Patient Information Leaflet: Information for the User

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

1. What VARDENAFIL DOC is and what it is used for

VARDENAFIL DOC 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 DOC 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 DOC enables the achievement and maintenance of an erection long enough to
complete sexual intercourse satisfactorily.

2. What you should know before taking VARDENAFIL DOC

Do not take VARDENAFIL DOC

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 DOC 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 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 DOC 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 DOC.
Exercise special caution with VARDENAFIL DOC:

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 deformities 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 orodispersible tablets (see section "Other medicines and VARDENAFIL DOC").
If you experience a sudden decrease or loss of vision, stop taking VARDENAFIL DOC and contact your doctor immediately.

Children and adolescents
VARDENAFIL DOC is not intended for use in children or adolescents under
18 years of age.
Other medicines and VARDENAFIL DOC
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 DOC could dangerously alter your blood
pressure. Do not take VARDENAFIL DOC 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 DOC 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 DOC film-coated tablets in combination with other
treatments for erectile dysfunction, including vardenafil orodispersible tablets.
VARDENAFIL DOC with food, beverages and alcohol

You may take VARDENAFIL DOC 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 DOC. It may interfere with the drug's effect.
Alcoholic beverages may worsen erectile difficulties.

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

3. How to take VARDENAFIL DOC

Take this medicine exactly as your doctor has told you. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is 10 mg.
Take one tablet of VARDENAFIL DOC 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 DOC and lasting up to four to five hours.
Swallow the tablet with a glass of water.
Do not take VARDENAFIL DOC more than once a day.
If you feel that the effect of VARDENAFIL DOC is too strong or too weak, talk to your doctor. Your doctor may advise you to take an alternative formulation of VARDENAFIL DOC with a different dosage, depending on how the medicine affects you.
If you take more VARDENAFIL DOC than you should
Patients who take an excessive amount of VARDENAFIL DOC may experience more side effects or severe lower back pain. If you take more VARDENAFIL DOC than you should, consult 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 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 DOC 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 bleeding) 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
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
Numbness and reduced tactile sensation
Drowsiness
Visual disturbances; red eyes, changes in colour vision, eye pain and discomfort, sensitivity to light
Ringing in the ears; dizziness
Rapid heartbeat or pounding heart sensation
Shortness of breath
Nasal congestion
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
Temporary reduction in blood flow to parts of the brain
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 estimated from the available data

Blood in the urine ( haematuria )
Bleeding from the penis ( penile haemorrhage )
Blood in the semen ( haemospermia )
Sudden death
Cerebral haemorrhage

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 DOC

Do not store above 30°C.
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 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 no longer required. This will help protect the environment.

6. Package contents and other information

What VARDENAFIL DOC contains

The active substance is vardenafil. Each 5 mg tablet contains 5 mg of vardenafil (as hydrochloride). Each 10 mg tablet contains 10 mg of vardenafil (as hydrochloride). Each 20 mg tablet contains 20 mg of vardenafil (as hydrochloride).
The other components are: Tablet core: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate. Film coating: Titanium dioxide (E171), talc (E553b), macrogol/PEG 3350 (E1521), methacrylic acid copolymer type C, yellow iron oxide (E172), sodium hydrogen carbonate (E500 (ii)), red iron oxide (E172).

Description of the appearance of VARDENAFIL DOC and package contents
VARDENAFIL DOC 5 mg: film-coated tablets, round, 6 mm in size, light yellow in colour, with 'A719' engraved on one side.
VARDENAFIL DOC 10 mg: film-coated tablets, round, 7 mm in size, light yellow in colour, with 'A721' engraved on one side.
VARDENAFIL DOC 20 mg: film-coated tablets, round, 8.5 mm in size, light yellow in colour, with 'A723' engraved on one side.
The tablets are available in blister packs in the following pack sizes:
5 mg: 4 tablets
10 mg: 2, 4 and 8 tablets
20 mg: 4 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici Srl, via Turati 40, 20121 Milano, Italy
Manufacturer:
ACTAVIS LTD., BLB 016, Bulebel Industrial Estate, Zejtun ZTN 3000, Malta