Vardenafil PensA

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Vardenafil PENSA 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets

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

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

Contents of this leaflet:

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

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

Vardenafil PENSA contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) 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 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. Whatever 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.
Vardenafil PENSA 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 PENSA enables the achievement and maintenance of an erection long enough to complete sexual intercourse satisfactorily.

2. What you need to know before taking Vardenafil PENSA

Do not take Vardenafil PENSA 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 have ever developed a severe skin rash, peeling, blisters, and/or mouth ulcers after taking Vardenafil PENSA.
• 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 PENSA 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 vision loss due to damage to 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 PENSA have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vardenafil PENSA.
Exercise special caution with Vardenafil PENSA:

• 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 curvature, Peyronie's disease, and cavernosal fibrosis.
• If you have a disease that may cause prolonged erections (priapism), such as sickle cell anemia, multiple myeloma, or 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 orodispersible tablets containing vardenafil (see section "Other medicines and Vardenafil PENSA").
• Severe skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, have been reported in association with vardenafil treatment. Stop taking Vardenafil PENSA and seek immediate medical attention if you notice any symptoms indicating these severe skin reactions described in section 4.
• If you experience sudden decrease or loss of vision, or if your vision becomes blurred or distorted while taking Vardenafil PENSA, stop taking Vardenafil PENSA and contact your doctor immediately.

Children and adolescents
Vardenafil PENSA is not intended for use in children or adolescents under 18 years of age.

Other medicines and Vardenafil PENSA
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:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Vardenafil PENSA could dangerously lower your blood pressure. Do not take Vardenafil PENSA and consult a doctor.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take Vardenafil PENSA and consult a doctor.
• 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 PENSA film-coated tablets in combination with other treatments for erectile dysfunction, including orodispersible tablets containing vardenafil.

Vardenafil PENSA with food and drink and alcohol
You may take Vardenafil PENSA 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 PENSA. It may interfere with the drug's effect.
Alcoholic beverages may worsen erectile difficulties.

Pregnancy and breastfeeding
Vardenafil PENSA is not intended for use by women.

Driving and using machines
In some people, Vardenafil PENSA may cause dizziness or vision disturbances. If you feel dizzy or experience vision problems after taking Vardenafil PENSA, do not drive or operate tools or machinery.

3. How to take Vardenafil PENSA

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 10 mg.
Take one Vardenafil PENSA tablet approximately 25 to 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 PENSA.
Swallow the tablet with a glass of water.
Do not take Vardenafil PENSA film-coated tablets together with any other formulation of vardenafil.
Do not take Vardenafil PENSA more than once a day.
If you feel that the effect of Vardenafil PENSA is too strong or too weak, talk to your doctor.
Your doctor may advise you to take an alternative formulation of Vardenafil PENSA with a different
dosage, depending on how the medicine affects you.
If you take more Vardenafil PENSA than you should
Patients who take an excessive amount of Vardenafil PENSA may experience more side effects or
severe lower back pain. If you take more Vardenafil PENSA 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 everyone experiences them. The effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss of vision, or distorted, blurred or fuzzy vision in one or both eyes. Stop taking Vardenafil PENSA 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 already 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 disorders
• Numbness and reduced tactile sensation
• Drowsiness
• Visual disturbances, red eyes, colour vision disturbances, eye pain and discomfort, light sensitivity
• Ringing in the ears (tinnitus), vertigo
• Rapid heartbeat or pounding sensation in the chest
• Shortness of breath
• Nasal congestion
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, malaise (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
• Memory loss (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
• Increased skin sensitivity to sunlight
• Painful erections
• Chest pain
• Temporary decrease in blood flow to parts of the brain

Very rare or unknown frequency (may affect less than 1 in 10,000 people or frequency cannot be determined from available data)

• Blood in the urine (haematuria)
• Bleeding from the penis (penile haemorrhage)
• Blood in the semen (haemospermia)
• Sudden death; Cerebral haemorrhage
• Flat, red, target-like or circular skin rashes on the trunk, often with central blisters, peeling, and ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
• Distorted, blurred or fuzzy central vision or sudden decrease in vision

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 PENSA

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 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 PENSA contains
The active substance is: vardenafil (as hydrochloride trihydrate) 5 mg, 10 mg or 20 mg.
The other components are:
Tablet core: Crospovidone, Magnesium stearate, Microcrystalline cellulose, Colloidal silicon dioxide
Tablet coating: Macrogol 400, Hypromellose, Titanium dioxide (E171), Iron oxide yellow (E172), Iron oxide red (E172)
Description of the appearance of Vardenafil PENSA and pack contents
5 mg: orange, cylindrical biconvex tablets, engraved with VR5.
10 mg: orange, cylindrical biconvex tablets, engraved with VR1.
20 mg: orange, cylindrical biconvex tablets, engraved with VR2.
Blister pack sizes:
5 mg: 4 film-coated tablets
10 mg: 2 and 4 film-coated tablets
20 mg: 4 film-coated tablets
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan, Italy
Manufacturer
Laboratorios CINFA, S.A.
Olaz-Chipi, 10-Poligono Industrial Area
31620 Huarte Pamplona (Navarra), SPAIN
This patient information leaflet was last approved on

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vardenafil PENSA 10 mg orodispersible tablets

Vardenafil
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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Vardenafil PENSA contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) 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 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. Whatever the cause, an insufficient amount of blood is retained in the penis to initiate and maintain an erection, due to changes in the muscles and blood vessels.
Vardenafil PENSA works only in the presence of sexual stimulation. The medicine reduces the action of a chemical substance naturally present in the body that causes the erection to subside. Vardenafil PENSA enables the achievement and maintenance of an erection long enough to complete sexual intercourse satisfactorily.

2. What you should know before taking Vardenafil PENSA

Do not take Vardenafil PENSA 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 have previously developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Vardenafil PENSA.
• 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 PENSA 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 itraconazolo, 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 vision loss due to damage to the optic nerve caused by 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 PENSA have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vardenafil PENSA.
Exercise particular caution with Vardenafil PENSA:

• If you have heart disorders. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or inherited heart diseases that alter the electrocardiogram.
• If you have a physical condition causing abnormalities 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), such as sickle cell anemia, multiple myeloma, or 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 orally disintegrating tablets containing vardenafil (see section "Other medicines and Vardenafil PENSA").
• Severe skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, have been reported in association with vardenafil treatment. Stop taking Vardenafil PENSA and seek immediate medical attention if you notice any symptoms indicating these severe skin reactions described in section 4.
• If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Vardenafil PENSA, stop taking Vardenafil PENSA and contact your doctor immediately.

Children and adolescents
Vardenafil PENSA is not intended for use in children or adolescents under 18 years of age.

Other medicines and Vardenafil PENSA
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 Vardenafil PENSA could dangerously lower your blood pressure. Do not take Vardenafil PENSA and consult a doctor.
• Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take Vardenafil PENSA and consult a doctor.
• 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 PENSA orally disintegrating tablets in combination with other treatments for erectile dysfunction, including film-coated tablets containing vardenafil.

Taking Vardenafil PENSA with food, drinks, and alcohol
You may take Vardenafil PENSA orally disintegrating tablets with or without food, but do not take this medicine with liquids.
Do not drink grapefruit juice when taking Vardenafil PENSA. It may interfere with the medicine's effect.
Alcoholic beverages may worsen erectile difficulties.

Pregnancy and breastfeeding
Vardenafil PENSA is not intended for use in women.

Driving and using machines
In some people, Vardenafil PENSA may cause dizziness or vision disturbances. If you feel dizzy or notice vision problems after taking Vardenafil PENSA, do not drive or operate tools or machinery.

Vardenafil PENSA 10 mg orally disintegrating tablets contain aspartame and lactose.
This medicine contains 1.5 mg of aspartame per 10 mg orally disintegrating tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
Each Vardenafil PENSA orally disintegrating tablet contains 92.55 mg of lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Vardenafil PENSA

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 Vardenafil PENSA 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 Vardenafil PENSA, and the effect may last up to four to five hours.

• Do not remove the orodispersible tablet from the blister pack until it is time to take it. With dry hands, remove the blister from the container and gently press on the top layer to release the tablet onto your hand. Do not crush the tablet.
• Place the intact orodispersible tablet on your tongue, where it will dissolve within a few seconds, then swallow it with saliva. The orodispersible tablet must be taken without any liquid.

Do not take the orodispersible tablets of Vardenafil PENSA together with any other formulation of vardenafil.
Do not take Vardenafil PENSA more than once a day.
If you feel that the effect of Vardenafil PENSA is too strong or too weak, talk to your doctor.
Your doctor may advise you to take an alternative formulation of Vardenafil PENSA with a different dosage, depending on how the medicine affects you.

If you take more Vardenafil PENSA than you should
Patients who take an excessive amount of Vardenafil PENSA may experience more side effects or severe back pain. If you take more Vardenafil PENSA than prescribed, 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 everybody gets them.
The effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent reduction or loss of vision, or distorted, blurred or fuzzy vision in one or both eyes. Stop taking Vardenafil PENSA 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.
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 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 heartbeat or pounding heart sensation
• Shortness of breath
• Nasal congestion
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, malaise (nausea), dry mouth
• Increased levels of liver enzymes in the blood
• Skin rash, flushed 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

Very rare or frequency not known (may affect less than 1 in 10,000 people or frequency cannot be determined from available data)

• Blood in the urine (haematuria)
• Bleeding from the penis (penile haemorrhage)
• Blood in the semen (haemospermia)
• Sudden death; Cerebral haemorrhage
• Flat, red, target-like or circular skin rashes on the trunk, often with central blisters, peeling, and ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
• Distorted, blurred or fuzzy central vision or sudden decrease in vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the blister after
Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture and light.
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 Vardenafil PENSA orodispersible tablets contain
The active substance is vardenafil. Each orodispersible tablet contains 10 mg of vardenafil (as
hydrochloride trihydrate).
The other components are:
Monohydrate lactose, calcium silicate, hydroxypropylcellulose, crospovidone, aspartame, mint flavour,
anise flavour, magnesium stearate, colloidal silicon dioxide.
Description of the appearance of Vardenafil PENSA and pack contents
Biconvex, cylindrical white tablets with the code VB on one side.
Blister pack containing: 4 orodispersible tablets
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan, Italy
Manufacturer
Laboratorios CINFA, S.A.
Olaz-Chipi, 10-Poligono Industrial Area
31620 Huarte Pamplona (Navarra), SPAIN
This patient information leaflet was last approved on