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Levitra 10 mg orodispersible tablets Vardenafil,Hydrochlorid
2014-10-23 22:29:37 来源: 作者: 【 】 浏览:330次 评论:0

For doctors

 

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.

What do you have to consider before using it?

Do not take Levitra

Take special care with Levitra

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:

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

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:

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 take Levitra orodispersible tablets with any other forms of Levitra .

Do not take Levitra 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)

Common (affects 1 to 10 users in 100)

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

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

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.

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For doctors

What is it?

Levitra is a medicine that contains the active substance vardenafil. It is available as round, orange film-coated tablets (5, 10 and 20 mg) and as round, white orodispersible tablets (10 mg). Orodispersible tablets are tablets that dissolve in the mouth.

What is it used for?

Levitra is used to treat adult men (aged 18 years or over) with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity. For Levitra to be effective, sexual stimulation is required.

The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Levitra is 10 mg, taken as one or two film-coated tablet about 25 to 60 minutes before sexual activity or as an orodispersible tablet (taken without liquid) about 60 minutes before sexual activity. If Levitra film-coated tablets are taken with a high fat meal, the onset of activity may be delayed. The dose of the film-coated tablets may be increased to a maximum of 20 mg or decreased to 5 mg, depending on the effectiveness of treatment and any side effects.

A starting dose of 5 mg should be considered for patients with mild and moderate liver problems. The dose may need to be adjusted in patients taking other medicines that inhibit enzymes that break down Levitra. For full details, see the package leaflet.

The maximum recommended dosing frequency is one tablet or orodispersible tablet per day.

How does it work?

The active ingredient of Levitra, 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, Levitra restores erectile function. Sexual stimulation is still needed to produce an erection.

How has it been studied?

Levitra tablets were compared with placebo (a dummy treatment) in four main studies including a total of 2,431 men with erectile dysfunction aged 20 to 83 years. One of these studies was carried out in diabetic men and another in men who had had their prostate gland removed.

The effectiveness of orodispersible tablets and placebo were compared in two main studies involving a total of 686 men with erectile dysfunction aged 21 to 84 years.

In all of the studies, the main measure of effectiveness was the ability to get and maintain an erection. This was recorded in two questionnaires completed at home. The studies lasted 12 weeks.

What benefits has it shown during the studies?

Levitra tablets and orodispersible tablets were significantly more effective than placebo for all measures in all of the studies.

What is the risk associated?

The most common side effect with Levitra (seen in more than 1 patient in 10) is headache. Flushing (reddening of the skin) is also seen in more than 1 patient in 10 taking the film-coated tablets. For the full list of all side effects reported with Levitra, see the package leaflet.

Levitra should not be used in people who may be 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 used in 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). Levitra must not be taken with nitrates (medicines used to treat angina). Because Levitra has not been studied in patients with severe liver or kidney disease, patients who have hypotension (low blood pressure) or patients who have had a stroke or a heart attack within the last six months must not use it. Levitra must not be taken with ketoconazole and itraconazole (used to treat fungal infections) in men over 75 years of age, or with ritonavir or indinavir (used to treat HIV infection).

Caution is needed when Levitra is taken with some other medicines. See the package leaflet for full details.

Why has it been approved?

The CHMP decided that Levitra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Levitra Page

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Levitra on 6 March 2003. The marketing authorisation holder is Bayer Schering Pharma AG. The marketing authorisation is valid for an unlimited period.

For more information about treatment with Levitra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 07-2010. Levitra Page

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Name

 

Levitra 10 mg orodispersible tablets

 

Composition

 

Each orodispersible tablet contains 10 mg of vardenafil (as hydrochloride).

Excipients:
7.96 mg sorbitol (E420), and 1.80 mg aspartame (E951) per orodispersible tablet.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Orodispersible tablet.
White round tablets.

 

Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

 

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