Nerhasilda 50 mg 16 orodispersible films

Phosphodiesterase-5 enzyme Inhibitor used in the treatment of erectile dysfunction, pulmonary edema, pulmonary arterial hypertension and Raynaud’s disease.

-Tablet: Administer with or without food 30 minutes to 4 hours before sexual activity. -Orodispersible films: One film to be placed on the tongue taken with dry hands when required.

-Auditory impairment and hearing loss, hypotension, painful priapism lasting >4 hours in duration has been reported rarely. -Flushing, dyspepsia, headache, visual disturbance (including vision color changes, blurred vision, and photophobia), epistaxis, angina pectoris, atrioventricular block, cardiac failure, cardiomyopathy , cerebral thrombosis, chest pain ,edema, facial edema, hypotension, ischemic heart disease, orthostatic hypotension, palpitations, peripheral edema , shock, syncope, tachycardia, contact dermatitis, dermal ulcer, diaphoresis, erythema of skin, exfoliative dermatitis, pruritus, skin photosensitivity, skin rash, urticaria, gout, hyperglycemia, hypernatremia , hyperuricemia, hypoglycemia, increased thirst, unstable diabetes, abdominal pain, colitis, diarrhea, dysphagia, esophagitis, gastritis, gastroenteritis, gingivitis, glossitis, nausea, stomatitis, vomiting, xerostomia, cystitis, ejaculatory disorder , genital edema, nocturia, urinary frequency, urinary incontinence, anemia, leukopenia, rectal hemorrhage, abnormal dreams, absent reflexes, anorgasmia, ataxia , chills, depression, dizziness, drowsiness hypertonia, hypoesthesia, insomnia, migraine , myasthenia, neuralgia, neuropathy, pain, paresthesia, vertigo, arthritis, asthenia, back pain, myalgia, osteoarthritis, , anterior chamber eye hemorrhage, cataract, conjunctivitis, dry eye syndrome, eye pain, mydriasis , retinal hemorrhage, asthma, bronchitis, dyspnea, exacerbation of dyspnea , increased bronchial secretions, increased cough , laryngitis , nasal congestion, pharyngitis , rhinitis, sinusitis.

-Elderly >65 years: Use with caution. In case of erectile dysfunction: Oral: Starting dose of 25 mg should be considered. -Incase of kidney impairment: If the creatinine clearance <30 mL/minute: Starting dose of 25 mg should be considered (when needed). -Incase of hepatic impairment: Starting dose of 25 mg should be considered(when needed). -In pediatric patients (1 to 17 years of age) with pulmonary arterial hypertension, an increased mortality risk was associated with long-term use (>2 years) at dosage levels of 0.88 to 2.5 mg/kg/dose administered three times daily. -Should not be given to patients suffering from hypersensitivity to sildenafil. -Avoid the concurrent use of alcohol, particularly in larger quantities, this combination may increase the risk for orthostatic hypotension, dizziness, tachycardia, and headache. -Use with caution in patients with bleeding disorders -Use with caution in patients with hypotension (<90/50 mm Hg); uncontrolled hypertension (>170/110 mm Hg); life-threatening arrhythmias, stroke or myocardial infarction within the last 6 months; cardiac failure or coronary artery disease causing unstable angina. -Use with caution in patients who have conditions which may predispose them to priapism (sickle cell anemia, multiple myeloma, leukemia). -Use with caution in patients with active peptic ulcer disease -Pulmonary arterial hypertension: Sudden cessation of sildenafil monotherapy could result in an exacerbation of pulmonary arterial hypertension. -Use of sildenafil is contraindicated in patients currently taking nitrate preparations. However, when nitrate administration becomes medically necessary, the guidelines support administration of nitrates only if 24 hours have elapsed after use of sildenafil.

Store at room temperature.

-Alcohol (Ethyl): May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. -Alpha1-Blockers: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Alpha1-Blockers -Blood pressure lowering Agents: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of blood pressure lowering agents. -Ciprofloxacin: May increase the serum concentration of Sildenafil. -Dapoxetine: May enhance the orthostatic hypotensive effect of Phosphodiesterase 5 Inhibitors. -Grapefruit Juice: May increase the serum concentration of Sildenafil. -Protease Inhibitors: May increase the serum concentration of Sildenafil.

-The use of sildenafil in pregnant women outside of a controlled clinical study is not currently recommended, Information related to the use of sildenafil for the treatment of pulmonary arterial hypertension (PAH) in pregnant women is limited. -Sildenafil is present in breast milk.

NERHADOU INTERNATIONAL CO.