CIALIS 10 mg Фильм-Coated Таблетки

Содержание инструкции

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

CIALIS 2,5 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is CIALIS and what is it used for

CIALIS 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.
CIALIS has been shown to significantly improve the ability to achieve an erection adequate for a
sexual intercourse.
CIALIS contains the active ingredient tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors. After sexual stimulation CIALIS helps to relax the blood
vessels in the penis, allowing blood flow to the penis. The result is improved
erectile function. CIALIS will not be of help if you do not have erectile dysfunction.
It is important to note that CIALIS 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 CIALIS

Do not take CIALIS 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 CIALIS 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 or uncontrolled high blood pressure.
• you have previously experienced 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 PDE5 inhibitors, such as CIALIS, increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, tell your doctor.

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

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

It is not known whether CIALIS 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 CIALIS, stop taking CIALIS and contact your doctor immediately.
In some patients taking tadalafil, a sudden decrease or loss of hearing has been observed. Although it is not known whether the event is directly related to tadalafil, if you experience a sudden decrease or loss of hearing, stop taking CIALIS and contact
your doctor immediately.
CIALIS is not indicated for use by women.

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

Other medicines and CIALIS
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Do not take CIALIS if you are already taking nitrates.
Some medicines can be affected by CIALIS or they themselves can affect how
CIALIS works. Tell your doctor or pharmacist if you are already taking:

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

CIALIS with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can
affect how CIALIS 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. In some
men, a decrease in sperm count has been observed. These effects are unlikely to cause
infertility.

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

CIALIS contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

CIALIS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take CIALIS

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
CIALIS 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
CIALIS. This dose will be given to you with a 2.5 mg tablet.
Do not take CIALIS more than once a day.
Daily administration of CIALIS may be useful for men who plan to
have sexual activity two or more times a week.
When taken once a day, CIALIS 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 CIALIS does not work if there is no sexual stimulation. You and your partner will need to
engage in foreplay as you would if you were not taking medication for
erectile dysfunction.
Drinking alcoholic beverages may interfere with your ability to achieve an erection and may
temporarily cause a decrease in your blood pressure. If you have taken or intend
to take CIALIS, 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 CIALIS than you should
Contact your doctor. Undesirable effects described in paragraph 4 may occur.

If you forget to take CIALIS
Take your dose as soon as you remember but do not take a double dose to compensate for
the missed tablet. You should not take CIALIS 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 everybody gets them.
These effects are normally mild to moderate in severity.

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

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain - do not use nitrates but seek immediate medical attention (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking CIALIS (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, hazy or sudden decrease in vision (frequency not known).

Other side effects have been reported:

Common(observed in 1-10 patients per 100)

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

Uncommon(observed in 1-10 patients per 1,000)

• 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(observed in 1-10 patients per 10,000)

• fainting, convulsions 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 CIALIS, 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 CIALIS. 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, hazy 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 CIALIS. Diarrhea has been reported more frequently in men over
65 years of age taking CIALIS.

Reporting of side effects
If you get any side effect, even if 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 CIALIS

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 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 CIALIS contains

• The activeingredient is tadalafil. Each tablet contains 2.5 mg of tadalafil.
• Other componentsare: Tablet: lactose monohydrate (see the end of paragraph 2), sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, see paragraph 2 “CIALIS 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 CIALIS and contents of the pack
CIALIS 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.
CIALIS 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. - 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 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

CIALIS 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is CIALIS and what it is used for

CIALIS contains the active ingredient tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors.
CIALIS 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. CIALIS has been shown to significantly improve the ability to achieve an erection adequate for sexual intercourse. After sexual stimulation CIALIS helps to relax the blood vessels in the penis, allowing blood flow to the penis. The result of this is improved erectile function. CIALIS will not help you if you do not have erectile dysfunction. It is important to note that CIALIS 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 at night. CIALIS improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms associated with benign prostatic hyperplasia. CIALIS has been shown to improve these urinary symptoms within 1-2 weeks of starting treatment.

2. What you need to know before taking CIALIS

Do not take CIALIS 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”). CIALIS has been shown to increase the effect of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• you have a serious heart condition or have recently had a heart attack, in the last 90 days.
• you have recently had a stroke, in the last 6 months.
• you have low or uncontrolled high blood pressure.
• you have previously experienced loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION), a condition described as “an eye stroke”.
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as CIALIS, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, tell your doctor.

Warnings and precautions
Talk to your doctor before taking CIALIS.
Be aware that sexual activity carries a potential risk for patients with heart disease, as it puts extra strain on the heart. If you have a heart problem, tell your doctor.
Because benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will perform checks for prostate cancer before starting treatment with CIALIS for benign prostatic hyperplasia. CIALIS does not cure prostate cancer.
Before taking the tablets, tell your doctor if you have:

• sickle cell anaemia (an abnormality of red blood cells).
• multiple myeloma (a cancer of bone marrow).
• leukaemia (a cancer of blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

It is not known whether CIALIS 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 CIALIS, stop taking CIALIS and contact your doctor immediately.
A sudden decrease or 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 CIALIS and contact your doctor immediately.
CIALIS is not indicated for use by women.

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

Other medicines and CIALIS
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take CIALIS if you are already taking nitrates.
Some medicines can be affected by CIALIS or can affect the way CIALIS works. Tell your doctor or pharmacist if you are already taking:

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

CIALIS with drinks and alcohol
Information about the effects of alcohol is given in section 3. Grapefruit juice can affect the way CIALIS 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 testicles was observed. A decrease in sperm count has been observed in some men. These effects are unlikely to cause infertility.

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

CIALIS contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

CIALIS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially ‘sodium-free’.

3. How to take CIALIS

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
CIALIS 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 CIALIS, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher) as this may increase the risk of
dizziness when you stand up.

For the treatment of erectile dysfunction
The recommended doseis one 5 mg tablet to be taken once daily at approximately
the same time of day. Your doctor may adjust the dose to 2.5 mg based on your response to
CIALIS. This dose will be given to you with a 2.5 mg tablet. Do not take CIALIS more than once
a day.
When taken once a day, CIALIS allows you to achieve an erection, if there is
sexual stimulation, at any time of day over the 24-hour period. The administration
of CIALIS once a day may be useful for men who anticipate having sexual activity
two or more times a week.
It is important to note that CIALIS 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 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 daily 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 daily.
DO NOT take CIALIS more than once a day.

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

If you forget to take CIALIS
Take your dose as soon as you remember, but do not take a double dose to compensate for
the forgotten tablet. You should not take CIALIS 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 everybody gets them.
These effects are normally mild to moderate in severity.

If you experience any of the following side effects, stop using the medicine and seek
immediate medical 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 CIALIS (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, hazy or sudden decrease in vision (frequency not known).

Other side effects have been reported:

Common(observed in 1-10 patients per 100)

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

Uncommon(observed in 1-10 patients per 1,000)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, presence of 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(observed in 1-10 patients per 10,000)

• fainting, convulsions 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, presence of blood in the semen and increased sweating.

Rarely, in men taking CIALIS, 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 CIALIS. 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 central vision, blurred, hazy 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 CIALIS. Diarrhea has been reported more frequently in men over
65 years of age taking CIALIS.

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 CIALIS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after
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 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. Contents of the pack and other information

What CIALIS contains

• The activeingredient is tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredientsare: Tablet:lactose monohydrate (see the end of paragraph 2), sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, see paragraph 2 “CIALIS contains lactose”. Film coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), talc.

Description of the appearance of CIALIS and contents of the pack
CIALIS 5 mg is a film-coated tablet of light yellow color with the shape of an almond and
has imprinted “C 5” on one side.
CIALIS 5 mg is available in blisters in packs 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, contact the local representative of the marketing
authorisation 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 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 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

CIALIS 10 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is CIALIS and what is it used for

CIALIS 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.
CIALIS has been shown to significantly improve the ability to achieve an erection adequate for a
sexual intercourse.
CIALIS contains the active ingredient tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors. After sexual stimulation CIALIS helps to relax the blood
vessels in the penis, allowing blood flow to the penis. The result is improved
erectile function. CIALIS will not help you if you do not have erectile dysfunction.
It is important to note that CIALIS 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 CIALIS

Do not take CIALIS 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”). CIALIS has been shown to increase the effect of these medicines. If you are taking any form of nitrate or have any doubts, tell your doctor.
• you have a serious heart condition or have had a heart attack recently, within the last 90 days.
• you have had a stroke recently, within the last 6 months.
• you have low or uncontrolled high blood pressure.
• you have previously experienced loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as CIALIS, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, tell your doctor.

Warnings and precautions
Talk to your doctor before taking CIALIS.
Be aware that sexual activity carries a potential risk for patients with a heart
condition, because it puts extra strain on the heart. If you have a heart problem, tell your
doctor.
Before taking the tablets, tell your doctor if you have:

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

It is not known whether CIALIS 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 CIALIS, stop taking CIALIS and contact your doctor immediately.
A sudden decrease or 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 CIALIS and contact
your doctor immediately.
CIALIS is not indicated for use by women.

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

Other medicines and CIALIS
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Do not take CIALIS if you are already taking nitrates.
Some medicines can be affected by CIALIS or they themselves can affect the way
CIALIS works. Tell your doctor or pharmacist if you are already taking:

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

CIALIS with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice may
affect the way CIALIS 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 testicles was observed. A decrease in sperm count has been observed in some
men. These effects are unlikely to cause infertility.

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

CIALIS contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your
doctor before taking this medicine.

CIALIS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take CIALIS

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
CIALIS 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. CIALIS tablets are for
oral use.
You can take the CIALIS tablet at least 30 minutes before sexual activity.
CIALIS may still be effective up to 36 hours after taking the tablet.
Do not take CIALIS more than once a day. CIALIS 10 mg and 20 mg is indicated to be used
before planned sexual activity and is not recommended for continuous daily use.
It is important to note that CIALIS 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 CIALIS, avoid excessive alcohol consumption (blood alcohol level
equal to 0.08% or higher) as this may increase the risk of dizziness when you stand up.

If you take more CIALIS than you should:
Contact your doctor. Undesirable effects as 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 using the medicine and seek
immediate medical attention:

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain - do not use nitrates but seek immediate medical attention (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking CIALIS (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, hazy or sudden decrease in vision (frequency not known).

Other side effects have been reported:

Common(observed in 1-10 patients per 100)

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

Uncommon(observed in 1-10 patients per 1,000)

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, presence of 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(observed in 1-10 patients per 10,000)

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

Rarely, in men taking CIALIS, 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 CIALIS. 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, hazy 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 CIALIS. Diarrhoea has been reported more frequently in men over
65 years of age taking CIALIS.

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 CIALIS

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./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 CIALIS contains

• The activeingredient is tadalafil. Each tablet contains 10 mg of tadalafil.
• Other ingredientsare: Tablet:lactose monohydrate (see the end of paragraph 2), sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, see paragraph 2 “CIALIS contains lactose”. Film coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), talc.

Description of the appearance of CIALIS and package contents
CIALIS 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.
CIALIS 10 mg is available in blisters in packs of 4 tablets.

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, contact the local representative of the marketing
authorisation 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

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

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

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 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

CIALIS 20 mg film-coated tablets

tadalafil

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not 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 CIALIS is and what it is used for
• 2. What you need to know before you take CIALIS
• 3. How to take CIALIS
• 4. Possible side effects
• 5. How to store CIALIS
• 6. Contents of the pack and other information

1. What is CIALIS and what is it used for

CIALIS 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.
CIALIS has been shown to significantly improve the ability to achieve an erection adequate for a
sexual intercourse.
CIALIS contains the active ingredient tadalafil which belongs to the class of medicines called
phosphodiesterase type 5 inhibitors. After sexual stimulation CIALIS helps to relax the blood
vessels in the penis, allowing blood flow to the penis. The result is improved
erectile function. CIALIS will not be helpful if you do not have erectile dysfunction.
It is important to note that CIALIS 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 CIALIS

Do not take CIALIS 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 CIALIS 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 PDE5 inhibitors, such as CIALIS, increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, tell your doctor.

Warnings and precautions
Talk to your doctor before taking CIALIS.
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 CIALIS 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 CIALIS, stop taking CIALIS and contact your doctor immediately.
A sudden decrease or 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 CIALIS and contact
your doctor immediately.
CIALIS is not indicated for use by women.

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

Other medicines and CIALIS
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Do not take CIALIS if you are already taking nitrates.
Some medicines can be affected by CIALIS or they themselves can affect how
CIALIS works. Tell your doctor or pharmacist if you are already taking:

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

CIALIS with drinks and alcohol
Information on the effects of alcohol is given in section 3. Grapefruit juice can
affect how CIALIS 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 taking CIALIS during clinical studies have reported dizziness. Carefully
check how you react to the tablets before driving or using machines.

CIALIS contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

CIALIS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take CIALIS

Take this medicine always exactly as your doctor has told you. If you have any doubts ask your
doctor or pharmacist.
CIALIS 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 the 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 CIALIS tablet at least 30 minutes before sexual activity.
CIALIS may still be effective up to 36 hours after taking the tablet.
Do not take CIALIS more than once a day. CIALIS 10 mg and 20 mg is indicated to be used
before planned sexual activity and is not recommended for continuous daily use.
It is important to note that CIALIS 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 CIALIS, 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 CIALIS than you should:
Contact your doctor. Side effects as described in section 4 may occur.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain - do not use nitrates but seek immediate medical attention (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking CIALIS (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, hazy or sudden decrease in vision (frequency not known).

Other side effects have been reported:

Common(observed in 1-10 patients per 100)

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

Uncommon(observed in 1-10 patients per 1,000)

• 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(observed in 1-10 patients per 10,000)

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

Rarely, in men taking CIALIS, 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 CIALIS. 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 central vision, blurred, hazy 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 CIALIS. Diarrhoea has been reported more frequently in men over
65 years of age taking CIALIS.

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 CIALIS

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 on the 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 CIALIS contains

• The activeingredient is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredientsare: Tablet:lactose monohydrate (see the end of paragraph 2), sodium croscarmellose, hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, see paragraph 2 “CIALIS contains lactose”. Film coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), talc.

Description of the appearance of CIALIS and package contents
CIALIS 20 mg is a film-coated tablet of yellow color, with the shape of an almond and has
“C 20” imprinted on one side.
CIALIS 20 mg is available in blisters in packs of 2, 4, 8, 10 or 12 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, contact the local representative of the marketing
authorisation 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 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
In light of the evaluation by 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 association, a dechallenge and/or a 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 amended
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 profile 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.