VARDENAFIL ACCORD

Main information

  • Trade name:
  • VARDENAFIL ACCORD
  • Dosage:
  • 10 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VARDENAFIL ACCORD
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • vardenafil

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PA1390/121/002
  • Authorization date:
  • 07-07-2017
  • Last update:
  • 13-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the user

Vardenafil Accord 5 mg film-coated tablets

Vardenafil Accord 10 mg film-coated tablets

Vardenafil Accord 20 mg film-coated tablets

vardenafil

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

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Keep this leaflet. You may need to read it again.

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If you have any further questions, ask your doctor or pharmacist.

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This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

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If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Vardenafil Accord is and what it is used for

What you need to know before you take Vardenafil Accord

How to take Vardenafil Accord

Possible side effects

How to store Vardenafil Accord

Contents of the pack and other information

1.

What Vardenafil Accord is and what it is used for

Vardenafil Accord contains vardenafil, a member of a class of medicines called phosphodiesterase

type 5 inhibitors. They are used for the treatment of erectile dysfunction in adult men, a condition

which implies difficulties in getting or keeping an erection.

At least one in ten men has trouble getting or keeping an erection at some time. There may be physical

or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel

changes not enough blood stays in the penis to make it hard and keep it hard.

Vardenafil Accord will only work when you are sexually stimulated. It reduces the action of the

natural chemical in your body which makes erections go away. Vardenafil Accord allows an erection

to last long enough for you to satisfactorily complete sexual activity.

2.

What you need to know before you take Vardenafil Accord

Do not take Vardenafil Accord

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If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section

6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of

breath.

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If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric

oxide donors, such as amyl nitrite. Taking these medicines with Vardenafil Accord could

seriously affect your blood pressure.

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If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus

(HIV) infections.

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If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal

medicines.

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If you have a severe heart or liver problem.

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If you are having kidney dialysis.

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If you have recently had a stroke or heart attack.

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If you have or have had low blood pressure.

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If your family has a history of degenerative eye diseases (such as retinitis pigmentosa).

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If you have ever had a condition involving loss of vision due to damage to the optic nerve from

insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).

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If you are taking riociguat. This drug 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 Levitra have

been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or

are unsure tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vardenafil Accord.

Take special care with Vardenafil Accord

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If you have heart trouble. It may be risky for you to have sex.

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If you suffer from irregular heart beat (cardiac arrythmia) or inherited heart diseases affecting

your electrocardiogram.

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If you have a physical condition affecting the shape of the penis. This includes conditions called

angulation, Peyronie’s disease and cavernosal fibrosis.

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If you have an illness that can cause erections which won’t go away (priapism). These include

sickle cell disease, multiple myeloma and leukaemia.

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If you have stomach ulcers (also called gastric or peptic ulcers).

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If you have a bleeding disorder (such as haemophilia).

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If you are using any other treatments for erection difficulties, including vardenafil

orodispersible tablets (see section: Other medicines and Vardenafil Accord).

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If you experience 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.

Other medicines and Vardenafil Accord

Please tell your doctor or pharmacist if you are using, have recently used or might use any other

medicines, including medicines obtained without a prescription.

Some medicines may cause problems, especially these:

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Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these

medicines with Vardenafil Accord could seriously affect your blood pressure. Talk to a doctor

without taking Vardenafil Accord.

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Medicine for the treatment of arrythmias, such as quinidine, procainamide, amiodarone or

sotalol.

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Ritonavir or indinavir, medicines for HIV. Talk to a doctor without taking Vardenafil Accord.

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Ketoconazole or itraconazole, anti-fungal medicines.

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Erythromycin, or clarithromycin, macrolide antibiotics.

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Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the

prostate (as benign prostatic hyperplasia).

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Riociguat.

Do not use Vardenafil Accord film-coated tablets combined with any other treatment for erectile

dysfunction, including vardenafil orodispersible tablets.

Vardenafil Accord with food, drink and alcohol

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You can take Vardenafil Accord with or without food – but preferably not after a heavy or

high-fat meal as this may delay the effect.

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Don’t drink grapefruit juice when you take this medicine. It can interfere with the usual effect of

the medicine.

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Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding

This medicine is not for use by women.

Driving and using machines

Vardenafil Accord might make some people feel dizzy, or affect their vision. If you feel dizzy or if

your vision is affected after taking this medicine don’t drive or operate any tools or machines.

3.

How to take Vardenafil Accord

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure. The recommended dose is 10 mg.

Take a Vardenafil Accord tablet about 25 to 60 minutes before sexual activity. With sexual stimulation

you may achieve an erection anywhere from 25 minutes up to four to five hours after taking

Vardenafil Accord.

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Swallow one tablet with a glass of water

Do not take Vardenafil Accord film-coated tablets with any other forms of vardenafil.

Do not take Vardenafil Accord more than once a day.

Tell your doctor if you think Vardenafil Accord is too strong or too weak. He or she may suggest a

switch to an alternative vardenafil formulation with a different dose, depending on how well it works

for you.

If you take more Vardenafil Accord than you should

Men who take too much Vardenafil Accord may experience more side effects or may get severe back

pain. If you take more Vardenafil Accord than you should, tell your doctor.

If you have any further questions on 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. Most of

the effects are mild or moderate.

Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been

experienced by patients. Stop taking this medicine and contact your doctor immediately.

Sudden decrease or loss of hearing has been reported.

The chance of having a side effect is described by the following categories:

Very common:

may affect more than 1 in 10 users

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Headache

Common:

may affect up to 1 in 10 users

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Dizziness

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Flushing

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Blocked or runny nose

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Indigestion

Uncommon:

may affect up to 1 in 100 users

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Swelling of skin and mucous tissue including swollen face, lips or throat

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Sleep disorder

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Numbness and impaired perception of touch

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Sleepiness

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Effects on vision; redness of the eye, effects on colour vision, eye pain and discomfort, light

sensitivity

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Ringing in the ears; vertigo

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Fast heart beat or pounding heart

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Breathlessness

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Stuffy nose

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Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; feeling sick (nausea), dry mouth

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Raised levels of liver enzymes in your blood

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Rash, reddened skin

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Back or muscle pain; increase in blood of a muscle enzyme (creatine phosphokinase), muscle

stiffness

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Prolonged erections

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Malaise

Rare:

may affect up to 1 in 1,000 users

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Inflammation of the eyes (conjunctivitis)

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Allergic reaction

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Anxiety

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Fainting

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Amnesia

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Seizure

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Increase pressure in the eye (glaucoma), lacrimation increased

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Effects on the heart (such as heart attack, altered heart beat or angina)

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High or low blood pressure

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Nose bleed

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Effect on results of blood tests to check liver function

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Sensitivity of the skin to sun light

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Painful erections

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Chest pain

Very rare or not known:

may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data

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Blood in the urine (Haematuria)

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Penile bleeding (Penile Haemorrhage)

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Presence of blood in the semen (Haematospermia)

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

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 carton after “EXP”. The expiry

date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Vardenafil Accord contains

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The active substance is vardenafil.

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Vardenafil Accord 5 mg film-coated tablets: Each tablet contains 5 mg vardenafil (as

hydrochloride trihydrate).

Vardenafil Accord 10 mg film-coated tablets: Each tablet contains 10 mg vardenafil (as

hydrochloride trihydrate).

Vardenafil Accord 20 mg film-coated tablets: Each tablet contains 20 mg vardenafil (as

hydrochloride trihydrate).

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The other ingredients of the tablets are:

Tablet core: crospovidone (type B), magnesium stearate, cellulose microcrystalline and silica

colloidal anhydrous.

Film-coat: macrogol 400, hypromellose (E464), titanium dioxide (E171), iron oxide red (E172)

and iron oxide yellow (E172).

What Vardenafil Accord looks like and contents of the pack

Vardenafil Accord 5 mg film-coated tablets are beige coloured, round shaped, approximately 5.5 mm

in diameter, biconvex, film-coated tablets debossed with 'FA1' on one side and plain on other side.

Vardenafil Accord 10 mg film-coated tablets are beige coloured, round shaped, approximately 6.8 mm

in diameter, biconvex, film-coated tablets debossed with 'FA2' on one side and plain on other side.

Vardenafil Accord 20 mg film-coated tablets are beige coloured, round shaped, approximately 8.9 mm

in diameter, biconvex, film-coated tablets debossed with 'FA3' on one side and plain on other side.

The tablets are provided in PVC/PVdC -Aluminium blister packs containing 2, 4, 8, 12 or 20 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare Limited

Sage house, 319 Pinner Road,

North Harrow,

Middlesex HA1 4HF,

United Kingdom

Manufacturer

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,

Spain

Pharmadox HeaIthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000

Malta

This medicinal product is authorised in the Member States of the EEA under the following

names:

Member States

Invented Names

Austria

Vardenafil Accord 5 mg/10 mg/20 mg Filmtabletten

Denmark

Vardenafil Accord 5 mg/10 mg/20 mg

Finland

Vardenafil Accord 5 mg/10 mg/20 mg kalvopäällysteiset tabletit

Ireland

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

Italy

Vardenafil Accord

Malta

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

Netherland

Vardenafil Accord 5 mg/10 mg/20 mg filmomhulde tabletten

Poland

Vardenafil Accord

Sweden

Vardenafil Accord 5 mg/10 mg/20 mg filmdragerad tabletter

United Kingdom

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

Spain

Vardenafil Accord 5 mg/10 mg/20 mg comprimidos recubiertos con película

France

VARDENAFIL ACCORD 5 mg/ 10 mg/ 20 mg, comprimé pelliculé

This leaflet was last revised in 05/2018.