VARDENAFIL ACCORD

Package leaflet: Information for the user

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

Generic medicine
Please read this leaflet carefully before you start 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Vardenafil Accord contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These medicines are used to treat erectile dysfunction in adult men, a condition that involves 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. Whatever the cause, an insufficient amount of blood is retained in the penis to allow and sustain an erection, due to changes in muscles and blood vessels.
Vardenafil Accord 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 Accord enables the achievement and maintenance of an erection long enough to complete sexual intercourse satisfactorily.

2. What you need to know before taking Vardenafil Accord

Do not take Vardenafil Accord

• 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 have ever developed severe skin rashes or skin peeling, blisters and/or mouth ulcers after taking Vardenafil Accord.
• 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 Accord can 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 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 secondary to blood clots). PDE5 inhibitors, such as Vardenafil Accord, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, consult your doctor.

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

• 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 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 orodispersible tablets (see section "Other medicines and Vardenafil Accord"). Severe skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, have been reported in association with vardenafil treatment. Stop taking Vardenafil Accord and seek immediate medical help if you notice any symptoms indicating these severe skin reactions described in section 4. If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Vardenafil Accord, stop taking Vardenafil Accord and contact your doctor immediately.

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

Other medicines and Vardenafil Accord
Tell 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 Accord can dangerously alter your blood pressure.
• Medicines used to treat arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV.
• Ketoconazole or itraconazolo, 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 Accord film-coated tablets in combination with other treatments for erectile dysfunction, including vardenafil orodispersible tablets.

Vardenafil Accord with food, beverages, and alcohol

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

Pregnancy and breastfeeding
This medicine is not intended for use in women.

Driving and using machines
In some people, Vardenafil Accord may cause dizziness or vision disturbances. If you feel dizzy or notice vision problems after taking this medicine, do not drive or operate tools or machinery.

3. How to take Vardenafil Accord

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 Accord 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 Accord, 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 Accord together with any other formulation of vardenafil.
Do not take Vardenafil Accord more than once a day.
If you feel that the effect of Vardenafil Accord is too strong or too weak, talk to your doctor.
Your doctor may advise you to take an alternative formulation of vardenafil at a different dose, depending on how the medicine affects you.
If you take more Vardenafil Accord than you should
Patients who take an excessive amount of Vardenafil Accord may experience more side effects or severe back pain. If you take more Vardenafil Accord than you should, consult your doctor.
If you have any doubts about how to use this medicine, speak to 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 a decrease or partial loss, sudden, temporary or permanent, of vision, or distorted, blurred, or fuzzy central vision in one or both eyes. Stop taking this medicine and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
Cases of sudden death, increased 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 these men 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
• 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 disturbance
• Numbness and reduced tactile sensation
• Drowsiness
• Visual disturbances, red eyes, disturbances in colour perception, eye pain or discomfort, light sensitivity
• Ringing in the ears, vertigo
• Increased 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 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
• Temporary reduction in blood flow to parts of the brain

Very rare or not known:
may affect up to 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)
• Sudden death; Cerebral haemorrhage
• Flat, non-elevated reddish, target-like or circular skin rashes on the trunk, often with central blisters, peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
• Distorted, blurred, or fuzzy central vision or sudden decrease in vision

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 the national reporting system at: 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 Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Vardenafil Accord contains

• The active substance is vardenafil.
• Vardenafil Accord 5 mg film-coated tablets: each tablet contains 5 mg of vardenafil (as hydrochloride trihydrate).
• Vardenafil Accord 10 mg film-coated tablets: each tablet contains 10 mg of vardenafil (as hydrochloride trihydrate).
• Vardenafil Accord 20 mg film-coated tablets: each tablet contains 20 mg of vardenafil (as hydrochloride trihydrate).
• The other ingredients of the tablets are: Tablet core: crospovidone (type B), magnesium stearate, microcrystalline cellulose and anhydrous colloidal silicon dioxide. Film coating: macrogol 400 (E1521), hypromellose (E464), titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

Description of the appearance of Vardenafil Accord and pack contents
Vardenafil Accord 5 mg film-coated tablets are beige, round, approximately 5.5 mm in diameter, biconvex, film-coated tablets marked with “FA1” on one side and plain on the other.
Vardenafil Accord 10 mg film-coated tablets are beige, round, approximately 6.8 mm in diameter, biconvex, film-coated tablets marked with “FA2” on one side and plain on the other.
Vardenafil Accord 20 mg film-coated tablets are beige, round, approximately 8.9 mm in diameter, biconvex, film-coated tablets marked with “FA3” on one side and plain on the other.
Packs containing 2, 4, 8, 12 or 20 tablets in PVC/PVdC-Aluminium blisters are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta, 08039
Barcelona, Spain

Manufacturer
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 Barcelona,
Spain
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names: