Tadalafil Teva

Patient Information Leaflet: Information for the User

Tadalafil Teva 5 mg film-coated tablets

Generic medicine
Please read this entire leaflet carefully before you start using 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. 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

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

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

Tadalafil Teva contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Teva 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 Teva has been shown to significantly improve the ability to obtain an erection suitable for sexual activity. Following sexual stimulation, Tadalafil Teva helps relax the blood vessels in the penis, allowing blood flow into the penis. The result is improved erectile function. Tadalafil Teva will not help you if you do not have erectile dysfunction. It is important to note that Tadalafil Teva 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 (BPH). This condition occurs when the prostate enlarges with age. Symptoms include difficulty starting urination, a sensation of incomplete bladder emptying, and a more frequent need to urinate, including during the night. Tadalafil Teva improves blood flow to the prostate and bladder and relaxes the muscles in these areas, which may reduce the symptoms of benign prostatic hyperplasia. Improvement in these urinary symptoms has been demonstrated as early as 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafil Teva

DO NOT take Tadalafil Teva if:

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

Warnings and precautions
Talk to your doctor before taking Tadalafil Teva.
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.
Since benign prostatic hyperplasia and prostate cancer may have similar symptoms, your doctor will rule out prostate cancer before starting treatment with Tadalafil Teva for benign prostatic hyperplasia.
Tadalafil Teva 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 blood cell disorder);
• any deformity of the penis;
• severe liver problems;
• severe kidney problems.

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

• pelvic surgery;
• removal of all or part of the prostate gland where the nerves to the prostate have been severed (radical prostatectomy without nerve-sparing technique).

If you experience sudden decrease or loss of vision, STOP taking Tadalafil Teva 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 Teva and contact your doctor immediately.
Tadalafil Teva is not intended for use by women.
Children and adolescents
Tadalafil Teva is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Teva
Inform your doctor if you are using, have recently used, or might use any other medicines.
DO NOT take Tadalafil Teva if you are already taking any form of nitrate (see "DO NOT take Tadalafil Teva").
Some medicines may be affected by Tadalafil Teva or may affect the efficacy of Tadalafil Teva.
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 (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection;
• phenobarbital, phenytoin, or carbamazepine (anticonvulsant medicines);
• rifampicin, erythromycin, clarithromycin, or itraconazole;
• other treatments for erectile dysfunction.

Tadalafil Teva with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect the efficacy of Tadalafil Teva and should be consumed with caution. Consult your doctor for further information.
Fertility
In treated dogs, reduced sperm development in the testes has been observed. In some men, a reduction in sperm count has been observed. These effects are unlikely to cause infertility.
Driving and using machines
Some men treated with Tadalafil Teva in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Tadalafil Teva

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Teva tablets are for oral use and for men only. Swallow the tablet whole with water.
The tablets may be taken regardless of food intake.
Consumption of alcoholic beverages may temporarily cause a reduction in your blood pressure.
If you have taken or plan to take Tadalafil Teva, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
Recommended dose: One 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Teva. This lower dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Teva more than once a day.
Daily administration of Tadalafil Teva may be beneficial for men who anticipate having sexual activity two or more times per week.
When taken once daily, Tadalafil Teva allows you to achieve an erection, provided there is sexual stimulation, at any time during the 24-hour period following administration.
It is important to note that Tadalafil Teva has no effect in the absence of sexual stimulation. You and your partner will need to engage in foreplay, as you would normally do even without taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia
Dose: 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 recommended dose remains one 5 mg tablet once daily.
Do not take Tadalafil Teva more than once a day.

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

If you forget to take Tadalafil Teva
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 Teva more than once a day.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• allergic reactions, including skin rash (uncommon frequency);
• chest pain – do not take nitrates but seek immediate medical help (uncommon frequency);
• priapism, a prolonged and potentially painful erection after taking Tadalafil Teva (rare frequency). If you have an erection lasting more than 4 hours, you must contact a doctor immediately;
• sudden loss of vision (rare frequency).

Other side effects have been reported:
Common (observed 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 (observed in 1 to 10 patients out of 1,000)

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

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

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

Rarely, heart attacks and strokes have also been reported in men taking Tadalafil Teva. Most of these individuals already had heart problems before taking the medicine.
Rare cases of partial, temporary or permanent decrease or loss of vision affecting 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 Teva. These include:

• migraine;
• facial swelling;
• severe allergic reaction causing swelling of the face or throat;
• severe skin rashes;
• disorders affecting blood circulation to the eyes;
• irregular heartbeat;
• angina;
• sudden cardiac death.

Dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Teva. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil Teva.
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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Teva

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 requires no 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 Teva contains

• The active substance is tadalafil. Each 5 mg tablet contains 5 mg of tadalafil.
• The other ingredients are monohydrate lactose, sodium lauryl sulfate, povidone, crospovidone and sodium stearyl fumarate.
• The tablet coating consists of polyvinyl alcohol, macrogol, titanium dioxide (E171), talc and yellow iron oxide (E172).

Description of the appearance of Tadalafil Teva and contents of the pack
Tadalafil Teva 5 mg is an oval, film-coated tablet with a yellowish to yellow colour. One side is marked with the number “5”, the other side is smooth. Length: 8.1 mm, width: 4.1 mm.
Tadalafil Teva is available in packs containing 14, 18, 28, 30 or 84 film-coated tablets in blisters, or in single-dose perforated blister packs containing 14x1, 28x1, 84x1, 98x1 or 112x1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan – Italy

Manufacturers:
Actavis International Ltd,
Tower Business Centre, 2nd floor, Tower Street, Swatar,
BKR4013, Malta
TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical Works Private Limited Company)
Debrecen, Pallagi út 13, H-4042
Hungary
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
United Kingdom
Teva Pharma B.V.
Swensweg 5, Haarlem 2031 GA
The Netherlands
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80, Krakow 31-546
Poland
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica, Zaragoza 50016
Spain
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren 89143
Germany
Merckle GmbH
Graf-Arco-Str. 3, Ulm 89079
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb 10000
Croatia
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Tadalafil ratiopharm
Belgium: Tadalafil Teva
Czech Republic: Tadalafil Teva
Germany: Tadalafil-ratiopharm
Denmark: Tadalafil Teva
Spain: Tadalafilo Teva
Finland: Tadalafil ratiopharm
France: Tadalafil Teva
Croatia: Tadalafil Pliva Hrvatska
Ireland: Tadalafil Teva
Iceland: Tadalafil ratiopharm
Italy: Tadalafil Teva
Luxembourg: Tadalafil-ratiopharm
The Netherlands: Tadalafil Teva
Norway: Tadalafil Teva
Poland: Tadalafil Teva
Portugal: Tadalafil Teva
Romania: TADALAFIL TEVA
Sweden: Tadalafil Teva
United Kingdom: Tadalafil
Hungary: Tadalafil Actavis

Package leaflet: Information for the user

Tadalafil Teva 10 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before using 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. 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

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

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

Tadalafil Teva is a treatment for adult men with erectile dysfunction. This condition occurs
when a man is unable to achieve or maintain an erection suitable for sexual intercourse.
Tadalafil Teva has been shown to significantly improve the ability to obtain an erection suitable for
sexual intercourse.
Tadalafil Teva contains the active substance tadalafil, which belongs to a class of medicines called
phosphodiesterase type 5 inhibitors. During sexual stimulation, Tadalafil Teva helps relax the blood
vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function.
Tadalafil Teva will not benefit you if you do not have erectile dysfunction.
It is important to note that Tadalafil Teva 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 Teva

DO NOT take Tadalafil Teva 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. These are a group of medicines ("nitrates") used to treat angina pectoris (or "chest pain"). Tadalafil Teva 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 (see section "Other medicines and Tadalafil Teva");
• you have a severe heart disease or have recently had a heart attack (within the last 90 days);
• you have recently had a stroke (within the last 6 months);
• you have low blood pressure or uncontrolled high blood pressure;
• you have previously experienced sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition sometimes described as "stroke of the eye";
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high lung pressure due to blood clots). PDE5 inhibitors such as Tadalafil Teva have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, contact your doctor.

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

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

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

• pelvic surgery;
• removal of all or part of the prostate gland with nerve bundles severed (nerve-destroying radical prostatectomy).

If you experience sudden decrease or loss of vision, STOP taking Tadalafil Teva 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 Teva and contact your doctor immediately.
Tadalafil Teva is not intended for use by women.
Children and adolescents
Tadalafil Teva is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Teva
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
DO NOT take Tadalafil Teva if you are already taking any form of nitrate (see "DO NOT take Tadalafil Teva").
Some medicines may be affected by Tadalafil Teva or may affect the efficacy of Tadalafil Teva.
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 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 Teva with food and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect the efficacy of Tadalafil Teva and should be consumed with caution. Consult your doctor for further information.
Fertility
In dogs treated with tadalafil, reduced sperm development in the testes has been observed. Reduced sperm count has also been observed in some men. These effects are unlikely to cause infertility.
Driving and use of machines
Some men treated with Tadalafil Teva in clinical studies reported dizziness. Carefully assess how you react to the tablets before driving or operating machinery.
Tadalafil Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Tadalafil Teva

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Tadalafil Teva tablets are for oral use and only for men. Swallow the tablet whole with water.
The tablets can be taken regardless of food intake.
The recommended dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafil Teva tablets are for oral use.
You can take a Tadalafil Teva tablet at least 30 minutes before sexual activity.
Tadalafil Teva may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil Teva more than once a day. Tadalafil Teva 10 mg and 20 mg is intended to be used prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil Teva has no effect without sexual stimulation. You and your partner will need to engage in foreplay, as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and can temporarily cause a lowering of your blood pressure. If you have taken or plan to take Tadalafil Teva, avoid excessive alcohol consumption (blood alcohol level equal to or greater than 0.08%) as this may increase the risk of dizziness when standing up.
If you take more Tadalafil Teva than you should
Contact your doctor. You may experience the side effects described in section 4.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• allergic reactions, including skin rash (uncommon frequency);
• chest pain – do not use nitrates but seek immediate medical help (uncommon frequency);
• priapism, a prolonged and potentially painful erection after taking Tadalafil Teva (rare frequency). If you have an erection of this type lasting more than 4 hours, you must contact a doctor immediately;
• sudden loss of vision (rare frequency).

Other side effects have been reported:
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;
• malaise (vomiting);
• reflux;
• blurred vision;
• eye pain;
• breathing difficulties;
• blood in the urine;
• prolonged erection;
• palpitations, rapid heartbeat, high blood pressure, low blood pressure;
• nosebleeds and ringing in the ears;
• swelling of the hands, feet or ankles and feeling tired.

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

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

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

• migraine;
• facial swelling;
• severe allergic reaction causing swelling of the face or throat;
• severe skin rashes;
• disorders affecting blood circulation to the eyes;
• irregular heartbeat;
• angina;
• sudden cardiac death.

Dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Teva. Diarrhea has been reported more frequently in men over 65 years of age taking Tadalafil Teva.
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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadalafil Teva

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 the month.
This medicine requires no 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 Teva contains

• The active substance is tadalafil. Each 10 mg tablet contains 10 mg of tadalafil.
• The other ingredients are monohydrate lactose, sodium lauryl sulfate, povidone, crospovidone, and sodium stearyl fumarate.
• The tablet coating consists of polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, and yellow iron oxide (E172).

Description of the appearance of Tadalafil Teva and pack contents
Tadalafil Teva 10 mg film-coated oval tablet, coloured from ochre to yellow. One side is marked with the number "10". The other side of the tablet is smooth. Length: 11.1 mm, width: 6.4 mm.
Tadalafil Teva is available in packs containing 4, 12, 18 or 28 film-coated tablets in blisters, or 4x1 or 24x1 film-coated tablets in perforated blister packs for single doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan – Italy

Manufacturers:
Actavis Export International Ltd.
Tower Business Centre, 2nd floor, Tower Street, Swatar,
BKR4013, Malta
TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical Works Private Limited Company)
Debrecen, Pallagi út 13, H-4042
Hungary
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
United Kingdom
Teva Pharma B.V.
Swensweg 5, Haarlem 2031 GA
The Netherlands
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80, Krakow 31-546
Poland
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica, Zaragoza 50016
Spain
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren 89143
Germany
Merckle GmbH
Graf-Arco-Str. 3, Ulm 89079
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb 10000
Croatia
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Tadalafil ratiopharm
Belgium: Tadalafil Teva
Czech Republic: Tadalafil Teva
Germany: Tadalafil-ratiopharm
Denmark: Tadalafil Teva
Spain: Tadalafilo Teva
Finland: Tadalafil ratiopharm
France: Tadalafil Teva
Croatia: Tadalafil Pliva Hrvatska
Ireland: Tadalafil Teva
Iceland: Tadalafil ratiopharm
Italy: Tadalafil Teva
Luxembourg: Tadalafil-ratiopharm
The Netherlands: Tadalafil Teva
Norway: Tadalafil Teva
Poland: Tadalafil Teva
Portugal: Tadalafil Teva
Romania: TADALAFIL TEVA
Sweden: Tadalafil Teva
United Kingdom: Tadalafil
Hungary: Tadalafil Actavis

Package leaflet: information for the user

Tadalafil Teva 20 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before using 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. 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 side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Tadalafil Teva 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 Teva has been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse.

Tadalafil Teva contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. During sexual stimulation, Tadalafil Teva helps relax the blood vessels in the penis, allowing blood to flow into the penis. The result is improved erectile function.
Tadalafil Teva will not help you if you do not have erectile dysfunction.
It is important to note that Tadalafil Teva 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 Teva

Do NOT take Tadalafil Teva 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. These are a group of medicines (“nitrates”) used to treat angina pectoris (or “chest pain”). Tadalafil Teva 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 (see section “Other medicines and Tadalafil Teva”);
• you have a severe heart disease or have recently had a heart attack (within the last 90 days);
• you have recently had a stroke (within the last 6 months);
• you have low blood pressure or uncontrolled high blood pressure;
• you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”;
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high lung pressure due to blood clots). PDE5 inhibitors such as Tadalafil Teva have been shown to increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or have any doubts, contact your doctor.

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

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

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

• pelvic surgery;
• removal of all or part of the prostate gland with nerve-sparing not preserved (radical prostatectomy without preservation of neurovascular bundles).

If you experience sudden decrease or loss of vision, STOP taking Tadalafil Teva and
contact your doctor immediately.
In some patients taking tadalafil, sudden decrease or loss of hearing has been reported.
Although it is not known whether this event is directly related to tadalafil, if you experience sudden
hearing decrease or loss, stop taking Tadalafil Teva and contact your doctor immediately.
Tadalafil Teva is not intended for use by women.
Children and adolescents
Tadalafil Teva is not intended for use in children and adolescents under 18 years of age.
Other medicines and Tadalafil Teva
Inform your doctor if you are using, have recently used, or might use any other medicines.
DO NOT take Tadalafil Teva if you are already taking any form of nitrate (see “Do NOT take Tadalafil Teva”).
Some medicines may be affected by Tadalafil Teva or may affect the effectiveness of Tadalafil Teva.
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, or carbamazepine (anticonvulsant medicines);
• rifampicin, erythromycin, clarithromycin, or itraconazole;
• other treatments for erectile dysfunction.

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

3. How to take Tadalafil Teva

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Tadalafil Teva tablets are for oral use and are intended only for men.
Daily dose
The recommended dose is one 5 mg tablet (equivalent to one-quarter of a 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 Teva. This dose will be provided as a 2.5 mg tablet.
Do not take Tadalafil Teva more than once a day.
Daily administration of Tadalafil Teva may benefit men who anticipate having sexual activity two or more times per week.
When taken once daily, Tadalafil Teva enables an erection to occur, provided there is sexual stimulation, at any time within 24 hours after dosing.
As-needed dose
The recommended starting dose is one 10 mg tablet (equivalent to half a tablet) taken before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg (equivalent to one whole tablet).
You may take a dose at least 30 minutes before sexual activity.
Tadalafil Teva may remain effective for up to 36 hours after dosing.
Do not take the 10 mg or 20 mg doses more than once a day. These doses are intended for use before anticipated sexual activity and are not recommended for continuous daily use.
It is important to note that Tadalafil Teva has no effect in the absence of sexual stimulation. You and your partner will need to engage in foreplay, as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily lower your blood pressure. If you have taken or plan to take Tadalafil Teva, avoid excessive alcohol consumption (blood alcohol levels equal to or greater than 0.08%) as this may increase the risk of dizziness upon standing.
Method of administration
Depending on your dosing regimen (once daily or as needed), the tablet may be divided into four parts (once daily) or in half (as needed).
Tadalafil Teva is for oral use and may be taken with or without food. Swallow the tablet or portion of it with water.
Divide the tablet into four parts (for a once-daily 5 mg tadalafil dose)

Divide the tablet in half (for a needed dose of 10 mg of tadalafil)

If you take more Tadalafil Teva than you should
Contact your doctor. You may experience the side effects described in section 4.
If you forget to take Tadalafil Teva
Take your dose as soon as you remember, but do not take a double dose to make up for the forgotten tablet. DO NOT take Tadalafil Teva more than once a day.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 use nitrates but seek immediate medical help (uncommon frequency);
• priapism, a prolonged and potentially painful erection after taking Tadalafil Teva (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).

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

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

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

• dizziness;
• stomach ache;
• feeling unwell;
• malaise (vomiting);
• reflux;
• blurred vision;
• eye pain;
• breathing difficulties;
• presence of blood in urine;
• prolonged erection;
• palpitations, increased heart rate, high blood pressure, low blood pressure;
• nosebleeds and ringing in the ears;
• swelling of the hands, feet or ankles and feeling tired.

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

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

Rarely, heart attacks and strokes have also been reported in men taking Tadalafil Teva. Most of these individuals already had pre-existing heart problems before taking the medicine.
Rare cases of partial, temporary or permanent decrease or loss of vision affecting 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 Teva. These include:

• migraine;
• facial swelling;
• severe allergic reaction causing swelling of the face or throat;
• severe skin rashes;
• disorders affecting blood circulation to the eyes;
• irregular heartbeat;
• angina;
• sudden cardiac death.

Dizziness has been reported more frequently in men over 75 years of age taking Tadalafil Teva. Diarrhea has been reported more frequently in men over 65 years of age taking Tadalafil Teva.
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 Teva

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 the 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 Teva contains

• The active substance is tadalafil. Each 20 mg tablet contains 20 mg of tadalafil.
• The other ingredients are monohydrate lactose, sodium lauryl sulfate, povidone, crospovidone, and sodium stearyl fumarate.
• The tablet coating consists of polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, and yellow iron oxide (E172).

Description of the appearance of Tadalafil Teva and contents of the pack
Tadalafil Teva 20 mg is an oval, film-coated tablet coloured yellowish-orange to yellow. One side of the tablet has a double breakline. The other side is marked with the number '20'. Length: 15.0 mm, width: 9.0 mm.
The tablet can be divided into two or four equal doses.
Tadalafil Teva is available in packs containing 2, 4, 5, 8, 10, 12, 15, 18, 24, 28, 36, 48 or 56 film-coated tablets in blister packs, or 2x1, 4x1, 8x1, 12x1, 24x1 or 36x1 film-coated tablets in perforated blister packs for single doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan – Italy

Manufacturers:
Actavis International Ltd.
Tower Business Centre, 2nd floor, Tower Street, Swatar,
BKR4013, Malta
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical Works Private Limited Company)
Debrecen, Pallagi út 13, H-4042
Hungary
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
United Kingdom
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80, Krakow 31-546
Poland
TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica, Zaragoza 50016
Spain
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren 89143
Germany
Merckle GmbH
Graf-Arco-Str. 3, Ulm 89079
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb 10000
Croatia

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Tadalafil ratiopharm
Belgium: Tadalafil Teva
Czech Republic: Tadalafil Teva
Denmark: Tadalafil Teva
Finland: Tadalafil ratiopharm
France: Tadalafil Teva
Croatia: Tadalafil Pliva
Germany: Tadalafil-ratiopharm
Hungary: Tadalafil Actavis
Iceland: Tadalafil ratiopharm
Ireland: Tadalafil Teva
Italy: Tadalafil Teva
Luxembourg: Tadalafil-ratiopharm
Netherlands: Tadalafil Teva
Norway: Tadalafil Teva
Poland: Tadalafil Teva
Portugal: Tadalafil Teva
Romania: TADALAFIL TEVA
Spain: Tadalafilo Teva
Sweden: Tadalafil Teva
United Kingdom: Tadalafil