Vivanza

Informazzjoni prinċipali

  • Isem kummerċjali:
  • Vivanza
  • Dominju tal-mediċina:
  • Bnedmin
  • Tip ta 'mediċina:
  • Droga allopatika

Dokumenti

Lokalizzazzjoni

  • Disponibbli fi:
  • Vivanza
    Unjoni Ewropea
  • Lingwa:
  • Ingliż

Informazzjoni terapewtika

  • Grupp terapewtiku:
  • UROLOGICALS
  • Żona terapewtika:
  • Erectile Dysfunction
  • Indikazzjonijiet terapewtiċi:
  • Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Vivanza to be effective, sexual stimulation is required.Vivanza is not indicated for use by women.
  • Sommarju tal-prodott:
  • Revision: 25

Status

  • Sors:
  • EMA - European Medicines Agency
  • L-istatus ta 'awtorizzazzjoni:
  • Authorised
  • Numru ta 'awtorizzazzjoni:
  • EMEA/H/C/000488
  • Data ta 'l-awtorizzazzjoni:
  • 03-03-2003
  • Kodiċi EMEA:
  • EMEA/H/C/000488
  • L-aħħar aġġornament:
  • 23-07-2019

Rapport ta 'Valutazzjoni Pubblika

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Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/43226/2016

EMEA/H/C/000488

EPAR summary for the public

Vivanza

vardenafil

This is a summary of the European public assessment report (EPAR) for Vivanza. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Vivanza.

What is Vivanza?

Vivanza is a medicine that contains the active substance vardenafil. It is available as film-coated

tablets (5, 10 and 20 mg) and as orodispersible tablets (10 mg). Orodispersible tablets are tablets that

dissolve in the mouth.

What is Vivanza used for?

Vivanza is used to treat adult men with erectile dysfunction (sometimes called impotence), when they

cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity. For Vivanza to be

effective, sexual stimulation is required.

The medicine can only be obtained with a prescription.

How is Vivanza used?

The recommended dose of Vivanza is 10 mg, taken by mouth with or without food, about 25 to 60

minutes before sexual activity; patients should not take more than one dose a day. The orodispersible

tablets must be taken without liquid. If Vivanza is taken with a high fat meal, the onset of activity may

be delayed. The dose may be increased to a maximum of 20 mg or decreased to 5 mg depending on

the effectiveness and side effects. Patients with liver problems or severe kidney problems should start

treatment on the 5 mg dose.

The dose may need to be adjusted in patients taking other medicines that block enzymes that break

down Vivanza. For full details, see the package leaflet.

How does Vivanza work?

The active ingredient of Vivanza, vardenafil, belongs to a group of medicines called phosphodiesterase

type 5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme which normally breaks

down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual

stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the

penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the

erection. By blocking the breakdown of cGMP, Vivanza restores erectile function. Sexual stimulation is

still needed to produce an erection.

How has Vivanza been studied?

Vivanza film-coated tablets have been compared with placebo (a dummy treatment) in four main

studies including 2,431 men aged 20 to 83 years. One study was carried out in diabetic men and

another in men who had had their prostate gland removed. Two additional main studies compared

orodispersible tablets with placebo in 701 men aged 21 to 84 years.

The main measure of effectiveness was the ability to get and maintain an erection. This was recorded

in two questionnaires completed at home.

What benefit has Vivanza shown during the studies?

Vivanza was significantly more effective than placebo for all measures in all studies.

What is the risk associated with Vivanza?

The most common side effect with Vivanza (seen in more than 1 patient in 10) is headache. For the full

list of all side effects reported with Vivanza, see the package leaflet.

Vivanza must not be used in people who are hypersensitive (allergic) to vardenafil or any of the other

ingredients. It must not be used when sexual activity is inadvisable, such as in men with severe heart

disease. It must also not be taken by patients who have ever had loss of vision because of a problem

with blood flow to the nerve in the eye (non arteritic anterior ischemic optic neuropathy or NAION).

Vivanza must not be taken with nitrates (medicines used to treat angina).

Because Vivanza has not been studied in the following groups of patients, they must not use the

medicine:

patients with severe liver disease or end-stage kidney disease requiring dialysis;

patients who have hypotension (low blood pressure);

patients who have had a stroke or a heart attack within the last six months;

patients with unstable angina or hereditary eye problems known as ‘retinal degenerative disorders’.

Vivanza must not be taken with some medicines, such as ketoconazole and itraconazole (to treat

fungal infections) in men over 75 years, or medicines called ‘HIV protease inhibitors’ such as ritonavir

or indinavir (to treat HIV infection).

In addition, Vivanza must not be taken with medicines known as guanylate cyclase stimulators,

including riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).

Why has Vivanza been approved?

The CHMP decided that Vivanza’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

What measures are being taken to ensure the safe and effective use of

Vivanza?

A risk management plan has been developed to ensure that Vivanza is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for Vivanza, including the appropriate precautions to be followed by healthcare

professionals and patients.

Other information about Vivanza

The European Commission granted a marketing authorisation valid throughout the European Union for

Vivanza on 4 March 2003.

The full EPAR for Vivanza can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Vivanza,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 01-2016.

Fuljett ta 'Informazzjoni għall-Pazjent: prodott - kompożizzjoni, indikazzjonijiet, effetti sekondarji, dożaġġ, interazzjonijiet, reazzjonijiet avversi, tqala, treddigħ

B.

PACKAGE LEAFLET

Package Leaflet: Information for the user

Vivanza 5 mg film-coated tablets

Vardenafil

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

information for you.

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

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

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.

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 Vivanza is and what it is used for

What you need to know before you take Vivanza

How to take Vivanza

Possible side effects

How to store Vivanza

Contents of the pack and other information

1.

What Vivanza is and what it is used for

Vivanza 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.

Vivanza will only work when you are sexually stimulated. It reduces the action of the natural chemical

in your body which makes erections go away. Vivanza allows an erection to last long enough for you to

satisfactorily complete sexual activity.

2.

What you need to know before you take Vivanza

Do not take Vivanza

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.

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 Vivanza could seriously affect

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 taking ketoconazole or itraconazole, anti-fungal medicines.

If you have a severe heart or liver problem.

If you are having kidney dialysis.

If you have recently had a stroke or 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 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).

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 Vivanza 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 Vivanza.

Take special care with Vivanza

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

If you suffer from irregular heart beat (

cardiac arrhythmia

) or inherited heart diseases affecting

your electrocardiogram.

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

angulation, Peyronie’s disease and cavernosal fibrosis.

If you have an illness that can cause erections which won’t go away (

priapism

). These include

sickle cell disease, multiple myeloma and leukaemia.

If you have stomach ulcers (also called

gastric

peptic ulcers

If you have a bleeding disorder (such as

haemophilia

If you are using any

other treatments for erection difficulties, including Vivanza orodispersible

tablets (see section Other medicines and Vivanza).

If you experience sudden decrease or loss of vision, stop taking Vivanza and contact your doctor

immediately.

Children and adolescents

Vivanza is not intended for use by children or adolescents under 18.

Other medicines and Vivanza

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:

Nitrates, medicines for angina, or nitric oxide donors

,

such as amyl nitrite. Taking these

medicines with Vivanza could seriously affect your blood pressure. Talk to a doctor without

taking Vivanza.

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

sotalol.

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

Ketoconazole or itraconazole, anti-fungal medicines.

Erythromycin or clarithromycin, macrolide antibiotics.

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

prostate (as

benign prostatic hyperplasia

Riociguat.

Do not use Vivanza film-coated tablets combined with any other treatment for erectile dysfunction,

including Vivanza orodispersible tablets.

Vivanza with food, drink and alcohol

You can take Vivanza with or without food but preferably not after a heavy or high-fat meal as this

may delay the effect.

Don’t drink grapefruit juice when you use Vivanza. It can interfere with the usual effect of the

medicine.

Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding

Vivanza is not for use by women.

Driving and using machines

Vivanza might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is

affected after taking Vivanza don’t drive or operate any tools or machines.

3.

How to take Vivanza

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 Vivanza 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 Vivanza.

Swallow one tablet with a glass of water.

Do not take Vivanza film-coated tablets

with any other forms of Vivanza.

Do not take Vivanza

more than once a day.

Tell your doctor if you think Vivanza 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 Vivanza than you should

Men who take too much Vivanza may experience more side effects or may get severe back pain. If you

take more Vivanza 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 Vivanza 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

Headache

Common:

may affect up to 1 in 10 users

Dizziness

Flushing

Blocked or runny nose

Indigestion

Uncommon:

may affect up to 1 in 100 users

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

Sleep disorder

Numbness and impaired perception of touch

Sleepiness

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

sensitivity

Ringing in the ears, vertigo

Fast heart beat or pounding heart

Breathlessness

Stuffy nose

Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (

nausea

), dry mouth

Raised levels of liver enzymes in your blood

Rash, reddened skin

Back or muscle pain, increase in blood of a muscle enzyme (

creatine phosphokinase

), muscle

stiffness

Prolonged erections

Malaise

Rare:

may affect up to 1 in 1,000 users

Inflammation of the eyes (

conjunctivitis

Allergic reaction

Anxiety

Fainting

Amnesia

Seizure

Increased pressure in the eye (

glaucoma

), lacrimation increased

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

angina

High or low blood pressure

Nose bleed

Effect on results of blood tests to check liver function

Sensitivity of the skin to sun light

Painful erections

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

Blood in the urine (

Haematuria

Penile bleeding (

Penile Haemorrhage

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 the national reporting system listed in Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.

How to store Vivanza

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.

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 Vivanza contains

The active substance is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride).

The other ingredients of the tablets are:

Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous

silica.

Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172),

ferric oxide red (E172).

What Vivanza looks like and contents of the pack

Vivanza 5 mg film-coated tablets are orange marked with a ‘v’ on one side and the strength (5) on the

other side. The tablets are provided in 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

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Lietuva

UAB Bayer

Tel: +370 523 36 868

България

Байер България ЕООД

Tел.: +359-(0)2-424 72 80

Luxembourg/Luxemburg

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Česká republika

Bayer s.r.o.

Tel: +420 266 101 111

Magyarország

Bayer Hungária KFT

Tel.: +36 14 87-4100

Danmark

Bayer A/S

Tlf: +45 45 23 50 00

Malta

Alfred Gera and Sons Ltd.

Tel: +35 621 44 62 05

Deutschland

Jenapharm GmbH & Co. KG

Tel: +49 (0)3641-64 8888

Nederland

Bayer B.V.

Tel: +31-(0)297-28 06 66

Eesti

Bayer OÜ

Tel: +372 655 85 65

Norge

Bayer AS

Tlf: +47-23 13 05 00

Ελλάδα

Bayer Ελλάς ΑΒΕΕ

Τηλ: +30 210 61 87 500

Österreich

Bayer Austria Ges. m. b. H.

Tel: +43-(0)1-711 46-0

España

Bayer Hispania S.L.

Tel: +34-93-495 65 00

Polska

Bayer Sp. z o.o.

Tel.: +48 22 572 35 00

France

Bayer HealthCare

Tél (N° vert) : +33-(0)800 87 54 54

Portugal

Bayer Portugal, Lda.

Tel: +351 21 416 42 00

Hrvatska

Bayer d.o.o.

Tel: + 385-(0)1-6599 900

România

SC Bayer SRL.

Tel: +40-21-529 59 00

Ireland

Bayer Limited

Tel: +353 1 2999313

Slovenija

Bayer d. o. o.

Tel: +386 (0)1 58 14 400

Ísland

Icepharma hf.

Sími: +354-540 8000

Slovenská republika

Bayer, spol. s r.o.

Tel: +421 2-59 21 31 11

Italia

Bayer S.p.A.

Tel: +39 02 397 81

Suomi/Finland

Bayer Oy

Puh/Tel: +358-20 785 21

Κύπρος

NOVAGEM Limited

Τηλ: +357 22 48 38 58

Sverige

Bayer AB

Tel: +46 (0)8 580 223 00

Latvija

SIA Bayer

Tel: +371 67 845 563

United Kingdom

Bayer plc

Tel: +44 (0) 118 206 3000

This leaflet was last revised in {month YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu

Package Leaflet: Information for the user

Vivanza 10 mg film-coated tablets

Vardenafil

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

information for you.

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

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

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.

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 Vivanza is and what it is used for

What you need to know before you take Vivanza

How to take Vivanza

Possible side effects

How to store Vivanza

Contents of the pack and other information

1.

What Vivanza is and what it is used for

Vivanza 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.

Vivanza will only work when you are sexually stimulated. It reduces the action of the natural chemical

in your body which makes erections go away. Vivanza allows an erection to last long enough for you to

satisfactorily complete sexual activity.

2.

What you need to know before you take Vivanza

Do not take Vivanza

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.

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 Vivanza could seriously affect

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 taking ketoconazole or itraconazole, anti-fungal medicines.

If you have a severe heart or liver problem.

If you are having kidney dialysis.

If you have recently had a stroke or 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 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).

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 Vivanza 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 Vivanza.

Take special care with Vivanza

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

If you suffer from irregular heart beat (

cardiac arrhythmia

) or inherited heart diseases affecting

your electrocardiogram.

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

angulation, Peyronie’s disease and cavernosal fibrosis.

If you have an illness that can cause erections which won’t go away (

priapism

). These include

sickle cell disease, multiple myeloma and leukaemia.

If you have stomach ulcers (also called

gastric

peptic ulcers

If you have a bleeding disorder (such as

haemophilia

If you are using any

other treatments for erection difficulties, including Vivanza orodispersible

tablets (see section Other medicines and Vivanza).

If you experience sudden decrease or loss of vision, stop taking Vivanza and contact your doctor

immediately.

Children and adolescents

Vivanza is not intended for use by children or adolescents under 18.

Other medicines and Vivanza

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:

Nitrates, medicines for angina, or nitric oxide donors

,

such as amyl nitrite. Taking these

medicines with Vivanza could seriously affect your blood pressure. Talk to a doctor without

taking Vivanza.

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

sotalol.

Ritonavir or indinavir, medicines for HIV.

Talk to a doctor without taking Vivanza.

Ketoconazole or itraconazole, anti-fungal medicines.

Erythromycin or clarithromycin, macrolide antibiotics.

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

prostate (as

benign prostatic hyperplasia

Riociguat.

Do not use Vivanza film-coated tablets combined with any other treatment for erectile dysfunction,

including Vivanza orodispersible tablets.

Vivanza with food, drink and alcohol

You can take Vivanza with or without food but preferably not after a heavy or high-fat meal as this

may delay the effect.

Don’t drink grapefruit juice when you use Vivanza. It can interfere with the usual effect of the

medicine.

Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding

Vivanza is not for use by women.

Driving and using machines

Vivanza might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is

affected after taking Vivanza don’t drive or operate any tools or machines.

3.

How to take Vivanza

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 Vivanza 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 Vivanza.

Swallow one tablet with a glass of water.

Do not take Vivanza film-coated tablets

with any other forms of Vivanza.

Do not take Vivanza

more than once a day.

Tell your doctor if you think Vivanza 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 Vivanza than you should

Men who take too much Vivanza may experience more side effects or may get severe back pain. If you

take more Vivanza 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 Vivanza 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

Headache

Common:

may affect up to 1 in 10 users

Dizziness

Flushing

Blocked or runny nose

Indigestion

Uncommon:

may affect up to 1 in 100 users

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

Sleep disorder

Numbness and impaired perception of touch

Sleepiness

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

sensitivity

Ringing in the ears, vertigo

Fast heart beat or pounding heart

Breathlessness

Stuffy nose

Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (

nausea

), dry mouth

Raised levels of liver enzymes in your blood

Rash, reddened skin

Back or muscle pain, increase in blood of a muscle enzyme (

creatine phosphokinase

), muscle

stiffness

Prolonged erections

Malaise

Rare:

may affect up to 1 in 1,000 users

Inflammation of the eyes (

conjunctivitis

Allergic reaction

Anxiety

Fainting

Amnesia

Seizure

Increased pressure in the eye (

glaucoma

), lacrimation increased

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

angina

High or low blood pressure

Nose bleed

Effect on results of blood tests to check liver function

Sensitivity of the skin to sun light

Painful erections

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

Blood in the urine (

Haematuria

Penile bleeding (

Penile Haemorrhage

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 the national reporting system listed in Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.

How to store Vivanza

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.

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 Vivanza contains

The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).

The other ingredients of the tablets are:

Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous

silica.

Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172),

ferric oxide red (E172).

What Vivanza looks like and contents of the pack

Vivanza 10 mg film-coated tablets are orange with a ‘v’ on one side and the strength (10) on the other

side. The tablets are provided in 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

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Lietuva

UAB Bayer

Tel: +370 523 36 868

България

Байер България ЕООД

Tел.: +359-(0)2-424 72 80

Luxembourg/Luxemburg

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Česká republika

Bayer s.r.o.

Tel: +420 266 101 111

Magyarország

Bayer Hungária KFT

Tel.: +36 14 87-4100

Danmark

Bayer A/S

Tlf: +45 45 23 50 00

Malta

Alfred Gera and Sons Ltd.

Tel: +35 621 44 62 05

Deutschland

Jenapharm GmbH & Co. KG

Tel: +49 (0)3641-64 8888

Nederland

Bayer B.V.

Tel: +31-(0)297-28 06 66

Eesti

Bayer OÜ

Tel: +372 655 85 65

Norge

Bayer AS

Tlf: +47-23 13 05 00

Ελλάδα

Bayer Ελλάς ΑΒΕΕ

Τηλ: +30 210 61 87 500

Österreich

Bayer Austria Ges. m. b. H.

Tel: +43-(0)1-711 46-0

España

Bayer Hispania S.L.

Tel: +34-93-495 65 00

Polska

Bayer Sp. z o.o.

Tel.: +48 22 572 35 00

France

Bayer HealthCare

Tél (N° vert) : +33-(0)800 87 54 54

Portugal

Bayer Portugal, Lda.

Tel: +351 21 416 42 00

Hrvatska

Bayer d.o.o.

Tel: + 385-(0)1-6599 900

România

SC Bayer SRL.

Tel: +40-21-529 59 00

Ireland

Bayer Limited

Tel: +353 1 2999313

Slovenija

Bayer d. o. o.

Tel: +386 (0)1 58 14 400

Ísland

Icepharma hf.

Sími: +354-540 8000

Slovenská republika

Bayer, spol. s r.o.

Tel: +421 2-59 21 31 11

Italia

Bayer S.p.A.

Tel: +39 02 397 81

Suomi/Finland

Bayer Oy

Puh/Tel: +358-20 785 21

Κύπρος

NOVAGEM Limited

Τηλ: +357 22 48 38 58

Sverige

Bayer AB

Tel: +46 (0)8 580 223 00

Latvija

SIA Bayer

Tel: +371 67 845 563

United Kingdom

Bayer plc

Tel: +44 (0) 118 206 3000

This leaflet was last revised in {month YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu

Package Leaflet: Information for the user

Vivanza 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.

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

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

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.

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 Vivanza is and what it is used for

What you need to know before you take Vivanza

How to take Vivanza

Possible side effects

How to store Vivanza

Contents of the pack and other information

1.

What Vivanza is and what it is used for

Vivanza 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.

Vivanza will only work when you are sexually stimulated. It reduces the action of the natural chemical

in your body which makes erections go away. Vivanza allows an erection to last long enough for you to

satisfactorily complete sexual activity.

2.

What you need to know before you take Vivanza

Do not take Vivanza

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.

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 Vivanza could seriously affect

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 taking ketaconazole or itraconazole, anti-fungal medicines.

If you have a severe heart or liver problem.

If you are having kidney dialysis.

If you have recently had a stroke or 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 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).

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 Vivanza 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 Vivanza.

Take special care with Vivanza

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

If you suffer from irregular heart beat (

cardiac arrhythmia

) or inherited heart diseases affecting

your electrocardiogram.

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

angulation, Peyronie’s disease and cavernosal fibrosis.

If you have an illness that can cause erections which won’t go away (

priapism

). These include

sickle cell disease, multiple myeloma and leukaemia.

If you have stomach ulcers (also called

gastric

peptic ulcers

If you have a bleeding disorder (such as

haemophilia

If you are using any

other treatments for erection difficulties, including Vivanza orodispersible

tablets (see section Other medicines and Vivanza).

If you experience sudden decrease or loss of vision, stop taking Vivanza and contact your doctor

immediately.

Children and adolescents

Vivanza is not intended for use by children or adolescents under 18.

Other medicines and Vivanza

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:

Nitrates, medicines for angina, or nitric oxide donors

,

such as amyl nitrite. Taking these

medicines with Vivanza could seriously affect your blood pressure. Talk to a doctor without

taking Vivanza.

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

sotalol.

Ritonavir or indinavir, medicines for HIV.

Talk to a doctor without taking Vivanza.

Ketoconazole or itraconazole, anti-fungal medicines.

Erythromycin or clarithromycin, macrolide antibiotics.

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

prostate (as

benign prostatic hyperplasia

Riociguat.

Do not use Vivanza film-coated tablets combined with any other treatment for erectile dysfunction,

including Vivanza orodispersible tablets.

Vivanza with food, drink and alcohol

You can take Vivanza with or without food but preferably not after a heavy or high-fat meal as this

may delay the effect.

Don’t drink grapefruit juice when you use Vivanza. It can interfere with the usual effect of the

medicine.

Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding

Vivanza is not for use by women.

Driving and using machines

Vivanza might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is

affected after taking Vivanza don’t drive or operate any tools or machines.

3.

How to take Vivanza

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 Vivanza 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 Vivanza.

Swallow one tablet with a glass of water.

Do not take Vivanza film-coated tablets

with any other forms of Vivanza.

Do not take Vivanza

more than once a day.

Tell your doctor if you think Vivanza 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 Vivanza than you should

Men who take too much Vivanza may experience more side effects or may get severe back pain. If you

take more Vivanza 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 Vivanza 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

Headache

Common:

may affect up to 1 in 10 users

Dizziness

Flushing

Blocked or runny nose

Indigestion

Uncommon:

may affect up to 1 in 100 users

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

Sleep disorder

Numbness and impaired perception of touch

Sleepiness

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

sensitivity

Ringing in the ears, vertigo

Fast heart beat or pounding heart

Breathlessness

Stuffy nose

Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (

nausea

), dry mouth

Raised levels of liver enzymes in your blood

Rash, reddened skin

Back or muscle pain, increase in blood of a muscle enzyme (

creatine phosphokinase

), muscle

stiffness

Prolonged erections

Malaise

Rare:

may affect up to 1 in 1,000 users

Inflammation of the eyes (

conjunctivitis

Allergic reaction

Anxiety

Fainting

Amnesia

Seizure

Increased pressure in the eye (

glaucoma

), lacrimation increased

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

angina

High or low blood pressure

Nose bleed

Effect on results of blood tests to check liver function

Sensitivity of the skin to sun light

Painful erections

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

Blood in the urine (

Haematuria

Penile bleeding (

Penile Haemorrhage

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 the national reporting system listed in Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.

How to store Vivanza

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.

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 Vivanza contains

The active substance is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride).

The other ingredients of the tablets are:

Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous

silica.

Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172),

ferric oxide red (E172).

What Vivanza looks like and contents of the pack

Vivanza 20 mg film-coated tablets are orange with a ‘v’ on one side and the strength (20) on the other

side. The tablets are provided in 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

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder.

België/Belgique/Belgien

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Lietuva

UAB Bayer

Tel: +370 523 36 868

България

Байер България ЕООД

Tел.: +359-(0)2-424 72 80

Luxembourg/Luxemburg

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Česká republika

Bayer s.r.o.

Tel: +420 266 101 111

Magyarország

Bayer Hungária KFT

Tel.: +36 14 87-4100

Danmark

Bayer A/S

Tlf: +45 45 23 50 00

Malta

Alfred Gera and Sons Ltd.

Tel: +35 621 44 62 05

Deutschland

Jenapharm GmbH & Co. KG

Tel: +49 (0)3641-64 8888

Nederland

Bayer B.V.

Tel: +31-(0)297-28 06 66

Eesti

Bayer OÜ

Tel: +372 655 85 65

Norge

Bayer AS

Tlf: +47-23 13 05 00

Ελλάδα

Bayer Ελλάς ΑΒΕΕ

Τηλ: +30 210 61 87 500

Österreich

Bayer Austria Ges. m. b. H.

Tel: +43-(0)1-711 46-0

España

Bayer Hispania S.L.

Tel: +34-93-495 65 00

Polska

Bayer Sp. z o.o.

Tel.: +48 22 572 35 00

France

Bayer HealthCare

Tél (N° vert) : +33-(0)800 87 54 54

Portugal

Bayer Portugal, Lda.

Tel: +351 21 416 42 00

Hrvatska

Bayer d.o.o.

Tel: + 385-(0)1-6599 900

România

SC Bayer SRL.

Tel: +40-21-529 59 00

Ireland

Bayer Limited

Tel: +353 1 2999313

Slovenija

Bayer d. o. o.

Tel: +386 (0)1 58 14 400

Ísland

Icepharma hf.

Sími: +354-540 8000

Slovenská republika

Bayer, spol. s r.o.

Tel: +421 2-59 21 31 11

Italia

Bayer S.p.A.

Tel: +39 02 397 81

Suomi/Finland

Bayer Oy

Puh/Tel: +358-20 785 21

Κύπρος

NOVAGEM Limited

Τηλ: +357 22 48 38 58

Sverige

Bayer AB

Tel: +46 (0)8 580 223 00

Latvija

SIA Bayer

Tel: +371 67 845 563

United Kingdom

Bayer plc

Tel: +44 (0) 118 206 3000

This leaflet was last revised in {month YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu

Package Leaflet: Information for the user

Vivanza 10 mg orodispersible tablets

Vardenafil

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

information for you.

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

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

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.

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 Vivanza is and what it is used for

What you need to know before you take Vivanza

How to take Vivanza

Possible side effects

How to store Vivanza

Contents of the pack and other information

1.

What Vivanza is and what it is used for

Vivanza 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.

Vivanza will only work when you are sexually stimulated. It reduces the action of the natural chemical

in your body which makes erections go away. Vivanza allows an erection to last long enough for you to

satisfactorily complete sexual activity.

2.

What you need to know before you take Vivanza

Do not take Vivanza

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.

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 Vivanza could seriously affect

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 taking ketoconazole or itraconazole, anti-fungal medicines.

If you have a severe heart or liver problem.

If you are having kidney dialysis.

If you have recently had a stroke or 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 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).

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 Vivanza 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 Vivanza.

Take special care with Vivanza

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

If you suffer from irregular heart beat (

cardiac arrhythmia

) or inherited heart diseases affecting

your electrocardiogram.

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

angulation, Peyronie’s disease and cavernosal fibrosis.

If you have an illness that can cause erections which won’t go away (

priapism

). These include

sickle cell disease, multiple myeloma and leukaemia.

If you have stomach ulcers (also called

gastric

peptic ulcers

If you have a bleeding disorder (such as

haemophilia

If you are using any other treatments for erection difficulties, including Vivanza film-coated

tablets (see section Other medicines and Vivanza).

If you experience sudden decrease or loss of vision, stop taking Vivanza and contact your doctor

immediately.

Children and adolescents

Vivanza is not intended for use by children or adolescents under 18.

Other medicines and Vivanza

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:

Nitrates, medicines for angina, or nitric oxide donors

,

such as amyl nitrite. Taking these

medicines with Vivanza could seriously affect your blood pressure. Talk to a doctor without

taking Vivanza.

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

sotalol.

Ritonavir or indinavir, medicines for HIV.

Talk to a doctor without taking Vivanza.

Ketoconazole or itraconazole, anti-fungal medicines.

Erythromycin or clarithromycin, macrolide antibiotics.

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

prostate (as

benign prostatic hyperplasia

Riociguat.

Do not use Vivanza orodispersible tablets combined with any other treatment for erectile dysfunction,

including Vivanza film-coated tablets.

Vivanza with food, drink and alcohol

You can take Vivanza orodispersible tablets with or without food but do not take this medicine with

any liquid.

Don’t drink grapefruit juice when you use Vivanza. It can interfere with the usual effect of the

medicine.

Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding

Vivanza is not for use by women.

Driving and using machines

Vivanza might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is

affected after taking Vivanza don’t drive or operate any tools or machines.

Vivanza 10 mg orodispersible tablets contain Aspartame and Sorbitol.

Aspartame: This medicine contains 1.80 mg aspartame in each 10 mg orodispersible tablet.

Aspartame

is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a

rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Sorbitol: This medicine contains 7.96 mg sorbitol in each 10 mg orodispersible tablet.

3.

How to take Vivanza

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 Vivanza 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 Vivanza.

Do not remove the orodispersible tablet from the blister until you are going to take it. With dry

hands, press gently to release the tablet on your hand.

Do not crush the tablet.

Place the entire orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds,

then swallow with saliva. The orodispersible tablet must be taken without any liquid.

Do not take Vivanza orodispersible tablets

with any other forms of Vivanza.

Do not take

Vivanza

more than once a day.

Tell your doctor if you think Vivanza is too strong or too weak. He or she may suggest a switch to an

alternative Vivanza formulation with a different dose, depending on how well it works for you.

If you take more Vivanza than you should

Men who take too much Vivanza may experience more side effects or may get severe back pain. If you

take more Vivanza 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 Vivanza 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

Headache

Common:

may affect up to 1 in 10 users

Dizziness

Flushing

Blocked or runny nose

Indigestion

Uncommon:

may affect up to 1 in 100 users

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

Sleep disorder

Numbness and impaired perception of touch

Sleepiness

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

sensitivity

Ringing in the ears, vertigo

Fast heart beat or pounding heart

Breathlessness

Stuffy nose

Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling sick (

nausea

), dry mouth

Raised levels of liver enzymes in your blood

Rash, reddened skin

Back or muscle pain, increase in blood of a muscle enzyme (

creatine phosphokinase

), muscle

stiffness

Prolonged erections

Malaise

Rare:

may affect up to 1 in 1,000 users

Inflammation of the eyes (

conjunctivitis

Allergic reaction

Anxiety

Fainting

Amnesia

Seizure

Increased pressure in the eye (

glaucoma

), lacrimation increased

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

angina

High or low blood pressure

Nose bleed

Effect on results of blood tests to check liver function

Sensitivity of the skin to sun light

Painful erections

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

Blood in the urine (

Haematuria

Penile bleeding (

Penile Haemorrhage

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 the national reporting system listed in Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.

How to store Vivanza

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.

Store in the original package in order to protect from humidity and light.

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 helpprotect the environment.

6.

Contents of the pack and other information

What Vivanza contains

The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride).

The other ingredients of the tablets are:

Magnesium stearate, aspartame (E951), peppermint flavour, mannitol (E421) sorbitol (E420),

crospovidone and silica colloidal hydrated. See section 2 “Vivanza 10 mg orodispersible tablets contain

Aspartame and Sorbitol”.

What Vivanza looks like and contents of the pack

Vivanza 10 mg orodispersible tablets are round and white. They are provided in packs of 4 x 1

orodispersible tablets in alu/alu perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Lietuva

UAB Bayer

Tel: +370 523 36 868

България

Байер България ЕООД

Tел.: +359-(0)2-424 72 80

Luxembourg/Luxemburg

Bayer SA-NV

Tél/Tel: +32-(0)2-535 63 11

Česká republika

Bayer s.r.o.

Tel: +420 266 101 111

Magyarország

Bayer Hungária KFT

Tel.: +36 14 87-4100

Danmark

Bayer A/S

Tlf: +45 45 23 50 00

Malta

Alfred Gera and Sons Ltd.

Tel: +35 621 44 62 05

Deutschland

Jenapharm GmbH & Co. KG

Tel: +49 (0)3641 64 8888

Nederland

Bayer B.V.

Tel: +31-(0)297-28 06 66

Eesti

Bayer OÜ

Tel: +372 655 85 65

Norge

Bayer AS

Tlf: +47-23 13 05 00

Ελλάδα

Bayer Ελλάς ΑΒΕΕ

Τηλ: +30 210 61 87 500

Österreich

Bayer Austria Ges. m. b. H.

Tel: +43-(0)1-711 46 0

España

Bayer Hispania S.L.

Tel: +34-93-495 65 00

Polska

Bayer Sp. z o.o.

Tel.: +48 22 572 35 00

France

Bayer HealthCare

Tél (N° vert) : +33-(0)800 87 54 54

Portugal

Bayer Portugal, Lda.

Tel: +351 21 416 42 00

Hrvatska

Bayer d.o.o.

Tel: + 385-(0)1-6599 900

România

SC Bayer SRL.

Tel: +40-21-529 59 00

Ireland

Bayer Limited

Tel: +353 1 2999313

Slovenija

Bayer d. o. o.

Tel: +386 (0)1 58 14 400

Ísland

Icepharma hf.

Sími: +354-540 8000

Slovenská republika

Bayer, spol. s r.o.

Tel: +421 2-59 21 31 11

Italia

Bayer S.p.A.

Tel: +39 02 397 81

Suomi/Finland

Bayer Oy

Puh/Tel: +358-20 785 21

Κύπρος

NOVAGEM Limited

Τηλ: +357 22 48 38 58

Sverige

Bayer AB

Tel: +46 (0)8 580 223 00

Latvija

SIA Bayer

Tel: +371 67 845 563

United Kingdom

Bayer plc

Tel: +44 (0) 118 206 3000

This leaflet was last revised in {month YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu