Tadalafil Mylan: detailed information

Package leaflet: Information for the user

Tadalafil Mylan 2.5 mg film-coated tablets

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

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

Contents of this leaflet

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

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

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

2. What you need to know before taking Tadalafil Mylan

Do not take Tadalafil Mylan

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

Warnings and precautions

Talk to your doctor before taking Tadalafil Mylan.

Be aware that sexual activity involves a potential risk for patients with heart disease, as it places additional strain on the heart. If you have any heart problems, inform your doctor.

Before taking the tablets, inform your doctor if you have:

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

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

pelvic surgery
removal of all or part of the prostate gland with damage to the nerves of the prostate (nerve-sparing radical prostatectomy).

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Mylan, stop taking Tadalafil Mylan and contact your doctor immediately.

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 sudden decrease or loss of hearing, stop taking Tadalafil Mylan and contact your doctor immediately.

Tadalafil Mylan is not intended for use by women.

Children and adolescents

Tadalafil Mylan is not intended for use in children and adolescents under 18 years of age.

Other medicines and Tadalafil Mylan

Inform your doctor if you are taking, have recently taken, or might take any other medicines.

Do not take Tadalafil Mylan if you are already taking nitrates.

Some medicines may be affected by Tadalafil Mylan or may themselves affect how Tadalafil Mylan works. Inform your doctor or pharmacist if you are taking:

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

Tadalafil Mylan with food and alcohol

Grapefruit juice may affect how Tadalafil Mylan works and should be consumed with caution. Consult your doctor for further information.

Drinking alcohol may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Mylan, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness upon standing.

Fertility

In treated dogs, reduced sperm development in the testes has been observed. A reduction in sperm count has also been observed in some men. These effects are unlikely to cause infertility.

Driving and using machines

Some men taking Tadalafil Mylan during clinical studies reported dizziness.

Carefully assess how you react to the tablets before driving or operating machinery.

Tadalafil Mylan contains lactose:

If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

Tadalafil Mylan contains sodium

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

3. How to take Tadalafil Mylan

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Mylan. This dose will be given as a 2.5 mg tablet.
Do not take Tadalafil Mylan more than once a day.
Tadalafil Mylan tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets may be taken regardless of food intake.
Daily administration of Tadalafil Mylan may be suitable for men who anticipate having sexual activity two or more times per week.
When taken once daily, Tadalafil Mylan allows you to achieve an erection, provided there is sexual stimulation, at any time during the 24 hours following intake.
If you take more Tadalafil Mylan than you should
Contact your doctor. The side effects described in section 4 may occur.
If you forget to take Tadalafil Mylan
Take your dose as soon as you remember, but do not take a double dose to make up for the missed tablet. Do not take Tadalafil Mylan more than once a day.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

Other side effects reported:
Common (observed in 1–10 patients out of 100)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, indigestion.

Uncommon (observed in 1–10 patients out of 1,000)

dizziness, stomach ache, feeling unwell, nausea (vomiting), reflux, blurred vision, eye pain, breathing difficulties, blood in urine, prolonged erection, sensation of rapid heartbeat, increased heart rate, high blood pressure, low blood pressure, epistaxis (nosebleed), tinnitus (ringing in the ears), swelling of hands, feet or ankles, and feeling tired.

Rare (observed in 1–10 patients out of 10,000)

fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (itchy, red, bruise-like marks on the skin), penile haemorrhage, blood in semen, and increased sweating.

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

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

Dizziness is the most frequently reported side effect in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Mylan contains

The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
The other components are:
Tablet: anhydrous lactose (see section 2 “Tadalafil Mylan contains lactose”), poloxamer 188, microcrystalline cellulose (pH101), povidone (K-25), sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silica. Film coating: monohydrate lactose, hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), triacetin.

Description of the appearance of Tadalafil Mylan and package contents
Tadalafil Mylan 2.5 mg is a light yellow, film-coated, biconvex tablet, marked with “M” on one side and “TL above 1” on the other side.
Tadalafil Mylan 2.5 mg is available in blisters in pack sizes of 28 and 56 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland
Manufacturer
McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13,
Ireland
Mylan Hungary Kft.
Mylan utca 1,
Komárom, 2900
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva (Lithuania)
Viatris bvba/sprl Mylan Healthcare UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: + 370 5 205 1288
България (Bulgaria) Luxembourg/Luxemburg
Майлан ЕООД Viatris bvba/sprl
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország (Hungary)
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: + 45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: + 31 (0)20 426 3300
Eesti (Estonia) Norge
BGP Products Switzerland GmbH Eesti filiaal Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00
Ελλάδα (Greece) Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: + 30 2100 100 002 Tel: + 43 1 416 2418
España Polska
Viatris Pharmaceuticals S.L.U. Mylan Healthcare Sp.z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00
France Portugal
Viatris Santé Mylan, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 214 127 2 00
Hrvatska (Croatia) România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: + 385 1 23 50 599 Tel: + 40 372 579 000
Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180
Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: + 421 2 32 199 100
Italia Suomi/Finland
Viatris Italia s.r.l. Viatris OY
Tel: + 39 (0) 2 612 46921 Puh/Tel: + 358 20 720 9555
Κύπρος (Cyprus) Sverige
Varnavas Hadjipanayis Ltd Viatris AB
Τηλ: +357 2220 7700 Tel: + 46 (0) 630 19 00
Latvija United Kingdom (Northern Ireland)
Mylan Healthcare SIA Mylan IRE Healthcare Limited
Tel: + 371 676 05580 Tel: +353 18711600
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

Package leaflet: information for the user

Tadalafil Mylan 5 mg film-coated tablets

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

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

Contents of this leaflet

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

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

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

erectile dysfunction. This condition occurs when a man is unable to achieve or maintain an erection sufficient for sexual intercourse. Tadalafil Mylan has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse. Following sexual stimulation, Tadalafil Mylan helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function. Tadalafil Mylan will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Mylan for the treatment of erectile dysfunction has no effect in the absence of sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.
urinary symptoms associated with a common condition called benign prostatic hyperplasia. This condition occurs when the prostate gland enlarges with age. Symptoms include difficulty starting urination, a sensation of not completely emptying the bladder, and a more frequent need to urinate, including during the night. Tadalafil Mylan improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce symptoms associated with benign prostatic hyperplasia. Tadalafil Mylan has been shown to improve these urinary symptoms within 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Mylan

Do not take Tadalafil Mylan

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

Warnings and precautions
Talk to your doctor before taking Tadalafil Mylan.
Be aware that sexual activity involves a potential risk for patients with heart disease, as it places additional strain on the heart. If you have any heart condition, inform your doctor.
Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Tadalafil Mylan for benign prostatic hyperplasia. Tadalafil Mylan does not treat prostate cancer.
Before taking the tablets, inform your doctor if you have:

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

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

pelvic surgery
removal of all or part of the prostate gland where the nerves to the prostate have been severed (nerve-sparing radical prostatectomy).

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

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

Tadalafil Mylan with food and alcohol
Grapefruit juice may affect how Tadalafil Mylan works and should be consumed with caution. Consult your doctor for further information.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Mylan, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some
men, a reduction in sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Mylan in clinical studies reported dizziness.
Carefully monitor how you react to the tablets before driving or operating machinery.
Tadalafil Mylan contains lactose:
If your doctor has informed you that you have an intolerance to certain sugars, contact him before taking this medicine.
Tadalafil Mylan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially 'sodium-free'.

3. How to take Tadalafil Mylan

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Tadalafil Mylan. This lower dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Mylan more than once a day.

When taken once daily, Tadalafil Mylan allows you to achieve an erection, provided there is sexual stimulation, at any time during the 24 hours following administration. Daily administration of Tadalafil Mylan may be beneficial for men who anticipate having sexual activity two or more times per week.

For the treatment of benign prostatic hyperplasia
The dose is one 5 mg tablet taken once daily at approximately the same time each day.

If you have both benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once daily.
Do not take Tadalafil Mylan more than once a day.

Tadalafil Mylan tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken with or without food.

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

If you forget to take Tadalafil Mylan
Take your dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. You must not take Tadalafil Mylan more than once a day.

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

4. Possible side effects

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

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

Other side effects reported include:
Common (seen in 1 to 10 out of 100 patients)

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

Uncommon (seen in 1 to 10 out of 1,000 patients)

dizziness, stomach discomfort, feeling unwell, nausea (vomiting), reflux, blurred vision, eye pain, increased difficulty breathing, presence of blood in urine, prolonged erection, sensation of rapid heartbeat, high heart rate, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet or ankles, and feeling tired.

Rare (seen in 1 to 10 out of 10,000 patients)

fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (itchy, red, bruise-like streaks on the skin), penile haemorrhage, presence of blood in semen, and increased sweating.

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

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

Dizziness is the most frequently reported side effect in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tadalafil Mylan contains

The active substance is tadalafil. Each tablet contains 5 mg of tadalafil.
The other components are: Tablet: anhydrous lactose (see section 2 “Tadalafil Mylan contains lactose”), poloxamer 188, microcrystalline cellulose (pH101), sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silica. Film coating: monohydrate lactose, hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), triacetin.

Description of the appearance of Tadalafil Mylan and package contents
Tadalafil Mylan 5 mg is a yellowish, round, film-coated tablet, marked with
“M” on one side and “TL above 2” on the other side.
Tadalafil Mylan 5 mg is available in blisters in pack sizes of 14, 28, 30, 56, 84 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13, Ireland
Mylan Hungary Kft.
Mylan utca 1,
Komárom, 2900
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva (Lithuania)
Viatris bvba/sprl Mylan Healthcare UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: + 370 5 205 1288

България (Bulgaria) Luxembourg/Luxemburg
Майлан ЕООД Viatris bvba/sprl
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország (Hungary) Viatris Healthcare
Viatris CZ s.r.o. Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: + 45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: + 31 (0)20 426 3300

Eesti (Estonia) Norge
BGP Products Switzerland GmbH Eesti filiaal Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα (Greece) Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: + 30 2100 100 002 Tel: + 43 1 416 2418

España Polska
Viatris Pharmaceuticals S.L.U. Mylan Healthcare Sp.z.o.o. Tel.: + 48 22 546
Tel: + 34 900 102 712 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 214 127 2 00

Hrvatska (Croatia) România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: + 385 1 23 50 599 Tel: + 40 372 579 000

Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: + 421 2 32 199 100

Italia Suomi/Finland
Viatris Italia s.r.l. Viatris OY
Tel: + 39 (0) 2 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος (Cyprus) Sverige
Varnavas Hadjipanayis Ltd Viatris AB
Τηλ: +357 2220 7700 Tel: + 46 (0) 630 19 00

Latvija United Kingdom (Northern Ireland)
Mylan Healthcare SIA Mylan IRE Healthcare Limited
Tel: + 371 676 05580 Tel: +353 18711600

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

Package leaflet: information for the user

Tadalafil Mylan 10 mg film-coated tablets

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

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

Contents of this leaflet

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

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

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

2. What you need to know before taking Tadalafil Mylan

Do not take Tadalafil Mylan

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

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

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

pelvic surgery
removal of all or part of the prostate gland where the nerves to the prostate have been severed (nerve-sparing radical prostatectomy).

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Tadalafil Mylan, stop taking Tadalafil Mylan and contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been observed.
Although it is not known whether this event is directly related to tadalafil, if you experience sudden decrease or loss of hearing, stop taking Tadalafil Mylan and contact your doctor immediately.
Tadalafil Mylan is not intended for use by women.
Children and adolescents
Tadalafil Mylan is not intended for use in children or adolescents under 18 years of age.
Other medicines and Tadalafil Mylan
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Tadalafil Mylan if you are already taking nitrates.
Some medicines may be affected by Tadalafil Mylan or may themselves affect how Tadalafil Mylan works. Inform 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 for high blood pressure.
riociguat.
a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
medicines such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for the treatment of AIDS or HIV infection.
phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
rifampicin, erythromycin, clarithromycin, or itraconazole.
other treatments for erectile dysfunction.

Tadalafil Mylan with food, grapefruit juice, and alcohol
Grapefruit juice may affect how Tadalafil Mylan works and should be consumed with caution. Consult your doctor for further information.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Mylan, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Mylan in clinical studies reported dizziness.
Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Mylan contains lactose:
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Tadalafil Mylan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.

3. How to take Tadalafil Mylan

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one 10 mg tablet before sexual activity. If this dose is not effective enough, your doctor may increase the dose to 20 mg. Tadalafil Mylan tablets are for oral use.
You can take the Tadalafil Mylan tablet at least 30 minutes before sexual activity. Tadalafil Mylan may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Mylan more than once a day. Tadalafil Mylan 10 mg and 20 mg is intended to be used before anticipated sexual activity and is not recommended for daily continuous use.
Tadalafil Mylan tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
If you take more Tadalafil Mylan than you should:
Contact your doctor. You may experience the side effects described in section 4.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Other side effects reported include:
Common (seen in 1 to 10 patients out of 100)

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

Uncommon (seen in 1 to 10 patients out of 1,000)

dizziness, stomach discomfort, feeling unwell, nausea (vomiting), reflux, blurred vision, eye pain, increased breathing difficulty, presence of blood in urine, prolonged erection, sensation of rapid heartbeat, high heart rate, high blood pressure, low blood pressure, epistaxis (nosebleeds), tinnitus (ringing in the ears), swelling of hands, feet or ankles, and feeling tired.

Rare (seen in 1 to 10 patients out of 10,000)

fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy, bruise-like marks on the skin), penile haemorrhage, blood in semen, and increased sweating.

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

Dizziness is the most frequently reported side effect in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. This medicine
does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tadalafil Mylan contains

The active substance is tadalafil. Each tablet contains 10 mg of tadalafil.
The other components are:
Tablet: anhydrous lactose (see section 2 “Tadalafil Mylan contains lactose”), poloxamer 188, microcrystalline cellulose (pH101), povidone (K-25), sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silica.
Film coating: monohydrate lactose, hypromellose (464), titanium dioxide (E171), yellow iron oxide (E172), triacetin.

Description of the appearance of Tadalafil Mylan and package contents
Tadalafil Mylan 10 mg is a light yellow, film-coated, round tablet, marked with “M” on one side and “TL3” on the other.
Tadalafil Mylan 10 mg is available in blisters in pack sizes of 4, 12, and 24 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13,
Ireland
Mylan Hungary Kft.
Mylan utca 1,
Komárom, 2900
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

België/Belgique/Belgien Lietuva (Lithuania)
Viatris bvba/sprl Mylan Healthcare UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: + 370 5 205 1288

България (Bulgaria) Luxembourg/Luxemburg
Майлан ЕООД Viatris bvba/sprl
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország (Hungary)
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: + 45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: + 31 (0)20 426 3300

Eesti (Estonia) Norge
BGP Products Switzerland GmbH Eesti filiaal Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα (Greece) Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: + 30 2100 100 002 Tel: + 43 1 416 2418

España Polska
Viatris Pharmaceuticals S.L.U. Mylan Healthcare Sp.z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska (Croatia) România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: + 385 1 23 50 599 Tel: + 40 372 579 000

Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: + 421 2 32 199 100

Italia Suomi/Finland
Viatris Italia s.r.l. Viatris OY
Tel: + 39 (0) 2 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος (Cyprus) Sverige
Varnavas Hadjipanayis Ltd Viatris AB
Τηλ: +357 2220 7700 Tel: + 46 (0) 630 19 00

Latvija United Kingdom (Northern Ireland)
Mylan Healthcare SIA Mylan IRE Healthcare Limited
Tel: + 371 676 05580 Tel: +353 18711600

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

Package leaflet: information for the user

Tadalafil Mylan 20 mg film-coated tablets

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

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

Contents of this leaflet

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

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

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

2. What you need to know before taking Tadalafil Mylan

Do not take Tadalafil Mylan

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

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

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

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

pelvic surgery
removal of all or part of the prostate gland where the nerves to the prostate have been cut (nerve-sparing radical prostatectomy).

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

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

Tadalafil Mylan with food, beverages and alcohol
Grapefruit juice may affect how Tadalafil Mylan works and should be consumed with caution. Consult your doctor for further information.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Mylan, avoid excessive consumption of alcoholic beverages (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness upon standing.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men taking Tadalafil Mylan in clinical studies reported dizziness.
Carefully monitor how you react to the tablets before driving or operating machinery.
Tadalafil Mylan contains lactose:
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Tadalafil Mylan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially 'sodium-free'.

3. How to take Tadalafil Mylan

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose is one 10 mg tablet before sexual activity. However, your doctor has prescribed you a dose of one 20 mg tablet because he/she has decided that the recommended 10 mg dose is too low for you.
You can take the Tadalafil Mylan tablet at least 30 minutes before sexual activity. Tadalafil Mylan may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Mylan more than once a day. Tadalafil Mylan 10 mg and 20 mg is intended to be used prior to anticipated sexual activity and is not recommended for continuous daily use.
Tadalafil Mylan tablets are for oral use and for men only. Swallow the tablet whole with water. The tablets can be taken regardless of food intake.
If you take more Tadalafil Mylan than you should:
Contact your doctor. You may experience the side effects listed in section 4.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Other side effects that have been reported include:
Common (observed in 1–10 patients out of 100)

headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, indigestion.

Uncommon (observed in 1–10 patients out of 1,000)

dizziness, stomach ache, feeling unwell, nausea (vomiting), acid reflux, blurred vision, eye pain, increased difficulty in breathing, blood in urine, prolonged erection, sensation of a pounding heartbeat, rapid heart rate, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling in hands, feet or ankles, and feeling tired.

Rare (observed in 1–10 patients out of 10,000)

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

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

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

Dizziness is the most frequently reported side effect in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. This medicine
does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tadalafil Mylan contains

The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
The other components are: Tablet: anhydrous lactose (see section 2 “Tadalafil Mylan contains lactose”), poloxamer 188, microcrystalline cellulose (pH101), povidone (K-25), sodium croscarmellose, magnesium stearate, sodium lauryl sulphate, anhydrous colloidal silica. Film-coating: monohydrate lactose, hypromellose (464), titanium dioxide (E171), iron oxide yellow (E172), triacetin.

Description of the appearance of Tadalafil Mylan and pack contents
Tadalafil Mylan 20 mg is a light yellow, film-coated, round tablet, marked with “M” on one side and “TL4” on the other side.
Tadalafil Mylan 20 mg is available in blister packs containing 2, 4, 8, 12 or 24 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13
Ireland
Mylan Hungary Kft.
Mylan utca 1,
Komárom, 2900
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva (Lithuania)
Viatris bvba/sprl Mylan Healthcare UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: + 370 5 205 1288

България (Bulgaria) Luxembourg/Luxemburg
Майлан ЕООД Viatris bvba/sprl
Тел.: + 359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)