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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS1This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are

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How to fill out opsumit inn- macitentan

01

Step 1: Read the medication guide provided by your pharmacist before you start taking Opsumit (macitentan) and each time you get a refill.

02

Step 2: Take Opsumit exactly as prescribed by your doctor. Do not take more or less than the recommended dose.

03

Step 3: Swallow the tablet whole with water. Do not crush or chew it.

04

Step 4: You can take Opsumit with or without food.

05

Step 5: If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

06

Step 6: It may take several weeks before you experience the full benefit of Opsumit. Keep taking it even if you feel well.

07

Step 7: Do not stop taking Opsumit without consulting your doctor, as this may worsen your condition.

08

Step 8: Store Opsumit at room temperature away from moisture and heat.

Who needs opsumit inn- macitentan?

01

Opsumit (macitentan) is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults with WHO functional class II-III symptoms.

02

It is used to delay disease progression, reduce hospitalizations, and improve exercise ability.

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What is opsumit inn- macitentan?

Opsumit inn-macitentan is a medication used to treat pulmonary arterial hypertension.

Who is required to file opsumit inn- macitentan?

Healthcare providers are required to file opsumit inn-macitentan for patients who are prescribed the medication.

How to fill out opsumit inn- macitentan?

Opsumit inn-macitentan can be filled out by providing patient information, dosage instructions, and other relevant details.

What is the purpose of opsumit inn- macitentan?

The purpose of opsumit inn-macitentan is to improve the symptoms and quality of life for patients with pulmonary arterial hypertension.

What information must be reported on opsumit inn- macitentan?

Information such as patient demographics, medical history, current medications, and dosage instructions must be reported on opsumit inn-macitentan.

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