Telefil

Package leaflet: Information for the user

Telefil 5 mg film-coated tablets

Tadalafil
Generic medicine
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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Telefil is and what it is used for

Telefil contains the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors.
Telefil 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. Telefil has been shown to significantly improve the ability to obtain an erection suitable for sexual intercourse. Following sexual stimulation, Telefil helps relax the blood vessels in the penis, allowing increased blood flow into the penis. The result is improved erectile function. Telefil will not help you if you do not have erectile dysfunction. It is important to note that Telefil 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 incomplete bladder emptying, and a more frequent need to urinate, including during the night. Telefil improves blood flow and relaxes the smooth muscle of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. Tadalafil has been shown to improve these urinary symptoms within 1–2 weeks after starting treatment.

2. What you need to know before taking Telefil

Do not take Telefil if:

• you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors, such as amyl nitrite. These are a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). It has been shown that Telefil increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• you have a severe heart disease or have recently had a heart attack (within the last 90 days).
• you have recently had a stroke (within the last 6 months).
• you have low blood pressure or uncontrolled high blood pressure.
• you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Telefil, 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 Telefil.
You should be aware that sexual activity involves a potential risk for patients with heart disease, as it places additional strain on the heart. If you have a heart condition, inform your doctor.
Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform tests for prostate cancer before starting treatment with Telefil for benign prostatic hyperplasia. Telefil 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 Telefil 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 (radical prostatectomy without nerve-sparing).

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Telefil, stop taking Telefil 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 hearing decrease or loss, stop taking Telefil and contact your doctor immediately.
The use of Telefil is not indicated in women.
Children and adolescents
The use of Telefil is not indicated in children and adolescents under 18 years of age.
Other medicines and Telefil
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Do not take Telefil if you are already taking nitrates.
Some medicines may be affected by Telefil or may themselves affect how Telefil 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 (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.

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

3. How to take Telefil

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Telefil tablets are for oral use and for men only. Swallow the tablet whole with
water. Tablets may be taken regardless of food intake.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or plan to take Telefil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.

For the treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to Telefil. This lower dose will be provided as a 2.5 mg tablet.
Do not take Telefil more than once a day.
When taken once daily, Telefil allows you to achieve an erection, provided there is sexual stimulation, at any time during the 24 hours following administration. Daily administration of Telefil may be beneficial for men who anticipate having sexual activity two or more times per week.
It is important to note that Telefil does not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to achieve an erection.

For the treatment of benign prostatic hyperplasia
The dose is one 5 mg tablet taken once daily at approximately the same time each day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once daily.
Do not take Telefil more than once a day.

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

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

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

4. Possible side effects

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

• allergic reactions, including skin rash (uncommon frequency).
• chest pain – do not take nitrates, but seek immediate medical assistance (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking Telefil (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 reported:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

Rarely, in men taking Telefil, heart attacks and strokes have been reported. 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 Telefil. These include:

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

The side effect dizziness has been reported more frequently in men over 75 years of age taking Telefil. Diarrhoea has been reported more frequently in men over 65 years of age taking Telefil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://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 Telefil

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.
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 Telefil contains

• The active substance is tadalafil. Each film-coated tablet contains 5 mg of tadalafil.
• The other components are:
  Tablet core: monohydrate lactose, pregelatinized starch, anhydrous colloidal silicon dioxide, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
  Tablet coating: hypromellose (E464), monohydrate lactose, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Telefil and package contents
Telefil 5 mg is a light yellow, oval-shaped, film-coated tablet marked "5" on one side and smooth on the other. The tablet measures 10 mm x 6.0 mm in diameter and 3.3 – 3.9 mm in thickness.
Packaging
Telefil 5 mg is available in blister packs containing 12 and 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milano
Italy

Manufacturers
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

Actavis Ltd.
BLB016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

Special Product’s Line SpA
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
IT: Telefil

Patient Information Leaflet: Information for the User

Telefil 10 mg film-coated tablets

Tadalafil
Generic medicine
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 yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Telefil is and what it is used for

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

Do not take Telefil if:

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

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

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

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

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

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

3. How to take Telefil

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Telefil tablets are for oral use and are intended only for men. Swallow the tablet whole with
water. The tablets can be taken regardless of food intake.
The recommended starting dose is one 10 mg tablet before sexual activity.
If this dose is not sufficiently effective, your doctor may increase the dose to 20 mg. Telefil tablets are for oral use.
You may take the Telefil tablet at least 30 minutes before sexual activity. Telefil may still be effective up to 36 hours after taking the tablet.
Do not take Telefil more than once a day. The use of Telefil 10 mg and 20 mg is indicated prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Telefil will not work without sexual stimulation. You and your partner will need to engage in foreplay as you normally would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily lower your blood pressure. If you have taken or plan to take Telefil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.
If you take more Telefil 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 nature.
If you experience any of the following side effects, stop using this medicine and
seek immediate medical help:

• allergic reactions, including skin rash (uncommon frequency).
• chest pain – do not use nitrates, but seek immediate medical help (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking Telefil (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), distorted central vision, blurred or unfocused vision, or sudden decrease in vision (frequency not known).

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

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

Uncommon (may affect up to 1 in 100 people)

• dizziness, stomach ache,
• feeling unwell, malaise (vomiting), reflux,
• blurred vision, eye discomfort, breathing difficulties, blood in urine, prolonged erection, awareness of heartbeat, fast heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus (ringing in the ears),
• swelling of the hands, feet or ankles, and feeling tired.

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

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

Rarely, heart attacks and strokes have been reported in men taking Telefil. Most of these individuals already had pre-existing heart conditions before taking the medicine.
Rarely, cases of partial, temporary or permanent reduction 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 Telefil. 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, unfocused vision, or sudden decrease in vision (frequency not known).

The side effect dizziness has been reported more frequently in men over 75 years of age taking Telefil. Diarrhoea has been reported more frequently in men over 65 years of age taking Telefil.
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 https://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 Telefil

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.
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 no longer required. This will help protect the environment.

6. Package contents and other information

What Telefil contains

• The active substance is tadalafil. Each film-coated tablet contains 10 mg of tadalafil.
• The other components are:
  Tablet core: lactose monohydrate, pregelatinized starch, anhydrous colloidal silica, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
  Tablet coating: hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Telefil and contents of the pack
Telefil 10 mg is a film-coated tablet (tablet) of light yellow color, oval in shape, marked with "10" on one side and smooth on the other. The tablet measures 11 mm x 6.6 mm in diameter and 3.9–4.5 mm in thickness.
Packs
Telefil 10 mg is available in blister packs containing 4 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan
Italy

Manufacturers
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Actavis Ltd.
BLB016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Special Product’s Line SpA
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
IT: Telefil

Package leaflet: information for the user

Telefil 20 mg film-coated tablets

Tadalafil
Generic medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

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

Contents of this leaflet:

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

1. What Telefil is and what it is used for

Telefil 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. Telefil has
been shown to significantly improve the ability to obtain an erection sufficient for sexual intercourse.
Telefil contains the active substance tadalafil, which belongs to a class of medicines known as phosphodiesterase type 5 inhibitors. Following sexual stimulation, Telefil helps relax the blood vessels in the
penis, allowing blood to flow into the penis. The result is improved erectile function. Telefil
will not help you if you do not have erectile dysfunction.
It is important to note that Telefil 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 Telefil

Do not take Telefil 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 ("chest pain"). It has been shown that Telefil enhances the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor.
• you have a severe heart condition or have had a heart attack recently, within the last 90 days.
• you have had a stroke recently, within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "stroke of the eye".
• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors such as Telefil 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 Telefil.
You should be aware that sexual activity involves a potential risk for patients with heart disease, as it places additional strain on the heart. If you have a heart condition, inform your doctor.
Before taking the tablets, inform your doctor if you have:

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

It is not known whether Telefil 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).

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

Telefil with food, beverages, and alcohol
Information on the effects of alcohol is provided in section 3. Grapefruit juice may affect how Telefil works and should be taken 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 taking Telefil in clinical studies reported dizziness. Carefully monitor how you react to the tablets before driving or operating machinery.
Telefil contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Telefil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How to take Telefil

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Telefil tablets are for oral use and are intended only for men. Swallow the tablet whole with
water. Tablets may be taken regardless of food intake.
The recommended starting dose is one 10 mg tablet taken before sexual activity.
However, you have been prescribed a dose consisting of one 20 mg tablet because your doctor has determined
that the recommended 10 mg dose is too low for you.
You may take the Telefil tablet at least 30 minutes before sexual activity. Telefil may still be effective up to 36 hours after taking the tablet.
Do not take Telefil more than once a day. The use of Telefil 10 mg and 20 mg is indicated prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Telefil will not work without sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may interfere with your ability to get an erection and may temporarily cause a reduction in your blood pressure. If you have taken or plan to take Telefil, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as this may increase the risk of dizziness when standing up.
If you take more Telefil 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 effects are usually mild to moderate in nature.
If you experience any of the following side effects, stop using the medicine and
seek immediate medical help:

• allergic reactions, including skin rashes (uncommon frequency).
• chest pain – do not use nitrates but seek immediate medical help (uncommon frequency).
• priapism, a prolonged and possibly painful erection after taking Telefil (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), blurred or distorted central vision, blurred or sudden decrease in vision (frequency not known).

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

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

Rarely, heart attacks and strokes have been reported in men taking Telefil. 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 Telefil. These include:

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

The side effect dizziness has been reported more frequently in men over 75 years of age taking Telefil. Diarrhoea has been reported more frequently in men over 65 years of age taking Telefil.
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 https://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 Telefil

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 Telefil contains

• The active substance is tadalafil. Each film-coated tablet contains 20 mg of tadalafil.
• The other components are:
  Tablet core: monohydrate lactose, pregelatinized starch, anhydrous colloidal silica, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.
  Tablet coating: hypromellose (E464), monohydrate lactose, titanium dioxide (E171), triacetin, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Telefil and package contents
Telefil 20 mg is a film-coated tablet (tablet) of light yellow color, oval in shape,
marked “20” on one side and smooth on the other. The tablet measures 12 mm x 7.4 mm in diameter and 4.60–5.20 mm in thickness.
Packaging
Telefil 20 mg is available in blister packs containing 2, 4, and 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milano
Italy
Manufacturers
Balkanpharma - Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Actavis Ltd.
BLB016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Special Product’s Line SpA
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
IT: Telefil