Albaliva

Patient Information Leaflet

Albaliva, 24 mg + 26 mg, film-coated tablets
Albaliva, 49 mg + 51 mg, film-coated tablets
Albaliva, 97 mg + 103 mg, film-coated tablets
Sacubitril + Valsartan
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet
What Albaliva is and what it is used for
Important information before taking Albaliva
How to take Albaliva
Possible side effects
How to store Albaliva
Contents of the package and other information

1. What Albaliva is and what it is used for

Albaliva is a heart medication containing an angiotensin receptor blocker and a neprilysin inhibitor. It delivers two active substances to the body: sacubitril and valsartan.
Albaliva 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 sufficient 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 Albaliva

When not to take Albaliva

• 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 (e.g. enalapril, lisinopril or ramipril), which is used to treat high blood pressure or heart failure. If the patient has previously taken an ACE inhibitor, they must wait 36 hours after taking the last dose of the ACE inhibitor before starting treatment with Albaliva (see section "Albaliva and other medicines");
• if the patient has ever had a reaction called angioedema (rapid swelling of the subcutaneous tissues or mucous membranes, such as in 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 "Albaliva and other medicines");
• if the patient has severe liver disease;
• if the patient is more than 3 months pregnant (see section "Pregnancy and breastfeeding").

If any of these situations apply to the patient, do not take Albaliva
and speak to a doctor.
Warnings and precautions
Before starting Albaliva, discuss this with your 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 Albaliva");
• if the patient has ever experienced angioedema (see section "When not to take Albaliva" and section 4 "Possible side effects");
• if the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Albaliva. The doctor will decide whether treatment should continue. Do not stop taking Albaliva on your own;
• if the patient has low blood pressure or is taking any other medicines that lower blood pressure (e.g. a medicine that increases urine production (diuretic)), or if the patient is experiencing 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 Albaliva;
• 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 symptoms even at rest).

If any of these situations apply to the patient, speak to a doctor,
pharmacist or nurse before taking Albaliva.
While being treated with Albaliva, the doctor may regularly check the patient's blood potassium and sodium levels. Additionally, the doctor may monitor the patient's blood pressure at the start of treatment and when increasing the dose.
Children and adolescents
Albaliva is not indicated for use in children and adolescents. Other medicines containing sacubitril + valsartan should be used in children and adolescents.
Albaliva and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take. It may be necessary to adjust the dose, take additional precautions, or even discontinue one of these medicines. This is particularly important for the following medicines:

• ACE inhibitors (such as enalapril, lisinopril or ramipril). Do not take Albaliva 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 Albaliva (see section "When not to take Albaliva"). If treatment with Albaliva is discontinued, the patient must wait 36 hours after taking the last dose of

Albaliva 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 "When not to take Albaliva");
• certain medicines called statins, used to lower high cholesterol levels (e.g. atorvastatin);
• sildenafil, tadalafil, vardenafil or avanafil, 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 at the start of treatment or when changing the dose (see "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, tenofovir, cidofovir (used to treat HIV/AIDS infection);
• metformin, a medicine used to treat diabetes.

If any of the above apply to the patient, tell the doctor or
pharmacist before taking Albaliva.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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 Albaliva.
Albaliva is not recommended during early pregnancy (first trimester) and must not be taken after 3 months of pregnancy (second and third trimesters), as it may seriously harm the unborn child if used after the third month of pregnancy.
Breastfeeding
Use of Albaliva is not recommended in breastfeeding mothers. Inform the doctor if the patient is breastfeeding or plans to start breastfeeding.
Driving and operating machinery
Before driving, operating tools or machinery, or performing any other activities requiring concentration, the patient should ensure how Albaliva affects them. If the patient feels dizzy or very tired while taking this medicine, they should not drive, ride a bicycle, or use tools or machinery.

3. How to take Albaliva

This medicine should always be taken according to the instructions given by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Adults
Treatment usually starts with taking one 49 mg + 51 mg tablet twice daily (one tablet in the morning and one tablet in the evening). Your doctor will then adjust the dose every 2–4 weeks depending on your response to treatment, until the optimal dose for you is established.
Your doctor will determine the exact starting dose based on your blood pressure as well as liver and kidney function. In special cases, depending on the type of medication previously taken, your doctor may prescribe a different medicine containing sacubitril + valsartan.
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)
Other medicines containing sacubitril + valsartan should be used in children and adolescents.
Method of administration
Tablets should be swallowed whole with a glass of water. Albaliva can be taken with or without food. Do not divide or crush the tablets.
Patients taking Albaliva may experience low blood pressure (dizziness, feeling faint), high levels of potassium in the blood (which can be detected in blood tests ordered by your doctor), or worsening kidney function. If this occurs, your doctor may reduce the dose of one of your other medications, temporarily reduce the dose of Albaliva, or permanently discontinue Albaliva treatment.
Overdose of Albaliva
If you accidentally take more tablets than prescribed, or if someone else takes these tablets, contact your doctor immediately. If severe dizziness and/or fainting occur, seek medical help immediately and lie down.
It is recommended to take the medicine at the same time each day. 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 a missed dose.
Stopping Albaliva treatment may worsen your condition. Do not stop taking this medicine unless instructed by your doctor.
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.

• Discontinue taking Albaliva and seek medical help immediately if the patient notices any swelling of the face, lips, tongue, and (or) throat, which may cause difficulty in breathing or swallowing (an uncommon adverse reaction, occurring in up to 1 in 100 people). These may be symptoms of angioedema.

Other possible adverse reactions:
If any of the symptoms listed below worsen, inform 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 lightheadedness (hypotension)
• high potassium levels in the blood, detected in blood tests (hyperkalaemia)
• reduced kidney function (renal impairment)

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

• cough
• dizziness
• diarrhoea
• low number of red blood cells, 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 (hypokalaemia)
• headache
• fainting
• weakness
• nausea
• low blood pressure (dizziness, lightheadedness) when changing position from sitting or lying down to standing
• inflammation of the stomach (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)

• itching
• rash
• 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 (hyponatraemia)

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

• seeing, hearing, or feeling things that are not real (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, jerking muscle contractions (myoclonus).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse.

5. How to store Albaliva

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

Contents of the pack and other information
What Albaliva contains

• The active substances are sacubitril and valsartan.
  o Each 24 mg + 26 mg film-coated tablet contains 24.3 mg of sacubitril (as sacubitril tromethamine) and 25.7 mg of valsartan (as potassium dihydrate valsartan tromethamine).
  o Each 49 mg + 51 mg film-coated tablet contains 48.6 mg of sacubitril (as sacubitril tromethamine) and 51.4 mg of valsartan (as potassium dihydrate valsartan tromethamine).
  o Each 97 mg + 103 mg film-coated tablet contains 97.2 mg of sacubitril (as sacubitril tromethamine) and 102.8 mg of valsartan (as potassium dihydrate valsartan tromethamine).
• Other ingredients are:
  o Tablet core: microcrystalline cellulose (type 302) (E460), microcrystalline cellulose, siliconized, crospovidone (type A) (E1202), magnesium stearate (E470b), colloidal hydrophobic silica (E551), low-substituted hydroxypropylcellulose (E463a), povidone K25 (E1201).
  o Tablet coating: polyethylene glycol grafted polyvinyl alcohol copolymer (E1209), talc (E553), glycerol monocaprylocaprylate (type I), partially hydrolyzed polyvinyl alcohol (E1203).

What Albaliva looks like and contents of the pack
Albaliva 24 mg + 26 mg is a white or almost white, oval, biconvex film-coated tablet with a stylized "E" and code 651 on one side and no marking on the other side. Approximate tablet dimensions are 9.5 mm × 4.5 mm.
Albaliva 49 mg + 51 mg is a white or almost white, oval, biconvex film-coated tablet with a stylized "E" and code 652 on one side and no marking on the other side. Approximate tablet dimensions are 12.5 mm × 6.5 mm.
Albaliva 97 mg + 103 mg is a white or almost white, oval, biconvex film-coated tablet with a stylized "E" and code 653 on one side and no marking on the other side. Approximate tablet dimensions are 15.5 mm × 8.0 mm.
Tablets are available in blisters made of OPA/Aluminum/PVC/Aluminum foil containing 28, 30, 56, 60, 120, 168, 180 or 196 tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturer:
Egis Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary

This medicine is authorized in the European Economic Area countries under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
EGIS Polska Sp. z o.o.
45D Komitetu Obrony Robotników Street
02-146 Warsaw
Tel.: +48 22 417 92 00