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Levitra Patient Information

Introduction

WHAT IS LEVITRA USED FOR?

LEVITRA is used to treat erectile dysfunction sometimes known as impotence in men. Erectile dysfunction is the inability to obtain and or maintain a hard erect penis for sexual activity. LEVITRA tablets contain the active ingredient vardenafil (present as vardenafil hydrochloride trihydrate) which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. These work by relaxing the blood vessels in the penis when you are sexually aroused. This allows blood to flow into the penis, allowing you to get an erection in the natural way. LEVITRA will only work if you are sexually excited. It will not increase your sex drive. LEVITRA is not approved for use in women. LEVITRA tablets are not addictive.

BEFORE YOU TAKE LEVITRA

When you must not take it:

Because sexual activity may place a strain on your heart, your doctor will need to check whether you are fit enough to use LEVITRA.

Do not take LEVITRA if you are being treated for angina (chest pain) or other heart conditions with certain medicines called nitrates. Nitrate medicines include glyceryl trinitrate (also called nitroglycerine). These medicines can be sold under tradenames:

Anginine tablets, Glytrin Spray, Minitran patches, Nitrocor patches, Nitro-Dur patches, Nitroderm TTS patches, Nitrolingual pump spray, Rectogesic ointment, Transiderm-Nitro patches Other nitrate medicines include sodium nitroprusside, isosorbide mononitrate and isosorbide dinitrate. Isosorbide mononitrate tablets can be sold under tradenames:

Corangin, Duride, Imdur Durules, Imtrate SR, ISMO 20, Isomonit, Monodur, Isosorbide dinitrate tablets can be sold under tradenames:

Coronex, Isordil, Sorbidin, There may be other tradenames not listed here.

Do not take LEVITRA if you are using the unapproved drug amyl nitrite. Amyl nitrite is also known as 'poppers', 'amyl' or 'rush'. Do not take LEVITRA if you are taking an alpha-blocker (a particular type of medicine used to treat an enlarged prostate or high blood pressure). Examples of alpha-blockers are terazosin, tamsulosin, and prazosin.

You should not use LEVITRA together with other treatments for erectile dysfunction.

Do not take LEVITRA if you have an allergy to vardenafil or other phosphodiesterase type 5 inhibitors, or any of the ingredients in LEVITRA tablets listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching, or difficulty breathing.

Before you start to take LEVITRA, tell your doctor if you:

have any allergies to vardenafil or any other ingredients in LEVITRA tablets, or to any other medicines that you have used in the past, or to any other substances such as food, preservatives or dyes, have any heart or blood vessel problems, have ever suffered a heart attack or stroke, have any kidney or liver problems, have leukaemia (cancer of the blood cells), have multiple myeloma (a cancer of the bone marrow), have any disease or deformity of your penis, have low blood pressure, have sickle cell anaemia, have stomach ulcers, have a serious eye condition called retinitis pigmentosa, are receiving any other treatment for impotence.

Some medicines may be affected by LEVITRA or vice versa. These medicines include:

ketoconazole and itraconazole, used to treat fungal infections, erythromycin, an antibiotic ritonavir and indinavir and other protease inhibitors used for the treatment of HIV infection, alpha-blockers, medicines used to treat an enlarged prostate (BPH) or high blood pressure. Examples of alpha-blockers areterazosin, tamsulosin and prazosin.

You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will be able to advise you. Your doctor or pharmacist will also have a more complete list of medicines to be careful with or avoid while taking LEVITRA.

HOW TO TAKE LEVITRA

Your doctor or pharmacist will tell you how much and how often you should take LEVITRA. Follow the directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

The dose ranges from 5 mg to 20 mg. Your doctor will determine the correct dose for you depending on your condition and response.

Do not take more than one dose of LEVITRA a day.

Take your dose of LEVITRA 25 to 60 minutes before you wish to have sex. Swallow the tablet whole with a glass of water.

Sexual stimulation is required for a natural response to treatment with LEVITRA.

LEVITRA can be taken with or without food.

The medicine may be taken anywhere between 15 minutes to up to 5 hours before sexual activity. The amount of time LEVITRA takes to start working varies from person to person, but it normally takes between 25 to 60 minutes.

If LEVITRA does not help you get an erection, or if your erection does not last long enough to complete sexual intercourse, tell your doctor. In these cases, your doctor may need to adjust your dose.

Things you must not do:

If you get an angina attack while taking LEVITRA, do not take nitrate medicines to relieve the pain. Tell your doctor immediately. Make sure that your doctor knows you are taking LEVITRA.

Do not take more than one dose of LEVITRA a day. If LEVITRA does not help you get an erection, or if your erection does not last long enough to complete sexual intercourse, tell your doctor.

Do not give your LEVITRA tablets to anyone else, even if they have the same condition as you.

What to be careful of:

Drinking alcohol can temporarily impair the ability to get an erection. To reduce impairment do not drink large amounts of alcohol before sexual activity.

Be careful driving or operating machinery until you know how LEVITRA affects you. LEVITRA tablets may cause dizziness or faintness in some patients. The ability to drive and/or operate machinery may be impaired. If you drink alcohol, dizziness or faintness may be worse.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LEVITRA. LEVITRA helps most men with erectile dysfunction, but it may have unwanted side effects. Sometimes they are serious, most of the time they are not. You may need to stop taking the tablets or have medical treatment if you get some of the serious side effects.

Tell your doctor if you notice any of the following and they worry you:

headache, flushing, dyspepsia (heartburn), nausea, dizziness or light-headedness, a stuffy or runny nose, sensitivity of the eye to sunlight, high or low blood pressure, stiffness in muscles, pain in the joints, rash, stomach or abdominal pain.

These are the more common side effects of LEVITRA. They are usually mild and short-lived. Very rarely, your erection may persist for longer than usual. If your erection continues for longer than four hours, or if you have a painful erection, you should seek medical attention.

Tell your doctor immediately, or go to the accident and emergency department at your nearest hospital if you notice any of the following: severe chest pain, angina, irregular heart beats, loss of consciousness.

These are serious side effects. You may need urgent medical attention or hospitalization.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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Reprinted with permission from Dialog Medical, DialogMedical.com.

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