Sildenafil + Dapoxetine

Dosage Forms Available

• Sildenafil + Dapoxetine is available as a tablet.

Age and Dose Restrictions

• This combination is approved only for men aged 18–64 years. Its safety and effectiveness have not been established in individuals younger than 18 years or those aged 65 years and older. It is also not approved for use in women.
• Take this combination as prescribed by your doctor, as needed before sexual activity. Do not take it as a regular daily medicine, and do not use it more than once in 24 hours.

Contraindications

This medicine should not be taken in the following conditions:

• Allergy to sildenafil, dapoxetine, or any other ingredient in the tablet.
• Heart disease in which your doctor has advised you to avoid sexual activity.
• Severe heart failure, serious abnormalities of the heart's electrical activity, severe vascular disease, or significant heart valve disease.
• A previous episode of syncope (fainting).
• A history of mania, bipolar disorder, or severe depression.
• Moderate or severe hepatic impairment.
• Use of medicines containing nitrates or riociguat.

Do not take this medicine without a thorough medical evaluation if you have recently had a heart attack, stroke, a life-threatening irregular heartbeat, or very low or uncontrolled high blood pressure.

Other Medications To Avoid With This Medicine

• Do not take this medicine with nitrates such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, or “poppers.” This combination may cause a dangerous fall in blood pressure.
• Do not use it with riociguat. Sildenafil is contraindicated with riociguat because the combination may excessively lower blood pressure.
• Dapoxetine should not be taken with monoamine oxidase inhibitors (MAOIs), thioridazine, other selective serotonin reuptake inhibitors (SSRIs), serotonin–noradrenaline reuptake inhibitors (SNRIs), or tricyclic antidepressants.
• Do not use it with tramadol, linezolid, lithium, triptan medicines used for migraine, tryptophan, or St John's wort because of the potential for serious serotonergic effects.
• Concomitant use may be contraindicated with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, and atazanavir.
• Tell your doctor if you are taking blood pressure-lowering medicines, alpha-blockers, anticoagulants, or any other medicine for erectile dysfunction.

Overdose and Missed Dose

• Taking too much of this medicine may cause a severe decrease in blood pressure, fainting, dizziness, vomiting, restlessness, a fast or irregular heartbeat, seizures, or serotonin syndrome. Seek immediate medical attention if you take more than the prescribed dose.
• This medicine is not taken on a regular dosing schedule. If you do not take the dose before planned sexual activity, skip it. Do not take two doses to make up for a missed dose, and do not take more than one dose within 24 hours.

Use In Driving And Operating Machinery

• This medicine may cause dizziness, drowsiness, fainting, and visual disturbances. Do not drive or operate machinery if you experience these symptoms. Avoid such activities until you feel completely well and alert after taking the medicine.

Use in Pregnancy and Lactation

• This combination medicine is approved only for men aged 18–64 years. It is not approved for use in women, pregnant women, or breastfeeding women.

Caution In Other Conditions

• Caution is required in patients with mild or moderate kidney disease. Dapoxetine is not recommended for use in patients with severe kidney disease.
• Tell your doctor if you have a bleeding or blood-clotting disorder, an active gastrointestinal ulcer, sickle cell anaemia, multiple myeloma, leukaemia, an anatomical deformity of the penis, an eye or hearing disorder, seizures, controlled epilepsy, blood pressure problems, or a mental health condition.
• Inform your doctor that you are taking this medicine before undergoing surgery or dental treatment.

Special Dietary & Lifestyle Recommendation

• Do not drink alcohol while taking this medicine. Alcohol may increase the risk of dizziness, reduced mental alertness, hypotension, and fainting.
• Do not consume grapefruit or grapefruit juice for 24 hours before taking the medicine.
• Swallow the tablet with at least one full glass of water. It may be taken with or without food.
• Use appropriate protective measures, such as condoms, to reduce the risk of sexually transmitted infections.