MAJEGRA SUPER DS Tablet

In adult men with erectile dysfunction and premature ejaculation, which is the inability to achieve or maintain a satisfactory sexual performance.

It is indicated for the treatment of erectile dysfunction (ED) in adult men.

It is indicated for the treatment of premature ejaculation (PE) in adult men aged 18-64 years.

It should only be prescribed to patients who meet all the following criteria:

An intravaginal ejaculatory latency time of less than 2 minutes; and

Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes; and

Marked personal distress or interpersonal difficulty as a consequence of PE; and

Poor control over ejaculation; and

A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.

Sildenafil & Dapoxetine Tablet should be administered only as on-demand treatment before anticipated sexual activity. It should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.

In order for Sildenafil & Dapoxetine Tablet to be effective, sexual stimulation is required.

Dosage and Administration

Use in adults

The initial recommend dose is 50mg and 30mg for Sildenafil and Dapoxetine respectively taken as needed approximately 1-3 hours before sexual activity. The maximum recommended dose is 100mg and 60mg for Sildenafil and Dapoxetine respectively. The maximum recommended dosing frequency is once per day. If the product is taken with food, the onset of activity may be delayed compared to the fasted state.

See the package insert about the details below.

Special populations

- Elderly patients

- Patients with renal impairment

- Patients with hepatic impairment

- Paediatric population

- Known CYP2D6 poor metabolizers or patients treated with potent CYP2D6 inhibitors.

Hypersensitivity to the active substance or to any of the excipients.

Sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.

Dapoxetine contraindicated in significant pathological cardiac conditions such as:

Heart failure (NYHA class Ⅱ-Ⅳ), Conduction abnormalities such as AV block or sick sinus syndrome, Significant ischemic heart disease, Significant valvular disease, A history of syncope and a history of mania or severe depression.

Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable.

Concomitant treatment with monoamine oxidase inhibitors (MAOIs) or thioridazine, or within 14 days of discontinuing treatment with an MAOI or thioridazine. Similarly, an MAOI or thioridazine should not be administered within 7 days after therapy of Sildenafil & Dapoxetine Tablet has been discontinued.

Concomitant treatment with serotonin reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or other medical/herbal products with serotonergic effects [e.g. L-tryptophan, triptans, tramadol, linezolid, lithium, St. John’s Wort (Hypericum perforatum)] or within 14 days of discontinuing treatment with these medicinal/herbal products. Similarly, these medicinal/herbal products should not be administered within 7 days after Sildenafil & Dapoxetine Tablet has been discontinued.

For Sildenafil, headache is very common adverse effect and along with headache, nausea and dizziness are the very common adverse effect associated with Dapoxetine.

Due to Sildenafil, the common effects are visual colour distortions, visual disturbance, vision blurred. flushing, hot flush, nasal congestion, nausea and dyspepsia.

The common effects due to Dapoxetine are anxiety, agitation, restlessness, insomnia, abnormal dreams, libido decreased, somnolence, disturbance in attention, tremor. paraesthesia, blurred vision, tinnitus, flushing, sinus congestion, yawning, diarrhoea, vomiting, constipation, abdominal pain, abdominal pain upper, dyspepsia, flatulence, stomach discomfort, abdominal distension, dry mouth, hyperhidrosis, fatigue, irritability and increase in blood pressure.

Uncommon adverse effects related to Sildenafil are rhinitis, hypersensitivity, somnolence, hypoaesthesia, lacrimation disorders, eye pain, photophobia, photopsia, ocular hyperaemia, visual brightness, conjunctivitis, vertigo, tinnitus, tachycardia, palpitations, hypertension, hypotension, epistaxis, sinus congestion, gastro oesophageal reflux disease, vomiting, abdominal pain upper, dry mouth, rash, myalgia, pain in extremity, haematuria, chest pain, fatigue, feeling hot and heart rate increased.

Uncommon adverse effects related to Dapoxetine are depression, depressed mood, euphoric mood, mood altered, nervousness, indifference, apathy, confusional state, disorientation, thinking abnormal, hypervigilance, sleep disorder, initial insomnia, middle insomnia, nightmare, bruxism, loss of libido, anorgasmia, syncope, syncope vasovagal, dizziness postural, akathisia, dysgeusia, hypersomnia, lethargy, sedation, depressed level of consciousness, mydriasis, eye pain, visual disturbance, vertigo, sinus arrest, sinus bradycardia, tachycardia, hypotension, systolic hypertension, hot flush, abdominal discomfort, epigastric discomfort, pruritis, cold sweat, ejaculation failure, male orgasmic disorder, paraesthesia of genital male, asthenia, feeling hot, feeling jittery, feeling abnormal, feeling drunk, heart rate increased, blood pressure diastolic increased, blood pressure orthostatic increased.

The rare effects related to Sildenafil are cerebrovascular accident, transient ischaemic attack, seizure, seizure recurrence, syncope, non-arteritic anterior ischaemic optic neuropathy, retinal vascular occlusion, retinal haemorrhage, arteriosclerotic retinopathy, retinal disorder, glaucoma, visual field defect, diplopia, visual acuity reduced, myopia, asthenopia, vitreous floaters, iris disorder. mydriasis, halo vision, eye oedema, eye swelling, eye disorder, conjunctival hyperaemia, eye irritation, abnormal sensation in eye, eyelid oedema, scleral discoloration, deafness, sudden cardiac death, myocardial infarction, ventricular arrhythmia, atrial fibrillation, unstable angina, throat tightness, nasal oedema, Nasal dryness, hypoaesthesia oral, Stevens-Johnson syndrome, toxic epidermal necrolysis, penile haemorrhage, priapism, haematospermia, erection increased and irritability.

The rare effects related to Dapoxetine are dizziness exertional, sudden onset of sleep, and defaecation urgency.

Abrupt discontinuation of chronically administered SSRIs used to treat chronic depressive disorders has been reported to result in the following symptoms: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania.

See “Special Precaution”.

Sildenafil is not indicated for use by women.

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and premature ejaculation and determine potential underlying causes, before pharmacological treatment is considered.

Sildenafil Citrate

Cardiovascular risk factors

Priapism

Concomitant use with other PDE5 inhibitors or other treatment for erectile dysfunction

Effects on vision

Concomitant use with ritonavir

Concomitant use with alpha-blockers

Effect on bleeding

Women

Dapoxetine Hydrochloride

Orthostatic hypotension

Suicide/suicidal thoughts

Syncope

Patients with cardiovascular factors

Use with recreational drugs

Ethanol

Medicinal products with vasodilatation properties

Moderate CYP3A4 inhibitors

Potent CYP2D6 inhibitors

Mania

Seizure

Paediatric population

Depression and/or psychiatric disorders

Haemorrhage

Renal impairment

Withdrawal effects

Eye disorders

Sildenafil Citrate: Pharmacotherapeutic group: Urologicals

Dapoxetine Hydrochloride: Pharmacotherapeutic group: Other Urologicals

The mechanism of sildenafil responsible for erection of the penis due to release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activated the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and following inflow of blood. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects. The mechanism of action of dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter’s action at pre-and postsynaptic receptors.