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Opsynvi 10/40 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 + tadalafil, tadalafil, macitentan

Pack: Opsynvi 10/40 tablet, 30, blister pack

Brand name

(ARTG)

: OPSYNVI 10/40 macitentan 10 mg / tadalafil 40 mg film-coated tablet blister pack

Consumer Medicine Information (CMI)

Read the CMI leaflet for facts you need to know before, during and after taking your medicine.

Listen to the audio transcription of the CMI leaflet.

For more information about CMIs and how to read them, please visit How to read Consumer Medicine Information (CMI).


What this medicine is used for

(ARTG)

OPSYNVI is indicated for the maintenance treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients of WHO functional class (FC) II and III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease with repaired shunts.,OPSYNVI is intended as substitution treatment only for patients currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Tablet, film coated
  • Oral
  • White to almost-white, oblong, film-coated tablet debossed with 1040 on one side and MT on the other side

Storage conditions

(ARTG)

  • Store below 30 degrees Celsius
  • Store in Original Container
  • Shelf lifetime is 24 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.

  • 30 pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient macitentan + tadalafil

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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