Vardenafil/Levitra 10 mg. 4 tablets
What is Levitra and what is it 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 in obtaining 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 shortness of breath.
- 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) infection.
- 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 kidney dialysis
- If you have had a stroke or heart attack soon
- If you have or have low blood pressure
- If you have a family of degenerative eye diseases (such as retinitis pigment)
- 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 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 an anatomical deformity of the 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 gastric ulcers (so-called gastric or peptic ulcers)
- If you have a bleeding disorder (such as hemophilia)
- If you are using other medicines to treat erectile dysfunction, e.g. all PDE5 inhibitors, including Levitra film-coated 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 (chest frogs) or nitric oxide releasing drugs such as amyl nitrite. By taking these medicines with Levitra, your blood pressure can be significantly affected. 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).
Do not use Levitra oral dispersible tablets in combination with any other means of treating erectile dysfunction, such as all PDE 5 inhibitors, including Levitra film-coated tablets.
Levitra with food and drink
- You can take Levitra orodispersible tablets with or without food, but do not take this medicine with liquids.
- Do not drink grapefruit juice when taking Levitra. It can affect the usual effect of the medicine
- Alcoholic beverages can make it difficult to get an erection. Pregnancy and breastfeeding
Levitra is not intended for use by women.
Driving and using machines
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:
- may affect more than 10 users
- may affect up to 1 in 10 users
- Obstruction of the nose or the nose
- Gastric disorder
- may 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 or muscle pain, increase in blood enzyme muscle (creatine phosphokinase), muscle stiffness
- Extended erection
- Physical discomfort
- may 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 erection
- Chest pain
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)
- Existence 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 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.
Store in the original package in order to protect from light and moisture.
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 does Levitra orodispersible tablet contain?
- The active substance is vardenafil. Each oral dispersible tablet contains 10 mg of vardenafil (as hydrochloride).
- The other ingredients are: magnesium stearate, aspartame (E951), mint flavor, mannitol (E421), sorbitol (E420), crospovidone and silica, colloidal hydrated.
What does Levitra 10 mg orodispersible tablet look like and contents of the pack?
The Levitra 10 mg oral dispersible tablets are round and white. They are available in packs of 1, 2, 4 or 8 tablets (contained in aluminum / aluminum blisters or in aluminum / aluminum blisters in blister holders).
Not all pack sizes may be marketed.