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Opsumit TM

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.

Active ingredients: macitentan

Brand name

(ARTG)

: OPSUMIT macitentan 10 mg film coated tablet blister pack

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

OPSUMIT, as monotherapy or in combination with approved PAH treatments (phosphodiesterase-5 inhibitors or inhaled prostanoids), is indicated for the treatment of: idiopathic pulmonary arterial hypertension heritable pulmonary arterial hypertension pulmonary arterial hypertension associated with connective tissue disease pulmonary arterial hypertension associated with congenital heart disease with repaired shunts in patients with WHO Functional class II, III or IV symptoms.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Tablet, film coated
  • Oral
  • The drug product is supplied as a white to off white, biconvex, round, film-coated tablet debossed with 10 on both sides.

Storage conditions

(ARTG)

  • Store below 30 degrees Celsius
  • Protect from Moisture
  • Shelf lifetime is 60 Months.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • 3 film coated tablets pack
  • 30 film coated tablets pack
  • 6 film coated tablets pack
  • 9 film coated tablets pack

Is this medicine subsidised ?

(PBS)

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on December, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient macitentan

This medicine is not considered safe during pregnancy. You should discuss this medicine with your doctor or pharmacist. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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Need more information?

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Pulmonary hypertension - Better Health Channel

Pulmonary hypertension is high blood pressure on the lungs.

Read more on Better Health Channel website

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