Nerhasilda 75 mg 8 orodispersible films

Trade Name:

Nerhasilda 75 mg

8 orodispersible films

Composition:

Sildenafil citrate 105.3 mg( eq. to Sildenafil 75 mg)

Inactive ingredients:

Maltodextrin (Glucidex IT6), Sucralose, Lemon flavor, Grapefruit flavor, Polyvinyl acetate dispersion 30% (Kolicoat SR 30D), Titanium dioxide, Indigotine EI32, Polysorbate 20 (Tween 20), Propylene glycol monocaprylate (type l) (Capryol 90), Glycerol, Water

Properties:

Sildenafil is a potent selective inhibitor of cycloguanosine monophosphate (CGMP)-specific phosphodiesterase type 5 (PDE5).

The implementation of the physiological mechanism of erection is associated with the release of nitric oxide (NO) in the cavernous body during sexual stimulation. This, in turn, leads to an increase in the level of CGMP, subsequent relaxation of the smooth muscle tissue of the cavernous body and an increase in blood flow.

A prerequisite for the effectiveness of sildenafil is sexual stimulation.

-the first and only sildenafil with Oral dispersible film Technology.

-absorbed through the tongue in 10 seconds without hepatic first pass effect so higher bioavailability and enhanced efficacy.

-starts working within 10 minutes only.

-provides hard and solid erection for maximum powerful sexual performance.

Indications:

Treatment of erectile dysfunction characterized by an inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse.

Dosage and administration:

Patients over 18 years of age: One 75 mg orodispersible film to be taken orally approximately within 1 hour before sexual activity. The effect may start in 10 minutes  after taking Nerhasilda, and may continue up to 4 hours.

Side effects:

Rare:

Auditory impairment and hearing loss, hypotension, painful priapism 

Common:

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.

Uncommon:

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.

Others:

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.

Contraindications:

-hypersensitivity to sildenafil or other ingredients 

-use in patients receiving constantly or intermittently nitric oxide donators, organic nitrates or nitrites in any form, since sildenafil enhances the hypotensive effect of nitrates;

-according to the registered indication, the drug Sildenafil is not intended for use in children and adolescents under the age of 18 years;

-according to the registered indication, the drug Sildenafil is not intended for use in women, including pregnant and breastfeeding;

-lactase deficiency, intolerance

Warnings and precautions:

• 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. 

Storage:

Store at a temperature not exceeding 30°C in a dry place.

Package:

Carton box holds 8 orodispersible films individually wrapped with four-layers pouches, and paper leaflet.