What is it and how is it used?

Levitra 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.

Levitra will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Levitra allows an erection to last long enough for you to satisfactorily complete sexual activity.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not take Levitra

  • If you are allergic (hypersensitive) to vardenafil or any of the other ingredients of Levitra. 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 Levitra 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).
Take special care with Levitra

  • 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 or peptic ulcers)
  • If you have a bleeding disorder (such as haemophilia)
  • If you are using any other treatments for erection difficulties, including Levitra film-coated tablets. See ?Using other medicines?.
  • If you experience sudden decrease or loss of vision, stop taking Levitra and contact your doctor immediately.

Children Levitra is not intended for use by children or adolescents 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.
Some medicines may cause problems, especially these:

  • Nitrates, medicines for angina, or nitric oxide donors , such as amyl nitrite. Taking these medicines with Levitra could seriously affect your blood pressure. Talk to a doctor without taking Levitra
  • 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 Levitra
  • 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).

Do not use Levitra orodispersible tablets combined with any other treatment for erectile dysfunction, including Levitra film-coated tablets.

Taking Levitra with food and drink

  • You can take Levitra orodispersible tablets with or without food, but do not take this medicine with any liquid.
  • Don?t drink grapefruit juice when you use Levitra. It can interfere with the usual effect of the medicine.
  • Alcoholic drink can make erection difficulties worse.

Pregnancy and breast-feeding

Levitra is not for use by women.

Driving and using machines

Levitra might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Levitra don?t drive or operate any tools or machines.

Important information about some of the ingredients of Levitra 10 mg orodispersible tablets:

  • Aspartameis a source of phenylalanine, and may be harmful for people with a disorder called phenylketonuria.
  • Sorbitol: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How is it used?

Always take Levitra 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 Levitra about 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 Levitra.

  • Do not remove the orodispersible tablet from the blister until you are going to take it. With dry hands, pull the blister edge from the blister holder and press gently on top 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 Levitra orodispersible tablets with any other forms of Levitra .

Do not takeLevitra more than once a day.

Tell your doctor if you think Levitra is too strong or too weak. He or she may suggest a switch to an alternative Levitra formulation with a different dose, depending on how well it works for you.

If you take more Levitra than you should

Men who take too much Levitra may experience more side effects or may get severe back pain. If you take more Levitra than you should, tell your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Levitra 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 Levitra 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(affects more than 1 user in 10)

  • Headache

Common(affects 1 to 10 users in 100)

  • Dizziness
  • Flushing
  • Blocked or runny nose
  • Indigestion

Uncommon(affects 1 to 10 users in 1,000)

  • 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(affects 1 to 10 users in 10,000)

  • 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

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

How should it be stored?

Keep out of the reach and sight of children.

Do not use Levitra 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.

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.

Further information

What Levitra orodispersible tablets contains

  • The active substance is vardenafil. Each orodispersible 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.

What Levitra 10 mg orodispersible tablets looks like and contents of the pack Levitra 10 mg orodispersible tablets are round and white. They are provided in packs of 1, 2, 4 or8 tablets (containing Alu/Alu blisters or Alu/Alu blisters in blister holders).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation HolderBayer Schering Pharma AG,
13342 Berlin,
Germany.

Manufacturer
Bayer Schering Pharma AG,
D-51368 Leverkusen,
Germany.

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

BelgiëBelgiqueBelgien Bayer SA-NV TélTel 32-02-535 63 11 T. 359-02 81 401 01 eská republika Bayer s.r.o. Tel 420 271 730 661 Danmark Bayer AS Tlf 45-45-235 000 Deutschland Bayer Vital GmbH Tel 49-0214-30 513 48 Eesti Bayer OÜ Tel 372 655 85 65 Bayer 30 210 618 75 00 España Quimica Farmacéutica Bayer S.L. Tel 34-93-495 65 00 France Bayer Santé Tél 33-03-28 16 34 00 Ireland Bayer Limited Tel 353-1-299 93 13 LuxembourgLuxemburg Bayer SA-NV TélTel 32-02-535 63 11 Magyarország Bayer Hungária Kft. Tel. 36-1-487-4100 Malta Alfred Gera and Sons Ltd. Tel 356-21 44 62 05 Nederland Bayer B.V., Bayer Schering Pharma Tel 31-0297-28 06 66 Norge Bayer AS Tlf47-24 11 18 00 Österreich Bayer Austria Ges. m. b. H. Tel 43-01-711 460 Polska Bayer Sp. z o.o. Tel. 48-22-572 35 00 Portugal Bayer Portugal S.A. Tel 351-21-416 42 00 România SC Bayer SRL. Tel 40-21-528 59 00 Slovenija Bayer d. o. o. Tel 386-1-58 14 400

Slovenská republika Bayer, spol. s r.o. Tel 421 2-59 21 31 11 SuomiFinland Bayer Oy, Bayer Schering Pharma PuhTel 358-20-785 21 Sverige Bayer AB Tel 46-08-580 223 00 United Kingdom Bayer plc Tel 44-01635-56 30 00 Ísland Icepharma hf. Sími 354-540 8000 Italia Bayer S.p.A. Tel 39-02-397 81 NOVAGEM Limited 357-22-747 747 Latvija SIA Bayer Tel 371 67 845 563 Lietuva UAB Bayer Tel 370 5 23 36 868

This leaflet was last approved in

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