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James Hartford
Contributing Editor
Monday August 12, 2003

GlaxoSmithKline Plc and Bayer AG won US approval on Tuesday (19th August, 2003) to sell impotence drug Levitra, second ED drug to be approved after Viagra. The approval of orange pill Levitra starts a new phase of war into the impotence drug market and ends the five-year dominance of Pfizer's Viagra, produced in blue diamond shapes. Levitra has already been approved in more than 50 countries, winning EU approval in March.

"We are committed to educating men and the doctors about Levitra and the important role it can play in improving their sexual health," Chris Viehbacher, president US pharmaceuticals at GSK, said. Levitra approval in U.S. now opens the road for GSK into the US male impotence market having estimated 30 million American males with some level of erectile dysfunction. Also, GSK believes that worldwide, an estimated 152m men, including more than half of males aged more than 40, suffer impotence to some degree.

Levitra, claimed to be sex-in-16-minute pill, is now selling at a few online pharmacies since it has been approved for sale in U.S. by the US Food and Drug Administration. You can buy cheap Levitra with total comfort and ease of mind. Enjoy your intimate moments for longer duration now and buy Levitra today.

Levitra works by blocking an enzyme known as PDE-5, which affects the blood flow to the penis, but the merits of each drug in terms of potency, speed and duration of action are widely debated.

In trials involving 1,020 men with erectile dysfunction who took Levitra for one year, the average success rate in maintaining erections improved from to 87 percent from 14 percent with the 10 mg Levitra dose and to 86 percent from 16 percent with the 20 mg Levitra dose.

More Levitra Patient Information:

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

1. What LEVITRA is and what it does
2. Before you take LEVITRA
3. How to take LEVITRA
4. Possible side effects
5. Storing LEVITRA
6. Further information

The active substance is vardenafil (as hydrochloride trihydrate). Each tablet contains 10 mg of vardenafil.
The other ingredients of the tablets are: In the tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica. In the film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172).

1. WHAT LEVITRA IS AND WHAT IT DOES
   
   LEVITRA 10 mg film-coated tablets are orange with the BAYER cross on one side and the strength (10) on the other. Each pack contains 2, 4, 8 or 12 tablets.
   
   Not all pack sizes may be marketed.
   
   LEVITRA is a treatment for erectile dysfunction (ED) in men - the medical name for difficulties in getting or keeping an erection.
   
   About erection difficulties
   At least one in ten men has trouble getting or keeping an erection at some time. There may be physical causes or psychological causes, or most likely, a mixture of both. Whatever the cause, the effect is the same: muscle and blood vessel changes mean that not enough blood stays in the penis to make it hard and keep it hard.
   
   How LEVITRA works
   Erections are usually controlled by a balance of two body chemicals. The first brings on erections; the second takes erections away. If the two chemicals are out of balance, you can lose an erection before it starts. LEVITRA works by reducing the action of the second chemical (called PDE-5). LEVITRA allows an erection to last long enough for you to satisfactorily complete sexual activity. It is taken about 25 to 60 minutes before sexual activity and it will only work when you are sexually stimulated.
   
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2. BEFORE YOU TAKE LEVITRA
   
   Do not use LEVITRA…
   • If you have an allergy (if you're hypersensitive) to vardenafil or any of the other ingredients of LEVITRA. See the ingredients in the box, over the page. Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
   • If you take nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these drugs with LEVITRA could seriously affect your blood pressure.
   • 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 low blood pressure, or used to
   • If your family has a history of degenerative eye diseases (such as retinitis pigmentosa)
   
   If any of these applies to you, talk to your doctor, without taking LEVITRA.
   
   Talk to your doctor first …
   • If you have heart trouble. It may be risky for you to have sex
   • 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.
   
   If any of these applies to you, make sure you've talked to the doctor before taking LEVITRA.
   
   Food and drink with LEVITRA
   • You can take LEVITRA 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 LEVITRA. It can interfere with the usual effect of the medicine.
   • Alcoholic drink can make erection difficulties worse.
   
   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.
   
   LEVITRA is for men of 18 years and over
   
   It is not intended for use by women, children or men under 18.
   
   Other medicines and LEVITRA
   
   Tell your doctor or pharmacist about any medicine you are taking, or recently took - even products you bought without a prescription, like herbals and vitamins. LEVITRA 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 LEVITRA could seriously affect your blood pressure. Talk to a doctor without taking LEVITRA
   • Ritonavir or indinavir, medicines for HIV
   • Ketoconazole or itraconazole, anti-fungal medicines
   • Erythromycin, an antibiotic
   • Alpha-blockers, a type of medicine used to treat high blood pressure and benign prostatic hyperplasia.
   
   If you have recently taken any of these medicines, please tell your doctor or pharmacist.
   
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3. HOW TO TAKE LEVITRA
   
   How much to take and how to take it
   
   Your doctor will have suggested a suitable dose for you.
   • Always take LEVITRA exactly as your doctor has instructed you, and check with the doctor or pharmacist if you are unsure.
   • Tell the doctor if you think LEVITRA is too strong or too weak. He or she may suggest a different dose, depending on how well it works for you. Take a LEVITRA 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 LEVITRA.
   • Swallow one tablet with a glass of water
   • You can take LEVITRA with or without food - but preferably not after a heavy or high-fat meal.
   
   Don't use LEVITRA more than once a day.
   
   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.
   
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4. POSSIBLE SIDE EFFECTS
   
   Taking LEVITRA can cause side effects, although not everybody gets them. Most of the effects are mild or moderate.
   
   Very common side effects
   (These may affect 1 in 10 people or more)
   • Headaches
   • Flushing
   
   Common side effects
   (These may affect between 1 in 10 and 1 in 100 people)
   • Indigestion
   • Feeling sick (nausea)
   • Dizziness
   • Blocked or runny nose
   
   Uncommon side effects
   (These may affect less than 1 in 100 people)
   • Sensitivity of the eye to sunlight
   • High or low blood pressure
   • Fainting
   • Stiffness in muscles
   • Effects on vision
   • Erectile disturbances (such as spontaneous or painful erections)
   
   If any of these affects you badly, or doesn't go away as you carry on taking LEVITRA, tell your doctor.
   
   If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
   
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5. STORING LEVITRA
   
   Keep out of the reach and sight of children.
   
   Do not use after the expiry date stated on the packaging.
   
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   SOURCE: BAYER/GSK www.levitra.co.uk

   
   
   This leaflet was last approved on March 2003
   
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