VARDENAFIL 5 mg Film-Coated Tablets

Зміст інструкції

1. Vardenafil Accord 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets
   1. What is Vardenafil Accord 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. Package Contents and Other Information

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

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Vardenafil Accord 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 for the treatment of erectile dysfunction in adult men, a condition that involves difficulty achieving or maintaining an erection.
At least one in ten men occasionally have difficulty achieving or maintaining an erection. It may
depend on physical or psychological causes or a combination of both. Whatever the cause, not
enough blood is retained in the penis to allow and maintain an erection, due to
changes in the muscles and blood vessels.
Vardenafil Accord only works in the presence of sexual stimulation. The medicine reduces the action of the
chemical present in the body, which causes the erection to cease. Vardenafil Accord allows you to
achieve and maintain an erection long enough to satisfactorily complete the
sexual intercourse.

2. What you need to know before taking Vardenafil Accord

Do not take Vardenafil Accord

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include skin 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 Accord may 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 of age and are being treated with ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.
• If you are undergoing kidney dialysis.
• If you have recently had a stroke or a heart attack.
• If you have, or have had, low blood pressure.
• If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have previously had a condition characterized by loss of vision due to damage to the optic nerve due to 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). It has been shown that PDE5 inhibitors, such as Vardenafil Accord, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vardenafil Accord.

Pay particular attention with Vardenafil Accord

• If you have heart problems. Sexual activity may be risky for you.
• If you suffer from irregular heartbeat (cardiac arrhythmia) or hereditary heart diseases that modify the electrocardiogram.
• If you have a physical condition that causes alterations in the shape of the penis. These include conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
• If you have a disease that can cause persistent erections (priapism), such as sickle cell anemia, multiple myeloma and leukemia.
• If you have stomach ulcers (also called 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 Other medicines and Vardenafil Accord).
• If you experience a sudden decrease or loss of vision, stop taking Vardenafil Accord and contact your doctor immediately.

Children and adolescents
Vardenafil Accord is not intended for use by 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, even those available without a prescription.
Some medicines may cause problems, particularly these:

• Nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these medicines together with Vardenafil Accord may dangerously alter your blood pressure. Do not take Vardenafil Accord 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 Accord 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 Accord film-coated tablets in association with other treatments for erectile dysfunction, including vardenafil orodispersible tablets.

Vardenafil Accord with food, drinks and alcohol

• You can take Vardenafil Accord with or without food - but preferably not after a heavy or fatty meal as this may delay its effect.
• Do not drink grapefruit juice when taking this medicine. It may interfere with the effect of the medicine.
• Alcoholic beverages can worsen erectile difficulties.

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

Driving and operating machinery
In some people Vardenafil Accord may cause dizziness or alter vision. If you feel dizzy or notice
problems with your vision after taking this medicine, do not drive vehicles or operate tools or machinery.

3. How to take Vardenafil Accord

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask 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 be able to achieve an erection within 25 minutes and up to four or five hours
after taking Vardenafil Accord.

• Swallow a tablet with a glass of water.

Do not take the film-coated tablets of Vardenafil Accordtogether with any other
formulation of vardenafil.

Do not take Vardenafil Accordmore than once a day.
If you feel that the effect of Vardenafil Accord is too strong or too weak, consult your doctor.
They may advise you to take an alternative formulation of vardenafil with a different dose, based on
the effect the medicine has on 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 this medicine and contact your doctor immediately.
Sudden decrease or loss of hearing has been reported.
The likelihood of an adverse reaction occurring is described by the following categories:

Very common:
may affect more than 1 in 10 users

• Headache Common:may affect up to 1 in 10 users
• Dizziness
• Hot flushes
• Blocked or runny nose
• Indigestion Uncommon:may affect up to 1 in 100 users
• Swelling of the skin and mucous membranes including swelling of the face, lips or throat
• Sleep disorder
• Numbness and decreased tactile perception
• Drowsiness
• Effects on vision; red eyes, effects on colour perception, eye pain and discomfort, sensitivity to light
• Ringing in the ears; vertigo
• Fast heartbeat or heart with pounding
• 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, reddened skin
• Back or muscle pain, increased levels of a muscle enzyme ( creatine phosphokinase) in the blood, muscle stiffness
• Prolonged erections
• Feeling unwell Rare:may affect up to 1 in 1,000 users
• Inflammation of the eyes ( conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Convulsion
• Increased eye pressure ( glaucoma), increased tearing
• Effects on the heart (such as heart attack, altered heartbeat or angina)
• High or low blood pressure
• Nosebleed
• Effect on liver function tests
• Skin sensitivity to sunlight
• Painful erections
• Chest pain Very rare or not known:may affect less than 1 in 10,000 users or the frequency cannot be estimated based on available data
• Blood in urine ( hematuria)
• Bleeding from the penis ( penile hemorrhage)
• Presence of blood in semen ( hematospermia)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 pack 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 any medicine in waste water 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 ingredient is vardenafil.
• Vardenafil Accord 5 mg film-coated tablets: each tablet contains 5 mg of vardenafil (as trihydrate hydrochloride).
• Vardenafil Accord 10 mg film-coated tablets: each tablet contains 10 mg of vardenafil (as trihydrate hydrochloride).
• Vardenafil Accord 20 mg film-coated tablets: each tablet contains 20 mg of vardenafil (as trihydrate hydrochloride).
• The other components of the tablets are:

Tablet core: crospovidone (type B), magnesium stearate, microcrystalline cellulose and anhydrous colloidal silica
Film coating: macrogol 400, hypromellose (E464), titanium dioxide (E171), iron oxide red (E172) and
iron oxide yellow (E172).

Description of the Appearance of Vardenafil Accord and Package Contents
Vardenafil Accord 5 mg film-coated tablets are beige-colored, round tablets approximately 5.5
mm in diameter, biconvex, film-coated, marked with “FA1” on one side and plain on the other.
Vardenafil Accord 10 mg film-coated tablets are beige-colored, round tablets approximately 6.8
mm in diameter, biconvex, film-coated, marked with “FA2” on one side and plain on the other.
Vardenafil Accord 20 mg film-coated tablets are beige-colored, round tablets approximately 8.9
mm in diameter, biconvex, film-coated, marked with “FA3” on one side and plain on the other.
Available pack sizes are 2, 4, 8, 12 or 20 tablets in PVC/PVdC-Aluminum blisters.
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

Manufacturers
Accord Healthcare Limited
Sage house, 319 Pinner Road,
North Harrow, Middlesex,
HA1 4HF,
United Kingdom
Wessling Hungary Kft
Fòti ùt 56., Budapest 1047,
Hungary
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

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