DIONIFIL 5 mg Film-Coated Tablets

Зміст інструкції

1. DIONIFIL 5 mg film-coated tablets
   1. What is DIONIFIL and what is it 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
2. DIONIFIL 10 mg film-coated tablets
   1. What is DIONIFIL and what is it 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
3. DIONIFIL 20 mg film-coated tablets
   1. What is DIONIFIL and what is it 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

DIONIFIL 5 mg film-coated tablets

Vardenafil
Generic medicine

Read this leaflet carefully before 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What DIONIFIL is and what it is used for
• 2. What you need to know before you take 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 is DIONIFIL and what is it used for

DIONIFIL contains vardenafil, which belongs to a class of medicines called type 5 phosphodiesterase inhibitors. These medicines are used for the treatment of erectile dysfunction in adult men, a condition that involves difficulty achieving or maintaining an erection. At least one in ten men occasionally have difficulty achieving or maintaining an erection. This may depend on physical or psychological causes or a combination of both. Whatever the cause, not enough blood is retained in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels. DIONIFIL only works in the presence of sexual stimulation. The medicine reduces the action of the chemical present in the body, which stops the erection. DIONIFIL allows you to achieve and maintain an erection long enough to satisfactorily complete 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). The signs of an allergic reaction include skin 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 of age and are being treated with ketoconazole or itraconazole, antifungal medicines;
• if you have serious heart or liver problems;
• if you are undergoing kidney dialysis;
• if you have recently had a stroke or heart attack;
• if you have or have had low blood pressure;
• if your family has a history of degenerative eye diseases (such as retinitis pigmentosa);
• if you have previously had a condition characterised by loss of vision due to damage to the optic nerve due to insufficient blood supply, known as non-arteritic anterior ischaemic 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 if you have any doubts, tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking DIONIFIL.

Pay particular attention with DIONIFIL

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or hereditary heart diseases that modify the electrocardiogram.
• If you have a physical condition that causes changes in the shape of the penis. These include conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
• If you have a condition that can cause persistent erections (priapism). These include sickle cell anaemia, multiple myeloma and leukaemia.
• If you have stomach ulcers (also called gastricor pepticulcers).
• 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 the age of 18.

Other medicines and DIONIFIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
Some medicines can cause problems, particularly these:

• 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 enlargement of the 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 can 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 can interfere with the effect of the medicine.
• Alcoholic beverages can worsen erectile difficulties.

Pregnancy and breastfeeding
DIONIFIL is not intended for use by women.

Driving and operating machinery
In some people DIONIFIL may cause dizziness or alter 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist. The recommended dose is 10 mg.
Take one tablet of DIONIFIL approximately 25-60 minutes before sexual activity. If you are sexually
stimulated, you may achieve an erection within 25 minutes and up to four to five hours after taking
DIONIFIL.

• Swallow one tablet with a glass of water.

Do not take the film-coated tablets of DIONIFILwith any other formulation of
vardenafil.

Do not take DIONIFILmore than once a day.
If you feel that the effect of DIONIFIL is too strong or too weak, consult your doctor.
They may advise you to take an alternative formulation of DIONIFIL with a different
dosage, based on the effect the medicine has on 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 doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the 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, fast or altered heartbeat, heart attack,
chest pain and problems with blood circulation in the brain (including temporarily
reduced blood flow to parts of the brain and brain bleeding) have been reported in men taking vardenafil. The
majority of men who experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were
directly related to vardenafil.
The likelihood that a side effect will occur is described by the following categories:

Very common:
may affect more than 1 in 10 people

• Headache.

Common:
may affect up to 1 in 10 people

• Dizziness
• Hot flushes
• Blocked 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 disorder
• Numbness and decreased tactile perception
• Drowsiness
• Effects on vision, red eyes, effects on color perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears, vertigo
• Fast heartbeat or heart with a hammering sensation
• Shortness of breath
• Blocked nose
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling unwell (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Skin rash, reddened skin
• Back or muscle pain, increased levels of a muscle enzyme (creatinephosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Feeling unwell.

Rare
may affect up to 1 in 1,000 people

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

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

• Blood in urine (hematuria)
• Bleeding from the penis (penile hemorrhage)
• Presence of blood in semen (hematospermia)
• Sudden death
• Brain bleeding.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the pack after ‘Exp’. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DIONIFIL contains

• The active ingredient is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride).
• The other ingredients 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 contents of the pack
DIONIFIL 5 mg film-coated tablets are light yellow tablets, with “A719” on one side. The tablets are supplied in blister packs of 4 tablets.

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

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

DIONIFIL 10 mg film-coated tablets

vardenafil
Generic Equivalent

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

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

Contents of this leaflet:

• 1. What DIONIFIL is and what it is used for
• 2. What you need to know before you take 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 is DIONIFIL and what is it 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 that involves difficulty achieving or maintaining an erection. At least one in ten men occasionally have difficulty achieving or maintaining an erection. This may depend on physical or psychological causes or a combination of both. Whatever the cause, not enough blood is retained in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels. DIONIFIL only works in the presence of sexual stimulation. The medicine reduces the action of the chemical present in the body, which stops the erection. DIONIFIL allows you to achieve and maintain an erection long enough to satisfactorily complete 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). The signs of an allergic reaction include skin 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 of age and are being treated with ketoconazole or itraconazole, antifungal medicines.
• if you have serious heart or liver problems;
• if you are undergoing kidney dialysis;
• if you have recently had a stroke or a heart attack;
• if you have or have had low blood pressure;
• if your family has a history of degenerative eye diseases (such as retinitis pigmentosa);
• if you have previously had a condition characterised by loss of vision due to damage to the optic nerve due to insufficient blood supply, known as non-arteritic anterior ischaemic 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 if you are unsure, tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking DIONIFIL.

Pay particular attention with DIONIFIL

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or hereditary heart diseases that modify the electrocardiogram.
• If you have a physical condition that causes alterations in the shape of the penis. These include conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
• If you have a condition that can cause persistent erections (priapism). These include sickle cell anaemia, multiple myeloma and leukaemia.
• If you have stomach ulcers (also called gastricor pepticulcers).
• 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 the age of 18.

Other medicines and DIONIFIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
Some medicines can cause problems, particularly these:

• 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 can 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 effect of the medicine.
• Alcoholic beverages can worsen erectile difficulties.

Pregnancy and breastfeeding
DIONIFIL is not intended for use by women.

Driving and operating machinery
In some people DIONIFIL may cause dizziness or alter 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist. The recommended dose is 10 mg.
Take one tablet of DIONIFIL approximately 25-60 minutes before sexual activity. If you are sexually
stimulated, you may achieve an erection within 25 minutes and up to four or five hours after taking
DIONIFIL.

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

Do not take DIONIFILmore than once a day.
If you feel that the effect of DIONIFIL is too strong or too weak, consult your doctor.
They may advise you to take an alternative formulation of DIONIFIL with a different
dosage, based on the effect the medicine has on 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the 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, fast or altered heartbeat, heart attack, chest pain and problems with the
cerebral circulation (including temporarily reduced blood flow to parts of the brain and cerebral
bleeding) have been reported in men taking vardenafil. Most men who have experienced these side
effects had heart problems before taking this medicine. It is not possible to determine whether these
events were directly related to vardenafil.
The likelihood that a side effect will occur is described by the following categories:

Very common:
may affect more than 1 in 10 people

• Headache.

Common:
may affect up to 1 in 10 people

• Dizziness
• Hot flushes
• Nasal congestion 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 disorder
• Numbness and decreased tactile perception
• Drowsiness
• Effects on vision, red eyes, effects on color perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears, vertigo
• Fast heartbeat or heart palpitations
• Shortness of breath
• Nasal congestion
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling unwell (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Skin rash, reddened skin
• Back or muscle pain, increased levels of a muscle enzyme (creatinephosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Feeling unwell.

Rare
may affect up to 1 in 1,000 people

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

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

• Blood in the urine (hematuria)
• Bleeding from the penis (penile hemorrhage)
• Presence of blood in the semen (hematospermia)
• Sudden death
• Cerebral bleeding.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through 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 at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the pack after ‘Exp’. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DIONIFIL contains

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 Roma
Italy

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

DIONIFIL 20 mg film-coated tablets

vardenafil
Generic Medicine

Read this leaflet carefully before 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What DIONIFIL is and what it is used for
• 2. What you need to know before you take 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 is DIONIFIL and what is it 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 that involves difficulty achieving or maintaining an erection. At least one in ten men occasionally have difficulty achieving or maintaining an erection. It may depend on physical or psychological causes or a combination of both. Whatever the cause, not enough blood is retained in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels. DIONIFIL only works in the presence of sexual stimulation. The medicine reduces the action of the chemical present in the body that stops the erection. DIONIFIL allows you to achieve and maintain an erection long enough to satisfactorily complete 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). The signs of an allergic reaction include skin 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 of age and are being treated with ketoconazole or itraconazole, antifungal medicines;
• if you have serious 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 your family has a history of degenerative eye diseases (such as retinitis pigmentosa);
• if you have previously had a condition characterised by loss of vision due to damage to the optic nerve due to insufficient blood supply, known as non-arteritic anterior ischaemic 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). It has been shown that PDE5 inhibitors, such as DIONIFIL, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking DIONIFIL.

Pay particular attention with DIONIFIL

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or hereditary heart diseases that modify the electrocardiogram.
• If you have a physical condition that causes alterations in the shape of the penis. These include conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
• If you have a disease that can cause persistent erections (priapism). These include sickle cell anaemia, multiple myeloma and leukaemia.
• If you have stomach ulcers (also called gastricor 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
Some medicines can cause problems, particularly these:

• 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, anti-fungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (such as benign prostatic hyperplasia).
• Riociguat.

Do not use DIONIFIL film-coated tablets in association with other treatments for erectile
dysfunction, including DIONIFIL orodispersible tablets.

DIONIFIL with food, drinks and alcohol

• You can 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 effect of the medicine.
• Alcoholic beverages can worsen erectile difficulties.

Pregnancy and breastfeeding
DIONIFIL is not intended for use by women.

Driving and operating machinery
In some people DIONIFIL may cause dizziness or alter 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist. The recommended dose is 10 mg.
Take one tablet of DIONIFIL approximately 25-60 minutes before sexual activity. If you are sexually
stimulated, you may achieve an erection after 25 minutes and up to four or five hours after taking
DIONIFIL.

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

Do not take DIONIFILmore than once a day.
If you feel that the effect of DIONIFIL is too strong or too weak, consult your doctor.
They may advise you to take an alternative formulation of DIONIFIL with a different
dosage, based on the effect the medicine has on 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 doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the 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, fast or altered heartbeat, heart attack,
chest pain and problems with blood circulation in the brain (including temporarily
reduced blood flow to parts of the brain and brain bleeding) have been reported in men taking vardenafil. The
majority of men who have experienced these side effects had heart problems before taking this medicine. It is not possible to determine whether these events were
directly related to vardenafil.
The likelihood that a side effect will occur is described by the following categories:

Very common:
may affect more than 1 in 10 people

• Headache.

Common:
may affect up to 1 in 10 people

• Dizziness
• Hot flushes
• 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 disorder
• Numbness and decreased sense of touch
• Drowsiness
• Effects on vision, red eyes, effects on color perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears, vertigo
• Fast heartbeat or heart with a pounding sensation
• Shortness of breath
• Stuffy nose
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling unwell (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Skin rash, reddened skin
• Back or muscle pain, increased levels of a muscle enzyme (creatinephosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Feeling unwell.

Rare
may affect up to 1 in 1,000 people

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

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

• Blood in urine (hematuria)
• Bleeding from the penis (penile hemorrhage)
• Presence of blood in semen (hematospermia)
• Sudden death
• Brain bleeding.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system 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 at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DIONIFIL contains

• The active substance is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride).
• The other ingredients 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, acrylic acid copolymer - Type A, yellow iron oxide (E172), sodium hydrogen carbonate [E500 (ii)], red iron oxide (E172)).

Description of DIONIFIL and contents of the pack
DIONIFIL 20 mg film-coated tablets are light yellow tablets, with “A723” on one side. The tablets are supplied in blister packs of 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