Patient leaflet - Sacubitril/valsartan 97 mg/103 mg film-coated tablets
1. What Sacubitril/Valsartan is and what it is used for
Sacubitril/Valsartan is a heart medicine containing an angiotensin receptor neprilysin inhibitor. It delivers two active substances, Sacubitril and Valsartan.
Sacubitril/Valsartan 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.
Sacubitril/Valsartan which is contained in Sacubitril/Valsartan film coated tablets is also authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.
2. What you need to know before you take Sacubitril/Valsartan
Do not take Sacubitril/Valsartan
if you are allergic to sacubitril, valsartan or any of the other ingredients of this medicine (listed in
if you are taking another type of medicine called an angiotensin converting enzyme (ACE) inhibitor
(for example enalapril, lisinopril or ramipril), which is 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 Sacubitril/Valsartan (see “Other medicines and Sacubitril/Valsartan”).
if you have ever had a reaction called angioedema (rapid swelling under the skin in areas such as the
face, throat, arms and legs which can be life threatening if throat swelling blocks the airway) when taking an ACE inhibitor or an angiotensin receptor blocker (ARB) (such as valsartan, telmisartan or irbesartan).
- if you have a history of angioedema which is hereditary or for which the cause is unknown (idiopathic).
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 Sacubitril/Valsartan”).
- if you have severe liver disease.
- if you are more than 3 months pregnant (see “Pregnancy and breast-feeding”). If any of the above applies to you, do not take Sacubitril/Valsartan and talk to your doctor Warnings and precautions
Talk to your doctor, pharmacist or nurse before or when taking Sacubitril/Valsartan:
if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren (see “Do not take
Sacubitril/Valsartan”).
if you have ever had angioedema (see “Do not take Sacubitril/Valsartan” and section 4 “Possible side
effects”).
if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Sacubitril/Valsartan.
Your doctor will decide on further treatment. Do not stop taking Sacubitril/Valsartan on your own.
if you have low blood pressure or are taking any other medicines that reduce your blood pressure
(for example, a medicine that increases urine production (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 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 while taking Sacubitril/
Valsartan.
- if you have hyperkalaemia (high levels of potassium in the blood).
if 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).
If any of the above applies to you, tell your doctor, pharmacist or nurse before you take Sacubitril/ Valsartan.
Your doctor may check the amount of potassium and sodium in your blood at regular intervals during Sacubitril/Valsartan treatment. In addition, your doctor may check your blood pressure at start of treatment and when the doses are increased.
Children and adolescents
Do not give this medicine to children aged below 1 year because it has not been studied in this age group. For children one year and older with a body weight below 40 kg, other market preparation of granules to be given instead of tablets.
Other medicines and Sacubitril/Valsartan
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 Sacubitril/Valsartan 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 Sacubitril/ Valsartan (see “Do not take Sacubitril/Valsartan”). If you stop taking Sacubitril/Valsartan, wait 36 hours after taking your last dose of Sacubitril/Valsartan 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 Sacubitril/Valsartan”).
some medicines known as statins that are used to lower high cholesterol levels (for example
atorvastatin).
sildenafil, tadalafil, vardenafil or avanafil, which are medicines 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 Sacubitril/Valsartan film coated tablets.
Pregnancy and breast-feeding
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.
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 Sacubitril/Valsartan. 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
Sacubitril/Valsartan is not recommended for mothers who are breast-feeding. Tell your doctor if you are breast-feeding 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 Sacubitril/Valsartan 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. Sacubitril/Valsartan film coated tablets contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium free’
3. How to take Sacubitril/Valsartan film coated tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults
You will usually start by taking a 24 mg/26 mg or 49 mg/51 mg tablet 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 and your blood pressure. Your doctor will then adjust the dose every 2-4 weeks 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).
Sacubitril/Valsartan which is contained in Sacubitril/Valsartan film coated tablets is also authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.
Patients taking Sacubitril/Valsartan 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 the Sacubitril/Valsartan dose, or stop Sacubitril/Valsartan treatment completely.
150 mm
Size: 150 x 600 mm (Front / Back)
8094848-7803 Swallow the tablets with a glass of water. You can take Sacubitril/Valsartan film coated tablets with or without food. Splitting or crushing of the tablets is not recommended.
If you take more Sacubitril/Valsartan film coated tablets than you should
If you have accidentally taken too many Sacubitril/Valsartan film coated 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 Sacubitril/Valsartan film coated tablets
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 dose.
If you stop taking Sacubitril/Valsartan film coated tablets
Stopping your treatment with Sacubitril/Valsartan film coated tablets 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/Valsartan and seek immediate medical attention if you notice any swelling of the face, lips, tongue and/or throat, which may cause difficulties in breathing or swallowing. These may be signs of angioedema (an uncommon side effect which may affect up to 1 in 100 people).
- Intestinal angioedema: a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea (a very rare side effect which may affect up to 1 in 10 000 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, which can cause symptoms of dizziness and light-headedness (hypotension)
- high level of potassium in the blood, shown in a blood test (hyperkalaemia)
- decreased kidney 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 (anaemia)
- tiredness (fatigue)
- (acute) inability of the kidney to work properly (renal failure)
- low level of potassium in the blood, shown in a blood test (hypokalaemia)
- headache
- fainting (syncope)
- weakness (asthenia)
- feeling sick (nausea)
- low blood pressure (dizziness, light-headedness) when switching from sitting or lying to standing position
- gastritis (stomach pain, nausea)
- spinning sensation (vertigo)
- low level of sugar in the blood shown in a blood test (hypoglycaemia)
Uncommon (may affect up to 1 in 100 people)
- allergic reaction with rash and itching (hypersensitivity)
- dizziness when switching from sitting to standing position (dizziness postural)
- low level of sodium in the blood, shown in a blood test (hyponatraemia)
Rare (may affect up to 1 in 1 000 people)
- seeing, hearing or feeling things that are not there (hallucinations)
- changes in sleeping pattern (sleep disorder)
Very rare (may affect up to 1 in 10 000 people)
- paranoia
Not known (frequency cannot be estimated from the available data)
- sudden involuntary muscle twitching (myoclonus)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sacubitril/Valsartan film coated tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sacubitril/Valsartan film coated tablets contains
The active substances are sacubitril and valsartan.
○ Each 24 mg/26 mg film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt).
○ Each 49 mg/51 mg film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt).
○ Each 97 mg/103 mg film-coated tablet contains 97.2 mg sacubitril and 102.8 mg valsartan
(as sacubitril valsartan sodium salt).
- The other ingredients in the tablet core are Cellulose microcrystalline, Hydroxypropylcellulose low substituted, Crospovidone (type-A), Colloidal hydrated silica, Povidone (K-30), Talc and Magnesium stearate (see end of section 2 under ‘Sacubitril/Valsartan film coated tablets contains sodium’).
The 24 mg/26 mg tablet coatings contain Hypromellose 2910 (E464), Titanium dioxide (E171),
Macrogol 4000 (E1521), Talc (E553b), Iron oxide black (E172) and Iron oxide red (E172).
The 49 mg/51 mg tablet coating contains Hypromellose 2910 (E464), Titanium dioxide (E171),
Macrogol 4000 (E1521), Talc (E553b), Iron oxide yellow (E172) and Iron oxide red (E172).
The 97 mg/103 mg tablet coating contains Hypromellose 2910 (E464), Titanium dioxide (E171),
Macrogol 4000 (E1521), Talc (E553b), Iron oxide red (E172) and Iron oxide black (E172). What Sacubitril/Valsartan film coated tablets looks like and contents of the pack
Sacubitril/Valsartan 24 mg/26 mg film-coated tablets are violet white colored, round shaped, biconvex film-coated tablet with beveled edges, unscored, debossed with “U4” on one side and plain on the other side. Approximate tablet dimension 6 mm.
Sacubitril/Valsartan 49 mg/51 mg film-coated tablets are pale yellow colored, oval shaped, biconvex film-coated tablet with beveled edges, unscored, debossed with “U5” on one side and plain on the other side. Approximate tablet dimensions 11.4 mm x 5.7 mm.
Sacubitril/Valsartan 97 mg/103 mg film-coated tablets are light pink colored, oval shaped, biconvex, film-coated tablet with beveled edges, unscored, debossed with “U7” on one side and plain on other side. Approximate tablet dimensions 15.1 mm x 6.0 mm.
The tablets are supplied in Aluminum (OPA/Alu/PVC) – Aluminum Blister packs containing 14, 20, 28, 56 or 196 film-coated tablets and in multipacks comprising 7 cartons, each containing 28 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd.
3rd Floor, Nexus Building
4 Gatwick Road
Crawley
West Sussex
RH10 9BG
United Kingdom
Manufacturer
Torrent Pharma Malta Ltd.
HHF 028 Hal Far Industrial Estate
Birzebbuga BBG 3000
Malta