Vardenafil Teva Italia

Patient Information Leaflet: Information for the User

Vardenafil Teva Italia 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets

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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Vardenafil Teva Italia is and what it is used for

Vardenafil Teva Italia contains the active substance 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 the inability to achieve or maintain an erection.
At least one man in ten occasionally experiences difficulty 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 Teva Italia works only in the presence of sexual stimulation. The medicine reduces the action of a chemical substance naturally present in the body, which causes the erection to subside. Vardenafil Teva Italia enables the achievement and maintenance of an erection long enough to complete sexual intercourse satisfactorily.

2. What you need to know before taking Vardenafil Teva Italia

Do not take Vardenafil Teva Italia

• 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 Teva Italia 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 loss of vision 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 Teva Italia 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 Teva Italia.
Take special care with Vardenafil Teva Italia

• 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 hemophilia).
• If you are using other treatments for erectile difficulties, including vardenafil in orodispersible tablets (see section: Other medicines and Vardenafil Teva Italia).
• If you notice a sudden decrease or loss of vision, stop taking Vardenafil Teva Italia and contact your doctor immediately.

Children and adolescents
Vardenafil Teva Italia is not intended for use in children and adolescents under 18 years of age.
Other medicines and Vardenafil Teva Italia
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 Teva Italia could dangerously lower your blood pressure. Do not take Vardenafil Teva Italia and consult a doctor.
• Medicines used to treat arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take Vardenafil Teva Italia 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 Teva Italia film-coated tablets in combination with other treatments for erectile dysfunction, including vardenafil in orodispersible tablets.
Vardenafil Teva Italia with food, beverages, and alcohol

• You may take Vardenafil Teva Italia 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 Teva Italia. It may interfere with the normal effect of the medicine.
• Alcoholic beverages may worsen difficulties in achieving an erection.

Pregnancy and breastfeeding
Vardenafil Teva Italia is not intended for use by women.
Driving and using machines
Vardenafil Teva Italia may cause dizziness or affect vision. If you feel dizzy or notice vision problems after taking Vardenafil Teva Italia, do not drive or operate tools or machinery.

3. How to take Vardenafil Teva Italia

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Most of the effects are mild to moderate in severity.
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been reported by patients. Discontinue Vardenafil Teva Italia 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.
• Stuffy 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.
• Drowsiness.
• Numbness and reduced tactile sensation.
• Vision disturbances; red eyes, changes in colour vision, eye pain and discomfort, light sensitivity.
• Ringing in the ears; dizziness.
• 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 user in 1,000

• 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.

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 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 the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vardenafil Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or the outer carton after "Exp". The expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Vardenafil Teva Italia contains

• The active substance is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride).
• The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).
• The active substance is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride).

The other components of the tablet are:

• Tablet core: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate.
• Film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), macrogol/PEG 3350 (E1521), methacrylic acid-ethyl acrylate copolymer type A, yellow iron oxide (E172), sodium bicarbonate (E500(ii)), red iron oxide (E172).

Description of the appearance of Vardenafil Teva Italia and contents of the pack
Vardenafil Teva Italia 5 mg film-coated tablets are light yellow tablets, 6 mm in diameter, marked with “A719” on one side.
Vardenafil Teva Italia 10 mg film-coated tablets are light yellow tablets, 7 mm in diameter, marked with “A721” on one side.
Vardenafil Teva Italia 20 mg film-coated tablets are light yellow tablets, 8.5 mm in diameter, marked with “A723” on one side.
The tablets are supplied in blister packs containing 2, 4, 8, 12, 20, 24, 36 and 48 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan – Italy

Manufacturer:
Actavis Ltd.
BLB015-016, Bulebel Industrial Estate
Zejtun ZTN 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names: