Tadalafil Lilly

Patient Information Leaflet: Information for the User

Tadalafil Lilly 2.5 mg Film-coated Tablets

tadalafil
Read this entire 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 adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

2. What you need to know before taking Tadalafil Lilly

Do not take Tadalafil Lilly if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donor, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Tadalafil Lilly has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• you have severe heart disease or have had a heart attack within the last 90 days.
• you have had a stroke within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "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). Phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Lilly.
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 malignant tumor of the bone marrow).
• leukemia (a malignant tumor of blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

It is not known whether Tadalafil Lilly 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 (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Lilly, stop taking Tadalafil Lilly and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether the event is directly related to tadalafil, if you experience sudden reduction or loss of hearing, stop taking Tadalafil Lilly and contact your doctor immediately.
Tadalafil Lilly is not intended for use by women.
Children and adolescents
Tadalafil Lilly is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Lilly
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Lilly if you are already taking nitrates.
Some medicines may be affected by Tadalafil Lilly or may themselves affect how Tadalafil Lilly works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary problems caused by a condition in which the prostate gland in men becomes enlarged).
• other medicines for treating high blood pressure.
• riociguat.
• a 5-alpha-reductase enzyme inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole or itraconazole (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
• erythromycin or clarithromycin (antibiotics for treating bacterial infections).
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines).
• rifampicin (an antibiotic for treating mycobacterial infections).
• other treatments for erectile dysfunction.

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

3. How to take Tadalafil Lilly

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Lilly 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 at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Lilly. This dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Lilly more than once a day.
Daily administration of Tadalafil Lilly may be beneficial for men who anticipate having sexual activity two or more times per week.
When taken once daily, Tadalafil Lilly allows you to achieve an erection if there is sexual stimulation, at any time of day within a 24-hour period. It is important to note that Tadalafil Lilly does not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a drop in blood pressure. If you have taken or plan to take Tadalafil Lilly, 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 Lilly than you should
Contact your doctor. You may experience side effects described in section 4.
If you forget to take Tadalafil Lilly
Take your dose as soon as you remember, but do not take a double dose to make up for the missed tablet. Do not take Tadalafil Lilly more than once a day.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop taking 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 Lilly (rare frequency). If you have an erection of this type lasting more than 4 consecutive hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency), distorted, blurred, fuzzy central vision, or sudden decrease in vision (frequency not known).

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

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

Uncommon (may affect up to 1 in 100 people)

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

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), bleeding from the penis, blood in semen, and increased sweating.

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

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• distorted, blurred, fuzzy central vision or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Lilly. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Lilly.
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 through the national reporting system listed in Annex V.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Tadalafil Lilly

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Do not store above 30°C.
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 Lilly contains

• The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• The other components are: Tablet core: Monohydrate lactose, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. See section 2 “Tadalafil Lilly contains lactose”.

Film coating: Monohydrate lactose, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc.
Description of the appearance of Tadalafil Lilly and pack contents
Tadalafil Lilly 2.5 mg is a film-coated tablet, light yellow-orange in colour, almond-shaped, with “C 2 ½” engraved on one side. The tablet measures 8.58 mm by 5.23 mm.
Tadalafil Lilly 2.5 mg is available in blisters in packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600
България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A/N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0) 2 548 84 84
Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100
Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500
Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800
Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S
Tel: + 372 6 817 280 Tlf: + 47 22 88 18 00
Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε Eli Lilly Ges.m.b.H
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780
España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: +34-91 663 50 00 Tel: +48 22 440 33 00
France Portugal
Lilly France Lilly Portugal - Produtos Farmacêuticos, Lda
Tél: +33-(0)1 55 49 34 34 Tel: + 351 21 4126600
Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000
Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10
Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 220 663 111
Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39-055 42571 Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46- (0) 8 7378800
Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: Eli Lilly and Company (Ireland) Limited

• 371 67364000 Tel: +353-(0) 1 661 4377
  More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Package leaflet: Information for the user

Tadalafil Lilly 5 mg film-coated tablets

tadalafil
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 other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• Erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Lilly has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse. After sexual stimulation, Tadalafil Lilly helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil Lilly will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Lilly for the treatment of erectile dysfunction has no effect without sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.
• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This condition occurs when the prostate enlarges with age. Symptoms include difficulty starting urination, a sensation of not completely emptying the bladder, and a more frequent need to urinate, including during the night. Tadalafil Lilly improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce symptoms associated with benign prostatic hyperplasia. Tadalafil Lilly has been shown to improve these urinary symptoms within 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Lilly

Do not take Tadalafil Lilly if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).

• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). It has been shown that Tadalafil Lilly increases the effect of these medicines.
  If you are taking any form of nitrate or have any doubts, inform your doctor.

• you have a severe heart disease or have recently had a heart attack (within the last 90 days).

• you have recently had a stroke (within the last 6 months).

• you have low blood pressure or uncontrolled high blood pressure.

• you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".

• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). Phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Lilly.
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.
Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Tadalafil Lilly for benign prostatic hyperplasia. Tadalafil Lilly 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 malignant tumor of the bone marrow).
• leukemia (a malignant tumor of blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

It is not known whether Tadalafil Lilly 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 severed (radical prostatectomy without preservation of neurovascular bundles).

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Lilly, stop taking Tadalafil Lilly and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether this event is directly related to tadalafil, if you experience sudden reduction or loss of hearing, stop taking Tadalafil Lilly and contact your doctor immediately.
Tadalafil Lilly is not intended for use by women.
Children and adolescents
Tadalafil Lilly is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Lilly
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Lilly if you are already taking nitrates.
Some medicines may be affected by Tadalafil Lilly, or they may affect how Tadalafil Lilly works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary problems caused by a condition in which the prostate gland in men becomes enlarged).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha-reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole or itraconazole (for treating fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• erythromycin or clarithromycin (antibiotics for treating bacterial infections).
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines).
• rifampicin (an antibiotic for treating mycobacterial infections).
• other treatments for erectile dysfunction.

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

3. How to take Tadalafil Lilly

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Tadalafil Lilly tablets are for oral use and are intended only for men. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
Drinking alcohol may temporarily cause a reduction in your blood pressure. If you have taken or are planning to take Tadalafil Lilly, 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 Lilly. This dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Lilly more than once a day.
When taken once daily, Tadalafil Lilly enables you to achieve an erection, provided there is sexual stimulation, at any time during the 24-hour period. Taking Tadalafil Lilly once daily may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that Tadalafil Lilly does not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve 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 Lilly more than once a day.

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

If you forget to take Tadalafil Lilly
Take your dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. You must not take Tadalafil Lilly 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 gets them. These side effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop taking the medicine and
seek immediate medical help:

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

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

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

Uncommon (may affect up to 1 in 100 people)

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

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), bleeding from the penis, blood in semen, and increased sweating.

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

Some additional rare side effects not observed during clinical studies have been reported in men taking Tadalafil Lilly. These include:

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, serious skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• distorted, blurred, hazy central vision or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Lilly. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Lilly.

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 listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Lilly

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Do not store above 25°C.
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 Lilly contains

• The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other components are: Tablet core: Monohydrate lactose, sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. See section 2 "Tadalafil Lilly contains lactose".

Film coating: Monohydrate lactose, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), talc.
Description of the appearance of Tadalafil Lilly and contents of the pack
Tadalafil Lilly 5 mg is a film-coated tablet, light yellow in colour, almond-shaped, with "C 5" engraved on one side. The tablet measures 9.59 mm by 5.85 mm.
Tadalafil Lilly 5 mg is available in blisters in pack sizes of 14, 28 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600
България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0) 2 548 84 84
Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100
Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500
Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800
Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S
Tel: + 372 6 817 280 Tlf: + 47 22 88 18 00
Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε Eli Lilly Ges.m.b.H
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780
España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 5000 Tel: +48 22 440 33 00
France Portugal
Lilly France Lilly Portugal - Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351 21 4126600
Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000
Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10
Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 220 663 111
Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39-055 42571 Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800
Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: Eli Lilly and Company (Ireland) Limited

• 371 67364000 Tel: +353-(0) 1 661 4377
  More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

Package leaflet: Information for the user

Tadalafil Lilly 10 mg film-coated tablets

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

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

Contents of this leaflet:

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

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

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

2. What you need to know before taking Tadalafil Lilly

Do not take Tadalafil Lilly if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Tadalafil Lilly has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• you have a serious heart condition or have recently had a heart attack (within the last 90 days).
• you have recently had a stroke (within the last 6 months).
• you have low blood pressure or uncontrolled high blood pressure.
• you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs due to blood clots). Phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

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

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

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

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

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Lilly, stop taking Tadalafil Lilly and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking Tadalafil Lilly and contact your doctor immediately.
Tadalafil Lilly is not intended for use by women.
Children and adolescents
Tadalafil Lilly is not intended for use in children or adolescents under 18 years of age.
Other medicines and Tadalafil Lilly
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Lilly if you are already taking nitrates.
Some medicines may be affected by Tadalafil Lilly or may affect how Tadalafil Lilly works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary problems caused by an enlarged prostate gland in men).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha-reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole or itraconazole (for treating fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• erythromycin or clarithromycin (antibiotics for treating bacterial infections).
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines).
• rifampicin (an antibiotic for treating mycobacterial infections).
• other treatments for erectile dysfunction.

Tadalafil Lilly with food, beverages and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Tadalafil Lilly 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. In some men, reduced sperm count has been observed. It is unlikely that these effects would cause infertility.
Driving and using machines
Some men taking Tadalafil Lilly in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Lilly contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Tadalafil Lilly contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Tadalafil Lilly

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Tadalafil Lilly tablets are for oral use and only for men. Swallow the tablet whole with water. Tadalafil Lilly tablets can be taken regardless of food intake.
The recommended dose is one 10 mg tablet taken before sexual activity. If this dose does not provide sufficient effect, your doctor may increase the dose to 20 mg. Tadalafil Lilly tablets are for oral use.
You may take the Tadalafil Lilly tablet at least 30 minutes before sexual activity.
Tadalafil Lilly may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Lilly more than once a day. Tadalafil Lilly 10 mg and 20 mg is intended to be used prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Lilly will not work without 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 blood pressure. If you have taken or plan to take Tadalafil Lilly, 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 Lilly than you should:
Contact 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 everyone gets them. These side effects are usually mild to moderate in intensity.
If you experience any of the following side effects, stop taking the medicine and
seek immediate medical help:

• allergic reactions, including skin 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 Lilly (rare frequency). If you have an erection of this type lasting for more than 4 consecutive hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency), distorted central vision, blurred or hazy vision, or sudden decrease in vision (frequency not known).

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

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

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach ache, nausea, vomiting, reflux, blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, palpitations, 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, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy patches on the skin), bleeding from the penis, blood in semen, and increased sweating.

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

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• distorted central vision, blurred, hazy vision, or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Lilly. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Lilly.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Lilly

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Do not store above 30°C.
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 Lilly contains

• The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other components are: Tablet core: Monohydrate lactose, sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. See section 2 “Tadalafil Lilly contains lactose”.

Film coating: Monohydrate lactose, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), talc.
Description of the appearance of Tadalafil Lilly and pack contents
Tadalafil Lilly 10 mg is a film-coated tablet, light yellow in colour, almond-shaped, with “C 10” engraved on one side. The tablet measures 10.81 mm by 6.59 mm.
Tadalafil Lilly 10 mg is available in blisters containing 4 tablets per pack.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600
България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0) 2 548 84 84
Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100
Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500
Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800
Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S
Tel: + 372 6 817 280 Tlf: + 47 22 88 18 00
Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε Eli Lilly Ges.m.b.H
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780
España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel +48 22 440 33 00
France Portugal
Lilly France Lilly Portugal - Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351 21 4126600
Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000
Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10
Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 220 663 111
Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39-055 42571 Puh/Tel: + 358-(0) 9 85 45 250
Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 737 88 00
Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā Tel: Eli Lilly and Company (Ireland) Limited

• 371 67364000 Tel: +353-(0) 1 661 4377
  More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Package leaflet: information for the user

Tadalafil Lilly 20 mg film-coated tablets

tadalafil
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, 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:

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

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

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

2. What you need to know before taking Tadalafil Lilly

Do not take Tadalafil Lilly if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (or “chest pain”). Tadalafil Lilly has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• you have a severe heart disease or have recently had a heart attack (within the last 90 days).
• you have recently had a stroke (within the last 6 months).
• you have low blood pressure or uncontrolled high blood pressure.
• you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). Phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor before taking Tadalafil Lilly.
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 any heart condition, inform your doctor.
Before taking the tablets, inform your doctor if you have:

• sickle cell anaemia (an abnormality of red blood cells).
• multiple myeloma (a malignant tumour of the bone marrow).
• leukaemia (a malignant tumour of blood cells).
• any deformity of the penis.
• severe liver problems.
• severe kidney problems.

It is not known whether Tadalafil Lilly 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 severed (non-nerve-sparing radical prostatectomy).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Lilly, stop taking Tadalafil Lilly and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed. Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking Tadalafil Lilly and contact your doctor immediately.
Tadalafil Lilly is not intended for use by women.
Children and adolescents
Tadalafil Lilly is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Lilly
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Lilly if you are already taking nitrates.
Some medicines may be affected by Tadalafil Lilly or may affect how Tadalafil Lilly works. Inform your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary problems due to an enlarged prostate gland in men).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha-reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole or itraconazole (for treating fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• erythromycin or clarithromycin (antibiotics for treating bacterial infections).
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines).
• rifampicin (an antibiotic for treating mycobacterial infections).
• other treatments for erectile dysfunction.

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

3. How to take Tadalafil Lilly

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Tadalafil Lilly 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 10 mg tablet taken before sexual activity. However, your doctor has prescribed you a dose of one 20 mg tablet because he has decided that the recommended 10 mg dose is too low for you.
You may take Tadalafil Lilly at least 30 minutes before sexual activity.
Tadalafil Lilly may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Lilly more than once a day. Tadalafil Lilly 10 mg and 20 mg is intended to be used prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Lilly will not work without 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 lowering of your blood pressure. If you have taken or plan to take Tadalafil Lilly, 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 Lilly than you should:
Contact your doctor. You may experience the side effects described in section 4.
If you have any doubts about how to use this medicine, talk to 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 severity.
If you experience any of the following side effects, stop taking 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 Lilly (rare frequency). If you have an erection of this type lasting for more than 4 consecutive hours, you must contact a doctor immediately.
• sudden loss of vision (rare frequency), distorted central vision, blurred or sudden decrease in vision (frequency not known).

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

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

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

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, certain disorders affecting blood circulation to the eyes, irregular heartbeat, angina, and sudden cardiac death.
• distorted central vision, blurred, hazy vision or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Lilly. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Lilly.
Reporting of side effects
If you experience any side effects, 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 listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Lilly

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Do not store above 30°C.
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 Lilly contains

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other components are:
  Tablet core: Monohydrate lactose, sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. See section 2 “Tadalafil Lilly contains lactose”.

Film coating: Monohydrate lactose, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), talc.

Description of the appearance of Tadalafil Lilly and pack contents
Tadalafil Lilly 20 mg is a yellow, film-coated tablet shaped like an almond, imprinted with “C 20” on one side. The tablet measures 12.09 mm by 7.37 mm.
Tadalafil Lilly 20 mg is available in blisters containing 2, 4, 8, or 12 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
TP "Eli Lilly Nederland" B.V. - Bulgaria Eli Lilly Benelux S.A./N.V.
tel. + 359 2 491 41 40 Tél/Tel: + 32-(0) 2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S
Tel: + 372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
FARMASERV-LILLY S.A. Eli Lilly Ges.m.b.H
Tel: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal - Produtos Farmacêuticos, Lda
Tél: +33-(0)1 55 49 34 34 Tel: + 351 21 4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39-055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Tel: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A. Representative Office in Latvia Tel: +371 67364000 Eli Lilly and Company (Ireland) Limited Tel: +353-(0) 1 661 4377

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION

Scientific conclusions
Taking into account the assessment by the Pharmacovigilance Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for tadalafil, the scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) are as follows:
In light of available data on central serous retinopathy from the literature and spontaneous reports, including in some cases a close temporal relationship, a dechallenge and/or a positive rechallenge, and in view of a plausible mechanism of action, the PRAC considers that a causal relationship between tadalafil and central serous retinopathy is at least a reasonable possibility.
The PRAC concluded that the product information for medicinal products containing tadalafil should be updated accordingly.
The CHMP agrees with the scientific conclusions of the PRAC.

Grounds for the variation to the terms of the marketing authorisation
Based on the scientific conclusions regarding tadalafil, the CHMP considers that the benefit-risk balance of medicinal products containing tadalafil remains unchanged, subject to the proposed amendments to the product information.
The CHMP recommends a variation to the terms of the marketing authorisation.