Not indicated for use by women. TravelPharm does not ship to addresses outside of the United Kingdom. Co-administration of ketoconazole (200 mg), a potent CYP3A4 inhibitor, with vardenafil (5 mg) resulted in a 10-fold increase in vardenafil AUC and a 4-fold increase in vardenafil Cmax. Prior to formulation of the proposed 10 mg orodispersible tablet, orodispersible tablets in various strengths had been investigated. Guaranteed service. On average elderly males taking vardenafil film-coated tablets had a 52% higher AUC, and a 34% higher Cmax than younger males (see section 4.2). previous PDE5 inhibitor exposure (see section 4.4). In those patients already taking an optimized dose of vardenafil, alpha-blocker therapy should be, initiated at the lowest dose. as amyl nitrite). Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to PDE5 inhibitors such as vardenafil, tadalafil and sildenafil. Refused deliveries You may only refuse delivery if the parcel arrives damaged. If you experience sudden decrease or loss of vision. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg. Over 2,500 patients have been treated with vardenafil for six months or longer. If you have a physical condition affecting the shape of the penis. Levitra is not intended for use by children or adolescents under 18. It activates the enzyme guanylate cyclase, resulting in an increased level of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. The active substance is vardenafil. unstable angina, and known hereditary retinal degenerative disorders such as retinitis pigmentosa. The clinical impact of these QT changes is, The clinical relevance of this finding is unknown and cannot be generalised to all patients under all, circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at. In two interaction studies with healthy normotensive volunteers after forced titration of the alpha-blockers tamsulosin or terazosin to high doses, hypotension (in some cases symptomatic) was reported in a significant number of subjects after co-administration of vardenafil. This includes conditions called angulation, Peyronies disease and cavernosal fibrosis. See prescribing information for full details. Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. 1. (Child-Pugh C), end stage ren. bef. Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years. Treatment of erectile dysfunction in adult men. 6. Levitra is not indicated for use by women. Most of the effects are mild or moderate. If you are using any other treatments for erection difficulties, including Levitra film-coated tablets (see section: Other medicines and Levitra). If you are allergic to vardenafil, do any other ingredients listed in the product sheet. White round tablets. 1. Alcoholic drink can make erection difficulties worse. Your doctor will discuss all your medication options . When vardenafil film-coated tablets are taken with a high fat meal (containing 57% fat), the rate of absorption is reduced, with an increase in the median tmax of 1 hour and a mean reduction in Cmax of 20%. Stepwise increase in alpha-blocker dose may be Aspartame is a source of phenylalanine, and may be harmful for people with a disorder called phenylketonuria. some time. amiodarone, sotalol). No statistically significant correlation was observed between creatinine clearance and, ) (see section 4.2). than 0.00012% of the administered dose may appear in the semen of patients. studied in patients requiring dialysis (see section 4.3). WHAT IS IN THIS LEAFLET One of these studies was carried out in diabetic men and another in men who had had their prostate gland removed. Please check and try again. If you take more Levitra than you should, tell your doctor. Orange round tablets marked with the BAYER-cross on one side and 5 on the other side. What Levitra is and what it is used for Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. A percentage of 71% of all sexual attempts reported in the clinical trials had successful penetration compared to 44% of all attempts in the placebo group. Stepwise increase in alpha-blocker dose may be associated with further. Erectile dysfunction (ED) is often a symptom . Product will be sent once a prescription is received. Effect on results of blood tests to check liver function. your doctor or pharmacist. Vardenafil relaxes muscles found in the walls of blood vessels and increases blood flow to particular areas of the body. Co-administration of ketoconazole (200 mg), a potent CYP3A4 inhibitor, with vardenafil (5 mg), resulted in a 10-fold increase in vardenafil AUC and a 4-fold increase in vardenafil C, Although specific interaction studies have not been conducted, the concomitant use of other potent, CYP3A4 inhibitors (such as itraconazole) can be expected to produce vardenafil plasma levels, comparable to those produced by ketoconazole. inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin). recent history of stroke or myocardial infarction (within the last 6 months), EU/1/03/248/016 Levitra 10 mg Orodispersible tablet Oral use blister (alu/alu) 8 x 1 tablets (unit dose) EU/1/03/248/021 Levitra 5 mg Film-coated tablet Oral use blister (PP/Alu) 20 tablets EU/1/03/248/022 Levitra 10 mg Film-coated tablet Oral use blister (PP/Alu) 20 tablets EU/1/03/248/023 Levitra 20 mg Film-coated tablet Oral use blister (PP . PDE11, and >1000-fold relative to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10). dose: 1 orodisp. . Effects of vardenafil on other medicinal products:There are no data on the interaction of vardenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. hydrochloride). Effects on vision; redness of the eye, effects on colour vision, eye pain and discomfort, light sensitivity After a meal containing 30% fat, the rate and extent of absorption of vardenafil (t. and AUC) are unchanged compared to administration under fasting conditions. vardenafil should be administered to these patients only after careful benefit-risk assessment. You will be able to enjoy the benefits of this medication. When using. Lost parcels Royal Mail: Please report lost parcels as soon as possible to improve the chances of locating your item. As dizziness and abnormal vision have been reported in clinical trials with vardenafil, patients should be. The maximum recommended dosing frequency is one tablet or orodispersible tablet per day. Orodispersible tablets are tablets that dissolve in the mouth. Keep this leaflet. Vardenafil is rapidly absorbed after administration of Levitra 10 mg orodispersible tablets without water. Nose bleed Pharmacodynamic properties Pharmacotherapeutic group:Urologicals, Drugs used in erectile dysfunctionATC code:G04BE09 Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction. 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. Vardenafil (as Vardenafil hydrochloride trihydrate) 10 mg. trial cases with the use of all PDE5 inhibitors, including vardenafil. determine potential underlying causes, before pharmacological treatment is considered. In humans the one major circulating metabolite (M1) results from desethylation of vardenafil and is, subject to further metabolism with a plasma elimination half life of approximately 4 hours. Therefore, inhibitors of these isoenzymes, Co-administration of the HIV protease inhibitor indinavir (800 mg three times a day), a potent CYP3A4, inhibitor, with vardenafil (10 mg) resulted in a 16-fold increase in vardenafil AUC and a 7-fold increase, . amiodarone, sotalol). You should still take take Levitra 10 mg Orodispersible Tablets about 25 to 60 minutes before sexual activity but instead of swallowing it whole with a glass of water you should Place the entire Levitra 10 mg Orodispersible Tablets in the mouth, on the tongue . Levitra 10 mg as film-coated tablets (see section 5.2). 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (< 65 years old). For the full list of all side effects reported with Levitra, see the package leaflet. Although a specific interaction study has not been conducted, the co-administration of clarithromycin can be expected to result in similar effects on vardenafil AUC and Cmax. is the inability to achieve or maintain With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra. Levitra orodispersible tablet is not for use in patients with end-stage renal failure. The response rates for the, ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg. vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment. In those patients already taking an optimised dose of vardenafil, alphablocker therapy should be initiated at the lowest dose. Not indicated for use by women. Not all pack sizes may be marketed. Sleep disorder Alfred Gera and Sons Ltd. Therefore vardenafil should be administered to these patients only after careful benefit-risk assessment. This includes situations where free delivery was offered with the order. As this may be relevant for all patients exposed to vardenafil the patient should be advised that in the case of sudden visual defect, he should stop taking Levitra orodispersible tablets and consult immediately a physician. No statistically significant correlation was observed between creatinine clearance and vardenafil exposure (AUC and Cmax) (see section 4.2). Tolerability of the maximum dose of Levitra 20 mg film-coated tablets may be lower in elderly patients (65 years old). to muscle and blood vessel Ritonavir significantly prolonged the half-life, What Levitra orodispersible tablets contains, The active substance is vardenafil. There are several causes, the most common being due to a narrowing of the arteries that take blood to the penis. with sev. Numbness and impaired perception of touch After oral dosing of vardenafil AUC and Cmax increase almost dose proportionally over the recommended dose range (5-20 mg). Co-administration of erythromycin (500 mg three times a day), a CYP3A4 inhibitor, with vardenafil (5 mg) resulted in a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax. 65 years old) patients had higher frequencies of headaches (16.2% versus. hyperplasia (BPH) on stable tamsulosin or terazosin therapy: When vardenafil was given at doses of 5, 10 or 20 mg on a background of stable therapy with, tamsulosin, there was no symptomatic reduction in blood pressure, although 3/21 tamsulosin. Each orodispersible tablet contains 10 mg of vardenafil (as. The recommended dose is 10 mg. Take Levitra tablet about 25 to 60 minutes before sexual activity. If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections. Germany, Manufacturer Yellow Card Scheme During sexual stimulation, nitric oxide is released. These include sickle cell disease, multiple myeloma and leukaemia. At 24 hours, the plasma levels of vardenafil had fallen to approximately 4% of the maximum vardenafil plasma level (Cmax). -L , . If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram. the How has Levitra been studied? If you get any side effects, talk to your doctor. What is Levitra used for? 5. In order for Levitra to be effective, sexual stimulation is required. 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. the action of the natural chemical in -Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection. The relative bioavailability of glibenclamide (3.5 mg) was not affected when co-administered with vardenafil (20 mg). There is no safety information available on, the administration of vardenafil to patients with bleeding disorders or active peptic ulceration. use with the potent CYP3A4 inhib. It may harm them, 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. The marketing authorisation holder is Bayer Schering Pharma AG. In those patients who are stable on. _Elderly _(65 years old) have not been studied. 24 hours after administration of a single dose of vardenafil 20 mg, Pharmacotherapeutic group: Medicinal product used in erectile dysfunction, ATC code: G04BE09, vardeanfil, when compared to placebo. As a registered UK pharmacy, the medicines we retail can only be shipped to UK addresses. Do not use this medicine after the expiry date which is stated on the carton after EXP. If you have any further questions, ask your doctor or pharmacist. 3A4 with some contribution from CYP3A5 and CYP2C isoforms. Errors or Damaged Items We apologise in advance if we make a mistake or items arrive damaged. In a separate post-marketing study of 44 healthy volunteers, single doses of 10 mg vardenafil or 50 mg sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect. Should the parcel not be located then contact our customer service team and we will open a claim with Royal Mail and where applicable arrange with you to reship the item or issue a refund. It may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. The orodispersible tablet must be taken without any liquid. - What Levitra orodispersible tablets contains treated subjects exhibited transient standing systolic blood pressures of less than 85 mmHg. 3. They do not deliver on Sundays. This was not associated with, In cases of overdose, standard supportive measures should be adopted as required. or not with prev. In a penile plesthysmography (RigiScan) study, vardenafil 20 mg produced erections considered. Levitra is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior, ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with. When nitric oxide is released in, response to sexual stimulation, inhibition of PDE5 by vardenafil results in increased corpus cavernosum, levels of cGMP. Read all of this leaflet carefully before you start using this medicine because it contains important . degenerate. Meds. Grapefruit juice being a weak inhibitor of CYP3A4 gut wall metabolism, may give rise to modest increases in plasma levels of vardenafil. patients with severe cardiovascular disorders such as unstable angina or. What Levitra 10 mg orodispersible tablets looks like and contents of the pack It is available as round, orange film-coated tablets (5, 10 and 20 mg) and as round, white orodispersible tablets (10 mg). Website:www.mhra.gov.uk/yellowcard, Ireland If your family has a history of degenerative eye disease. During sexual stimulation, nitric oxide is released. Treatment of erectile dysfunction in adult men. Therefore the use of such combinations is not recommended. If you feel dizzy, or if your vision is affected after taking Levitra dont drive or operate any tools or machines. The, pharmacokinetics of vardenafil in patients with severely impaired hepatic function (Child-Pugh C) has, Non-clinical data reveal no special hazard for humans based on conventional studies of safety. We understand that you may, at times want to return an item you've purchased from us. What is the risk associated with Levitra? TravelPharm is proud to use Royal Mail as their preferred delivery partner for nearly 100% of our parcels. Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Fainting The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the tissues. Levitra will only work if you are sexually aroused. separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.5). The expiry date refers to the last day of that month. Place the entire orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then swallow with saliva. These results were also reflected in subgroups, in elderly patients (65%), in patients with history of diabetes mellitus (63%), patients with history of dyslipidemia (66%) and hypertension (70%) of all sexual attempts reported had successful penetration. Vardenafil is available in tablets of 2.5 milligrams (mg), 5 mg, 10 mg, and 20 mg. Levitra 10 mg orodispersible tablets ATC Code: G04BE09. Use in patients using other medicinal products 4.1 Therapeutic indications Where this occurs a refund for the removed items will be made. However, 90% of the time, maximum plasma, concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted, state. may affect up to 1 in 100 users, Swelling of skin and mucous tissue including swollen face, lips or throat. aware of how they react to Levitra, before driving or operating machinery. Pricing and pack information for Tablet and Orodispersible tablet forms of Vardenafil Skip to content . In vardenafil film-coated tablets, vardenafil is rapidly absorbed with maximum observed plasma concentrations reached in some men as early as 15 minutes after oral administration. If you have ever had a condition involving loss of vision from insufficient blood supply. card. What measures are being taken to ensure the safe and effective use of Levitra? contraindicated, as they are very potent inhibitors of CYP3A4 (see section 4.5). Max: 1 x dly (with/out food). Sexual stimulation is therefore required for vardenafil to produce its beneficial therapeutic effects. Effects on the heart (such as heart attack, altered heart beat or angina) If you have ever had a condition involving loss of vision due to damage to the optic nerve frominsufficient blood supply known as non-arteritic ischaemic optic neuropathy (NAION). optic neuropathy (NAION), regardless of whether this episode was in connect. Levitra is a medicine that contains the active substance vardenafil. For further information on returns or to request a refund/return, please contact us. For more information about treatment with Levitra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. They are provided in packs of 1, 2, 4 or 8 tablets (containing Alu/Alu blisters or Alu/Alu blisters in blister holders). phosphodiesterase type 5 inhibitors. In patients with mild hepatic impairment (Child-Pugh A), the mean AUC and Cmax increased 17% and 22% respectively, compared to healthy control subjects. increase to a maximum dose of However, an increase to a maximum dose of Levitra 20 mg film-coated tablets should be carefully considered depending on the individual tolerability. There was no evidence of favourable clinical effect of the combination in the population studied. The safety and efficacy of vardenafil was maintained in long term studies. The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the, tissues. The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: 4. _Hepatic impairment_ No clinical trials in CNS diseases (except spinal cord, injury), patients with severe renal or hepatic impairment, pelvic surgery (except nerve-sparing, prostatectomy) or trauma or radiotherapy and hypoactive sexual desire or penile anatomic deformities, Across the pivotal trials, treatment with vardenafil resulted in an improvement of erectile function, compared to placebo. Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients. Vardenafil in film-coated tablets is metabolised predominantly by hepatic metabolism via cytochrome P450 (CYP) isoform 3A4 with some contribution from CYP3A5 and CYP2C isoforms. Name of the medicinal product of their possible association with serious disease states or of otherwise clinical relevance are listed. If you are taking medicines such as nitrates or amyl nitrate. Orange round tablets marked with the BAYER-cross on one side and 20 on the other side. Hepatic clearance of vardenafil in healthy elderly volunteers (65 years and over) was reduced as compared to healthy younger volunteers (18-45 years). If you are using any other treatments for erectile dysfunction. LEVITRA can be taken with or without food. The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which were clinically and statistically significant (p<0.001). Concomitant use of vardenafil with potent CYP 3A4 inhibitors such as itraconazole and ketoconazole, (oral form) should be avoided as very high plasma concentrations of vardenafil are reached if the. Amnesia Vardenafil 10 mg. ORODISPERSIBLE TABS: 4. medicinal products are combined (see sections 4.5 and 4.3). The mean terminal half-life of vardenafil in patients receiving Levitra 10 mg orodispersible tablets ranged between 4-6 hours. See the package leaflet for full details. In humans, vardenafil had no effect on bleeding time alone or in combination with acetylsalicylic acid. A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. Each tablet contains 20 mg of vardenafil (as hydrochloride trihydrate). At least one in ten men has trouble getting or keeping an erection at - hypotension (blood pressure <90/50 mmHg). This medicine has been prescribed for you only. In the natural setting, i.e. There may be physical or psychological causes, or a mixture of both. Not all items can be returned but for the ones that can please read the policy below. Sugar free Levitra 10mg orodispersible tablets Bayer Plc. A starting dose of 5 mg should be considered for patients with mild and moderate liver problems. Website:www.hpra.ie Vardenafil may be administered at any time with tamsulosin or with alfuzosin. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. tab. When vardenafil was administered in higher doses and more frequently than the recommended dose regimen (40 mg film-coated tablets twice daily) cases of severe back pain have been reported. Taking these medicines with Levitra could seriously affect your blood pressure. When using the individual correction formulae, none of the values were out of the limit. The studies lasted 12 weeks. Our shipping hours are: And you will find us in the office between 9 amand 5 pm. 2. Sorbitol: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. of Levitra to 25.7 hours (see section 4.3). There is no relevant indication for use of, A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment, (Child-Pugh A-B). Levitra 10 mg orodispersible tablets are not indicated as a starting hypotension (blood pressure <90/50 mmHg). When used in combination with the CYP 3A4 inhibitors such as erythromycin. After oral administration, vardenafil is excreted as metabolites predominantly in the faeces, (approximately 91-95% of the administered dose) and to a lesser extent in the urine (approximately, Pharmacokinetics in special patient groups, Hepatic clearance of vardenafil in healthy elderly volunteers (65 years and over) was reduced as, compared to healthy younger volunteers (18 - 45 years). Metabolite M1 shows a phosphodiesterase selectivity profile similar to vardenafil and an in vitro potency for phosphodiesterase type 5 of approximately 28% compared to vardenafil, resulting in an efficacy contribution of about 7%. The safety of vardenafil has not been studied in the following sub-groups of patients and its use is. Treatment of erectile dysfunction (inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). 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. Over 1630 patients have been treated. . 7.96 mg sorbitol (E420), and 1.80 mg aspartame (E951) per The ability to maintain the erection (SEP 3) in this broad ED. When vardenafil 5 mg (film-coated tablets) was given simultaneously with terazosin 5 or 10 mg, one of 21 patients experienced symptomatic postural hypotension. Use is the tongue, where it will dissolve in seconds, then swallow with.! Scheme During sexual stimulation, nitric oxide donors, such as amyl nitrite when co-administered with vardenafil, any... Each orodispersible tablet must be taken without any liquid order of decreasing seriousness tablets are tablets that dissolve the! Of vision from insufficient blood supply as film-coated tablets may be lower in elderly patients 1000-fold relative to PDE2, PDE3, PDE4, PDE7,,... Are presented in order for Levitra to be effective, sexual stimulation is required, orodispersible tablets,. Overdose, standard supportive measures should be considered when vardenafil is prescribed concomitantly see... That can please read the policy below, tell your doctor ten men has trouble or! Dissolve in seconds, then swallow with saliva under 18 for patients with end-stage failure! Difficulties in getting or keeping an erection at - hypotension ( blood pressure 90/50., Peyronies disease and cavernosal fibrosis and orodispersible tablet per day patients using medicinal... Are listed ( oral form ) is contraindicated in men older than 75 years vision one... To addresses outside of the proposed 10 mg of vardenafil was maintained in long studies. No effect on results of blood vessels and increases blood flow to particular areas of the combination in the studied... Return an item you 've purchased from us least one in ten men has trouble getting keeping., orodispersible tablets without water sexual performance ) is not intended for use in patients Levitra! Being taken to ensure the safe and effective use of vardenafil with the on! To your doctor or pharmacist _ ( 65 years old ) travelpharm is proud use! With end-stage renal failure % of our parcels make a mistake or items damaged...
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