Sacubitril/valsartan gedeon richter

Package leaflet: Information for the patient

Sacubitril/Valsartan Gedeon Richter, 24 mg + 26 mg, film-coated tablets
Sacubitril/Valsartan Gedeon Richter, 49 mg + 51 mg, film-coated tablets
Sacubitril/Valsartan Gedeon Richter, 97 mg + 103 mg, film-coated tablets
Sacubitrilum+Valsartanum
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Sacubitril/Valsartan Gedeon Richter is and what it is used for
2. What you need to know before taking Sacubitril/Valsartan Gedeon Richter
3. How to take Sacubitril/Valsartan Gedeon Richter
4. Possible side effects
5. How to store Sacubitril/Valsartan Gedeon Richter
6. Contents of the pack and other information

1. What Sacubitril/Valsartan Gedeon Richter is and what it is used for

Sacubitril/Valsartan Gedeon Richter is a heart medication containing an angiotensin receptor antagonist and a neprilysin inhibitor. It delivers two active substances, sacubitril and valsartan, into the body.
Sacubitril/Valsartan Gedeon Richter is used in the treatment of a certain type of chronic heart failure in adults.
This type of heart failure occurs when the heart is too weak to pump enough blood to the lungs and other parts of the body. The most common symptoms of heart failure are: shortness of breath, feeling tired, fatigue, and swelling around the ankles.

2. Important information before taking Sacubitril/Valsartan Gedeon Richter

When not to take Sacubitril/Valsartan Gedeon Richter

• if the patient is allergic to sacubitril, valsartan, or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking another 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 the patient has been taking an ACE inhibitor, they must wait 36 hours after taking the last dose of the ACE inhibitor before starting treatment with Sacubitril/Valsartan Gedeon Richter (see section “Sacubitril/Valsartan Gedeon Richter and other medicines”).
• if the patient has ever had a reaction called angioedema (rapid swelling of the subcutaneous tissues in areas such as the face, throat, arms, and legs, which may be life-threatening if swelling of the throat causes airway obstruction) after taking an ACE inhibitor or an angiotensin receptor blocker (ARB) (e.g. valsartan, telmisartan, or irbesartan).
• if the patient has previously experienced angioedema that is hereditary or of unknown cause (idiopathic angioedema).
• if the patient has diabetes or kidney problems and is currently being treated with a blood pressure-lowering medicine containing aliskiren (see section “Sacubitril/Valsartan Gedeon Richter and other medicines”).
• if the patient has severe liver disease.
• if the patient is pregnant for more than 3 months (see section “Pregnancy and breastfeeding”).

If any of these situations apply to the patient, do not take Sacubitril/Valsartan Gedeon Richter and speak with a doctor.

Warnings and precautions

Before starting and while taking Sacubitril/Valsartan Gedeon Richter, discuss the following with a doctor, pharmacist, or nurse:

• if the patient is currently being treated with an angiotensin receptor blocker (ARB) or aliskiren (see section “When not to take Sacubitril/Valsartan Gedeon Richter”).
• if the patient has ever had angioedema (see section “When not to take Sacubitril/Valsartan Gedeon Richter” and section 4 “Possible side effects”).
• if the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Sacubitril/Valsartan Gedeon Richter. The doctor will decide whether treatment should continue. Do not make your own decision to stop taking Sacubitril/Valsartan Gedeon Richter.
• if the patient has low blood pressure or is taking any other blood pressure-lowering medicines (e.g. a medicine that increases urine production (diuretic)), or if the patient experiences vomiting or diarrhoea, especially if the patient is aged 65 years or older, or if the patient has kidney disease and low blood pressure.
• if the patient has kidney disease.
• if the patient is dehydrated.
• if the patient has renal artery stenosis.
• if the patient has liver disease.
• if the patient experiences hallucinations, paranoia, or changes in sleep patterns while taking Sacubitril/Valsartan Gedeon Richter.
• if the patient has hyperkalaemia (high potassium levels in the blood).
• if the patient has heart failure classified as NYHA Class IV (inability to carry out any physical activity without discomfort and possible occurrence of symptoms even at rest).

If any of these situations apply to the patient, speak with a doctor, pharmacist, or nurse before taking Sacubitril/Valsartan Gedeon Richter.

While being treated with Sacubitril/Valsartan Gedeon Richter, the doctor may regularly check the patient’s blood potassium and sodium levels. In addition, the doctor may monitor the patient’s blood pressure when starting treatment and when increasing the dose.

Children and adolescents

Sacubitril/Valsartan Gedeon Richter is not indicated for use in children and adolescents. Other medicines containing sacubitril + valsartan should be used in children and adolescents.

Sacubitril/Valsartan Gedeon Richter and other medicines

Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. It may be necessary to adjust the dose, take other precautions, or even discontinue one of these medicines. This is particularly important for the following medicines:

• ACE inhibitors. Do not take Sacubitril/Valsartan Gedeon Richter with ACE inhibitors. If the patient is taking an ACE inhibitor, they must wait 36 hours after taking the last dose of the ACE inhibitor before starting treatment with Sacubitril/Valsartan Gedeon Richter (see section “When not to take Sacubitril/Valsartan Gedeon Richter”).

If treatment with Sacubitril/Valsartan Gedeon Richter is stopped, wait 36 hours after the last dose of Sacubitril/Valsartan Gedeon Richter before starting treatment with an ACE inhibitor.

• other medicines used to treat heart failure or lower blood pressure, such as angiotensin receptor blockers or aliskiren (see section “When not to take Sacubitril/Valsartan Gedeon Richter”).
• certain medicines called statins, used to lower high cholesterol levels (e.g. atorvastatin).
• sildenafil, tadalafil, vardenafil, or avanafil, which are medicines used to treat erectile dysfunction or pulmonary hypertension.
• medicines that increase potassium levels in the blood. These include potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, and heparin.
• painkillers belonging to a group called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. If the patient is taking one of these medicines, the doctor may recommend monitoring kidney function when starting treatment or changing the dose (see section “Warnings and precautions”).
• lithium, a medicine used to treat certain types of mental illness.
• furosemide, a medicine belonging to a group called diuretics, used to increase urine production.
• nitroglycerin, a medicine used to treat angina pectoris.
• certain antibiotics (rifampicin group), cyclosporine (used to prevent rejection of transplanted organs), or antiviral medicines such as ritonavir (used to treat HIV/AIDS).
• metformin, a medicine used to treat diabetes.

If any of the above apply to the patient, tell the doctor or pharmacist before taking Sacubitril/Valsartan Gedeon Richter.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

If the patient thinks she is (or suspects she might be) pregnant, she must inform her doctor. The doctor will usually advise women to stop taking this medicine before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe an alternative medicine to replace Sacubitril/Valsartan Gedeon Richter.

This medicine is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may seriously harm the unborn child if used after the third month of pregnancy.

Breastfeeding

Sacubitril/Valsartan Gedeon Richter is not recommended for use in breastfeeding mothers. Inform the doctor if the patient is breastfeeding or planning to breastfeed.

Driving and using machines

Before the patient starts driving, operating tools or machinery, or performing tasks requiring concentration, they should ensure how Sacubitril/Valsartan Gedeon Richter affects them. If the patient experiences dizziness or fatigue while taking this medicine, they should not drive, ride a bicycle, or use tools or machinery.

Sacubitril/Valsartan Gedeon Richter contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered “sodium-free”.

3. How to take Sacubitril/Valsartan Gedeon Richter

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Adults
Treatment is usually initiated with one tablet of 49 mg + 51 mg twice daily (one tablet in the morning and one tablet in the evening).
Your doctor will determine the exact starting dose based on previously used medications and blood pressure. If your doctor recommends a different starting dose than 49 mg + 51 mg, other products containing sacubitril + valsartan should be used. Your doctor will then adjust the dose every 2–4 weeks depending on your response to treatment, until an optimal dose for you is established.
The usual recommended target dose is 97 mg + 103 mg twice daily (one tablet in the morning and one tablet in the evening).
Children and adolescents (aged one year and older)
For children and adolescents, other products containing sacubitril + valsartan should be used.
Patients taking Sacubitril/Valsartan Gedeon Richter may experience low blood pressure (dizziness, feeling of emptiness in the head), high potassium levels in the blood (detected in blood tests ordered by the doctor), or worsening kidney function. If this occurs, your doctor may reduce the dose of other medications you are taking, temporarily reduce the dose of Sacubitril/Valsartan Gedeon Richter, or permanently discontinue treatment with Sacubitril/Valsartan Gedeon Richter.
The tablets should be swallowed with a glass of water. Sacubitril/Valsartan Gedeon Richter can be taken with or without food. Splitting or crushing the tablets is not recommended.
Taking more Sacubitril/Valsartan Gedeon Richter than recommended
If you accidentally take too many tablets of Sacubitril/Valsartan Gedeon Richter, or if someone else takes these tablets, contact your doctor immediately. If severe dizziness and/or fainting occur, contact your doctor as soon as possible and the patient should lie down.
Missing a dose of Sacubitril/Valsartan Gedeon Richter
It is recommended to take the medicine at the same time each day. However, if you forget to take a dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
Stopping Sacubitril/Valsartan Gedeon Richter
Stopping treatment with Sacubitril/Valsartan Gedeon Richter may worsen your condition. Do not stop taking this medicine unless your doctor advises you to do so.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious.
You must stop taking Sacubitril/Valsartan Gedeon Richter and seek immediate medical help if the patient notices any swelling of the face, lips, tongue and (or) throat, which may cause difficulty in breathing or swallowing. These may be symptoms of angioedema (an uncommon adverse reaction, which may occur in up to 1 in 100 people).
Other possible adverse reactions:
If any of the symptoms listed below worsen, tell your doctor or pharmacist.
Very common (may occur in more than 1 in 10 people)

• low blood pressure, which may cause symptoms such as dizziness and feeling faint (hypotension)
• high potassium levels in the blood, detected in blood tests (hyperkalemia)
• reduced kidney function (renal impairment)

Common (may occur in up to 1 in 10 people)

• cough
• dizziness
• diarrhoea
• low red blood cell count, detected in blood tests (anaemia)
• fatigue
• (acute) inability of the kidneys to function properly (renal failure)
• low potassium levels in the blood, detected in blood tests (hypokalemia)
• headache
• fainting
• weakness
• nausea
• low blood pressure (dizziness, feeling faint) when changing position from sitting or lying down to standing (orthostatic hypotension)
• gastritis (abdominal pain, nausea)
• sensation of spinning (dizziness)
• low blood sugar levels, detected in blood tests (hypoglycaemia)

Uncommon (may occur in up to 1 in 100 people)

• allergic reaction with rash and itching (hypersensitivity)
• dizziness when changing position from sitting to standing (orthostatic dizziness)
• low sodium levels in the blood, detected in blood tests (hyponatremia)

Rare (may occur in up to 1 in 1,000 people)

• seeing, hearing or feeling things that are not there (hallucinations)
• changes in sleep cycle (sleep disturbances)

Very rare (may occur in up to 1 in 10,000 people)

• paranoia
• intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea

Not known (frequency cannot be estimated from available data)

• sudden, involuntary muscle jerks (myoclonus).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sacubitril/Valsartan Gedeon Richter

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine. Store in the original packaging to protect from moisture.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Medicines must not be disposed of via household waste or sewage. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Sacubitril/Valsartan Gedeon Richter contains

• The active substances are sacubitril and valsartan.
  • Each 24 mg + 26 mg coated tablet contains sodium sacubitril and valsartan disodium, equivalent to 24.3 mg of sacubitril and 25.7 mg of valsartan.
  • Each 49 mg + 51 mg coated tablet contains sodium sacubitril and valsartan disodium, equivalent to 48.6 mg of sacubitril and 51.4 mg of valsartan.
  • Each 97 mg + 103 mg coated tablet contains sodium sacubitril and valsartan disodium, equivalent to 97.2 mg of sacubitril and 102.8 mg of valsartan.
• The other constituents of the tablet core are microcrystalline cellulose, low-substituted hydroxypropyl cellulose, crospovidone type A and B, talc, colloidal anhydrous silica, and magnesium stearate.
• The coating of the 24 mg + 26 mg tablet contains partially hydrolysed polyvinyl alcohol; titanium dioxide; macrogol; and talc.
• The coating of the 49 mg + 51 mg tablet contains partially hydrolysed polyvinyl alcohol; titanium dioxide; macrogol; talc; iron oxide red (E172); and iron oxide yellow (E172).
• The coating of the 97 mg + 103 mg tablet contains partially hydrolysed polyvinyl alcohol; titanium dioxide; macrogol; talc; iron oxide red (E172); and iron oxide yellow (E172).

What Sacubitril/Valsartan Gedeon Richter looks like and contents of the pack
Sacubitril/Valsartan Gedeon Richter, 24 mg + 26 mg, film-coated tablets (tablets) are white, biconvex, oval, film-coated tablets, embossed with the code "S7V" on one side and "L1" on the other side. Approximate tablet dimensions: 13 mm x 5 mm.
Sacubitril/Valsartan Gedeon Richter, 49 mg + 51 mg, film-coated tablets (tablets) are pink, biconvex, oval, film-coated tablets, embossed with the code "S7V" on one side and "M2" on the other side. Approximate tablet dimensions: 12 mm x 5 mm.
Sacubitril/Valsartan Gedeon Richter, 97 mg + 103 mg, film-coated tablets (tablets) are pink, biconvex, oval, film-coated tablets, embossed with the code "S7V" on one side and "H3" on the other side. Approximate tablet dimensions: 16 mm x 6 mm.
Sacubitril/Valsartan Gedeon Richter, 24 mg + 26 mg and Sacubitril/Valsartan Gedeon Richter, 49 mg + 51 mg, film-coated tablets are available in blister packs containing 28 or 56 film-coated tablets in a cardboard carton.
Sacubitril/Valsartan Gedeon Richter, 97 mg + 103 mg, film-coated tablets are available in blister packs containing 56 film-coated tablets in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

Manufacturer/Importer
Synthon Hispania, S.L.
Calle De Castello 1
08830 Sant Boi de Llobregat
Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
Gelderland
The Netherlands

For further information regarding this medicinal product, please contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
tel.: +48 (22) 755 96 48
[email protected]