OPSYNVI

Macitentan 10mg, Tadalafil 40mg, Oral tablet

Alcohol

· Severity: Major

· Notes for Consumers: Do not drink alcohol while taking this medication. Drinking alcohol while taking this medication increases the risk for dangerously low blood pressure. Contact your care team right away if you experience dizziness, feeling faint or lightheaded, or blurry vision.

· Notes for Professionals: Advise patients to avoid alcohol consumption while taking tadalafil. Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood pressure lowering effects may be increased. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including an increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil (10 mg or 20 mg) did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations.

Macitentan 10mg, Tadalafil 40mg, Oral tablet

Grapefruit juice

· Severity: Moderate

· Notes for Consumers: Grapefruit juice and grapefruit-containing foods may increase the side effects of Tadalafil (Cialis). Do not significantly alter grapefruit juice intake while taking this drug, or avoid grapefruit juice if possible. When taking Cialis, contact your prescriber immediately if you experience chest pain, dizziness, fainting or falling spells, palpitations, shortness of breath, or a change in your usual heart beat (fast, slow, or irregular heart beat).

· Notes for Professionals: Tadalafil is metabolized via the CYP3A4 isozyme. Grapefruit juice has been reported to decrease the metabolism of drugs metabolized via this enzyme. Grapefruit juice contains a compound that inhibits CYP3A4 in enterocytes in the GI tract. Tadalafil levels may increase; it is possible that tadalafil-induced side effects could also be increased in some individuals.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>