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  • For more information, please download leaflet.

    • The brand name of your medication is Lyratan® and the generic name is Macitentan.
    • Lyratan® is available as film-coated tablet containing 10 mg Macitentan. Every 7 tablets are packed in a blister and 4 blisters are packaged in one box.

    1 Why Lyratan® is prescribed?

    Lyratan® is used to treat hypertension in pulmonary artery in adults.

    This medication can be used alone or in combination with other medicines. pulmonary arterial hypertension is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. It causes patients to feel tired, dizzy, and shortness of breath.

    How is Lyratan® tablet given?

    - Use the medicine exactly as directed, your Doctor gives you details. - Take this medicine with or without food. - Swallow the whole tablet with a glass of water, do not chew, break or crush the tablet. - It is recommended to take Lyratan® at the same time each day. - Do not stop taking your medicine unless your doctor tells you, do not change the dose of medication without checking with your doctor. - Consult with your doctor or pharmacist how to throw away medicines, you no longer require. - If you have any further questions about Lyratan® ,ask your doctor, pharmacist or other health care provider.

    2 What special precautions should you follow during treatment with Lyratan®?

    • Prevent pregnancy during treatment and at least for one month after stopping treatment by using acceptable methods of contraception. Lyratan® can cause serious birth defects if taken during pregnancy. Females must not be pregnant during treatment.
    • It is not known if Lyratan® passes into your breastmilk. You should not breastfeed if you take Lyratan®.
    • Your doctor will do tests periodically during treatment with Lyratan®. The tests include blood tests to check your blood cells and liver function.
    • Consult with your doctor before taking any medicines with Lyratan®. Do not start any new medicine until you check with your doctor.
    • Tell your doctor if you have not taken your medication for any reason.
    • Lyratan® can cause side effects such as headache or hypotension, so be careful not to drive or operate machines that need awareness.
    • If you are a parent or caregiver of a girl who started taking Lyratan® before reaching puberty, you should check your child regularly to see if she is developing signs of puberty, tell your doctor right away if you notice that she is developing any signs of puberty.
    • Your child may reach puberty before having her first menstrual period.
    • Lyratan® can cause increased liver enzymes, liver toxicity and hepatic impairment. Your doctor should do blood tests to check your liver before you start taking Lyratan® and during treatment. Tell your doctor if you have any of the following symptoms of liver problems while taking this medicine: pain in the upper right stomach, nausea, vomiting, loss of appetite, fever, itching, dark urine or yellowing of your skin or whites of your eyes.
    • Do not take any other medications without consulting with your doctor and always Keep a list of all your medications (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.

    3 What are some side effects that you need to call your doctor about right away?

    • Signs of an allergic reaction, like rash; hives; itching; red, peeling skin with or without fever, swelling of the mouth, face, lips, tongue, or throat, wheezing; tightness in the chest or throat; trouble breathing or talking or unusual hoarseness.
    • Burning or pain when passing urine.
    • Swelling or rapid weight gain.
    • Signs of liver problems like nausea, pain in the upper stomach, itching, feeling tired, not hungry, dark urine, light-colored stools or yellow skin or eyes.
    • In case of any kidney problem
    • In the case of anemia signs, such as fatigue, weakness, irregular heartbeat, dizziness and pale skin.
    • new lung problems: anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.
    • Low blood pressure;
    • Call your doctor immediately if you notice any symptoms or health problems that do not get better or get worse over time.

    4 What is the storage condition of Lyratan®?

    • Store Lyratan® below 30° C and away from light and moisture.
    • Keep Lyratan® out of the sight and reach of children.
    • Do not use Lyratan® after the expiry date which is stated on the box or blister.
  • For more information, please download leaflet.

    • LYRATAN® is available as film-coated tablets containing 10 mg macitentan

    1 INDICATIONS AND USAGE

    1.1. Pulmonary Arterial Hypertension

    MACITENTAN is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). MACITENTAN also reduced hospitalization for PAH.

    2 DOSAGE AND ADMINISTRATION

      2.1. Recommended Dosage

    • The recommended dosage of MACITENTAN is 10 mg once daily for oral administration. Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended.
    • 2.2. Pregnancy Testing in Females of Reproductive Potential

    • Initiate treatment with MACITENTAN in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy test during treatment.

    3 CONTRAINDICATIONS

    • Hypersensitivity to the active substance, soya or to any of the excipients.
    • Pregnancy
    • Women of childbearing potential who are not using reliable contraception.
    • Breastfeeding
    • Patients with severe hepatic impairment (with or without cirrhosis).
    • Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 × ULN).

    4 USE IN SPECIFIC POPULATIONS

    • 4.1. Pregnancy
    • Pregnancy Category: X

      MACITENTAN may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy. Macitentan was teratogenic in rabbits and rats at all doses tested.

      A no-effect dose was not established in either species. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential hazard to a fetus.

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