VARDENAFIL ZENTIVA

Package leaflet: Information for the patient

Vardenafil Zentiva 20 mg film-coated tablets

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 other people, even if their symptoms are the same as yours, as it may 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 Vardenafil Zentiva is and what it is used for
2. What you need to know before taking Vardenafil Zentiva
3. How to take Vardenafil Zentiva
4. Possible side effects
5. How to store Vardenafil Zentiva
6. Contents of the pack and other information

1. What is Vardenafil Zentiva and what is it used for?

Vardenafil Zentiva 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 is retained in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels.
Vardenafil Zentiva 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. Vardenafil Zentiva 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 Vardenafil Zentiva

Do not take Vardenafil Zentiva 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 (dyspnea).
• 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 Vardenafil Zentiva could dangerously affect your blood pressure.
• you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
• you are over 75 years old and are being treated with ketoconazole or itraconazole, antifungal medicines.
• you have severe heart or liver problems.
• you are undergoing renal dialysis.
• you have recently had a stroke or heart attack.
• you have, or have had, low blood pressure.
• there is a family history of degenerative eye diseases (such as retinitis pigmentosa).
• you have previously experienced a condition characterized by loss of vision due to damage of the optic nerve from insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• 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 Vardenafil Zentiva, 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 Vardenafil Zentiva if

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

Children and adolescents
Vardenafil Zentiva is not intended for use in children or adolescents under 18 years of age.
Other medicines and Vardenafil Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Some medicines may cause problems, particularly these:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Vardenafil Zentiva could dangerously affect 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 Vardenafil Zentiva film-coated tablets in combination with other treatments for erectile dysfunction, including orodispersible tablets containing vardenafil.

Taking Vardenafil Zentiva with food and drink
You may take Vardenafil Zentiva 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 Vardenafil Zentiva. It may interfere with the medicine's effect.
Alcoholic beverages may worsen erectile difficulties.
Pregnancy and breastfeeding
Vardenafil Zentiva is not intended for use in women.
Driving and using machines
In some people, Vardenafil Zentiva may cause dizziness or vision disturbances. If you feel dizzy or notice any vision problems after taking Vardenafil Zentiva, do not drive or operate tools or machinery.

3. How to take Vardenafil Zentiva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The recommended dose is 10 mg.
Take one tablet of Vardenafil Zentiva approximately 25 to 60 minutes before sexual activity. If you are
sexually stimulated, you may achieve an erection as early as 25 minutes after taking Vardenafil Zentiva, and
the effect may last up to four to five hours.
Swallow the tablet with a glass of water.
Do not take the film-coated tablets of Vardenafil Zentiva together with any other formulation
of vardenafil.
Do not take Vardenafil Zentiva more than once a day.
If you feel that the effect of Vardenafil Zentiva is too strong or too weak, consult your
doctor.
Your doctor may advise you to take an alternative formulation of Vardenafil Zentiva with a different
dosage, depending on how the medicine affects you.
If you take more Vardenafil Zentiva than you should
Men who take an excessive amount of Vardenafil Zentiva may experience more side effects or severe
lower back pain. If you take more Vardenafil Zentiva than you should, consult your
doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes. Stop taking Vardenafil Zentiva 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 haemorrhage) have been reported in men taking vardenafil. Many of the men who experienced these side effects 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 disorder
• Numbness and altered sense of touch
• Drowsiness
• Visual disturbances; red eyes, changes in colour vision, eye pain and discomfort, sensitivity to light
• Ringing in the ears, dizziness
• Rapid heartbeat or pounding sensation in the chest
• Shortness of breath
• Nasal congestion
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, 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 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
• Effects on liver function test results
• Skin sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary reduction in blood flow to parts of the brain

Frequency not known (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, tell 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Vardenafil Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and blister pack following 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 Vardenafil Zentiva contains
The active substance is vardenafil (as hydrochloride trihydrate) 20 mg.
The other components are:
Tablet core: Microcrystalline cellulose; anhydrous colloidal silicon dioxide;
Crospovidone (type A); Stearic acid.
Tablet coating: Hypromellose; Macrogol 400; Titanium dioxide (E171); Yellow iron oxide (E172); Red iron oxide (E172).

Description of the appearance of Vardenafil Zentiva and package contents
Orange, round tablets with a diameter of approximately 8 mm, marked with "20" on one side and a decorative line on the other side. The score line on the tablet is intended to facilitate breaking for easier swallowing and is not intended for dividing the tablet into equal doses.

Blister packs containing: 2, 4, 8, 12, 24, 48 and 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale Bodio 37/B
20158 Milano
Italy

Manufacturer
Zentiva, k.s.
U kabelovny 130
102 37 Praha 10,
Dolní Měcholupy
Czech Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany, Italy, United Kingdom: Vardenafil Zentiva

Package leaflet: information for the patient

Vardenafil Zentiva 10 mg film-coated tablets

Equivalent 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 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Vardenafil Zentiva is and what it is used for

Vardenafil Zentiva 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 man in ten 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, insufficient blood is retained in the penis to achieve and maintain an erection, due to changes in the muscles and blood vessels.
Vardenafil Zentiva 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. Vardenafil Zentiva enables you to achieve and maintain an erection long enough to complete sexual intercourse satisfactorily.

2. What you should know before taking Vardenafil Zentiva

Do not take Vardenafil Zentiva 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 (dyspnea).
• 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 Vardenafil Zentiva could dangerously alter your blood pressure.
• you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
• you are over 75 years old and are being treated with ketoconazole or itraconazole, antifungal medicines.
• you have severe heart or liver problems.
• you are undergoing renal dialysis.
• you have recently had a stroke or heart attack.
• you have, or have had, low blood pressure.
• you or your family have a history of degenerative eye diseases (such as retinitis pigmentosa).
• you have previously experienced loss of vision due to damage to the optic nerve from insufficient blood flow, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• 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 Vardenafil Zentiva 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 Vardenafil Zentiva if

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

Children and adolescents
Vardenafil Zentiva is not intended for use in children or adolescents under 18 years of age.
Other medicines and Vardenafil Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Some medicines may cause problems, particularly these:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Vardenafil Zentiva 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 itraconazolo, 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 Vardenafil Zentiva film-coated tablets in combination with other treatments for erectile dysfunction, including orodispersible tablets containing vardenafil.

Taking Vardenafil Zentiva with food and drinks
You may take Vardenafil Zentiva 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 Vardenafil Zentiva. It may interfere with the medicine’s effect.
Alcoholic beverages may worsen erectile difficulties.
Pregnancy and breastfeeding
Vardenafil Zentiva is not intended for use in women.
Driving and using machines
In some people, Vardenafil Zentiva may cause dizziness or vision disturbances. If you feel dizzy or notice vision problems after taking Vardenafil Zentiva, do not drive or operate tools or machinery.

3. How to take Vardenafil Zentiva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The recommended dose is 10 mg.
Take one tablet of Vardenafil Zentiva 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 Vardenafil Zentiva.
Swallow the tablet with a glass of water.
Do not take the film-coated tablets of Vardenafil Zentiva together with any other formulation
of vardenafil.
Do not take Vardenafil Zentiva more than once a day.
If you feel that the effect of Vardenafil Zentiva is too strong or too weak, talk to your
doctor.
They may advise you to take an alternative formulation of Vardenafil Zentiva with a different
dosage, depending on how the medicine affects you.
If you take more Vardenafil Zentiva than you should
Men who take an excessive amount of Vardenafil Zentiva may experience more side effects or severe
back pain. If you take more Vardenafil Zentiva than you should, consult your doctor.
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. The effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss of vision, in one or both eyes. Stop taking Vardenafil Zentiva 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. Many of the 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 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
• 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 altered tactile perception
• Somnolence
• Visual disturbances; red eyes, disturbances in colour vision, eye pain and discomfort, light sensitivity
• Tinnitus, vertigo
• Rapid heartbeat or pounding heart
• Shortness of breath
• Nasal congestion
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, nausea, dry mouth
• Increased levels of liver enzymes in blood
• Rash, red skin
• Back or muscle pain, increased levels of a muscle enzyme (creatine phosphokinase) in 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 tearing
• 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 decrease in blood flow to parts of the brain

Frequency not known (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 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 Vardenafil Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label 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 Vardenafil Zentiva contains
The active substance is vardenafil (as hydrochloride trihydrate) 10 mg.
The other ingredients are:
Tablet core: Microcrystalline cellulose; anhydrous colloidal silica;
Crospovidone (type A); Stearic acid.
Tablet coating: Hypromellose; Macrogol 400; Titanium dioxide (E171);
Yellow iron oxide (E172); Red iron oxide (E172).

Description of the appearance of Vardenafil Zentiva and package contents
Yellow-orange, round film-coated tablets approximately 6 mm in diameter, engraved with "10" on one side and a decorative line on the other. The score line on the tablet is intended to facilitate swallowing by allowing the tablet to be broken into two parts, but it is not intended for dividing the tablet into equal doses.

Pack sizes in blister packs: 2, 4, 8, 12, 24, 48 and 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale Bodio 37/B
20158 Milan, Italy

Manufacturer
Zentiva, k.s.
U kabelovny 130
102 37 Praha 10, Dolní Měcholupy
Czech Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany, Italy, United Kingdom: Vardenafil Zentiva

Patient information leaflet

Vardenafil Zentiva 5 mg film-coated tablets

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

1. What Vardenafil Zentiva is and what it is used for

Vardenafil Zentiva 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 involving difficulty in achieving or maintaining an erection.
At least one man in ten occasionally experiences difficulty in achieving or maintaining an erection. This may depend on physical or psychological causes, or a combination of both. Whatever 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.
Vardenafil Zentiva 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. Vardenafil Zentiva 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 Vardenafil Zentiva

Do not take Vardenafil Zentiva 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 (dyspnea).
• 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 Vardenafil Zentiva could dangerously lower your blood pressure.
• you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
• you are over 75 years old and are being treated with ketoconazole or itraconazole, antifungal medicines.
• you have severe heart or liver problems.
• you are undergoing renal dialysis.
• you have recently had a stroke or heart attack.
• you have, or have had, low blood pressure.
• you have a family history of degenerative eye diseases (such as retinitis pigmentosa).
• you have previously experienced loss of vision due to damage to the optic nerve from insufficient blood flow, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• 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 Vardenafil Zentiva 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 Vardenafil Zentiva if

• you have heart disorders. Sexual activity may be risky for you.
• you suffer from irregular heartbeat (cardiac arrhythmia) or inherited heart diseases that
• alter the electrocardiogram (ECG).
• 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.
• you have a disease that may cause prolonged erections (priapism). These include sickle cell anemia, multiple myeloma, or leukemia.
• you have stomach ulcers (also known as gastric or peptic ulcers).
• you have a bleeding disorder (such as hemophilia).
• you are using other treatments for erectile difficulties, including orodispersible tablets containing vardenafil (see section Other medicines and Vardenafil Zentiva).
• you experience a sudden decrease or loss of vision, stop taking Vardenafil Zentiva and contact your doctor immediately.

Children and adolescents
Vardenafil Zentiva is not intended for use in children or adolescents under 18 years of age.
Other medicines and Vardenafil Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
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 Vardenafil Zentiva 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 Vardenafil Zentiva film-coated tablets in combination with other treatments for erectile dysfunction, including orodispersible tablets containing vardenafil.

Taking Vardenafil Zentiva with food and drinks
You may take Vardenafil Zentiva 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 Vardenafil Zentiva. It may interfere with the medicine’s effect.
Alcoholic beverages may worsen erectile difficulties.
Pregnancy and breastfeeding
Vardenafil Zentiva is not intended for use in women.
Driving and using machines
In some people, Vardenafil Zentiva may cause dizziness or vision disturbances. If you feel dizzy or notice vision problems after taking Vardenafil Zentiva, do not drive or operate tools or machinery.

3. How to take Vardenafil Zentiva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 10 mg.
Take one tablet of Vardenafil Zentiva approximately 25–60 minutes before sexual activity. If you are sexually stimulated, you may achieve an erection as early as 25 minutes after taking Vardenafil Zentiva and up to four to five hours afterwards.
Swallow the tablet with a glass of water.
Do not take the film-coated tablets of Vardenafil Zentiva together with any other formulation of vardenafil.
Do not take Vardenafil Zentiva more than once a day.
If you feel that the effect of Vardenafil Zentiva is too strong or too weak, talk to your doctor.
Your doctor may advise you to take an alternative formulation of Vardenafil Zentiva with a different dosage, depending on how the medicine affects you.

If you take more Vardenafil Zentiva than you should
Men who take an excessive amount of Vardenafil Zentiva may experience more side effects or severe back pain. If you take more Vardenafil Zentiva than you should, consult your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes. Stop taking Vardenafil Zentiva 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 haemorrhage) have been reported in men taking vardenafil. Many of the men who experienced these side effects 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
• 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 disorders
• Numbness and altered tactile sensation
• Drowsiness
• Visual disturbances; red eyes, disturbances in colour vision, eye pain and discomfort, light sensitivity
• Ringing in the ears (tinnitus), vertigo
• Rapid or pounding heartbeat
• Shortness of breath
• Nasal congestion
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, 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 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
• Effects on liver function test results
• Skin sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary reduction in blood flow to parts of the brain

Frequency not known (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, 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 Vardenafil Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the 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 Vardenafil Zentiva contains
The active substance is vardenafil (as hydrochloride trihydrate) 5 mg.
The other components are: Tablet core: Microcrystalline cellulose; anhydrous colloidal silica;
Crospovidone (type A); Stearic acid.
Tablet coating: Hypromellose; Macrogol 400; Titanium dioxide (E171); Yellow iron oxide (E172); Red iron oxide (E172).
Description of the appearance of Vardenafil Zentiva and contents of the pack
Slightly yellow to slightly brown, round film-coated tablets, approximately 6 mm in size, with "5" engraved on one side.
Blister packs containing: 2, 4, 8, 12 and 24 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale Bodio 37/B
20158 Milano
Italy
Manufacturer
Zentiva, k.s.
U kabelovny 130
102 37 Praha 10,
Dolní Měcholupy
Czech Republic
This medicinal product is authorized in the European Economic Area countries under the following
names:
Germany, Italy, United Kingdom: Vardenafil Zentiva