adolescents
Tadalafil Accord is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Tadalafil Accord
Tell 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 can be affected by Tadalafil Accord or they themselves can affect how
Tadalafil Accord works. Tell 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 to treat high blood pressure.
• riociguat.
• a 5 alpha-reductase enzyme inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (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 drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect how
Tadalafil Accord works and should be taken with caution. Ask your doctor for further
information.

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

Breastfeeding
Do not breastfeed while taking these tablets because 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 dogs treated with the drug, a reduction in sperm development in the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machinery
Some men taking Tadalafil Accord during clinical studies have reported dizziness. Carefully
check how you react to the tablets before driving or using machinery.

Tadalafil Accord contains lactose:
If you have an intolerance to some 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, ask your
doctor or pharmacist.
Swallow the tablet whole with water. The tablets can be taken independently
of food intake.

For the treatment of erectile dysfunction
The recommended doseis one 5 mg tablet to be taken once a day at approximately the same
time of day. Your doctor may adjust the 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.
When taken once a day, Tadalafil Accord allows you to achieve an erection, if there is
sexual stimulation, at any time of the day within 24 hours. The administration of
Tadalafil Accord once a day may be useful for men who plan to have sexual activity
two or more times a week.
It is important to note that Tadalafil Accord does not work if there is no 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.
Drinking alcohol may interfere with your ability to achieve an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend 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 you stand up.

For the treatment of benign prostatic hyperplasia
The dose is one 5 mg tablet to be taken once a day at approximately the same time of
day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet to
be taken once a day.

If you take more Tadalafil Accord than you should
If you or anyone else takes more tablets than you should, contact your doctor or go immediately
to hospital, taking the medicine or the packaging with you. 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 a missed
tablet. You should not take Tadalafil Accord more than once a day.
If you have any questions about using 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.
These effects are normally mild to moderate in severity.

If any of the following side effects occur, stop using the medicine and seek
immediate medical assistance:

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain - do not use nitrates but seek immediate medical assistance (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking Tadalafil Accord (rare frequency). If you have an erection of this type that lasts for more than 4 hours, you should 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 aches, pain in the arms and legs, flushing of the face, nasal congestion and digestive disorders.

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye discomfort, difficulty breathing, blood in the urine, prolonged erection, palpitations, fast heartbeat,

high blood pressure, low blood pressure, nosebleeds, 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, convulsions and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and hives (itchy red patches on the skin), bleeding of the penis, blood in the semen and increased sweating. Rarely, heart attacks and strokes have been reported in men taking tadalafil. Most of these subjects had pre-existing heart problems before using the medicine.

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

Some further rare side effectsthat had not been observed during clinical trials 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, some disorders that alter blood flow 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 who
were taking tadalafil. Diarrhea has been reported more frequently in men over 65 years of age who
were taking tadalafil.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 package and on the blister after Exp. The
expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water 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 substanceis tadalafil.
• Each film-coated tablet contains 5 mg of tadalafil.
• The other ingredientsare: Tablet Core:lactose monohydrate, sodium croscarmellose, hypromellose, microcrystalline cellulose, sorbitan stearate and magnesium stearate. Film Coating:lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, talc and yellow iron oxide (E172).

Description of the appearance of Tadalafil Accord and package contents
Tadalafil Accord 5 mg is a film-coated tablet of light yellow color, capsule-shaped, approximately
8.6 mm long and 4.8 mm thick, with a beveled edge, biconvex and imprinted with “T5” on one side and
plain on the other side.
Tadalafil Accord 5 mg is available in PVC/PE/PVdC and clear Aluminium blisters in packs 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
Manufacturer:
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 with the following
names:

Tadalafil Accord 10 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tadalafil Accord contains the active substance tadalafil which belongs to the 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 satisfactory sexual intercourse. Tadalafil Accord has been shown to significantly
improve the ability to achieve an erection sufficient for satisfactory sexual intercourse. After sexual stimulation Tadalafil
Accord helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result is a
better 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 if there is no 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 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”). Tadalafil Accord has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• you have had a stroke in the last 6 months.
• you have low or uncontrolled high blood pressure.
• you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• 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, tell 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, because it puts extra strain on the heart. If you have a heart problem, tell your doctor.
Before taking the tablets, tell your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (a malignant bone marrow tumor).
• leukemia (a malignant tumor of the blood cells).
• any deformity of the penis or involuntary or persistent erections that last longer than 4 hours.
• 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 of the prostate have been cut (radical prostatectomy without nerve sparing).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Accord and contact
your doctor immediately.
A decrease or sudden loss of hearing has been observed in some patients taking tadalafil.
Although it is not known whether the event is directly related to tadalafil, if you experience a decrease
or sudden loss of hearing, stop taking Tadalafil Accord and contact your doctor immediately.

Tadalafil Accord should not be used in the treatment of erectile dysfunction by women, because
these are health problems specific to men.
Children and adolescents
Tadalafil Accord is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Tadalafil Accord
Tell 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 can be affected by Tadalafil Accord or they themselves can affect how
Tadalafil Accord works. Tell 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 to treat high blood pressure.
• riociguat.
• a 5 alpha-reductase enzyme inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (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 drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect how
Tadalafil Accord works and should be taken with caution. Ask your doctor for further
information.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, 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 because 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 dogs treated with it, a reduction in sperm development in the testicles has been observed. A reduction in sperm count has been observed in some men. These effects are unlikely to cause infertility.

Driving and using machines
Some men who were taking Tadalafil Accord during clinical trials reported dizziness. Check
carefully how you react to the tablets before driving or using machines.

Tadalafil Accord contains lactose:
If you have an intolerance to some 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, ask your
doctor or pharmacist.
Swallow the tablet whole with water. The tablets can be taken independently
of food intake.

For the treatment of erectile dysfunction
The recommended starting doseis one 10 mg tablet to be taken before sexual activity. If
the effect of this dosage is too weak, 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 indicated for use before
planned sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Accord does not work if there is no 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.
Drinking alcohol may interfere with your ability to get an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend 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 you stand up.

If you take more Tadalafil Accord than you should
If you or anyone else takes more tablets than you should, contact your doctor or go immediately
to hospital, bringing the medicine or the packaging with you. 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 forgetting
the tablet. You should not take Tadalafil Accord more than once a day.
If you have any questions about using 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.
These effects are normally mild to moderate in severity.

If any of the following side effects occur, stop using the medicine and seek
immediate medical attention:

• allergic reactions, including skin rashes (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 that lasts for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare frequency). Other side effects that have been reported include:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in the arms and legs, flushing of the face, nasal congestion and digestive disorders. Uncommon(may affect up to 1 in 100 people)
• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in the urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.

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

• fainting, convulsions and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and urticaria (itchy red patches on the skin surface), bleeding of the penis, blood in the semen and increased sweating.

Rarely, in men taking tadalafil, heart attacks and strokes have been reported. Most of these
subjects had heart problems already before using the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in
one or both eyes have been reported.

Some further rare side effectsthat had not been observed during clinical trials 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, some disorders that alter 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. Diarrhea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 package and on the blister after Exp. The
expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in 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 substanceis tadalafil.
• Each film-coated tablet contains 10 mg of tadalafil.
• The other ingredientsare: Tablet Core:lactose monohydrate, sodium croscarmellose, hypromellose, microcrystalline cellulose, sorbitan stearate and magnesium stearate. Film Coating:lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, talc and yellow iron oxide (E172).

Description of the appearance of Tadalafil Accord and package contents
Tadalafil Accord 10 mg is a light yellow film-coated capsule-shaped tablet, approximately
11 mm long and 5.5 mm thick, with a beveled edge, biconvex and imprinted with “T10” on one side and
plain on the other side.
Tadalafil Accord 10 mg is available in PVC/PE/PVdC and aluminum blister packs in packs of 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
Manufacturer:
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 StateProposed 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
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
FR

Tadalafil Accord 20 mg film-coated tablets

Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tadalafil Accord contains the active substance tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Accord is indicated to treat:

• Erectile dysfunction in adult men. This condition occurs when a man cannot achieve or maintain an erection adequate for sexual intercourse. Tadalafil Accord has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse. After sexual stimulation Tadalafil Accord helps to relax the blood vessels in the penis, allowing blood flow to 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 if there is no sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking medicine for erectile dysfunction.
• Pulmonary arterial hypertension in adults: It works by helping to relax the blood vessels in the lungs, 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 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 for the treatment of angina pectoris (or “chest pain”). Tadalafil Accord has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, within 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 loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• you are taking riociguat. This medicine is used for the treatment of 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). It has been shown that PDE5 inhibitors, such as tadalafil, increase the hypotensive effect of this medicine. If you are taking
riociguat or if you have any doubts, tell 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 a heart condition, because it puts extra strain on the heart. If you have a heart problem, tell your doctor.
Before taking the tablets, tell your doctor if you have:

• any heart problems other than high blood pressure.
• problems with blood pressure.
• any hereditary eye disease.
• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (a cancerous tumor of the bone marrow).
• leukemia (a cancerous tumor of the 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 of the prostate have been cut (radical prostatectomy without nerve sparing).

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

Tadalafil Accord should not be used in the treatment of erectile dysfunction by women, because
these are health problems specific to men.
Children and adolescents
Tadalafil Accord is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Tadalafil Accord
Tell 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 can be affected by Tadalafil Accord or they themselves can affect how
Tadalafil Accord works. Tell your doctor or pharmacist if you are already 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 to treat high blood pressure.
• riociguat.
• a 5 alpha-reductase enzyme inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (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 drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect how
Tadalafil Accord works and should be taken with caution. Ask your doctor for further
information.

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

Breastfeeding
Do not breastfeed while taking these tablets because 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 dogs treated, a reduction in sperm development in the testicles was observed. In some men, a
reduction in sperm count has been observed. It is unlikely that these effects will cause infertility.

Driving and using machines
Some men taking Tadalafil Accord during clinical studies have reported dizziness. Check
carefully how you react to the tablets before driving or using machines.

Tadalafil Accord contains lactose:
If you have an intolerance to some 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, ask your
doctor or pharmacist.
Swallow the tablet whole with water. The tablets can be taken independently
of food intake.

For the treatment of erectile dysfunction

• The recommended starting doseis one 10 mg tablet to be taken before sexual activity. However, you have been prescribed a dose of one 20 mg tablet because your doctor has decided that the recommended 10 mg dose is too low.

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 indicated for use before
planned sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Accord does not work if there is no 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.
Drinking alcohol may interfere with your ability to achieve an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend 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 you stand 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 a
day. You should take both tablets at the same time, one after the other. If you suffer from
mild and moderate liver or kidney problems, your doctor may advise you to take only one
20 mg tablet a day.

If you take more Tadalafil Accord than you should
If you or anyone else takes more tablets than you should, contact your doctor or go immediately
to hospital, taking the medicine or the packaging with you. It is possible that the adverse 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 a missed
tablet. You should 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 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.
These effects are normally mild to moderate in severity.

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

• allergic reactions, including skin rashes (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 that lasts for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare frequency).

Other side effects have been reported and these 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 the arms and legs, flushing of the face, nasal congestion and digestive disorders.

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach discomfort, blurred vision, nausea, vomiting, reflux, eye irritation, breathing difficulties, blood in the urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, 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 and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, and hives (itchy red patches on the skin surface), bleeding of the penis, blood in the semen and increased sweating.

Rarely, in men taking tadalafil, heart attacks and strokes have been reported. Most of these subjects had
heart problems already before using the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of vision in one or both eyes have been
reported.

Some further rare side effectsthat had not been observed during clinical trials have been
reported in men taking tadalafil. These include:

• migraine, facial swelling, a severe allergic reaction causing swelling of the face and throat, severe skin reactions, some disorders that alter 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. Diarrhea 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, hives, excessive sweating, bleeding of the penis, blood in the semen and/or urine, high blood pressure, fast heartbeat, sudden cardiac death and ringing in the ears. Most but not all men for whom fast heartbeat, irregular heartbeat, heart attack, stroke and sudden cardiac death were reported had known heart problems before taking tadalafil. It is not possible to determine whether these events were directly associated with tadalafil.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 package and on the blister after Exp. The
expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in 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 substanceis tadalafil.
• Each film-coated tablet contains 20 mg of tadalafil.
• The other ingredientsare: Tablet Core:lactose monohydrate, sodium croscarmellose, hypromellose, microcrystalline cellulose, sorbitan stearate and magnesium stearate. Film Coating:lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, talc and yellow iron oxide (E172).

Description of the appearance of Tadalafil Accord and package contents
Tadalafil Accord 20 mg is a film-coated tablet, yellow in colour, capsule-shaped, approximately 14.3
mm long and 7 mm thick, with a bevelled edge, biconvex and imprinted with “T20” on one side and
plain on the other side.
Tadalafil Accord 20 mg is available in PVC/PE/PVdC and Aluminium blister packs in packs of 2, 4, 8,
12, 56 or 60 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
Manufacturer:
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 with the following
names:
Member StatesProposed 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
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
FR