Vardenafil Tecnigen

Italy
Brand name Vardenafil Tecnigen
Form tablets, film-coated
Active substance / Dosage
VARDENAFIL
Prescription type Prescription only
ATC code
G04BE09
Registration number 049308
Manufacturer TECNIGEN S.R.L.

Table of Contents

Package leaflet: Information for the user

Vardenafil Tecnigen 5 mg film-coated tablets

Vardenafil
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 others, even if they have the same symptoms as you, because it could be harmful.
  • If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Vardenafil Tecnigen 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 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, 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 Tecnigen 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 Tecnigen enables the achievement and maintenance of an erection long enough to satisfactorily complete sexual intercourse.

2. What you need to know before taking Vardenafil Tecnigen

Do not take Vardenafil Tecnigen

  • If you are allergic to vardenafil or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and shortness of breath.
  • If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with Vardenafil Tecnigen could dangerously lower your blood pressure.
  • If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
  • If you are over 75 years old and are being treated with ketoconazole or itraconazole, antifungal

medicines.

  • If you have severe heart or liver problems.
  • If you are undergoing renal dialysis.
  • If you have recently had a stroke or heart attack.
  • If you have, or have had, low blood pressure.
  • If there is a family history of degenerative eye diseases (such as retinitis pigmentosa).
  • If you have ever had, or currently have, a condition characterized by sudden vision loss due to damage of the optic nerve from insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION).
  • If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as Vardenafil Tecnigen, 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 Tecnigen.
Be especially careful with Vardenafil Tecnigen

  • 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 known as gastric or peptic ulcers).
  • If you have a bleeding disorder (such as haemophilia).
  • If you are using other treatments for erection difficulties, including Vardenafil Tecnigen orodispersible tablets (see section "Other medicines and Vardenafil Tecnigen").
  • If you experience a sudden decrease or loss of vision, stop taking Vardenafil Tecnigen and contact your doctor immediately.

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

  • Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Vardenafil Tecnigen could dangerously lower your blood pressure. Talk to a doctor before taking Vardenafil Tecnigen.
  • Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
  • Ritonavir or indinavir, medicines for HIV. Talk to a doctor before taking Vardenafil Tecnigen.
  • 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 Tecnigen film-coated tablets in combination with other treatments for
erectile dysfunction.
Vardenafil Tecnigen with food, drinks and alcohol

  • You may take Vardenafil Tecnigen 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 Tecnigen. It may interfere with the medicine's effect.
  • Alcoholic beverages may worsen erection difficulties.

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

3. How to take Vardenafil Tecnigen

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 Tecnigen 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 Tecnigen and up to four to five hours afterwards.

  • Swallow the tablet with a glass of water.

Do not take Vardenafil Tecnigen more than once a day.
If you feel that the effect of Vardenafil Tecnigen is too strong or too weak, talk to your doctor. Your doctor may advise you to take an alternative formulation of Vardenafil Tecnigen with a different dosage, depending on how the medicine affects you.
If you take more Vardenafil Tecnigen than you should
Patients who take an excessive amount of Vardenafil Tecnigen may experience more side effects or severe back pain. If you take more Vardenafil Tecnigen 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 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 Tecnigen and contact your doctor immediately. Sudden decrease or loss of hearing has also been reported.
The likelihood of experiencing a side effect is described using the following categories:
Very common
(may affect more than 1 user in 10)

  • Headache.

Common
(may affect up to 1 user in 10)

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

Uncommon
(may affect up to 1 user in 100)

  • Swelling of the skin and mucous membranes, including swelling of the face, lips or throat.
  • Sleep disorders.
  • Numbness and reduced tactile perception.
  • Drowsiness.
  • Visual disturbances, red eyes, disturbances in colour perception, eye pain and discomfort, sensitivity to light.
  • Ringing in the ears, vertigo.
  • Rapid or pounding heartbeat.
  • Shortness of breath.
  • 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 user in 1,000)

  • 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.
  • Skin sensitivity to sunlight.
  • Painful erections.
  • Chest pain.

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

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the website 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 Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Vardenafil Tecnigen contains
The active substance is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride
trihydrate).
The other components of the tablets are:
Tablet core: microcrystalline cellulose, crospovidone type B, anhydrous colloidal silicon dioxide,
magnesium stearate.
Film coating: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol 400, red iron oxide (E172).
Description of the appearance of Vardenafil Tecnigen and pack contents
Vardenafil Tecnigen 5 mg film-coated tablets are round, biconvex, film-coated tablets of orange-brown colour with a diameter of 6 mm.
Vardenafil Tecnigen film-coated tablets are supplied in blister packs containing 4 tablets.
Marketing Authorization Holder:
TECNIGEN S.r.l.
via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy
Manufacturer
Pharmaceutical Works Polpharma S.A.
19 Pelplińska Street
83-200 Starogard Gdanski
Poland
This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Italy: Vardenafil Tecnigen.
Portugal: Vardenafil Tecnigen.
Spain: Vardenafilo TecniGen 5 mg, 10 mg, 20 mg comprimidos recubiertos con película EFG.

Package leaflet: Information for the user

Vardenafil Tecnigen 10 mg film-coated tablets

Vardenafil
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, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

7. What Vardenafil Tecnigen is and what it is used for

Vardenafil Tecnigen 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 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, 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 Tecnigen 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 Tecnigen enables the achievement and maintenance of an erection long enough to complete sexual intercourse satisfactorily.

8. What you need to know before taking Vardenafil Tecnigen

Do not take Vardenafil Tecnigen

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

  • 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 deformities 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 known as gastric or peptic ulcers).
  • If you have a bleeding disorder (such as haemophilia).
  • If you are using other treatments for erectile dysfunction, including Vardenafil Tecnigen orodispersible tablets (see section "Other medicines and Vardenafil Tecnigen").
  • If you experience a sudden decrease or loss of vision, stop taking Vardenafil Tecnigen and contact your doctor immediately.

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

Other medicines and Vardenafil Tecnigen
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 together with Vardenafil Tecnigen could dangerously lower your blood pressure. Talk to a doctor before taking Vardenafil Tecnigen.
  • Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
  • Ritonavir or indinavir, medicines for HIV. Talk to a doctor before taking Vardenafil Tecnigen.
  • 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 Tecnigen film-coated tablets in combination with other treatments for erectile dysfunction.

Vardenafil Tecnigen with food, beverages, and alcohol

  • You may take Vardenafil Tecnigen 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 Tecnigen. It may interfere with the medicine's effect.
  • Alcoholic beverages may worsen erectile difficulties.

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

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

9. How to take Vardenafil Tecnigen

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 Tecnigen 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 Tecnigen and up to four to five hours afterwards.

  • Swallow the tablet with a glass of water.

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

10. 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 Tecnigen and contact your doctor immediately. Sudden decrease or loss of hearing has also been reported.
The likelihood of experiencing a side effect 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
  • 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 vision, eye pain and discomfort, light sensitivity
  • Ringing in the ears (tinnitus), dizziness
  • Rapid or pounding heartbeat
  • 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, 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
  • Heart-related effects (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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the website 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.

11. How to store Vardenafil Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

12. Package contents and other information

What Vardenafil Tecnigen contains
The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride
trihydrate).
The other components of the tablets are:
Tablet core: microcrystalline cellulose, crospovidone type B, anhydrous colloidal silicon dioxide,
magnesium stearate.
Film coating: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 400.
Description of the appearance of Vardenafil Tecnigen and contents of the pack
Vardenafil Tecnigen 10 mg film-coated tablets are round, biconvex, film-coated tablets of light orange colour, 8 mm in diameter.
Vardenafil Tecnigen film-coated tablets are supplied in blister packs containing 2, 4 or 8 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
TECNIGEN S.r.l.
via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy
Manufacturer
Pharmaceutical Works Polpharma S.A.
19 Pelplińska Street
83-200 Starogard Gdanski
Poland
This medicinal product is authorised in the European Economic Area (EEA) Member States under the
following names:
Italy: Vardenafil Tecnigen.
Portugal: Vardenafil Tecnigen.
Spain: Vardenafilo TecniGen 5 mg, 10 mg, 20 mg comprimidos recubiertos con película EFG.

Package leaflet: Information for the user

Vardenafil Tecnigen 20 mg film-coated tablets

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

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

Contents of this leaflet

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

13. What Vardenafil Tecnigen is and what it is used for

Vardenafil Tecnigen 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 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, an insufficient amount of blood remains in the penis to achieve and maintain an erection, due to changes in the muscles and blood vessels.
Vardenafil Tecnigen 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 end of an erection. Vardenafil Tecnigen enables the achievement and maintenance of an erection long enough to satisfactorily complete sexual intercourse.

14. What you need to know before taking Vardenafil Tecnigen

Do not take Vardenafil Tecnigen

  • If you are allergic to vardenafil or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and shortness of breath.
  • If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with Vardenafil Tecnigen could dangerously lower your blood pressure.
  • If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
  • If you are over 75 years old and are being treated with ketoconazole or itraconazole, antifungal

medicines.

  • If you have severe heart or liver problems.
  • If you are on renal dialysis.
  • If you have recently had a stroke or heart attack.
  • If you have, or have had, low blood pressure.
  • If there is a family history of degenerative eye diseases (such as retinitis pigmentosa).
  • If you have ever had a condition characterized by sudden vision loss due to damage of the optic nerve from insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION).
  • If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Vardenafil Tecnigen, have been shown to increase the hypotensive effect of this drug. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vardenafil Tecnigen.
Take special care with Vardenafil Tecnigen

  • 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 penile deformity. 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 known as gastric or peptic ulcers).
  • If you have a bleeding disorder (such as haemophilia).
  • If you are using other treatments for erectile difficulties, including Vardenafil Tecnigen orodispersible tablets (see section Other medicines and Vardenafil Tecnigen).
  • If you experience a sudden decrease or loss of vision, stop taking Vardenafil Tecnigen and contact your doctor immediately.

Children and adolescents
Vardenafil Tecnigen is not intended for use in children or adolescents under 18
years of age.
Other medicines and Vardenafil Tecnigen
Inform your doctor or pharmacist if you are using, have recently used, or might use 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 Tecnigen could dangerously lower your blood pressure. Talk to a doctor before taking Vardenafil Tecnigen.
  • Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
  • Ritonavir or indinavir, medicines for HIV. Talk to a doctor before taking Vardenafil Tecnigen.
  • Ketoconazole or itraconazole, antifungal medicines.
  • Erythromycin or clarithromycin, macrolide antibiotics.
  • Alpha-blockers, a type of medicine used to treat high blood pressure and prostate enlargement (such as benign prostatic hyperplasia).
  • Riociguat.

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

  • You may take Vardenafil Tecnigen 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 Tecnigen. It may interfere with the drug's effect.
  • Alcoholic beverages may worsen erectile difficulties.

Pregnancy and breastfeeding
Vardenafil Tecnigen is not intended for use in women.
Driving and using machines
In some people, Vardenafil Tecnigen may cause dizziness or vision disturbances. If you feel
dizzy or notice vision problems after taking Vardenafil Tecnigen, do not drive or operate
tools or machinery.
Vardenafil Tecnigen contains Sunset Yellow FCF (E 110)
Vardenafil Tecnigen 20 mg film-coated tablets contain Sunset Yellow FCF (E 110),
which may cause allergic reactions.

15. How to take Vardenafil Tecnigen

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 Tecnigen 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 Tecnigen and lasting up to four to five hours.

  • Swallow the tablet with a glass of water.

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

16. 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 in one or both eyes. Stop taking Vardenafil Tecnigen and contact your doctor immediately. Sudden decrease or loss of hearing has also been reported.
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 reduced tactile sensation
  • Somnolence
  • Visual disturbances, red eyes, disturbances in colour perception, eye pain and discomfort, light sensitivity
  • Ringing in the ears, vertigo
  • Rapid or pounding heartbeat
  • 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 eye (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

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)
  • Presence of blood in the semen (haemospermia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the website 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.

17. How to store Vardenafil Tecnigen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

18. Package contents and other information

What Vardenafil Tecnigen contains
The active substance is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride
trihydrate).
The other components of the tablets are:
Tablet core: microcrystalline cellulose, crospovidone type B, colloidal anhydrous silica,
magnesium stearate.
Film coating: hypromellose, titanium dioxide (E171), yellow iron oxide (E172), macrogol
400, red iron oxide (E172), sunset yellow FCF (E 110).
Description of the appearance of Vardenafil Tecnigen and package contents
Vardenafil Tecnigen 20 mg film-coated tablets are round, biconvex, film-coated tablets of light orange colour, 10 mm in diameter.
Vardenafil Tecnigen film-coated tablets are supplied in blister packs containing 4 tablets.
Marketing Authorization Holder:
TECNIGEN S.r.l.
via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy
Manufacturer
Pharmaceutical Works Polpharma S.A.
19 Pelplińska Street
83-200 Starogard Gdanski
Poland
This medicinal product is authorized in the European Economic Area (EEA) Member States under
the following names:
Italy: Vardenafil Tecnigen.
Portugal: Vardenafil Tecnigen.
Spain: Vardenafilo TecniGen 5 mg, 10 mg, 20 mg comprimidos recubiertos con película EFG.