| Composition |
| Each Orodispersible Tablet contains:Vardenafil (as hydrochloride) 10 mg. |
| Excipients |
| Aspartame, Peppermint flavor, Magnesium stearate, Crospovidone, Mannitol , Silica dioxide colloidal, Sorbitol. |
| Pharmacodynamic |
Max Fil is an oral therapy for the improvement of erectile function in men with erectile dysfunction. In the natural setting, i.e. with sexual stimulation it restores impaired erectile function by increasing blood flow to the penis.
Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5.
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| Pharmacokinetic properties |
| Max Fil is rapidly absorbed after administration of vardenafil 10 mg tablets without water. The median time to reach Cmax varied between 45 to 90 minutes, and highly bound to plasma proteins (approximately 95% ) .vardenafil tablets can be taken with or without food. tablets must be taken without liquid, The mean terminal half-life of vardenafil in patients receiving vardenafil 10 mg orodispersible tablets ranged between 4 – 6 hours, 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 2-6% of the administered dose). |
| Indications |
Max Fil is indicatedTreatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order to be effective, sexual stimulation is required.
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| Contraindications |
1. Administration of vardenafil with nitrates or with nitric oxide donors is contraindicated.
2. Hypersensitivity to any of the ingredients.
3. In case of 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 previous phosphodiesterase 5 (PDE5) inhibitor exposure
4. should generally not be used in men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure .
5. 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:
- severe hepatic impairment (Child-Pugh C).
- end stage renal disease requiring dialysis,
- hypotension (blood pressure <90/50 mmHg),
- recent history of stroke or myocardial infarction (within the last 6 months),
- unstable angina.
- known hereditary retinal degenerative disorders such as retinitis pigmentosa.
6. Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years.
Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is contraindicated, as they are very potent inhibitors of CYP3A4 .The co-administration of PDE5 inhibitors, including vardenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.
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| Warning and precaution |
1. A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
2. Physicians should consider the cardiovascular status of their patients and the degree of cardiac risk associated with sexual activity.
3. The use of this drug with other treatments for erectile dysfunction is not recommended.
4. This drug should be used with caution in patients with anatomical deformation of the penis. Or in patients who have conditions that may predispose them to priapism (sickle cell anemia, leukemia).
5. There is no safety information available on the administration of vardenafil to patients with bleeding disorders or active peptic ulceration. Therefore vardenafil should be administered to these patients only after careful benefit-risk assessment.
6. The patient should be advised that in the case of sudden visual defect, he should stop taking tablets and consult immediately a physician .
7. Medicinal products that may prolong QTc interval, including vardenafil, are best avoided in patients with relevant risk factors, for example, hypokalaemia, congenital QT prolongation, concomitant administration of antiarrhythmic medicinal products in Class IA (e.g. quinidine, procainamide), or Class III (e.g. amiodarone, sotalol.
8. The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators.
9. Concomitant use of vardenafil with potent CYP 3A4 inhibitors such as itraconazole and ketoconazole (oral form) should be avoided .
10. Vardenafil dose adjustment might be necessary if moderate CYP 3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly.
11. Concomitant intake of grapefruit or grapefruit juice is expected to increase the plasma concentrations of vardenafil. The combination should be avoided.
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| Adverse reactions |
Common: Headache, dizziness, flushing, nasal congestion, dyspepsia.
Uncommon: Allergic oedema and angioedema Sleep disorder, Somnolence,
Paraesthesia and dysaesthesia, Ocular hyperaemia, Visual colour distortions ,Eye pain and eye discomfort,Photophobia,Tinnitus,Vertigo,Palpitation,Tachycardia,Dyspnoea,Sinus congestion, Gastro-oesophageal reflux disease ,Gastritis, Gastrointestinal and abdominal pain, Diarrhoea ,Vomiting ,Nausea, Dry mouth, Increase in transaminases, Erythema ,Rash, Back pain, Increase in creatine phosphokinase ,Myalgia, Increased muscle tone and cramping,Increase in erection, Feeling unwell.
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| Drug interactions |
The pharmacokinetics of vardenafil was not affected by co-administration with the H2-antagonist ranitidine (150 mg twice daily), digoxin, warfarin, glibenclamide, doses of antacid (magnesium hydroxide/aluminium hydroxide)
Vardenafil dose adjustment might be necessary if moderate CYP 3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly .
Concomitant intake of grapefruit or grapefruit juice is expected to increase the plasma concentrations of vardenafil. The combination should be avoided .
alpha- blockers: this product should not be taken as starting dose in patients treated with alpha- blockers.
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| pregnancy and lactation |
| Max Fil Not indicated for use by women |
| Effects on ability to drive and use machines |
| As dizziness and abnormal vision have been reported in clinical trials with vardenafil, patients should be aware of how they react to orodispersible tablets, before driving or operating machine. |
| Dosage and administration |
For adult men only.
Max Fil 10 mg orodispersible tablet is not bioequivalent to 10 mg film-coated tablet.
The maximum is 10 mg daily
Max Fil should be taken orally, as needed, approximately25- 60 minutes before sexual activity.
Sexual stimulation is required for a response to treatment.
should be placed on the tongue where it will rapidly disintegrate then swallowed with saliva. The tablet should be taken without liquid. It should be taken immediately upon removal from the blister.
Max Fil can be taken with or without food.
Dose adjustments are not required in elderly patients(≥65 years old).
Renal impairment:
No dose adjustment is required in patients with mild to moderate renal impairment.
In patients with severe renal impairment (creatinine clearance <30 ml/min) a starting dose of vardenafil 5 mg film-coated tablets should be considered. Based on tolerability and efficacy, the dose may be increased to vardenafil 10 mg and 20 mg film-coated tablets, or vardenafil 10 mg orodispersible tablets.
orodispersible tablet is not for use in patients with end-stage renal failure.
Hepatic impairment:
10 mg orodispersible tablets are not for use in patients with moderate and severe hepatic impairment.
Max Fil orodispersible tablets are not indicated for individuals below 18 years of age. There is no relevant indication for use of Max Fil orodispersible tablets in children and adolescents.
Max Fil dose adjustment is necessary if moderate or potent CYP 3A4 inhibitors are given concomitantly.
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| Overdosage |
| In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine. |
| Packaging |
Max Fil: a carton box 4 O.D. Tablets packed in blister with a leaflet.
Max Fil: a carton box 2 O.D. Tablets packed in blister with a leaflet.
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| Storage conditions |
Store at temperature between (15-30)⁰C.
Protect from light and moisture.
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