Entresto 24 mg / 26 mg film-coated tablets, Entresto 49 mg / 51 mg film-coated tablets, Entresto 97 mg / 103 mg film-coated tablets
sakubitril / valsartan
1. What Entresto is and what it is used for
Entresto is a medicine that contains an angiotensin receptor-neprilysin inhibitor. It consists of two active substances, sacubitril, and valsartan.
Entresto is used to treat a type of chronic heart failure in adults.
This type of heart failure means that the heart is weak and does not have the strength to pump enough blood to the lungs and the rest of the body. The most common symptoms of heart failure are shortness of breath, fatigue, fatigue, and swollen ankles.
2. What you need to know before taking Entresto
Do not take Entresto
- 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 inhibitor ( ACE ) (eg 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 36 hours after the last dose before taking Entresto (see “Other medicines and Entresto”).
- if you or a member of your family have ever reacted with so-called angioedema(swelling of the face, lips, tongue, and/or throat, as well as difficulty breathing) when taking an ACE inhibitor or an angiotensin II receptor blocker (ARB) (t (eg valsartan, telmisartan or irbesartan).
- if you have diabetes or renal impairment and are also being treated with a blood pressure-lowering medicine containing aliskiren (see “Other medicines and Entresto”).
- if you have severe liver disease.
- if you have been pregnant for more than 3 months (it is also better to avoid this medicine in early pregnancy, see “Pregnancy and breast-feeding”).
If any of the above apply to you, do not take Entresto without talking to your doctor.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Entresto:
- if you are being treated with an angiotensin II receptor blocker (ARB) or with aliskiren (see ‘Do not take Entresto’).
- if you have ever had angioedema (see “Do not take Entresto” and section 4 “Possible side effects”).
- if you have low blood pressure or are taking any other medicines that lower your blood pressure (such as diuretics) or if you have vomiting or diarrhea, especially if you are 65 years of age or older, or if you have kidney disease and low blood pressure.
- if you have severe kidney disease.
- if you are dehydrated.
- if you have a narrowing of a renal artery.
- if you have liver disease.
Your doctor may check the amount of potassium in your blood at regular intervals during Entresto treatment.
If any of the above applies to you, tell your doctor, pharmacist, or nurse before taking Entresto.
Children and young people
Do not give this medicine to children (under 18 years of age) as it has not been studied in this age group.
Other medicines and Entresto
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change your dose, take other precautions, or even stop any of the treatments. This is especially important with the following medicines:
- ACE inhibitors Do not take Entresto with ACE inhibitors. If you have taken an ACE inhibitor, wait 36 hours after the last dose of an ACE inhibitor before taking Entresto (see “Do not take Entresto”). If you stop taking Entresto, wait 36 hours after the last dose of Entresto before starting to take an ACE inhibitor.
- other medicines for heart failure or low blood pressure, such as angiotensin II receptor blockers or aliskiren (see “Do not take Entresto”).
- so-called statins, which are used to lower high cholesterol levels (eg atorvastatin).
- sildenafil, a medicine used to treat erectile dysfunction or high blood pressure in the lungs.
- drugs that increase the amount of potassium in the blood. Such drugs are potassium supplements, salt substitutes that contain potassium, potassium-sparing drugs, and heparin.
- certain painkillers, such as non-steroidal anti-inflammatory drugs ( NSAIDs ) or selective cyclooxygenase -2 inhibitors ( COX-2 inhibitors). If you are taking any of these medicines, your doctor may need to check your kidney function when you start or make any changes to your treatment (see “Warnings and Precautions”).
- lithium, which is used to treat certain types of mental illness.
- furosemide, a drug in the diuretic group, is used to increase urine production
- nitroglycerin, an anticonvulsant drug.
- some antibiotics (rifamycin group), ciclosporin (used to prevent rejection of transplanted organs), or medicines for viral infections, such as ritonavir (for the treatment of HIV / AIDS).
- metformin, a medicine used to treat diabetes
If any of the above apply to you, tell your doctor or pharmacist before taking Entresto.
Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will usually 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 Entresto.
This medicine is not recommended in early pregnancy and should not be taken after the 3rd month of pregnancy, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Entresto is not recommended for breastfeeding women. Tell your doctor if you are breast-feeding or planning to start breast-feeding.
Driving and using machines
Before you drive a vehicle, use any tools or machines, or do anything else that requires you to concentrate, you need to know how Entresto affects you. If you feel dizzy or very tired while taking this medicine, do not drive, cycle or use any tools or machines.
3. How to take Entresto
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual starting dose is 24 mg / 26 mg or 49 mg / 51 mg twice daily (one tablet in the morning and one tablet in the evening). Your doctor will decide the exact starting dose based on which medicines you have taken before. The doctor will then adjust the dose depending on how you respond to the treatment until you have found the dose that is best for you.
The usual recommended dose is 97 mg / 103 mg twice daily (one tablet in the morning and one tablet in the evening).
Patients taking Entresto may develop low blood pressure (dizziness, dizziness), a high level of potassium in the blood (which may be detected when your doctor has performed a blood test), or impaired kidney function. If this happens, your doctor may reduce the dose of one of the other medicines you are taking, temporarily lower your Entresto dose or stop Entresto treatment completely.
Swallow the tablets with a glass of water. You can take Entresto with or without food.
If you take more Entresto then you should
If you have accidentally taken too many Entresto tablets or if someone else has taken your tablets, contact your doctor immediately. If you feel very dizzy and/or faint, tell your doctor as soon as possible and lie down.
If you forget to take Entresto
It is best to take your medicine at the same time each day, but if you forget to take a dose, just take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Entresto
If you stop taking Entresto, your disease may get worse. Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions on the use of this product, 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 can be serious.
- Stop taking Entresto and seek immediate medical attention if you notice swelling of the face, lips, tongue, and/or throat, which may lead to difficulty breathing or swallowing. This may be a sign of angioedema (a less common side effect, which may affect up to 1 in 100 people).
Other possible side effects are
If any of the following side effects become serious, talk to your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)
- low blood pressure (you may feel dizzy and dizzy)
- high potassium content in the blood (detected by blood tests)
- renal impairment.
Common (may affect up to 1 in 10 people)
- cough
- dizziness
- diarrhea
- low red blood cell count (detected by blood tests)
- fatigue
- ( acute ) renal failure (severe kidney disease)
- low potassium content in the blood (detected by blood tests)
- headache
- fainting
- weakness
- nausea
- low blood pressure (you may feel dizzy and dizzy) when changing position from sitting or lying to standing
- gastritis (stomach pain, nausea)
- spinning feeling
- low blood sugar level (detected by blood tests).
Uncommon (may affect up to 1 in 100 people)
- allergic reaction with rash and itching
- dizziness when changing position from sitting to standing.
5. How to store Entresto
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 expiration date is the last day of the specified month.
No special temperature instructions.
Store in the original package. Moisture sensitive.
Do not use this medicine if you notice that the package is damaged or appears to have been opened earlier.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substances are sacubitril and valsartan.
- One 24 mg / 26 mg film-coated tablet contains 24.3 mg sacubitrile and 25.7 mg valsartan (as sacubitrile valsartan-sodium salt complex).
- A 49 mg / 51 mg film-coated tablet contains 48.6 mg sacubitrile and 51.4 mg valsartan (as sacubitrile valsartan-sodium salt complex).
- One 97 mg / 103 mg film-coated tablet contains 97.2 mg sacubitrile and 102.8 mg valsartan (as sacubitrile valsartan-sodium salt complex).
- The other ingredients in the tablet core are microcrystalline cellulose, low-substituted hydroxypropylcellulose, crospovidone, magnesium stearate, talc, and anhydrous colloidal silica.
- The film coatings on the 24 mg / 26 mg and 97 mg / 103 mg tablets contain hypromellose, titanium dioxide (E171), macrogol (4000), talc, red iron oxide (E172), and black iron oxide (E172).
- The film coating on the 49 mg / 51 mg tablets contains hypromellose, titanium dioxide (E171), macrogol (4000), talc, red iron oxide (E172), and yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Entresto 24 mg / 26 mg film-coated tablets are purple-white oval tablets marked with “NVR” on one side and “LZ” on the other. The approximate tablet size is 13.1 mm x 5.2 mm.
Entresto 49 mg / 51 mg film-coated tablets are light yellow oval tablets marked with “NVR” on one side and “L1” on the other. The approximate tablet size is 13.1 mm x 5.2 mm.
Entresto 97 mg / 103 mg film-coated tablets are light pink oval tablets marked with “NVR” on one side and “L11” on the other. The approximate tablet size is 15.1 mm x 6.0 mm.
The tablets are supplied in packs of 14, 20, 28, 56, 168, or 196 tablets and multipacks comprising 7 cartons each containing 28 tablets). The tablets of 49 mg / 51 mg and 97 mg / 103 mg are also supplied in multipacks of 3 cartons, each containing 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Farma SpA
Via Provito Schito 131
80058 Torre Annunziata (NA)
Italy
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
LEK farmacevtska družba dd, Poslovna enota PROIZVODNJA LENDAVA
Trimlini 2D
Lendava 9220
Slovenia
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 | Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11 |
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| DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872 |
| GermanyNovartis Pharma GmbHTel: +49 911 273 0 | The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111 |
| EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 | NorwayNovartis Norge ASTel: +47 23 05 20 00 |
| GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 | AustriaNovartis Pharma GmbHTel: +43 1 86 6570 |
| SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 | PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600 |
| CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 | RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01 |
| IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 | SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439 |
| ItalyNovartis Farma SpATel: +39 02 96 54 1 | Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200 |
| LatviaSIA Novartis BalticsTel: +371 67 887 070 | United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370 |