Dionifil

Patient Information Leaflet: Information for the User

DIONIFIL 5 mg film-coated tablets

Vardenafil
Generic medicine
Please read all of this 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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DIONIFIL is and what it is used for

DIONIFIL contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These medicines are used for the treatment of erectile dysfunction in adult men, a condition characterized by difficulty in achieving or maintaining an erection. At least one in ten men occasionally experiences difficulty in achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, an insufficient amount of blood remains in the penis to achieve and maintain an erection, due to changes in the muscles and blood vessels.
DIONIFIL works only in the presence of sexual stimulation. The medicine reduces the action of a chemical substance in the body that causes the erection to subside. DIONIFIL enables the achievement and maintenance of an erection long enough to allow satisfactory completion of sexual intercourse.

2. What you need to know before taking DIONIFIL

Do not take DIONIFIL:

• if you are allergic to vardenafil or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and shortness of breath;
• if you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with DIONIFIL could dangerously lower your blood pressure;
• if you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections;
• if you are over 75 years old and are being treated with ketoconazole or itraconazole, antifungal medicines;
• if you have severe heart or liver problems;
• if you are on kidney dialysis;
• if you have recently had a stroke or heart attack;
• if you have or have had low blood pressure;
• if there is a family history of degenerative eye diseases (such as retinitis pigmentosa);
• if you have previously experienced a condition characterized by sudden vision loss due to damage of the optic nerve from insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION);
• 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 DIONIFIL 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 or pharmacist before taking DIONIFIL.
Take special care with DIONIFIL

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat ( cardiac arrhythmia ) or inherited heart diseases that affect the electrocardiogram.
• If you have a physical condition causing changes in the shape of the penis. These include conditions known as penile curvature, Peyronie’s disease, and cavernosal fibrosis.
• If you have a disease that may cause prolonged erections ( priapism ). These include sickle cell anemia, multiple myeloma, and leukemia.
• If you have stomach ulcers (also called gastric or peptic ulcers ).
• If you have a bleeding disorder (such as hemophilia ).
• If you are using other treatments for erectile difficulties, including DIONIFIL orodispersible tablets (see section ‘Other medicines and DIONIFIL’ ).
• If you experience sudden decrease or loss of vision, stop taking DIONIFIL and contact your doctor immediately.

Children and adolescents
DIONIFIL is not intended for use by children or adolescents under 18 years of age.
Other medicines and DIONIFIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those without a prescription.
Some medicines may cause problems, particularly the following:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with DIONIFIL could dangerously lower your blood pressure.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV.
• Ketoconazole or itraconazole, antifungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and prostate enlargement (such as benign prostatic hyperplasia ).
• Riociguat. Do not use DIONIFIL film-coated tablets in combination with other treatments for erectile dysfunction, including DIONIFIL orodispersible tablets.

DIONIFIL with food, beverages, and alcohol

• You may take DIONIFIL with or without food, but preferably not after a heavy or fatty meal, as this may delay its effect.
• Do not drink grapefruit juice when taking DIONIFIL. It may interfere with the medicine's effect.
• Alcoholic beverages may worsen erectile difficulties.

Pregnancy and breastfeeding
DIONIFIL is not intended for use by women.
Driving and using machines
In some people, DIONIFIL may cause dizziness or vision disturbances. If you feel dizzy or notice vision problems after taking DIONIFIL, do not drive or operate tools or machinery.

3. How to take DIONIFIL

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. The recommended dose is 10 mg.
Take one DIONIFIL tablet approximately 25–60 minutes before sexual activity. If you are sexually stimulated, you may achieve an erection as early as 25 minutes and up to four to five hours after taking DIONIFIL.

• Swallow the tablet with a glass of water.

Do not take DIONIFIL film-coated tablets together with any other formulation of vardenafil.
Do not take DIONIFIL more than once a day.
If you feel that the effect of DIONIFIL is too strong or too weak, consult your doctor.
Your doctor may advise you to take an alternative formulation of DIONIFIL with a different dosage, based on how the medicine affects you.
If you take more DIONIFIL than you should
Patients who take an excessive amount of DIONIFIL may experience more adverse effects or severe back pain. If you take more DIONIFIL than you should, consult your doctor.
If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Most side effects are mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes. Stop taking DIONIFIL and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
Cases of sudden death, increased or irregular heartbeat, heart attack, chest pain and problems with cerebral circulation (including temporarily reduced blood flow to parts of the brain and cerebral haemorrhage) have been reported in men taking vardenafil. Most of the men who experienced these side effects had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

The likelihood of experiencing a side effect is described using the following categories:

Very common:
may affect more than 1 in 10 users

• Headache

Common:
may affect up to 1 in 10 users

• Dizziness
• Flushing
• Stuffy or runny nose
• Indigestion

Uncommon:
may affect up to 1 in 100 users

• Swelling of the skin and mucous membranes, including swelling of the face, lips or throat
• Sleep disturbance
• Numbness and reduced tactile sensation
• Drowsiness
• Visual disturbances, red eyes, disturbances in colour perception, eye pain or discomfort, sensitivity to light
• Ringing in the ears, dizziness
• Rapid heartbeat or pounding heart sensation
• Shortness of breath
• Stuffy nose
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling unwell (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Rash, red skin
• Back or muscle pain, increased levels of a muscle enzyme (creatine phosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Malaise

Rare:
may affect up to 1 in 1,000 users

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Seizure
• Increased intraocular pressure (glaucoma), increased tear production
• Effects on the heart (such as heart attack, irregular heartbeat or angina)
• High or low blood pressure
• Nosebleeds
• Effect on liver function test results
• Skin sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary reduction in blood flow to parts of the brain

Very rare or not known:
may affect less than 1 in 10,000 users or the frequency cannot be estimated from the available data

• Blood in the urine (haematuria)
• Bleeding from the penis (penile haemorrhage)
• Blood in the semen (haemospermia)
• Sudden death
• Cerebral haemorrhage

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor. You can also report side effects directly via the national reporting system at http://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 DIONIFIL

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton after 'Exp'. The expiry date refers to the last day of that month.
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 DIONIFIL contains

• The active substance is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride).
• The other components are: Tablet core: crospovidone Type A, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica. Film coating: water for injections, Opadry® 200F520070 Yellow (polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), macrogol (E1521) - Type 3350, methacrylic acid copolymer - Type A, iron oxide yellow (E172), sodium hydrogen carbonate [E500 (ii)], iron oxide red (E172)).

Description of the appearance of DIONIFIL and pack contents
DIONIFIL 5 mg film-coated tablets are light yellow tablets, marked with "A719" on one side. The tablets are supplied in blister packs containing 4 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 Rome
Italy

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

Package Leaflet: Information for the User

DIONIFIL 10 mg film-coated tablets

vardenafil
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 doubts, consult 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 reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DIONIFIL is and what it is used for

DIONIFIL contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These medicines are used for the treatment of erectile dysfunction in adult men, a condition characterized by difficulty in achieving or maintaining an erection. At least one in ten men occasionally experiences difficulty in achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, an insufficient amount of blood remains in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels.
DIONIFIL works only in the presence of sexual stimulation. The medicine reduces the action of a chemical substance in the body that causes the erection to subside. DIONIFIL enables the achievement and maintenance of an erection long enough to allow satisfactory completion of sexual intercourse.

2. What you need to know before taking DIONIFIL

Do not take DIONIFIL

• if you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and shortness of breath;
• if you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with DIONIFIL could dangerously alter your blood pressure;
• if you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections;
• if you are over 75 years old and are being treated with ketoconazole or itraconazole, antifungal medicines;
• if you have severe heart or liver problems;
• if you are undergoing renal dialysis;
• if you have recently had a stroke or heart attack;
• if you have or have had low blood pressure;
• if there is a family history of degenerative eye diseases (such as retinitis pigmentosa);
• if you have ever had a condition characterized by loss of vision due to damage to the optic nerve from insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION);
• 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 DIONIFIL 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 or pharmacist before taking DIONIFIL.
Take special care with DIONIFIL

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or inherited heart diseases that affect the electrocardiogram.
• If you have a physical condition causing changes in the shape of the penis. These include conditions such as curvature, Peyronie's disease, and cavernosal fibrosis.
• If you have a condition that may cause prolonged erections (priapism). These include sickle cell anemia, multiple myeloma, and leukemia.
• If you have stomach ulcers (also known as gastric or peptic ulcers).
• If you have a bleeding disorder (such as hemophilia).
• If you are using other treatments for erectile difficulties, including DIONIFIL orodispersible tablets (see section “Other medicines and DIONIFIL”).
• If you experience sudden decrease or loss of vision, stop taking DIONIFIL and contact your doctor immediately.

Children and adolescents
DIONIFIL is not intended for use in children or adolescents under 18 years of age.
Other medicines and DIONIFIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Some medicines may cause problems, particularly the following:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with DIONIFIL could dangerously alter your blood pressure.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV.
• Ketoconazole or itraconazole, antifungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlarged prostate (such as benign prostatic hyperplasia).
• Riociguat.

Do not use DIONIFIL film-coated tablets in combination with other treatments for erectile dysfunction, including DIONIFIL orodispersible tablets.
DIONIFIL with food, drinks, and alcohol

• You may take DIONIFIL with or without food, but preferably not after a heavy or high-fat meal, as this may delay its effect.
• Do not drink grapefruit juice when taking DIONIFIL. It may interfere with the medicine's effect.
• Alcoholic beverages may worsen erectile difficulties.

Pregnancy and breastfeeding
DIONIFIL is not intended for use in women.
Driving and using machines
In some people, DIONIFIL may cause dizziness or affect vision. If you feel dizzy or notice vision problems after taking DIONIFIL, do not drive or operate tools or machinery.

3. How to take DIONIFIL

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist. The recommended dose is 10 mg.
Take one DIONIFIL tablet approximately 25–60 minutes before sexual activity. If you are sexually stimulated, you may achieve an erection as early as 25 minutes after taking DIONIFIL and up to four to five hours afterwards.

• Swallow the tablet with a glass of water. Do not take DIONIFIL film-coated tablets together with any other vardenafil formulation.

Do not take DIONIFIL more than once a day.
If you feel that the effect of DIONIFIL is too strong or too weak, talk to your doctor.
Your doctor may recommend that you take an alternative DIONIFIL formulation with a different dosage, depending on how the medicine affects you.
If you take more DIONIFIL than you should
Patients who take an excessive amount of DIONIFIL may experience more side effects or severe back pain. If you take more DIONIFIL than you should, consult your doctor.
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 gets them. Most side effects are mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss of vision, in one or both eyes. Stop taking DIONIFIL and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
Cases of sudden death, increased or irregular heartbeat, heart attack, chest pain and problems with cerebral circulation (including temporarily reduced blood flow to parts of the brain and cerebral bleeding) have been reported in men taking vardenafil. Most of these men had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.
The likelihood of experiencing a side effect is described using the following categories:

Very common:
may affect more than 1 in 10 people

• Headache

Common:
may affect up to 1 in 10 people

• Dizziness
• Flushing
• Stuffy or runny nose
• Indigestion

Uncommon:
may affect up to 1 in 100 people

• Swelling of the skin and mucous membranes, including swelling of the face, lips or throat
• Sleep disturbance
• Numbness and reduced tactile sensation
• Drowsiness
• Visual disturbances, red eyes, disturbances in colour perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears, vertigo
• Rapid or pounding heartbeat
• Shortness of breath
• Stuffy nose
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling unwell (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Skin rash, red skin
• Back or muscle pain, increased levels of a muscle enzyme (creatine phosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Malaise

Rare:
may affect up to 1 in 1,000 people

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Seizure
• Increased eye pressure (glaucoma), increased tear production
• Effects on the heart (such as heart attack, irregular heartbeat or angina)
• High or low blood pressure
• Nosebleeds
• Effect on liver function test results
• Skin sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary reduction in blood flow to parts of the brain

Very rare or frequency not known:
may affect fewer than 1 in 10,000 people or the frequency cannot be estimated from the available data

• Blood in the urine (haematuria)
• Bleeding from the penis (penile haemorrhage)
• Blood in the semen (haematospermia)
• Sudden death
• Cerebral bleeding

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store DIONIFIL

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the carton after 'Exp'. The expiry date refers to the last day of that month.
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 DIONIFIL contains

• The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).
• The other components are: Tablet core: crospovidone Type A, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica. Film coating: water for injections, Opadry® 200F520070 Yellow (polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), macrogol (E1521) - Type 3350, methacrylic acid copolymer - Type A, yellow iron oxide (E172), sodium hydrogen carbonate [E500(ii)], red iron oxide (E172)).

Description of the appearance of DIONIFIL and package contents
DIONIFIL 10 mg film-coated tablets are light yellow tablets, marked with "A721" on one side. The tablets are supplied in blister packs containing 2 or 4 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 Rome
Italy

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

Package Leaflet: Information for the User

DIONIFIL 20 mg film-coated tablets

vardenafil
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, consult 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 reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DIONIFIL is and what it is used for
2. What you need to know before taking DIONIFIL
3. How to take DIONIFIL
4. Possible side effects
5. How to store DIONIFIL
6. Package contents and other information

1. What DIONIFIL is and what it is used for

DIONIFIL contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These medicines are used to treat erectile dysfunction in adult men, a condition characterized by difficulty in achieving or maintaining an erection. At least one in ten men occasionally experiences difficulty in achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, an insufficient amount of blood is retained in the penis to achieve and maintain an erection, due to changes in the muscles and blood vessels.
DIONIFIL works only in the presence of sexual stimulation. The medicine reduces the action of a chemical substance in the body that causes the erection to subside. DIONIFIL enables the achievement and maintenance of an erection long enough to allow satisfactory completion of sexual intercourse.

2. What you need to know before taking DIONIFIL

Do not take DIONIFIL

• if you are allergic to vardenafil or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and shortness of breath;
• if you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with DIONIFIL could dangerously lower your blood pressure;
• if you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections;
• if you are over 75 years old and are being treated with ketoconazole or itraconazole, antifungal medicines;
• if you have severe heart or liver problems;
• if you are on renal dialysis;
• if you have recently had a stroke or heart attack;
• if you have or have had low blood pressure;
• if there is a family history of degenerative eye diseases (such as retinitis pigmentosa);
• if you have ever had a condition characterized by sudden vision loss due to damage of the optic nerve from insufficient blood flow, known as non-arteritic anterior ischemic optic neuropathy (NAION);
• 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 due to blood clots). PDE5 inhibitors such as DIONIFIL 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 or pharmacist before taking DIONIFIL.
Take special care with DIONIFIL

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or inherited heart conditions that affect the electrocardiogram.
• If you have a physical condition causing deformities of the penis. These include conditions known as penile curvature, Peyronie's disease, and cavernosal fibrosis.
• If you have a disease that may cause prolonged erections (priapism). These include sickle cell anemia, multiple myeloma, and leukemia.
• If you have stomach ulcers (also known as gastric or peptic ulcers).
• If you have a bleeding disorder (such as haemophilia).
• If you are using other treatments for erectile difficulties, including DIONIFIL orodispersible tablets (see section ‘Other medicines and DIONIFIL’).
• If you experience a sudden decrease or loss of vision, stop taking DIONIFIL and contact your doctor immediately.

Children and adolescents
DIONIFIL is not intended for use by children or adolescents under 18 years of age.
Other medicines and DIONIFIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those not requiring a prescription.
Some medicines may cause problems, particularly the following:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these together with DIONIFIL could dangerously lower your blood pressure.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV.
• Ketoconazole or itraconazole, antifungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlarged prostate (such as benign prostatic hyperplasia).
• Riociguat.

Do not use DIONIFIL film-coated tablets in combination with other treatments for erectile dysfunction, including DIONIFIL orodispersible tablets.
DIONIFIL with food, beverages, and alcohol

• You may take DIONIFIL with or without food, but preferably not after a heavy or fatty meal, as this may delay its effect.
• Do not drink grapefruit juice when taking DIONIFIL. It may interfere with the medicine's effect.
• Alcoholic beverages may worsen erectile difficulties.

Pregnancy and breastfeeding
DIONIFIL is not intended for use by women.
Driving and using machines
In some people, DIONIFIL may cause dizziness or vision disturbances. If you feel dizzy or notice any visual problems after taking DIONIFIL, do not drive or operate tools or machinery.

3. How to take DIONIFIL

Take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist. The recommended dose is 10 mg.
Take one DIONIFIL tablet approximately 25–60 minutes before sexual activity. If you are sexually stimulated, you may achieve an erection as early as 25 minutes after taking DIONIFIL and up to four to five hours afterwards.

• Swallow the tablet with a glass of water. Do not take the film-coated tablets of DIONIFIL together with any other formulation of vardenafil.

Do not take DIONIFIL more than once a day.
If you feel that the effect of DIONIFIL is too strong or too weak, talk to your doctor.
Your doctor may recommend that you take an alternative formulation of DIONIFIL with a different dosage, depending on how the medicine affects you.
If you take more DIONIFIL than you should
Patients who take an excessive amount of DIONIFIL may experience more frequent adverse effects or severe back pain. If you take more DIONIFIL than you should, consult your doctor.
If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Most of these side effects are mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss of vision, in one or both eyes. Stop taking DIONIFIL and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
Cases of sudden death, rapid or irregular heartbeat, heart attack, chest pain and problems with cerebral circulation (including temporarily reduced blood flow to parts of the brain and cerebral bleeding) have been reported in men taking vardenafil. Most of these men had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.
The likelihood of experiencing a side effect is described using the following categories:
Very common:
may affect more than 1 in 10 users

• Headache.

Common:
may affect up to 1 in 10 users

• Dizziness
• Flushing
• Nasal congestion or runny nose
• Indigestion.

Uncommon:
may affect up to 1 in 100 users

• Swelling of the skin and mucous membranes, including swelling of the face, lips or throat
• Sleep disorder
• Numbness and reduced tactile perception
• Drowsiness
• Visual disturbances, red eyes, disturbances in colour vision, eye pain and discomfort, light sensitivity
• Ringing in the ears, vertigo
• Rapid heartbeat or pounding sensation in the chest
• Shortness of breath
• Nasal congestion
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling unwell (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Rash, red skin
• Back or muscle pain, increased levels of a muscle enzyme (creatine phosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Malaise.

Rare:
may affect up to 1 in 1,000 users

• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Seizure
• Increased eye pressure (glaucoma), increased tear production
• Effects on the heart (such as heart attack, irregular heartbeat or angina)
• High or low blood pressure
• Nosebleeds
• Effect on liver function test results
• Skin sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary reduction in blood flow to parts of the brain.

Very rare or frequency not known:
may affect less than 1 in 10,000 users or the frequency cannot be estimated from the available data

• Blood in the urine (haematuria)
• Bleeding from the penis (penile haemorrhage)
• Blood in the semen (haemospermia)
• Sudden death
• Cerebral haemorrhage.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You may also report side effects directly via the national reporting system at http://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 DIONIFIL

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
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 DIONIFIL contains

• The active substance is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride).
• The other components are: Tablet core: crospovidone Type A, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silicon dioxide. Film coating: water for injections, Opadry® 200F520070 Yellow (polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), macrogol (E1521) - Type 3350, methacrylic acid copolymer - Type A, yellow iron oxide (E172), sodium hydrogen carbonate [E500 (ii)], red iron oxide (E172)).

Description of the appearance of DIONIFIL and pack sizes
DIONIFIL 20 mg film-coated tablets are light yellow tablets, marked with "A723" on one side. The tablets are supplied in blister packs containing 4 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 Rome – Italy
Manufacturer
Actavis Ltd.
BLB016,
Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta