5 mg film-coated tablets
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 adult men, a condition that makes it difficult to get and maintain an erection .
At least 1 in 10 men ever have problems getting or maintaining an erection . There may be physical causes or psychological causes, or a mixture of both. Whatever the reason, changes in muscles and blood vessels mean that there is not enough blood left in the penis to make it stiff and keep it stiff.
Levitra only works when you are sexually stimulated. Levitra reduces the effect of the natural substances in your body, which makes an erection disappear. Levitra allows an erection to last long enough for you to have a satisfying sexual activity
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 skin rash, itching , swollen face or swollen lips and shortness of breath.
- If you are taking medicines containing nitrates, such as glycerol trinitrate for angina or nitric oxide donors such as amyl nitrite. Your blood pressure can be severely affected by taking these medicines at the same time as Levitra.
- If you are taking ritonavir or indinavir, medicines used to treat infection you with the human immunodeficiency virus ( HIV ).
- If you are over 75 years old and taking ketoconazole or itraconazole, antifungal medicines.
- If you have severe heart or liver problems.
- If you receive kidney dialysis.
- If you have recently had a stroke or heart attack.
- If you have or have had low blood pressure .
- If there are hereditary eye diseases in your family (such as retinitis ).
- If you have ever had a condition that caused you to lose your sight due to damage to the optic nerve , which can be caused by insufficient blood supply, so-called non-arteritic anterior ischemic optic infarction / neuropathy (NAION).
- If you take riociguat. 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). PDE5 inhibitors, such as Levitra, have been shown to increase the antihypertensive effect of this medicine. If you are taking riociguat or if you are not sure, talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Levitra.
Take special care with Levitra
- If you have heart problems. It can be risky for you to have sex.
- If you have an irregular heartbeat (heart arrhythmia ) or congenital heart disease that affects your electrocardiogram ( ECG ).
- If you have any physical condition that affects the shape of your penis. This includes conditions called angulation, Peyronie’s disease and connective tissue disease of the corpora cavernosa.
- If you have a disease that can give you an erection that does not go away ( priapism ). These include sickle cell anemia, multiple myeloma and leukemia .
- If you have a stomach ulcer (also called a gastric or peptic ulcer ).
- If you have disorders of the blood’s ability to coagulate (such as haemophilia ).
- If you are taking any other treatments for erectile dysfunction, including Levitra orodispersible tablets (see section Other medicines and Levitra).
- If you experience sudden visual impairment 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 taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines can cause problems, especially these:
- Nitrates, anticonvulsants or nitric oxide donors, such as amyl nitrite. Your blood pressure can be severely affected by taking these medicines at the same time as Levitra.
- Drugs that affect the heart rhythm, such as quinidine , procainamide , amiodarone or sotalol.
- Ritonavir or indinavir, medicines for HIV .
- Ketoconazole or itraconazole, antifungal drugs.
- Erythromycin or clarithromycin, macrolide antibiotics.
- Alpha-receptor blockers, a type of medicine used to treat high blood pressure and benign prostatic hyperplasia.
Do not use Levitra film-coated tablets in combination with any other treatment for erectile dysfunction , including Levitra orodispersible tablets.
Levitra with food, drink and alcohol
- You can take Levitra with or without food, but preferably not after a heavy or high-fat meal as it may delay the effect.
- Do not drink grapefruit juice while using Levitra. It may affect the effect of the medicine.
- Consumption of alcohol can make erection difficulties worse.
Pregnancy and breastfeeding
Levitra should not be used in women.
Driving and using machines
Levitra may make some people feel dizzy or affect their vision. Do not drive or use any tools or machines if you feel dizzy, or if your vision is affected after taking Levitra.
How to take Levitra
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The recommended dose is 10 mg.
Take Levitra tablet about 25 to 60 minutes before sexual activity. With sexual stimulation, you can get an erection sometime between 25 minutes and up to 4 to 5 hours after taking Levitra.
- Swallow one tablet with a glass of water.
Do not take Levitra film-coated tablets with any other form of Levitra.
Do not use Levitra more than once a day.
Tell your doctor if you think Levitra is too strong or too weak. He or she may prescribe switching to a different formulation of Levitra 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 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 product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity.
Partial, sudden, temporary or permanent visual impairment or loss of vision in one or both eyes has been experienced by patients. Stop taking Levitra and contact your doctor immediately. Sudden hearing loss or deafness has been reported.
Cases of sudden death, rapid or altered heartbeat, myocardial infarction, chest pain and problems with blood circulation in the brain (including temporary decrease in blood flow to parts of the brain and cerebral haemorrhage) have been reported in men taking vardenafil.
Most of the men who experienced these side effects had heart problems before taking this drug. It is not possible to determine if these events were due to a world file.
Possible side effects are reported in the following categories:
Very common: may affect more than 1 user in 10
Common: may affect up to 1 in 10 users
- Nasal congestion or runny nose
- Stomach upset
Uncommon: may affect up to 1 in 100 people
- Swelling of the skin and mucous membranes that includes swelling of the face, lips and throat
- Difficulty sleeping
- Numbness and decreased sensitivity to touch
- Visual disturbances such as red eyes, effects on color vision, eye pain and discomfort, photosensitivity
- Ringing in the ears, dizziness
- Increased heart rate or palpitations
- Respiratory distress
- Nasal congestion
- Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, nausea, dry mouth
- Elevated levels of liver enzymes in the blood
- Skin rash, reddening of the skin
- Back or muscle pain, increase in a muscle enzyme in the blood (creatine phosphokinase), muscle stiffness
- Prolonged erection er
- Feeling sick
Rare: may affect up to 1 in 1,000 users
- Inflammation of the eye ( conjunctivitis )
- Allergic reaction
- Memory loss
- Increased pressure in the eye ( glaucoma ), increased tear flow
- Effects on the heart (such as heart attack, altered heart rhythm or angina)
- High or low blood pressure
- Nasal blood
- Influence on the results of blood tests to examine liver function
- Hypersensitivity of the skin to sunlight
- Painful erection er
- Chest pain
- Temporarily reduced blood flow to parts of the brain
Very rare or no known frequency : may occur in less than 1 in 10,000 users or frequency can not be calculated from the available data
- Blood in the urine ( hematuria )
- Penile bleeding
- Blood in the sperm ( hematospermia )
- Sudden death
- Cerebral haemorrhage
How to store Levitra
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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.
Contents of the pack and other information
- The active substance is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride).
- The other ingredients in the tablets are:
Tablet core : crospovidone, magnesium stearate, microcrystalline cellulose, colloidal silica (anhydrous).
Film coating : macrogol 400, hypromellose, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172).
What the medicine looks like and contents of the pack
Levitra 5 mg film-coated tablets are orange with the BAYER logo on one side and the strength (5) on the other. Each pack contains blister cards of 2, 4, 8, 12 or 20 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder