Patient Medication Information: uses, side effects, how to take - Sandoz Sacubitril-Valsartan
Serious warnings and precautions box
What Sandoz Sacubitril-Valsartan is used for:
Sandoz Sacubitril-Valsartan is used to treat heart failure in adults. It has been shown to lower the:
- risk of death that is caused from heart and blood vessel related problems
- need for hospitalisation due to heart failure.
How Sandoz Sacubitril-Valsartan works:
Sandoz Sacubitril-Valsartan contains sacubitril and valsartan. These two ingredients work by blocking a specific enzyme and a specific receptor in your body.
Sandoz Sacubitril-Valsartan helps treat heart failure by:
- relaxing your blood vessels. This makes it easier for your heart to pump blood around your body.
- helping your body retain less water.
The ingredients in Sandoz Sacubitril-Valsartan are:
Medicinal ingredients: sacubitril and valsartan, as sodium salt complex.
Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, low-substituted hydroxypropylcellulose, Macrogol 4000, magnesium stearate (vegetable origin), microcrystalline cellulose, talc and titanium dioxide.
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Sandoz Sacubitril-Valsartan comes in the following dosage forms:
Film-coated tablet:
24 mg sacubitril/ 26 mg valsartan (violet white). Each tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium hydrate complex).
49 mg sacubitril/ 51 mg valsartan (pale yellow). Each tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium hydrate complex).
97 mg sacubitril/ 103 mg valsartan (light pink). Each tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium hydrate complex).
Do not use Sandoz Sacubitril-Valsartan if:
- you are allergic to sacubitril or valsartan or any of the other ingredients in Sandoz Sacubitril-Valsartan.
- you are taking angiotensin converting enzyme (ACE) inhibitors. You must wait at least 36 hours after your last dose of the ACE Inhibitor before starting Sandoz Sacubitril-Valsartan.
you have had angioedema, a swelling of the face, lips, tongue and/or throat, with or without difficulty in breathing:
- while taking an ACE inhibitor or an ARB in the past
- due to any other reason. The exception is an allergic reaction to a bee sting, insect or snake bite.
If this occurs, stop Sandoz Sacubitril-Valsartan immediately, and contact your doctor.
- you have an inherited condition called “hereditary angioedema,” an increased risk of getting an allergic reaction (angioedema) that is passed down through families.
- you are taking aliskiren-containing medicines, such as Rasilez, and have Diabetes or Kidney disease.
you are pregnant or planning to become pregnant. Taking Sandoz Sacubitril-Valsartan during pregnancy can cause injury and even death to your baby.
- you are breastfeeding. Sandoz Sacubitril-Valsartan passes into the breast milk.
- you are having symptoms related to low blood pressure.
- you are 18 years or younger.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Sacubitril-Valsartan. Talk about any health conditions or problems you may have, including if you:
- have severe kidney disease.
- have severe liver disease.
- ever had a reaction called angioedema (swelling of the face, lips, tongue, and/or throat, difficulties in breathing).
- have low blood pressure, or are taking other drugs to lower your blood pressure, such as, a diuretic or water pill.
- are taking any drugs that increase the amount of potassium in your blood (such as potassium supplements, or salt substitutes containing potassium, potassium-sparing drugs, and heparin). Your doctor may check the potassium levels in your blood at regular times while you are taking Sandoz Sacubitril-Valsartan. • have one or both of arteries to your kidney that are severely narrowed.
Other warnings you should know about:
Black patients may have a higher risk of angioedema.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Sandoz Sacubitril-Valsartan :
- ACE inhibitors (such as enalapril, ramipril, lisinopril and fosinopril).
Drugs used for lowering blood pressure or to treat heart failure:
- ARB (such as losartan, telmisartan, valsartan and candesartan)
- Aliskiren-containing drugs.
- Drugs used to lower cholesterol levels. These are known as ‘statins’ (such as atorvastatin).
- Sildenafil, a drug used to treat erectile dysfunction.
- Drugs that increase the amount of potassium in the blood (such as potassium supplements, or salt substitutes containing potassium, potassium-sparing diuretics or heparin).
Drugs used to treat inflammation and pain:
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Cox-2 inhibitors (such as celecoxib).
- Lithium, a drug used to treat some types of depression, bipolar or hypomanic disorders.
- Drugs used after organ transplants to protect against transplant rejection (such as cyclosporin)
- Drugs used to treat HIV/AIDS (such as ritonavir).
- Warfarin, a drug used to make blood thinner and less likely to clot.
- Furosemide, a diuretic (water pill) used to reduce the fluid build-up in your body.
- Metformin, used to treat diabetes.
Ask your doctor or pharmacist if you are not sure if any of the medicines you take are included in the list above.
How to take Sandoz Sacubitril-Valsartan :
If you were taking ACE inhibitors, you must wait at least 36 hours after your last dose of the ACE inhibitor before starting Sandoz Sacubitril-Valsartan.
Swallow the tablet whole. Do NOT break the tablet.
Take Sandoz Sacubitril-Valsartan :
- exactly as prescribed;
- every 12 hours, at about the same time every day;
with or without food.
Usual dose:
Recommended starting dose: Sandoz Sacubitril-Valsartan 49 mg sacubitril/ 51 mg valsartan twice a day
Maximum daily dose: Sandoz Sacubitril-Valsartan 97 mg sacubitril/ 103 mg valsartan twice a day
Your doctor may start you on Sandoz Sacubitril-Valsartan 24 mg sacubitril/ 26 mg valsartan twice a day if you:
- have previously taken low doses of an ACE inhibitor or ARB for the treatment of heart failure
- are 75 years of age or older
- have low blood pressure
Your doctor may change your dose depending on how Sandoz Sacubitril-Valsartan works for you.
Do not take more than the maximum daily dose.
Do not reduce the dose or stop taking Sandoz Sacubitril-Valsartan without consulting your doctor. This could make your disease worse.
Overdose:
| If you think you, or a person you are caring for, have taken too much Sandoz Sacubitril-Valsartan, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed dose:
If you miss a dose, take it as soon as you remember. You can take your next dose at the normal time, but do NOT double the dose to make up for the missed one.
Possible side effects from using Sandoz Sacubitril-Valsartan :
These are not all the possible side effects you may have when taking Sandoz Sacubitril-Valsartan. If you experience any side effects not listed here, tell your healthcare professional.
- low blood pressure
- excessively high level of potassium in the blood, as shown in a blood test
- kidney disorder (signs of renal impairment)
- cough
- dizziness
- tiredness (fatigue)
- sudden loss of consciousness
- feeling sick (nausea)
- weakness
- rash
- itchiness
- low blood pressure when switching from sitting or lying down to standing position
- spinning sensation
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Uncommon | |||
| Angioedema: Swollen face, tongue or throat, difficulty breathing | X | ||
| Anaphylactic reaction or hypersensitivity: Difficulty breathing or swallowing, rash, itching, hives, dizziness | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
- Store your tablets in the original package. Protect from moisture.
- Do not take this medicine after the expiry date, which is stated on the label.
- Do not store above 30°C.
Keep out of reach and sight of children.
If you want more information about Sandoz Sacubitril-Valsartan :
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.sandoz.ca); or by calling 1-800-361-3062.