Patient Information Leaflet

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

Equivalent medicine
Please read all of 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 yours, because 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:

What Vardenafil Sandoz is and what it is used for
What you need to know before taking Vardenafil Sandoz
How to take Vardenafil Sandoz
Possible side effects
How to store Vardenafil Sandoz
Contents of the pack and other information

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

Vardenafil Sandoz 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 difficulty in achieving or maintaining an erection.
At least one in ten men occasionally experiences difficulty in achieving or maintaining an erection. This may depend on 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 Sandoz 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 Sandoz enables the achievement and maintenance of an erection long enough to allow satisfactory sexual intercourse.

2. What you need to know before taking Vardenafil Sandoz

Do not take Vardenafil Sandoz

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 Sandoz could dangerously alter your blood pressure.
If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
If you are over 75 years 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 a condition involving 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 Sandoz have been shown to increase the blood pressure-lowering 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 Sandoz.
Exercise special caution with Vardenafil Sandoz

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 affect the electrocardiogram.
If 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.
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 Sandoz orodispersible tablets (see section: Other medicines and Vardenafil Sandoz).
If you experience sudden decrease or loss of vision, stop taking Vardenafil Sandoz and contact your doctor immediately.

Children and adolescents
Vardenafil Sandoz is not intended for use in children and adolescents under 18 years of age.
Other medicines and Vardenafil Sandoz
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 Sandoz could dangerously alter your blood pressure. Do not take Vardenafil Sandoz 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 Sandoz 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 prostate enlargement (such as benign prostatic hyperplasia).
Riociguat.

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

You may take Vardenafil Sandoz 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 Sandoz. It may interfere with the normal effect of the medicine.
Alcoholic beverages may worsen erectile difficulties.

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

3. How to take Vardenafil Sandoz

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

If you take more Vardenafil Sandoz than you should
Patients who take an excessive amount of Vardenafil Sandoz may experience more adverse effects or severe back pain. If you take more Vardenafil Sandoz 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.
Most side effects are usually 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. Stop taking Vardenafil Sandoz 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
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 disturbance
Drowsiness
Numbness and reduced tactile sensation
Vision disturbances; red eyes, changes in colour vision, eye pain or 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 liver enzyme levels 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

Very rare or not known:
may affect less than 1 in 10,000 people or frequency cannot be estimated 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 or pharmacist. You can also report side effects directly via the national reporting system at 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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or the carton 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.

6. Package contents and other information

What Vardenafil Sandoz 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 ingredients 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 copolymer – Type A, yellow iron oxide
(E172), sodium bicarbonate (E500 (ii)), red iron oxide (E172).
Description of the appearance of Vardenafil Sandoz and contents of the pack
Vardenafil Sandoz 5 mg film-coated tablets are light yellow, 6 mm in size, marked “A719” on one side.
Vardenafil Sandoz 10 mg film-coated tablets are light yellow, 7 mm in size, marked “A721” on one side.
Vardenafil Sandoz 20 mg film-coated tablets are light yellow, 8.5 mm in size, marked “A723” on one side.
The tablets are supplied in packs containing 2, 4, 8, 12, 20, 24, 36 and 48
tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy
Manufacturers
Actavis Ltd.
BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000,
Malta
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
Sachsen-Anhalt, 39179 Barleben,
Germany
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
Austria Vardenafil Sandoz 5 mg – filmtabletten
Vardenafil Sandoz 10 mg – filmtabletten
Vardenafil Sandoz 20 mg – filmtabletten
Belgium Vardenafil Sandoz 5 mg filmomhulde tabletten
Vardenafil Sandoz 10 mg filmomhulde tabletten
Vardenafil Sandoz 20 mg filmomhulde tabletten
Estonia Vardenafil Sandoz
France Vardenafil Sandoz 5 mg, comprimé pelliculé
Vardenafil Sandoz 10 mg, comprimé pelliculé
Vardenafil Sandoz 20 mg, comprimé pelliculé
Germany Vardenafil HEXAL 5 mg Filmtabletten
Vardenafil HEXAL 10 mg Filmtabletten
Vardenafil HEXAL 20 mg Filmtabletten
Italy Vardenafil Sandoz
Latvia Vardanafil Sandoz 5 mg apvalkotas tabletes
Vardanafil Sandoz 10 mg apvalkotas tabletes
Vardanafil Sandoz 20 mg apvalkotas tabletes
Lithuania Vardenafil Sandoz 5 mg pleveleden gnostabletes
Vardenafil Sandoz 10 mg pleveleden gnostabletes
Vardenafil Sandoz 20 mg pleveleden gnostabletes
Netherlands Vardenafil Sandoz 5 mg filmomhulde tabletten
Vardenafil Sandoz 10 mg filmomhulde tabletten
Vardenafil Sandoz 20 mg filmomhulde tabletten
Romania Vardenafil Sandoz 5 mg comprimate filmate
Vardenafil Sandoz 10 mg comprimate filmate
Vardenafil Sandoz 20 mg comprimate filmate
Spain Vardenafilo Sandoz 5 mg comprimidos recubiertos con pelicula EFG
Vardenafilo Sandoz 10 mg comprimidos recubiertos con pelicula EFG
Vardenafilo Sandoz 20 mg comprimidos recubiertos con pelicula EFG