Zivales

• Heart failure
  • To reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in patients with chronic HF.
  • Treatment of symptomatic HF with systemic left ventricular systolic dysfunction in pediatric patients ≥1 year of age.

Oral, with or without food

Warnings & Precautions

Talk to your doctor or pharmacist before you take this medicine if you have any of the following:

• You are being treated with an Angiotensin Receptor Blocker (ARB) or aliskiren.
• You have ever had angioedema (sudden swelling under the skin or mucous membranes, often affecting the face, lips, or throat)
• You experience abdominal pain, nausea, vomiting or diarrhoea after taking Sacubitril/Valsartan.
• You have low blood pressure, are taking medicines that reduce your blood pressure, or are suffering from vomiting or diarrhoea, especially if you are aged 65 years or more, or if you have kidney disease and low blood pressure.
• You have kidney disease.
• You are suffering from dehydration.
• Your kidney artery has narrowed.
• You have liver disease.
• You experience hallucinations, paranoia or changes in sleeping pattern while taking Sacubitril/Valsartan.
• You have hyperkalaemia (high levels of potassium in the blood).
• You suffer from heart failure classified as NYHA class IV (unable to carry on any physical activity without discomfort and may have symptoms even when resting).

Pregnancy & Breastfeeding

• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• This medicine is not recommended in pregnancy and breast-feeding.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including the following:

• Aliskiren (Antihypertensive agent)
• Angiotensin-Converting Enzyme Inhibitors (e.g., Captopril, Enalapril, and Lisinopril)
• Antihepaciviral Combination Products
• Isocarboxazid (Antidepressant)
• Lithium (Bipolar disorder agent)

Side effects with incidence greater than 10% include:

• Hypotension (low blood pressure), hyperkalemia (high level of potassium in the blood), and decreased kidney function

If you take more Zivales® than you should
Tell your doctor immediately. If you experience severe dizziness and/or fainting, tell your doctor as
quickly as possible and lie down.

If you forget to take Zivales®
Take the next dose of Zivales® at the scheduled time.
Do not take a double dose to make up for the forgotten dose.

• Hypersensitivity to sacubitril, valsartan, or any component of the formulation
• History of angioedema related to previous ACE inhibitor or ARB therapy
• Concomitant use or use within 36 hours of ACE inhibitors
• Concomitant use of aliskiren in patients with diabetes

• Keep Zivales® at a temperature below 30°C and away from light and moisture.
• Keep Zivales® in the original container.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date.

Zivales® is supplied as blisters containing 28 film-coated tablets.