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What Vardenafil is and what it is used for
Vardenafil 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.
Vardenafil 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 Vardenafil
Do not take Vardenafil
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 and taking ketoconazole or itraconazole, antifungal medicines;
If you have a severe heart or liver problem;
If you are on dialysis;
If you have recently had a cerebral hemorrhage or heart attack;
If you have or have had 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).
Warnings and precautions
Talk to your doctor before taking Vardenafil
Take special care with Vardenafil
If you have heart disease. 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). These include sickle cell anemia, multiple myeloma and leukemia;
If you have gastric ulcers (so-called gastric or peptic ulcers);
If you have bleeding disorders (such as hemophilia);
If you use other medicines to treat 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 Vardenafil
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 (chest frogs), or drugs 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;
Arrhythmia medicines 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 medicine used to treat high blood pressure and enlarge the prostate (such as benign prostatic hyperplasia).
Do not use Levitra film-coated tablets in combination with any other means of treating erectile dysfunction, including Vardenafil orodispersible tablets.
Vardenafil with food and drink
You can take Levitra with or without food - it is preferable not to eat after a heavy meal or a high fat meal, as this may delay the effect of the medicine;
Do not drink grapefruit juice when taking Levitra. It can affect the usual effect of the drug;
Alcoholic beverages can make it difficult to get an erection.
Pregnancy and breastfeeding
Vardenafil is not intended for use by women.
Driving and using machines
Vardenafil can cause dizziness in some people and affect their
If you take more Vardenafil than you should
Men who take a lot more Vardenafil may experience more side effects or have severe back pain. If you take more Vardenafil 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:
Very common: may affect more than 1 in 10 users:
Common: may affect up to 1 in 10 users:
Nasal or runny nose obstruction;
Uncommon: may affect up to 1 in 100 users:
Swelling of the skin and mucous membranes, including swelling of the face, lips or throat;
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;
Accelerated heart rate, palpitations;
Acids, gastritis, abdominal pain, diarrhea, vomiting; general malaise (nausea), dry mouth;
Increased levels of liver enzymes in the blood;
Rash, skin redness;
Back and muscle pain, increase in blood enzyme muscle (creatine phosphokinase), muscle stiffness;
Rare: May affect up to 1 in 1,000 users:
Eye inflammation (conjunctivitis);
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;
Effect on blood test results to monitor liver function;
Sensitivity of the skin to sunlight;
Very rare or unknown frequency: may affect less than 1 in 10,000 users:
Blood in urine (hematuria);
Hemorrhage in the penis (hemorrhage in the penis);
Presence of blood in the seminal fluid (hemospermia).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. How to store Vardenafil
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 Vardenafil 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 (E 172).
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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