Tadalafil Krka: detailed information

Package leaflet: Information for the patient

Tadalafil Krka 2.5 mg film-coated tablets

tadalafil
Equivalent medicine
Please read all of 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 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, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tadalafil Krka contains the active substance tadalafil, which belongs to a class of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Krka 2.5 mg is a treatment for adult men with erectile dysfunction. This condition occurs when a
man is unable to achieve or maintain an erection suitable for sexual activity.
Tadalafil has been shown to significantly improve the ability to obtain a penile erection suitable for sexual
activity.
Following sexual stimulation, Tadalafil Krka works by helping the blood vessels in the penis to relax, allowing
blood to flow into the penis. The result is improved erectile function. Tadalafil will not help you if you do not
have erectile dysfunction.
It is important to emphasize that Tadalafil Krka does not work without sexual stimulation. You and your
partner will need to engage in foreplay, just as if you were not taking a medicine for erectile dysfunction.

2. What you should know before taking Tadalafil Krka

Do not take Tadalafil Krka

if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrates or are unsure, consult your doctor.
if you have a severe heart disease or have recently had a heart attack within the last 3 months.
if you have recently had a stroke within the last 6 months.
if you have low blood pressure or uncontrolled high blood pressure.
if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
if you are taking riociguat. This medicine is used for the treatment of pulmonary arterial hypertension (e.g. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (e.g. high blood pressure in the lungs following blood clots). PDE5 inhibitors, such as Tadalafil Krka, have been shown to enhance the hypotensive effect of this medicine. If you are taking riociguat or are unsure, inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tadalafil Krka.
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:

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

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

pelvic surgery
removal of all or part of the prostate gland with nerve-sparing prostatectomy (radical prostatectomy without preservation of neurovascular bundles).

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

In some patients treated with tadalafil, reduced or sudden impairment 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 Krka and contact your doctor immediately.

Tadalafil Krka 2.5 mg is not indicated for use in women.

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

Other medicines and Tadalafil Krka
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
DO NOT take Tadalafil Krka if you are already taking other nitrates.
Some medicines may be affected by Tadalafil Krka or may affect how Tadalafil Krka works. Inform your doctor or pharmacist if you are taking:

an alpha-blocker (used for the treatment of high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
other medicines used to treat high blood pressure.
riociguat (for the treatment of certain forms of pulmonary hypertension).
a 5-alpha reductase inhibitor (for the treatment of benign prostatic hyperplasia).
protease inhibitors for the treatment of AIDS or HIV infections (e.g. ritonavir).
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin (for the treatment of bacterial infections).
medicines such as ketoconazole or itraconazole (to treat fungal infections).
other treatments for erectile dysfunction.

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

Fertility
In treated dogs, reduced sperm development in the testes has been observed. A reduction in sperm count has been observed in some men. It is unlikely that these effects may lead to infertility.

Driving and using machines
Some men taking tadalafil have reported dizziness in clinical studies.
Carefully assess how you react to the medicine before driving or operating machinery.

Tadalafil Krka contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Tadalafil Krka

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Krka 2.5 mg tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken with or without food.
The recommended dose is one 5 mg tablet taken once daily, approximately at the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Krka. This dose will be given as a 2.5 mg tablet.
Do not take Tadalafil Krka more than once a day.
The daily dose of Tadalafil Krka may benefit men who expect to have sexual activity two or more times per week.
When taken once daily, Tadalafil Krka allows you to achieve an erection if sexually stimulated, at any time during the 24 hours of the day.
It is important to note that Tadalafil Krka will not work without sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Krka, 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 than you should
Inform your doctor. You may experience some of the side effects listed in section 4.
If you forget to take Tadalafil Krka
Take the 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 Krka more than once a day.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop using the 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 Krka (rare frequency). If such an erection occurs and lasts continuously for 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 indigestion.

Uncommon (may affect up to 1 in 100 people):

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

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), increased sweating, bleeding from the penis, and presence of blood in semen. Heart attacks and strokes have rarely been reported in men taking tadalafil. Most of these men had known heart problems before taking this medicine.

A partial, temporary or permanent decrease or loss of vision in one or both eyes has been rarely reported.
Some additional rare side effects have been reported in men taking tadalafil that were not observed during clinical studies. These include:
migraine, facial swelling, severe allergic reaction causing swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina, and sudden cardiac death.
The adverse reaction 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 Krka contains

The active substance is tadalafil. Each film-coated tablet contains 2.5 mg of tadalafil.
The other components are: hypromellose phthalate, mannitol, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E470b) in the tablet core; and lactose monohydrate, hypromellose, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and triacetin (E1518) in the coating. See section 2 “Tadalafil Krka contains lactose and sodium”.

Description of the appearance of Tadalafil Krka and contents of the pack
Tadalafil Krka 2.5 mg film-coated tablets (tablets) are: light orange, round, slightly biconvex, film-coated tablets with bevelled edges. Tablet diameter: approximately 5 mm.
Tadalafil Krka 2.5 mg is available in boxes containing 2, 4, 8, 12, 14, 28, 56 and 84 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy
This medicinal product is authorised in the European Economic Area Member States under the following names:

Member State Name	Product Name
Slovenia, Austria, Belgium, Denmark, Finland, France, Ireland, Iceland, Italy, Norway, Portugal, Sweden, United Kingdom	Tadalafil Krka
Spain	Tadalafil Krka

More detailed information about this medicine is available on the AIFA website www.aifa.gov.it.

Patient Information Leaflet

Tadalafil Krka 5 mg film-coated tablets

tadalafil
Equivalent medicine
Please 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, 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, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

Erectile dysfunction. This condition occurs when a man cannot achieve or maintain an erection suitable for sexual activity. Tadalafil has been shown to significantly improve the ability to obtain a penile erection suitable for sexual activity. Following sexual stimulation, Tadalafil Krka works by helping the blood vessels in the penis to relax, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction. It is important to emphasize that Tadalafil Krka for the treatment of erectile dysfunction does not work without sexual stimulation. You and your partner will need to engage in foreplay, just as if you were not taking a medicine for erectile dysfunction.
Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This condition is characterized by enlargement of the prostate gland as men 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 symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms as early as 1–2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Krka

Do not take Tadalafil Krka

if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). It has been shown that tadalafil increases the effects of these medicines. If you are

taking any form of nitrates or are unsure, inform your doctor.

if you have a severe heart disease or have recently had a heart attack within the last 3 months.
if you have recently had a stroke within the last 6 months.
if you have low blood pressure or uncontrolled high blood pressure.
if in the past you have experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
if you are taking riociguat. This medicine is used for the treatment of pulmonary arterial hypertension (e.g. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (e.g. high blood pressure in the lungs following blood clots). PDE5 inhibitors, such as Tadalafil Krka, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tadalafil Krka.
Be aware that sexual activity involves a potential risk for patients with heart disease,
because it puts additional strain on the heart. If you have a heart condition, inform your doctor.
Since benign prostatic syndrome and prostate cancer can cause the same symptoms, your doctor
will check whether you have prostate cancer before starting treatment with Tadalafil Krka for benign
prostatic hyperplasia. Tadalafil Krka does not treat prostate cancer.
Before taking the tablets, inform your doctor if you have:

sickle cell anemia (an abnormality of red blood cells)
multiple myeloma (a tumor of the bone marrow)
leukemia (a tumor of blood cells)
any deformity of the penis
a serious liver problem
a serious kidney problem. It is not known whether Tadalafil Krka is effective in patients who have had:
pelvic surgery
removal of all or part of the prostate gland with nerves to the prostate cut (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Krka and
contact your doctor immediately.
In some patients treated with tadalafil, reduced or sudden hearing impairment 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 Krka and contact your doctor immediately.
Tadalafil Krka 5 mg is not intended for use in women.
Children and adolescents
Tadalafil Krka is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Krka
Inform your doctor if you are using, have recently used, or might use any other medicines.
DO NOT take Tadalafil Krka if you are already taking other nitrates.
Some medicines may be affected by Tadalafil Krka or may affect how Tadalafil Krka works. Inform your doctor or pharmacist if you are already taking:

an alpha-blocker (used for the treatment of high blood pressure or urinary symptoms associated

with benign prostatic hyperplasia).

other medicines used for the treatment of high blood pressure.
riociguat (for the treatment of certain forms of pulmonary hypertension).
a 5-alpha reductase inhibitor (for the treatment of benign prostatic hyperplasia).
protease inhibitors for the treatment of AIDS or HIV infections (e.g. ritonavir).
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin (for the treatment of bacterial infections).
medicines such as ketoconazole or itraconazole (for treating fungal infections).
other treatments for erectile dysfunction.

Tadalafil Krka with food, beverages and alcohol
Information on the effects of alcohol is included in section 3.
Grapefruit juice may affect how Tadalafil Krka works and should be consumed with caution. Consult your
doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed.
Reduced sperm count has been observed in some men. These effects are unlikely to lead to
impaired fertility.
Driving and using machines
Some men taking tadalafil have reported dizziness in clinical studies.
Carefully assess how you react to the medicine before driving or using machines.
Tadalafil Krka contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Tadalafil Krka

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Tadalafil Krka 5 mg tablets are for oral use only in men. Swallow the tablet whole with water. The tablets can be taken with or without food.
Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Krka, 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 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 Krka. This may be given as a 2.5 mg tablet. Alternatively, the 2.5 mg dose may be obtained by splitting the 5 mg tablet into two equal parts.
Do not take Tadalafil Krka more than once a day.
When taken once daily, Tadalafil Krka allows you to achieve an erection when sexually stimulated, at any time during the 24-hour period. Daily dosing of Tadalafil Krka may be suitable for men who anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil Krka will not work without sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection.

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.
Do not take Tadalafil Krka more than once a day.

If you take more Tadalafil than you should
Contact your doctor. You may experience some of the side effects listed in section 4.

If you forget to take Tadalafil Krka
Take the 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 Krka more than once a day.

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

4. Possible side effects

allergic reactions including 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 Krka (rare frequency). If you experience an erection lasting continuously for more than 4 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, arm and leg pain, facial flushing, nasal congestion, and indigestion. Uncommon (may affect up to 1 in 100 people):
dizziness, stomach ache, reflux, feeling unwell, feeling sick (vomiting), blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleed, ringing in the ears, swelling of the hands, feet and ankles, feeling tired. Rare (may affect up to 1 in 1000 people):
fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (itchy red patches on the skin), increased sweating, bleeding from the penis, and blood in semen.

Heart attacks and strokes have been rarely reported in men taking tadalafil. Most of these men had known heart problems before taking this medicine.
A partial, temporary or permanent decrease or loss of vision in one or both eyes has also been rarely reported.
Some additional rare side effects have been reported in men taking tadalafil that were not observed during clinical studies. These include:

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

The adverse reaction 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Tadalafil Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. 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 Krka contains

The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
The other components are: hypromellose phthalate, mannitol, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E470b) in the tablet core; lactose monohydrate, hypromellose, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), triacetin (E1518) in the coating. See section 2 “Tadalafil Krka contains lactose and sodium”.

Description of the appearance of Tadalafil Krka and contents of the pack
Tadalafil Krka 5 mg film-coated tablets (tablets): light yellow, oval, biconvex, film-coated tablets, engraved on one side and marked with "5" on the other side. The tablet can be divided into equal doses. Tablet size: approximately 9 mm in length and 6 mm in width.
Tadalafil Krka 2.5 mg is available in boxes containing 2, 4, 8, 12, 14, 28, 56 and 84 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy
This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country	Product Name
Slovenia, Austria, Belgium, Denmark, Spain, Finland, France, Ireland, Iceland, Italy, Norway, Portugal, Sweden, United Kingdom	Tadalafil Krka
Spain	Tadalafil Krka

This leaflet was last reviewed on
More detailed information about this medicine is available on the AIFA website www.aifa.gov.it.

Patient Information Leaflet: Information for the patient

Tadalafil Krka 10 mg film-coated tablets

tadalafil
Generic medicine
Please 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 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tadalafil Krka contains the active substance tadalafil, which belongs to a class of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Krka 10 mg is a treatment for adult men with erectile dysfunction. This condition occurs when a
man is unable to achieve or maintain an erection suitable for sexual activity.
Tadalafil has been shown to significantly improve the ability to achieve a penile erection suitable for
sexual activity.
Following sexual stimulation, Tadalafil Krka works by helping the blood vessels in the penis to relax, thus
allowing blood to flow into the penis. The result is an improvement in erectile function. Tadalafil will not
help you if you do not have erectile dysfunction.
It is important to emphasize that Tadalafil Krka does not work without sexual stimulation. You and your
partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile
dysfunction.

2. What you need to know before taking Tadalafil Krka

Do not take Tadalafil Krka

if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris ("chest pain"). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrates or are unsure, inform your doctor.
if you have a severe heart disease or have recently had a heart attack within the last 3 months.
if you have recently had a stroke within the last 6 months.
if you have low blood pressure or uncontrolled high blood pressure.
if in the past you have experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
if you are taking riociguat. This medicine is used for the treatment of pulmonary arterial hypertension (e.g. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (e.g. high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as Tadalafil Krka, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, inform your doctor.

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

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

pelvic surgery
removal of all or part of the prostate gland where the nerves of the prostate (radical prostatectomy) were severed without preservation of the neurovascular bundles.

If you experience a sudden decrease or loss of vision, stop taking Tadalafil Krka and
contact your doctor immediately.
In some patients treated with tadalafil, reduced or sudden hearing impairment
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 Krka and contact
your doctor immediately.
Tadalafil Krka 10 mg is not intended for use in women.
Children and adolescents
Tadalafil Krka is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Krka
Inform your doctor or pharmacist if you are using, have recently used, or might use any other
medicines.
DO NOT take Tadalafil Krka if you are already taking other nitrates.
Some medicines may be affected by Tadalafil Krka or may affect how
Tadalafil Krka works. Inform your doctor or pharmacist if you are already taking:

an alpha-blocker (used for the treatment of high blood pressure or for urinary symptoms associated with benign prostatic hyperplasia).
other medicines used to treat high blood pressure.
riociguat (for the treatment of certain forms of pulmonary hypertension).
a 5-alpha reductase inhibitor (for the treatment of benign prostatic hyperplasia).
protease inhibitors for the treatment of AIDS or HIV infections (e.g. ritonavir).
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin (for the treatment of bacterial infections).
medicines such as ketoconazole or itraconazolo (to treat fungal infections).
other treatments for erectile dysfunction.

Tadalafil Krka with food and alcohol
Information on the effects of alcohol is included in section 3.
Grapefruit juice may affect how Tadalafil Krka works and should be consumed with caution. Consult your doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed.
A reduction in sperm count has been observed in some men. It is unlikely that these effects may lead to
infertility.
Driving and using machines
Some men taking tadalafil have reported dizziness in clinical studies.
Carefully assess how you react to the medicine before driving or using machines.
Tadalafil Krka contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Tadalafil Krka

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
Tadalafil Krka 10 mg tablets are for oral use and only for men. Swallow the tablet whole with water. The tablets can be taken with or without food.
The recommended starting dose is one 10 mg tablet before sexual activity.
However, you may take a 20 mg tablet if your doctor has decided that the recommended 10 mg dose is not sufficient. Tadalafil Krka tablets are for oral use.
You should take Tadalafil Krka at least 30 minutes before sexual activity.
Tadalafil Krka may be effective for up to 36 hours after taking the tablet.
Do not take Tadalafil Krka more than once a day. Tadalafil Krka 10 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Krka will not work without sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection and can temporarily lower blood pressure. If you have taken or plan to take Tadalafil Krka, 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 than you should
Inform your doctor. You may experience some of the side effects listed in section 4.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 help:

allergic reactions including 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 Krka (rare frequency). If you experience such an erection lasting continuously for more than 4 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 indigestion.

Uncommon (may affect up to 1 in 100 people):

dizziness, stomach discomfort, reflux, feeling unwell, feeling sick (nausea), blurred vision, eye pain, breathing difficulties, blood in urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet and ankles, 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, urticaria (red, itchy patches on the skin), increased sweating, bleeding from the penis and presence of blood in semen. Heart attacks and strokes have been rarely reported in men taking tadalafil. Most of these men had known heart problems before taking this medicine.

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

The adverse reaction 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 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Krka

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 pack 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 Krka contains

The active substance is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
The other components are: hypromellose phthalate, mannitol, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate (E470b) in the tablet core; lactose monohydrate, hypromellose, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172) and triacetin (E1518) in the coating. See section 2 “Tadalafil Krka contains lactose and sodium”.

Description of the appearance of Tadalafil Krka and package contents
Tadalafil Krka 10 mg film-coated tablets (tablets): yellow, oval, biconvex film-coated tablets with the symbol 10 on one side. Tablet size: approximately 12 mm in length and 7.5 mm in width.
Tadalafil Krka is available in cardboard boxes containing 2, 4, 8, 12, 14, 28, 56 and 84 film-coated tablets in blisters.
Not all pack sizes may be marketed.

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

Member State Name	Product Name
Slovenia, Austria, Belgium, Denmark, Finland, France, Ireland, Iceland, Italy, Norway, Portugal, Sweden, United Kingdom	Tadalafil Krka
Spain	Tadalafil Krka

This leaflet was last reviewed on
More detailed information on this medicinal product is available on the AIFA website www.aifa.gov.it.

Patient information leaflet: information for the patient

Tadalafil Krka 20 mg film-coated tablets

tadalafil
Generic medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Tadalafil Krka is used for the treatment of adult men with erectile dysfunction. This condition
occurs when a man cannot achieve or maintain an erection suitable for sexual activity.
Tadalafil has been shown to significantly improve the ability to obtain a penile erection suitable
for sexual activity.
Tadalafil Krka contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation, Tadalafil Krka works by helping
the blood vessels in the penis relax, allowing blood flow into the penis. The result is improved
erectile function. Tadalafil will not help you if you do not have erectile dysfunction.
It is important to emphasize that Tadalafil Krka does not work without sexual stimulation. You and your
partner will need to engage in foreplay, just as if you were not taking a medicine for erectile
dysfunction.

2. What you need to know before taking Tadalafil Krka

Do not take Tadalafil Krka

if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
if you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrates or are unsure, inform your doctor.
if you have a severe heart disease or have recently had a heart attack within the last 90 days.
if you have recently had a stroke within the last 6 months.
if you have low blood pressure or uncontrolled blood pressure.
if you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (e.g. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (e.g. high pressure in the lungs following blood clots). PDE5 inhibitors,
such as Tadalafil Krka, have been shown to increase the hypotensive effect of this
medicine. If you are taking riociguat or are unsure, inform your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tadalafil Krka.
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, you must 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 tumor of the bone marrow)
leukemia (a tumor of blood cells)
any deformity of the penis
severe liver problems
severe kidney problems.

It is not known whether Tadalafil Krka 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 Krka and
contact your doctor immediately.
In some patients treated with tadalafil, reduced or sudden hearing impairment 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 Krka and contact
your doctor immediately.
Tadalafil Krka is not intended for use in women.
Children and adolescents
Tadalafil Krka is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Krka
Inform your doctor if you are using, have recently used, or might use any other medicines.
DO NOT take Tadalafil Krka if you are already taking other nitrates.
Some medicines may be affected by Tadalafil Krka or may affect how Tadalafil Krka works. Inform your doctor or pharmacist if you are already taking:

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

Tadalafil Krka with food and alcohol
Information on the effects of alcohol consumption is provided in section 3.
Grapefruit juice may affect how Tadalafil Krka works and should be consumed with caution.
Consult your doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. A reduction
in sperm count has been observed in some men. It is unlikely that these effects could lead to
infertility.
Driving and use of machines
In clinical studies, some men taking tadalafil reported dizziness.
Carefully assess how you react to the medicine before driving or operating machinery.
Tadalafil Krka contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Tadalafil Krka

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Tadalafil Krka tablets are for oral use in men only. Swallow the tablet whole with water.
The tablets may be taken with or without food.
The recommended starting dose is 10 mg prior to anticipated sexual activity. This dose can be administered either as one 10 mg tablet or by dividing a 20 mg tablet into two equal doses.
However, if your doctor decides that the recommended dose of 10 mg is insufficient, you will be given a dose of one 20 mg tablet.
You must take Tadalafil Krka at least 30 minutes before sexual activity.
Tadalafil Krka may be effective for more than 36 hours after taking the tablet.
Do not take Tadalafil Krka more than once a day.
Tadalafil Krka 10 mg and 20 mg are indicated for use prior to anticipated sexual activity and are not
recommended for continuous daily use.
It is important to note that Tadalafil Krka will not work without sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Krka, 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 than you should
Inform your doctor. You may experience side effects described in section 4.
If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

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

allergic reactions including rash (uncommon frequency).
chest pain – do not take nitrates, but seek immediate medical help (uncommon frequency).
priapism, a prolonged and possibly painful erection after taking Tadalafil Krka (rare frequency). If such an erection occurs and lasts continuously for more than 4 hours, 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, arm and leg pain, facial flushing, nasal congestion, and indigestion.

Uncommon (may affect up to 1 in 100 people):

dizziness, stomach ache, acid reflux, feeling unwell, feeling sick (vomiting), blurred vision, eye pain, breathing difficulty, blood in urine, prolonged erection, palpitations, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the hands, feet and ankles, 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, hives (itchy, pink, raised patches on the skin), increased sweating, bleeding from the penis and blood in semen. Heart attacks and strokes have been rarely reported in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medicine.

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

The adverse reaction 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 Krka contains

The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
The other ingredients are: hypromellose phthalate, mannitol, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate (E470b) in the tablet core; monohydrate lactose, hypromellose, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), triacetin (E1518) in the coating. See section 2 “Tadalafil Krka contains lactose and sodium”.

Description of the appearance of Tadalafil Krka and contents of the pack
Tadalafil Krka 20 mg film-coated tablets (tablets) are: yellow-brown, oval, biconvex, film-coated tablets, engraved on one side and marked "20" on the other side. The tablet can be divided into equal doses. Tablet size: approximately 14 mm in length and 9.5 mm in width.
Tadalafil Krka is available in cardboard boxes containing 2, 4, 8, 12, 14, 24, 28, 56 and 84 film-coated tablets in blisters.
Not all pack sizes may be marketed.

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

Member State Name	Product Name
Slovenia, Austria, Belgium, Denmark, Finland, France, Ireland, Iceland, Italy, Norway, Portugal, Sweden, United Kingdom	Tadalafil Krka
Spain	Tadalafil Krka

This leaflet was last reviewed on
More detailed information on this medicine is available on the AIFA website www.aifa.gov.it.