Healthdirect Free Australian health advice you can count on.

Medical problem? Call 1800 022 222. If you need urgent medical help, call triple zero immediately

healthdirect Australia is a free service where you can talk to a nurse or doctor who can help you know what to do.

beginning of content

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

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

Back to top back to top

Need more information?

These trusted information partners have more on this topic.

Top results

Pulmonary hypertension - Better Health Channel

Pulmonary hypertension is high blood pressure on the lungs.

Read more on Better Health Channel website

Healthdirect 24hr 7 days a week hotline

24 hour health advice you can count on

1800 022 222

Government Accredited with over 140 information partners

We are a government-funded service, providing quality, approved health information and advice

Australian Government, health department logo ACT Government logo New South Wales government, health department logo Northen Territory Government logo Queensland Government logo Government of South Australia, health department logo Tasmanian government logo Victorian government logo Government of Western Australia, health department logo

Healthdirect Australia acknowledges the Traditional Owners of Country throughout Australia and their continuing connection to land, sea and community. We pay our respects to the Traditional Owners and to Elders both past and present.