TADALAFIL 2.5 мг Фильм-coated таблетки

Содержание инструкции

1. Tadalafil Lilly 2,5 mg film-coated tablets
   1. What is Tadalafil Lilly and what is it 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. Package contents and other information
2. Tadalafil Lilly 5 mg film-coated tablets
   1. What is Tadalafil Lilly and what is it 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. Package contents and other information
3. Tadalafil Lilly 10 mg film-coated tablets
   1. What is Tadalafil Lilly 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. Package contents and other information
4. Tadalafil Lilly 20 mg film-coated tablets
   1. What is Tadalafil Lilly 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. Package contents and other information

Tadalafil Lilly 2,5 mg film-coated tablets

tadalafil

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of this leaflet:

• 1. What Tadalafil Lilly is and what it is used for
• 2. What you need to know before you take 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 is Tadalafil Lilly and what is it 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 adequate for sexual intercourse. Tadalafil Lilly has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse.
Tadalafil Lilly contains the active ingredient tadalafil, which belongs to the class of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Lilly helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result is improved erectile function. Tadalafil Lilly will not be helpful if you do not have erectile dysfunction.
It is important to note that Tadalafil Lilly will not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking medication for erectile dysfunction.

2. What you need to know before taking Tadalafil Lilly

Do not take Tadalafil Lilly if:

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

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

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 of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

Children and adolescents
Tadalafil Lilly is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Tadalafil Lilly
Tell 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 can be affected by Tadalafil Lilly or they themselves can affect how Tadalafil Lilly works. Tell your doctor or pharmacist if you are already taking:

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

Tadalafil Lilly with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect how Tadalafil Lilly works and should be taken with caution. Ask your doctor for further information.

Fertility
In dogs treated with the drug, a reduction in sperm development in the testes was observed. A decrease in sperm has been observed in some men. These effects are unlikely to cause infertility.

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

Tadalafil Lilly contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Tadalafil Lilly tablets are for oral use and only for men. Swallow the tablet
whole with water. The tablets can be taken independently of food intake.

The recommended doseis one 5 mg tablet to be taken once a day at approximately the
same time of day. Your doctor may adjust the dose to 2.5 mg based on your response to
Tadalafil Lilly. This dose will be given to you with a 2.5 mg tablet.
Do not take Tadalafil Lilly more than once a day.
Daily administration of Tadalafil Lilly may be useful for men who plan to
have sexual activity two or more times a week.
When taken once a day, Tadalafil Lilly allows you to achieve an erection, if there is
sexual stimulation, at any time of the day within 24 hours. It is important to note
that Tadalafil Lilly does not work if there is no sexual stimulation. You and your partner will need to
engage in foreplay as you would if you were not taking a medicine for erectile
dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend
to take Tadalafil Lilly, avoid excessive alcohol consumption (blood alcohol level of
0.08% or higher) as this may increase the risk of dizziness when you
stand up.

If you take more Tadalafil Lilly than you should
Contact your doctor. Undesirable effects described in paragraph 4 may occur.

If you forget to take Tadalafil Lilly
Take your dose as soon as you remember but do not take a double dose to compensate for
the missed tablet. You must not take Tadalafil Lilly more than once a day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These effects are normally mild to moderate in severity.

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

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

Other side effects have been reported:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in the arms and legs, flushing of the face, nasal congestion, and digestive disorders.

Uncommon(may affect up to 1 in 100 people)

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

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

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

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

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

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and blister after
Expiry./EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture. Do not store at a
temperature higher than 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Lilly contains

• The activesubstance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• The other ingredientsare: Tablet core: Lactose monohydrate, Sodium croscarmellose, Hydroxypropylcellulose, Microcrystalline cellulose, Sodium lauryl sulfate, Magnesium stearate. See paragraph 2 “Tadalafil Lilly contains lactose”.

Film coating: Lactose monohydrate, Hypromellose, Triacetin, Titanium dioxide
(E171), Yellow iron oxide (E172), Red iron oxide (E172), Talc.

Description of the appearance of Tadalafil Lilly and package contents
Tadalafil Lilly 2.5 mg is a film-coated tablet with a light yellow-orange color in the shape
of an almond and has “C 2 ½” imprinted on one side. The tablet is 8.58 mm by 5.23 mm.
Tadalafil Lilly 2.5 mg is available in blisters in packs of 28 tablets.

Marketing authorization holder and manufacturer
Marketing authorization 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, contact the local representative of the marketing
authorization holder.

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

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - Bulgaria
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A/N.V.
Tél/Tel: + 32-(0) 2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S
Tlf: + 47 22 88 18 00

Ελλάδα
PHARMASERV-LILLY A.E.B.E
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: +34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0)1 55 49 34 34

Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351 21 4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39-055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46- (0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel:

+371 67364000

United Kingdom (Northern Ireland)
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

Tadalafil Lilly 5 mg film-coated tablets

tadalafil

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of this leaflet:

• 1. What Tadalafil Lilly is and what it is used for
• 2. What you need to know before you take 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 is Tadalafil Lilly and what is it used for

Tadalafil Lilly contains the active ingredient tadalafil which belongs to the 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 cannot achieve or maintain an erection adequate for sexual intercourse. Tadalafil Lilly has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse. After sexual stimulation Tadalafil Lilly helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result of this is improved erectile function. Tadalafil Lilly will not be helpful if you do not have erectile dysfunction. It is important to note that Tadalafil Lilly for the treatment of erectile dysfunction has no effect if there is no sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking medication for erectile dysfunction.
• urinary symptoms associated with a common condition called benign prostatic hyperplasia.This condition occurs when the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, a feeling of not emptying the bladder completely, and a more frequent need to urinate, even during the night. Tadalafil Lilly improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms associated with benign prostatic hyperplasia. Tadalafil Lilly has been shown to improve these urinary symptoms within 1-2 weeks of starting treatment.

2. What you need to know before taking Tadalafil Lilly

Do not take Tadalafil Lilly if:

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (or

“chest pain”). 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, tell your doctor.

• you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• you have had a stroke recently, within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). It has been shown that phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, increase the hypotensive effect of this drug. If you are taking riociguat or have any doubts, tell 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 a heart
condition, because it puts extra strain on the heart. If you have a heart problem, tell your
doctor.
Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, the
doctor will perform checks for prostate cancer before starting treatment with
Tadalafil Lilly for benign prostatic hyperplasia. Tadalafil Lilly does not cure prostate cancer.
Before taking the tablets, tell your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (a cancerous tumor of the bone marrow).
• leukemia (a cancerous tumor of 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 of the prostate have been cut (radical prostatectomy without nerve-sparing).

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

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

Other medicines and Tadalafil Lilly
Tell 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 can be affected by Tadalafil Lilly or they themselves can affect the
way Tadalafil Lilly works. Tell your doctor or pharmacist if you are already taking:

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

Tadalafil Lilly with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can
affect the way Tadalafil Lilly works and should be taken with caution. Ask your
doctor for further information.

Fertility
In dogs treated, a reduction in sperm development in the testicles was observed. A decrease in sperm has been observed in some
men. These effects are unlikely to cause
infertility.

Driving and using machines
Some men who were taking Tadalafil Lilly during clinical studies reported dizziness.
Carefully check how you react to the tablets before driving or using machines.

Tadalafil Lilly contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your
doctor 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 following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Tadalafil Lilly tablets are for oral use and only for men. Swallow the tablet
whole with water. The tablets can be taken independently of food intake.
Drinking alcohol may temporarily cause a reduction in your
blood pressure. If you have taken or intend to take Tadalafil Lilly, avoid excessive intake of
alcoholic beverages (blood alcohol level of 0.08% or higher) as this may increase the
risk of dizziness when you stand up.

For the treatment of erectile dysfunction
The recommended doseis one 5 mg tablet to be taken once a day at approximately the
same time of day. Your doctor may adjust the dose to 2.5 mg based on your response to
Tadalafil Lilly. This dose will be given to you with a 2.5 mg tablet.
Do not take Tadalafil Lilly more than once a day.
When taken once a day, Tadalafil Lilly allows you to achieve an erection, if there is
sexual stimulation, at any time of the day within 24 hours. The administration
of Tadalafil Lilly once a day may be useful for men who plan to have sexual
activity two or more times a week.
It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation. You and your
partner will need to engage in foreplay as you would if you were not taking a drug
for erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia
The doseis one 5 mg tablet to be taken once a day at approximately the same time
of day.
If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg
tablet to be taken once a day.
Do not take Tadalafil Lilly more than once a day.

If you take more Tadalafil Lilly than you should
Contact your doctor. Side effects as described in section 4 may occur.

If you forget to take Tadalafil Lilly
Take your dose as soon as you remember, but do not take a double dose to compensate for
forgetting the tablet. You should not take Tadalafil Lilly more than once a day.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects are normally mild to moderate in severity.

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

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

Other side effects have been reported:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in the arms and legs, flushing of the face, nasal congestion and digestive disorders.

Uncommon(may affect up to 1 in 100 people)

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

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

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

Rarely, in men taking Tadalafil Lilly, heart attacks and strokes have been reported. The
majority of these subjects had pre-existing heart problems before using the medicine.
Rarely, cases of partial, temporary or permanent decrease or loss of
vision in one or both eyes have been reported.

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

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, some disorders that alter blood circulation to the eyes, irregular heartbeat, angina and sudden cardiac death.
• distorted central vision, blurred, fuzzy 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. Diarrhea has been reported more frequently in men over
65 years of age taking Tadalafil Lilly.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell
your doctor or pharmacist. You can also report side effects directly through
the national reporting system 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 which is stated on the box and blister after
Expiry./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 at
a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Lilly contains

• The activeingredient is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredientsare: Tablet core:Lactose monohydrate, Sodium croscarmellose, Hydroxypropylcellulose, Microcrystalline cellulose, Sodium lauryl sulfate, Magnesium stearate. See paragraph 2 “Tadalafil Lilly contains lactose”.

Film coating: Lactose monohydrate, Hypromellose, Triacetin, Titanium dioxide
(E171), Yellow iron oxide (E172), Talc.

Description of the appearance of Tadalafil Lilly and package contents
Tadalafil Lilly 5 mg is a film-coated tablet of light yellow color with the shape of an
almond and has “C 5” imprinted on one side. The tablet is 9.59 mm by 5.85 mm.
Tadalafil Lilly 5 mg is available in blisters in packs of 14, 28 or 84 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, Netherlands
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
For further information on this medicinal product, contact the local representative of the marketing
authorization holder.

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

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0) 2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 5000

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351 21 4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39-055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība LatvijāTel:

+371 67364000

United Kingdom (Northern Ireland)
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

Tadalafil Lilly 10 mg film-coated tablets

tadalafil

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of this leaflet:

• 1. What Tadalafil Lilly is and what it is used for
• 2. What you need to know before you take 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 is Tadalafil Lilly and what it is used for

Tadalafil Lilly is a treatment for adult men with erectile dysfunction. This condition occurs when a man cannot achieve or maintain an erection adequate for sexual intercourse. Tadalafil Lilly has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse.
Tadalafil Lilly contains the active ingredient tadalafil which belongs to the class of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation Tadalafil Lilly helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result is improved erectile function. Tadalafil Lilly will not be helpful if you do not have erectile dysfunction.
It is important to note that Tadalafil Lilly has no effect if there is no sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking medication 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 any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines (“nitrates”) used for the treatment of angina pectoris (or “chest pain”). It has been shown that Tadalafil Lilly increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious heart condition or have 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 loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). It has been shown that phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, increase the hypotensive effect of this drug. If you are taking riociguat or have any doubts, tell 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 a heart
condition, because it puts extra strain on the heart. If you have a heart problem, tell your
doctor.
Before taking the tablets, tell your doctor if you have:

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (a cancer of bone marrow).
• leukemia (a cancer 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 of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of vision or your vision is distorted or blurred while
taking Tadalafil Lilly, stop taking Tadalafil Lilly and contact your
doctor immediately.
A decrease or sudden loss of hearing has been observed in some patients taking tadalafil. Although it is not known whether this event is directly related to tadalafil, if you
experience a sudden decrease or loss of hearing, stop taking Tadalafil Lilly and
contact your doctor immediately.
Tadalafil Lilly is not indicated for use by women.

Children and adolescents
Tadalafil Lilly is not indicated for use by children or adolescents under the age of 18 years.

Other medicines and Tadalafil Lilly
Tell 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 can be affected by Tadalafil Lilly or they themselves can affect the
way Tadalafil Lilly works. Tell your doctor or pharmacist if you are already taking:

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

Tadalafil Lilly with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can
affect the way Tadalafil Lilly works and should be taken with caution. Ask your
doctor for further information.

Fertility
A reduction in sperm development in the testes has been observed in dogs treated with the drug. A reduction in sperm has been observed in some
men. These effects are unlikely to cause infertility.

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

Tadalafil Lilly contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your
doctor 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 following exactly the instructions of your doctor. If you have doubts, consult
your doctor or pharmacist.
Tadalafil Lilly tablets are for oral use and only for men. Swallow the tablet
whole with water. The tablets can be taken independently of food intake.

The recommended doseis one 10 mg tablet before sexual activity. If the effect of this
dosage is too weak, your doctor may increase the dose to 20 mg. Tadalafil Lilly
tablets are for oral use.
You can 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 indicated for
use before planned sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation. You and your
partner will need to engage in foreplay as you would if you were not taking a drug
for erectile dysfunction.
Drinking alcoholic beverages may interfere with your ability to have an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend
to take Tadalafil Lilly, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher) because this may increase the risk of dizziness when you
stand up.

If you take more Tadalafil Lilly than you should:
Contact your doctor. Undesirable effects described in paragraph 4 may occur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects are normally mild to moderate in severity.

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

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

Other side effects have been reported:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in the arms and legs, flushing of the face, nasal congestion and digestive disorders.

Uncommon(may affect up to 1 in 100 people)

• dizziness, stomach pain, nausea, vomiting, heartburn, blurred vision, eye pain, difficulty breathing, 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 and transient memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red patches on the skin), bleeding of the penis, blood in semen and increased sweating.

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

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

• migraine, facial swelling, severe allergic reaction causing swelling of the face and throat, severe skin reactions, some disorders that change the blood circulation to the eyes, irregular heartbeat, angina and sudden cardiac death.
• distorted central vision, blurred, fuzzy 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. Diarrhea has been reported more frequently in men over
65 years of age taking Tadalafil Lilly.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and blister after
Expiry./EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture. Do not store at
temperatures above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Lilly contains

• The activeingredient is tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredientsare: Tablet core:Monohydrate lactose, Sodium croscarmellose, Hydroxypropylcellulose, Microcrystalline cellulose, Sodium lauryl sulfate, Magnesium stearate. See paragraph 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 package contents
Tadalafil Lilly 10 mg is a film-coated tablet of light yellow color, has the shape of an
almond and has “C 10” imprinted on one side. The tablet is 10.81 mm by 6.59 mm.
Tadalafil Lilly 10 mg is available in blisters in packs of 4 tablets.

Marketing authorization holder and manufacturer
Marketing authorization 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, contact the local representative of the marketing
authorization holder.

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

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0) 2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli LillyNederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S
Tlf: + 47 22 88 18 00

Ελλάδα
FARMASERV-LILLY A.E.B.E
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351 21 4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39-055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 737 88 00

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel:

+371 67364000

United Kingdom (Northern Ireland)
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

Tadalafil Lilly 20 mg film-coated tablets

tadalafil

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

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

Contents of this leaflet:

• 1. What Tadalafil Lilly is and what it is used for
• 2. What you need to know before you take 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 is Tadalafil Lilly 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 satisfactory sexual intercourse. Tadalafil Lilly has been shown to significantly improve the ability to achieve an erection sufficient for sexual intercourse.
Tadalafil Lilly contains the active substance tadalafil, which belongs to the class of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafil Lilly helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result is improved erectile function. Tadalafil Lilly will not be helpful if you do not have erectile dysfunction.
It is important to note that Tadalafil Lilly will not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking 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 any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (or “chest pain”). It has been shown that Tadalafil Lilly increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• you have had a stroke recently, within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). It has been shown that phosphodiesterase-5 (PDE5) inhibitors, such as Tadalafil Lilly, increase the hypotensive effect of this drug. If you are taking riociguat or have any doubts, tell 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, because it puts extra strain on the heart. If you have a heart problem, tell your doctor.
Before taking the tablets, tell your doctor if you have:

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

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

• pelvic surgery
• removal of all or part of the prostate gland where the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

Children and adolescents
Tadalafil Lilly is not indicated for use by children and adolescents under the age of 18 years.

Other medicines and Tadalafil Lilly
Tell 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 can be affected by Tadalafil Lilly or they themselves can affect how Tadalafil Lilly works. Tell your doctor or pharmacist if you are already taking:

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

Tadalafil Lilly with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can affect how Tadalafil Lilly works and should be taken with caution. Ask your doctor for further information.

Fertility
In dogs treated, a reduction in sperm development in the testicles was observed. A decrease in sperm has been observed in some men. These effects are unlikely to cause infertility.

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

Tadalafil Lilly contains lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor 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 following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Tadalafil Lilly tablets are for oral use and only for men. Swallow the tablet
whole with water. The tablets can be taken independently of food intake.

The recommended doseis one 10 mg tablet before sexual activity. However, you have been
prescribed a dose consisting of a 20 mg tablet because your doctor has decided that the recommended
dose of 10 mg is too low.
You can 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 indicated for
use before planned sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Lilly does not work if there is no sexual stimulation. You and your
partner will need to engage in foreplay as you would if you were not taking medication
for erectile dysfunction.
Drinking alcoholic beverages may interfere with your ability to have an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend
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 you
stand up.

If you take more Tadalafil Lilly than you should:
Contact your doctor. Undesirable effects described in paragraph 4 may occur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These effects are normally mild to moderate in severity.

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

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

Other side effects have been reported:

Common(may affect up to 1 in 10 people)

• headache, back pain, muscle aches, pain in the arms and legs, flushing of the face, nasal congestion, and digestive disorders.

Uncommon(may affect up to 1 in 100 people)

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

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

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

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

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

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system 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 which is stated on the package and blister after
Expiry date/EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture. Do not store at
temperatures above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Lilly contains

• The activesubstance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other componentsare: Tablet core:Lactose monohydrate, Sodium croscarmellose, Hydroxypropylcellulose, Microcrystalline cellulose, Sodium lauryl sulfate, Magnesium stearate. See paragraph 2 “Tadalafil Lilly contains lactose”.

Film coating: Lactose monohydrate, Hypromellose, Triacetin, Titanium dioxide
(E171), Yellow iron oxide (E172), Talc.

Description of the appearance of Tadalafil Lilly and contents of the pack
Tadalafil Lilly 20 mg is a film-coated tablet of yellow color, in the shape of an almond
and has “C 20” imprinted on one side. The tablet is 12.09 mm by 7.37 mm.
Tadalafil Lilly 20 mg is available in blisters in packs of 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, Netherlands
Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
For further information on this medicinal product, contact the local representative of the marketing
authorization holder.

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

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0) 2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S
Tlf: + 47 22 88 18 00

Ελλάδα
PHARMASERV-LILLY A.E.B.E
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0)1 55 49 34 34

Portugal
Lilly Portugal - Produtos Farmacêuticos, Lda
Tel: + 351 21 4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39-055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel:
+371 67364000

United Kingdom (Northern Ireland)
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 JUSTIFICATION FOR THE VARIATION OF THE
MARKETING AUTHORISATION
Scientific conclusions
Taking into account the evaluation of the Pharmacovigilance and 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 the available data on central serous chorioretinopathy from the literature and spontaneous
reports including in some cases a close temporal relationship, a dechallenge and/or positive rechallenge
and in light of a plausible mechanism of action, the PRAC considers that a causal relationship between
tadalafil and central serous chorioretinopathy is at least a reasonable possibility.
The PRAC concluded that the product information for products containing tadalafil should be
modified accordingly.
The CHMP agrees with the scientific conclusions of the PRAC.

Justification for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on tadalafil, the CHMP considers that the benefit/risk ratio
of medicinal products containing tadalafil is unchanged, save for the proposed changes to the product
information.
The CHMP recommends the variation of the terms of the marketing authorisation.