1. What Sacvaly is and what it is used for
Sacvaly is a medicine containing an angiotensin receptor neprilysin inhibitor. It delivers two active
substances, sacubitril and valsartan.
Sacvaly is used to treat a type of long-term heart failure in adults.
This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs
and the rest of the body. The most common symptoms of heart failure are breathlessness, fatigue,
tiredness and ankle swelling.
2. Before You Take Sacvaly
Do not take Sacvaly
if you are allergic to sacubitril, valsartan or any of the other ingredients of this medicine (listed in
section 6).
if you are taking another type of medicine called an angiotensin converting enzyme (ACE) inhibitor
(for example enalapril, lisinopril or ramipril). ACE inhibitors are used to treat high blood pressure
or heart failure. If you have been taking an ACE inhibitor, wait for 36 hours after taking the last dose
before you start to take Sacvaly (see “Other medicines and Sacvaly”).
if you or a member of your family have ever had a reaction called angioedema (swelling of the face,
lips, tongue and/or throat, difficulties in breathing) when taking an ACE inhibitor or an angiotensin
receptor blocker (ARB) (such as valsartan, telmisartan or irbesartan).
if you have diabetes or impaired kidney function and you are being treated with a blood pressure
lowering medicine containing aliskiren (see “Other medicines and Sacvaly”).
if you have severe liver disease.
if you are more than 3 months pregnant (it is also better to avoid this medicine in early pregnancy,
see “Pregnancy and breast-feeding”).
If any of the above applies to you, do not take Sacvaly and talk to your
doctor. Warnings and precautions
Talk to your doctor, pharmacist or nurse before or when taking Sacvaly:
if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren (see “Do not take
Sacvaly”).
if you have ever had angioedema (see “Do not take Sacvaly” and section 4 “Possible sideeffects”).
if you have low blood pressure or are taking any other medicines that reduce your blood pressure (for
example, a diuretic) 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.
if you have severe kidney disease.
if you are suffering from dehydration.
if your kidney artery has narrowed.
if you have liver disease.
if you experience hallucinations, paranoia or changes in sleeping pattern.
Your doctor may check the amount of potassium in your blood at regular intervals during
Sacvaly treatment.
If any of the above applies to you, tell your doctor, pharmacist or nurse before you take
Sacvaly Children and adolescents
Do not give this medicine to children (aged below 18 years) because it has not been studied in this age
group.
Other medicines and Sacvaly
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
medicines. It may be necessary to change the dose, to take other precautions, or even to stop taking
one of the medicines. This is particularly important for the following medicines:
ACE inhibitors. Do not take Sacvaly with ACE inhibitors. If you have been taking an ACE
inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting to take
Sacvaly (see “Do not Sacvaly”). If you stop taking FAVVAL-SCT, wait 36 hours after taking
your last dose of Sacvaly before starting an ACE inhibitor.
other medicines used to treat heart failure or lower blood pressure, such as angiotensin receptor
blockers or aliskiren (see “Do not take Sacvaly”).
some medicines known as statins that are used to lower high cholesterol levels (for example
atorvastatin).
sildenafil, a medicine used to treat erectile dysfunction or lung hypertension.
medicines that increase the amount of potassium in the blood. These include potassium supplements,
salt substitutes containing potassium, potassium-sparing medicines and heparin.
painkillers of the type called non-steroidal anti-inflammatory medicines (NSAIDs) or selective
cyclooxygenase-2 (Cox-2) inhibitors. If you are taking one of these, your doctor may want to check
your kidney function when starting or adjusting treatment (see “Warnings and precautions”).
lithium, a medicine used to treat some types of psychiatric illness.
furosemide, a medicine belonging to the type known as diuretics, which are used to increase the
amount of urine you produce.
nitroglycerine, a medicine used to treat angina pectoris.
some types of antibiotics (rifamycin group), ciclosporin (used to prevent rejection of transplanted
organs) or antivirals such as ritonavir (used to treat HIV/AIDS).
metformin, a medicine used to treat diabetes.
If any of the above applies to you, tell your doctor or pharmacist before you take Sacvaly
Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally
advise you to stop taking this medicine before you become pregnant or as soon as you know you are
pregnant, and will advise you to take another medicine instead of Sacvaly.
This medicine is not recommended in early pregnancy, and must not be taken when more than
3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of
pregnancy.
Breast-feeding
Sacvaly is not recommended for mothers who are breast-feeding. Tell your doctor if you are breastfeeding or about to start breast-feeding.
Driving and using machines
Before you drive a vehicle, use tools or operate machines, or carry out other activities that require
concentration, make sure you know how Sacvaly affects you. If you feel dizzy or very tired while
taking this medicine, do not drive a vehicle, cycle or use any tools or machines.
3. How to take Sacvaly
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
You will usually start by taking 24 mg/26 mg or 49 mg/51 mg twice a day (one tablet in the morning
and one tablet in the evening). Your doctor will decide your exact starting dose based on which
medicines you have been taking previously. Your doctor will then adjust the dose depending on how
you respond to the treatment until the best dose for you is found.
The usual recommended target dose is 97 mg/103 mg twice a day (one tablet in the morning and one
tablet in the evening).
Patients taking Sacvaly can develop low blood pressure (dizziness, light-headedness), a high level of
potassium in the blood (which would be detected when your doctor performed a blood test) or decreased
kidney function. If this happens, your doctor may reduce the dose of any other medicine you are taking,
temporarily reduce your Sacvaly dose, or stop your Sacvaly treatment completely.
Swallow the tablets with a glass of water. You can take Sacvaly with or without food. Splitting or
crushing of the tablets is not recommended.
If you take more Sacvaly than you should
If you have accidentally taken too many Sacvaly tablets, or if someone else has taken your tablets,
contact 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 Sacvaly
It is advisable to take your medicine at the same time each day. However, if you forget to take a dose, you
should simply take the next one at the scheduled time. Do not take a double dose to make up for a forgotten
tablet.
If you stop taking Sacvaly
Stopping your treatment with Sacvaly may cause your condition to get worse. Do not stop taking your
medicine unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious.
Stop taking Sacubitril and Valsartan and seek immediate medical attention if you notice anyswelling
of the face, lips, tongue and/or throat, which may cause difficulties in breathing orswallowing. These
may be signs of angioedema (an uncommon side effect which may affect up to 1in 100 people).
Other possible side effects:
If any of the side effects listed below becomes severe, tell your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)
low blood pressure (dizziness, light-headedness)
high level of potassium in the blood (shown in a blood test)
decreased renal function (renal impairment)
Common (may affect up to 1 in 10 people)
cough
dizziness
diarrhoea
low level of red blood cells (shown in a blood test)
tiredness
(acute) renal failure (severe kidney disorder)
low level of potassium in the blood (shown in a blood test)
headache
fainting
weakness
feeling sick (nausea)
low blood pressure (dizziness, light-headedness) when switching from sitting or lying to standing
position
gastritis (stomach pain, nausea)
spinning sensation
low level of sugar in the blood (shown in a blood test)
Uncommon (may affect up to 1 in 100 people)
allergic reaction with rash and itching
dizziness when switching from sitting to standing position
Rare (may affect up to 1 in 1,000 people)
hallucinations
changes in sleeping pattern
Very rare (may affect up to 1 in 10,000 people)
paranoia
Reporting of side effects
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor, health care provider or pharmacist.
5. How to store Sacvaly
Store below 30°C.
Keep out of reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry
date refers to the last day of the month.
If you have any suspension left in the bottle more than 90 days after it was first opened, do not useit.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect theenvironment.
n: HPMC 2910/Hypromellose, Di-Acetylated monoglycerides, Iron oxide
Red and Titanium Dioxide.