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What Levitra is and what it is used for
Levitra contains vardenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. They are used to treat erectile dysfunction in older men - a condition characterized by difficulty getting or maintaining an erection
At least one in ten men sometimes have difficulty getting or maintaining an erection. The reasons for this may be physical or psychological, or a combination of both. Whatever the reason, due to changes in the muscles and blood vessels there is not enough blood in the penis to receive and maintain an erection.
Levitra will only work when you are sexually stimulated. The drug reduces the action of a natural substance in your body, which weakens your erection. Levitra allows the erection to last long enough for you to perform a satisfying sexual act.
2. What you need to know before taking Levitra
Do not take Levitra
- If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching, swelling of the face or lips and difficulty breathing.
- If you are taking medicines containing nitrates, such as glycerol trinitrate for breast frogs (angina pectoris) or medicines that release nitric oxide, such as amyl nitrite. By taking these medicines with Levitra, your blood pressure can be significantly affected
- If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
- If you are over 75 years old and take ketoconazole or itraconazole, antifungal medicines.
- If you have a severe heart or liver problem.
- If you are on dialysis.
- If you have had a cerebral hemorrhage or heart attack recently.
- If you have or have low blood pressure.
- If you have evidence of degenerative eye diseases (such as retinitis pigmentosa) in the family.
- If you have ever had a condition associated with loss of vision due to damage to the optic nerve by insufficient blood flow, known as non-arterial ischemic optic neuropathy (NAION).
- If you are taking rhyociguate. This medicine is used to treat pulmonary arterial hypertension (ie, high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie, high blood pressure in the lungs due to blood clots). PDE 5 inhibitors, such as Levitra, have been shown to potentiate the blood pressure lowering effect of this drug. If you are taking rhiziguat or you are not sure, tell your doctor.
Warnings and precautions
Talk to your doctor before taking Levitra.
Take special care with Levitra
- If you have a heart condition. It can be risky for you if you have sex.
- If you suffer from cardiac arrhythmia or congenital heart disease that affect your electrocardiogram.
- If you have a physical condition that has affected the shape of your penis. This includes conditions called angulation, Peyronie's disease and cavernous fibrosis.
- If you have a condition that causes an erection that cannot resolve (priapism). This includes sickle cell anemia, multiple myeloma and leukemia.
- If you have stomach ulcers (so-called gastric or peptic ulcers).
- If you have a bleeding disorder (such as hemophilia).
- If you use other medicines for the treatment of erectile dysfunction, including Levitra oral dispersible tablets (see “Other medicines and Levitra”).
- If you have sudden deterioration or loss of vision, stop taking Levitra and contact your doctor immediately.
Children and adolescents
Levitra is not intended for use in children or adolescents under 18 years of age.
Other medicines and Levitra
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Some medicines can cause problems, especially the following:
- Nitrates, angina pectoris (breast frog), or medicines that release nitric oxide such as amyl nitrite. Taking these medicines with Levitra can seriously affect your blood pressure. Talk to your doctor before taking Levitra.
- Medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone or sotalol.
- Ritonavir or indinavir, HIV medicines. Talk to your doctor before taking Levitra.
- Ketoconazole or itraconazole, fungal medicines.
- Erythromycin or clarithromycin, macrolide antibiotics.
- Alpha blockers, a type of medication used to treat high blood pressure and enlarge the prostate (such as benign prostatic hyperplasia).
- The riotsiguat.
Do not use Levitra film-coated tablets in combination with any other means of treating erectile dysfunction, including Levitra orodispersible tablets.
Levitra with food, drink and alcohol
- You can take it
How to take Levitra
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is 10 mg.
Take a Levitra tablet 25 to 60 minutes before intercourse. With sexual stimulation, you can get an erection of 25 minutes to four to five hours after taking Levitra.
- Swallow one tablet of Levitra with a glass of water
Do not take Levitra film-coated tablets with any other form 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 that you switch to an alternative dosage form of Levitra, depending on your effect.
If you take more Levitra than you should
Men who take a lot more Levitra may experience more side effects or have severe back pain. If you take more Levitra than the prescribed dose, tell your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of them are mild or moderately pronounced.
Some patients have partial, sudden, temporary or permanent deterioration or loss of vision in one or both eyes. Stop taking Levitra and contact your doctor immediately.
Sudden hearing loss or hearing loss has been reported.
The likelihood of an adverse reaction is described by the following categories:
can affect more than 1 in 10 users
can affect up to 1 in 10 users
- Obstruction of the nose or the nose
- Gastric disorder
can affect up to 1 in 100 users
- Swelling of the skin and mucous membranes, including swelling of the face, lips or throat
- Sleep disorders
- Tingling and impaired sense of touch
- Changes in vision, redness of eyes, change in color vision, pain and discomfort in the eyes, sensitivity to light
- Tinnitus, vertigo
- Pulse rate, heartbeat
- Shortness of breath
- Stuffy nose
- Acids, gastritis, abdominal pain, diarrhea, vomiting; general malaise (nausea), dry mouth
- Elevated levels of liver enzymes in the blood
- Rash, redness of the skin
- Back and muscle pain, increase in blood enzyme muscle (creatine phosphokinase), muscle stiffness
- Extended erection
- Physical discomfort
can affect up to 1 in 1,000 users
- Eye inflammation (conjunctivitis)
- Alergic reaction
- A seizure
- Increased intraocular pressure (glaucoma), increased lacrimation
- Effects on the heart (such as heart attack, change in heart rhythm or angina)
- High or low blood pressure
- Bleeding from the nose
- Effect on blood test results to monitor liver function
- Skin sensitivity to sunlight
- Painful reaction
- Chest pain
Very rare or of unknown frequency:
may affect less than 1 in 10,000 users, or no estimates can be made from the available data
- Blood in urine (hematuria)
- Hemorrhage in the penis (hemorrhage in the penis)
- Existence of blood in the seminal fluid (hemospermia)
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can contribute to receiving more information on the safety of this medicine.
How to store Levitra
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Levitra contains
- The active substance is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride).
- The other ingredients are:
Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, silica, colloidal anhydrous.
Film coating: macrogol 400, hypromellose, titanium dioxide (E171), iron oxide, yellow (E172), iron oxide, red (E172).
What Levitra looks like and contents of the pack
Levitra 20 mg film-coated tablets are orange in color, marked with a BAYER cross on one side and "20" on the other. The tablets are available in blister packs containing 2, 4, 8, 12 or 20 tablets. Not all pack sizes may be marketed.
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