Package leaflet: information for the user

ELUTATIS 5 mg film-coated tablets, 10 mg film-coated tablets, 20 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, 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, because 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:

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

1. What ELUTATIS is and what it is used for

ELUTATIS 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 that causes 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, insufficient blood is retained in the penis to achieve and maintain an erection, due to changes in the muscles and blood vessels.
ELUTATIS 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. ELUTATIS enables the achievement and maintenance of an erection long enough to complete sexual intercourse satisfactorily.

2. What you should know before taking ELUTATIS

Do not take ELUTATIS

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 ELUTATIS 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 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 ELUTATIS, 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 ELUTATIS.
Take special care with ELUTATIS

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 that causes changes in the shape of the penis. These include conditions called 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 erection difficulties, including ELUTATIS orodispersible tablets (see section Other medicines and ELUTATIS).
If you notice a sudden decrease or loss of vision, stop taking ELUTATIS and contact your doctor immediately.

Children and adolescents
ELUTATIS is not intended for use in children or adolescents under 18 years of age.
Other medicines and ELUTATIS
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 ELUTATIS could dangerously lower your blood pressure. Do not take ELUTATIS and consult your doctor.
Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
Ritonavir or indinavir, medicines for HIV. Do not take ELUTATIS and consult your 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 ELUTATIS film-coated tablets in combination with other treatments for erectile dysfunction.
ELUTATIS with food, drinks, and alcohol

You may take ELUTATIS 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 ELUTATIS. It may interfere with the medicine’s effect.
Alcoholic beverages may worsen erection difficulties.

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

3. How to take ELUTATIS

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 ELUTATIS 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 ELUTATIS and up to four to five hours after administration.
Swallow the tablet with a glass of water.
Do not take the film-coated tablets of ELUTATIS together with any other formulation of ELUTATIS.
Do not take ELUTATIS more than once a day.
If you feel that the effect of ELUTATIS is too strong or too weak, consult your doctor.
Your doctor may advise you to take an alternative formulation of ELUTATIS with a different dosage, depending on how the medicine affects you.
If you take more ELUTATIS than you should
Patients who take an excessive amount of ELUTATIS may experience more side effects or severe lower back pain. If you take more ELUTATIS 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 experiences them.
The effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent reduction or loss of vision, in one or both eyes.
Stop taking ELUTATIS 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
Hot flushes
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 disturbances
Numbness and reduced tactile sensation
Drowsiness
Vision disturbances; red eyes, disturbances in colour perception, eye pain and discomfort, light sensitivity
Ringing in the ears; dizziness
Rapid or pounding heartbeat
Shortness of breath
Stuffy nose
Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; 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
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
Effect 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 the 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.
You can also report side effects directly via
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 ELUTATIS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on 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 ELUTATIS 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 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 (1:1) - Type A, yellow iron oxide (E172), sodium bicarbonate (E500 (ii)), red iron oxide (E172).

Description of the appearance of ELUTATIS and package contents
ELUTATIS 5 mg: round, film-coated, light yellow tablets, 6 mm in diameter, marked with “A719” on one side.
ELUTATIS 10 mg: round, film-coated, light yellow tablets, 7 mm in diameter, marked with “A721” on one side.
ELUTATIS 20 mg: round, film-coated, light yellow tablets, 8.5 mm in diameter, marked with “A723” on one side.
5 mg: tablets are available in blisters containing 4 tablets.
10 mg: tablets are available in blisters containing 2, 4, 8, and 12 tablets.
20 mg: tablets are available in blisters containing 4 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
F.I.R.M.A. S.p.A. - Via di Scandicci, 37, 50143 – Florence, Italy (IT).

Manufacturer
Actavis Ltd - BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: ELUTATIS
Italy: ELUTATIS