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TIMEONN-J (SILDENAFIL ORAL JELLY 100 MG)
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Product Details:
| Strength | 100 mg |
| Pack Size | 5 gm |
| Brand | TIMEONN - J |
NDICATIONS:TIMEONN is indicated for the treatment of erectile dysfunction in adult men.DOSAGE AND ADMINISTRATION:Adults: The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. Renal & Hepatic Impairment: Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg and 100 mg as necessary.Paediatric population;TIMEONN is not indicated for individuals below 18 years of age.Method of Administration: For Oral Use.WARNINGS AND PRECAUTION: Prior to prescribing TIMEONN, physicians should consider the cardiovascular status of the patient, since cardiac risk is associated with sexual activity.It should be used caution in patients with anatomical deformation of the penis.Patients should be advised that in the event of any sudden visual defect, they should stop taking TIMEONN and consult a physician immediately.It should be administered cautiously to the patients with bleeding disorders or peptic ulceration.Patients with rare hereditary problems of galactose intolerance should not take TIMEONN.SIDE EFFECTS:Common: Headache, Dizziness, Visual disturbance, Hot flush, Nasal congestion, Nausea, Dyspepsia.Uncommon: Rhinitis, Hypersensitivity, Hypoaesthesia, Lacrimation disorders, Conjunctivitis, Vertigo, Tinnitus, Tachycardia, Hypertension, Hypotension, Epistaxis, GERD, Vomiting, Dry mouth, Rash, Myalgia, Haematuria, Chest pain, Fatigue.Rare: Seizure, Non-arteritic anterior ischaemic optic neuropathy (NAION), Glaucoma, Myocardial infarction, Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Priapism, retinal vascular oculusion.DRUG INTERACTIONS:Co-administration of the HIV protease inhibitor (ritonavir, saquinavir) with TIMEONN resulted in an increase in Cmax and plasma AUC.A single 100mg dose of TIMEONN was administered with erythromycin, resulted in an increase in systemic exposure (AUC).Co-administration of the cimetidine with TIMEONN caused an increase in plasma concentrations.Co-administration of the endothelin antagonist, bosentan with TIMEONN resulted in decrease AUC and Cmax, respectively.Concomitant administration of the strong CYP3A4 inducers such as rifampin, causes greater decrease in plasma concentrations of Sildenafil.Concomitant administration of Sildenafil with alpha-blocker therapy may lead to symptomatic hypotension. Addition of single dose of sildenafil to socubitril/valsartan in patients with hypertension was associated with a significantly greater blood pressure reduction.PREGNANCY AND LACTATION: TIMEONN is not indicated for use by women.OVERDOSAGE:The symptoms observed in case of overdose are headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision.Appropriate symptomatic treatment should be provided.CONTRAINDICATION:TIMEONN is contraindicated in patients: Hypersensitivity to active ingredient or to any of the excipients. In men for whom sexual activity is inadvisable. (e.g, Patients with severe cardiovascular disorders such as angina or severe cardiac failure.) In patients who have loss of vision in one eye because of NAION. In patients with hepatic impairment, hypotension, recent history of stroke.STORAGE:TIMEONNStore below 30°C. Protect from heat and light. Keep out of reach of children. TIMEONN - JStore at a temperature not exceeding 30°C, protected from light and humidity.Keep out of reach of children.PRESENTATION:TIMEONN10 x 1 x 10 Tablets in printed carton with pack insert.
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