Vivanza 5 mg film-coated tablets

Vivanza belongs to a group of medicines which are used to treat difficulties in getting or keeping an erection (erectile dysfunction).

About erection difficulties

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.

How Vivanza works

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.

Do not take Vivanza

• If you are allergic (hypersensitive) to vardenafil or any of the other ingredients of Vivanza. See the ingredients 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 for HIV
• 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)

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 arrythmia) 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 or peptic ulcers)
If you have a bleeding disorder (such as haemophilia)
If you are using anyother treatments for erection difficulties
If you experience sudden decrease or loss of vision, stop taking Vivanza and contact your doctor immediately

Vivanza is for men of 18 years and over

It is not intended for use by women, children or men under 18.

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Vivanza will usually be fine with most medicines. But some 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 arrythmias, such as quinidine, procainamide, amiodarone or sotalolRitonavir 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)

Taking Vivanza with food and drink

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.

Always take Vivanza exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual 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
Don?t use Vivanza more than once a day.

Tell the doctor if you think Vivanza is too strong or too weak. He or she may suggest 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.

Like all medicines, Vivanza can cause side effects, although not everybody gets them. Most of the effects are mild or moderate. The chance of having a side effect is described by the following categories:

Very common(affects more than 1 user in 10)
Headache
Flushing

Common(affects 1 to 10 users in 100)
Indigestion
Feeling sick (nausea)
Dizziness
Blocked or runny nose

Uncommon(affects 1 to 10 users in 1,000)
Sensitivity of the skin to sunlight
High or low blood pressure
Back or muscle pain
Effects on vision
Bloodshot or watery eyes
Rash
Sleepiness
Effect in results of blood tests to check liver function
Increase in blood of a muscle enzyme (creatine phosphokinase)
Breathlessness
Fast heart beat or pounding heart
Nose bleeds
Facial swelling

Rare(affects 1 to 10 users in 10,000)
Fainting
Muscle stiffness
Increase pressure in the eye (glaucoma)
Prolonged or painful erections
Allergic reaction
Effects on the heart (such as angina)
Anxiety
Swelling inside the throat
Temporary loss of memory (such as transient global amnesia)
Seizure

Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients.
Sudden decrease or loss of hearing has been reported.

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

Do not use Vivanza after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Vivanza contains

• The active substance is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride trihydrate).
• 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 with the BAYER cross on one side and the strength (5) on the other side. The tablets are provided in blister packs containing 2, 4, 8 or 12 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:Bayer Schering Pharma AG, 13342 Berlin, Germany

Manufacturer: Bayer Schering Pharma AG, 51368 Leverkusen, Germany

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

BelgiëBelgiqueBelgien Bayer S.A.N.V. TélTel 32-02-535 63 11 LuxembourgLuxemburg Bayer S.A.N.V. TélTel 32-02-535 63 11

T. 359 02 81 401 01 Magyarország Bayer Hungária Kft. Tel. 36-1-487-4100

eská republika GlaxoSmithKline s.r.o. Tel 420 2 22001111 Malta Alfred Gera and Sons Ltd. Tel 356-21 44 62 05

Danmark Bayer AS Tlf 45-45-23 50 00 Nederland Bayer B.V., Bayer Schering Pharma Tel 31-0297-28 06 66

Deutschland Bayer Vital GmbH Tel 49-0214-30 513 48 Norge Bayer AS Tlf47 24 11 18 00

Österreich Bayer Austria Ges. m. b. H. Tel 43-01-711 46-0 Eesti GlaxoSmithKline Eesti OÜ Tel 372 6676900 EstoniaGSK.com

ALAPIS PHARMA T. 30 2130 175000 Polska Bayer Sp. z o.o. Tel. 48-22-572 35 00

España Quimica Farmacéutica Bayer S.L. Tel 34-93-495 65 00 Portugal Bayer Portugal S.A. Tel 351-21-416 42 00

France Bayer Santé Tél 33-3 - 20 20 80 80 România GlaxoSmithKline GSK S.R.L. Tel 4021 3028 208

Ireland Bayer Limited Tel 353 1 299 93 13 Slovenija Bayer d. o. o. Tel 386 1 58 14 400

Ísland Vistor hf. Sími 354 535 70 00 Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel 421 02 48261111

Italia Bayer S.p.A. Tel 39-02-397 81 SuomiFinland Bayer Oy, Bayer Schering Pharma PuhTel 358-20 785 21

Bayer 30 210 618 75 00 Sverige Bayer AB Tel 46 08 580 223 00

Latvija GlaxoSmithKline Latvia SIA Tel 371-67312687 United Kingdom Bayer plc Tel 44-01635-563000

Lietuva
UAB ?GlaxoSmithKline Lietuva?
Tel: +370 5 264 90 00

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