Pregnancy: Maacy® may harm unborn babies. Therefore you must not take Maacy® if you are pregnant and you must also not become pregnant while taking Maacy® or soon after stopping. Pregnancy can also lead to severe deterioration in pulmonary arterial hypertension symptoms.
Contraception: You need to use a reliable form of birth control (contraception) while you are taking Maacy®. Be sure to discuss any questions you may have with your doctor. You should have a pregnancy test before initiation of Maacy® and every month during treatment even if you think that you are not pregnant.
Blood tests for anaemia and liver function: Maacy® can induce anaemia (a reduced number of red blood cells) and can cause liver injury. You will have blood tests before you start treatment and regularly during treatment to check: • whether you have anaemia • whether your liver is working properly
Signs that your liver may not be working properly include: • nausea (feeling sick) vomiting • fever (high temperature) • pain in your stomach (abdomen) • jaundice (yellowing of your skin or the whites of your eyes) • dark-coloured urine
• itching of your skin • lethargy or fatigue (unusual tiredness or exhaustion) flu-like • syndrome ( joint and muscle pain with fever)
If you forget to take Maacy
take a dose as soon as you remember
Ask your doctor or pharmacist if you have any questions about your treatment
This document contains important safety information you need to be aware of when receiving treatment with Maacy
Pregnancy can lead to severe deterioration in pulmonary arterial hypertension symptoms
Use a reliable form of birth control while taking Maacy
Key Findings
If you have any questions about your treatment, ask your doctor or pharmacist
This card contains important safety information you need to be aware of when receiving treatment with Maacy®. Carry this card with you at all times and show it to any doctor involved in your medical care
Macitentan 10mg film coated tablet. This Document is approved by Executive Directorate of Pharmacovigilance at Saudi Food & Drug Authority (SFDA)
Contraception: You need to use a reliable form of birth control while you are taking Maacy®
Be sure to discuss any questions you may have with your doctor
