Sacubitril and valsartan Doc Generici

Patient Information Leaflet

SACUBITRIL AND VALSARTAN DOC Generics 24 mg/26 mg film-coated tablets, 49 mg/51 mg film-coated tablets, 97 mg/103 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What SACUBITRIL AND VALSARTAN DOC Generics is and what it is used for
2. What you need to know before taking SACUBITRIL AND VALSARTAN DOC Generics
3. How to take SACUBITRIL AND VALSARTAN DOC Generics
4. Possible side effects
5. How to store SACUBITRIL AND VALSARTAN DOC Generics
6. Contents of the pack and other information

1. What SACUBITRIL E VALSARTAN DOC Generici is and what it is used for

SACUBITRIL E VALSARTAN DOC Generici is a heart medicine containing a neprilysin inhibitor and an angiotensin receptor blocker. It releases two active substances, sacubitril and valsartan.
SACUBITRIL E VALSARTAN DOC Generici is used to treat a type of long-term heart failure in adults, children, and adolescents (from one year of age onwards).
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 shortness of breath, breathlessness, fatigue, tiredness, and swelling of the ankles.

2. What you need to know before taking SACUBITRIL AND VALSARTAN DOC Generics

Do not take SACUBITRIL AND VALSARTAN DOC Generics:

• 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), which is used to treat high blood pressure or heart failure. If you are taking an ACE inhibitor, wait 36 hours after taking the last dose before starting SACUBITRIL AND VALSARTAN DOC Generics (see "Other medicines and SACUBITRIL AND VALSARTAN DOC Generics").
• 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 swelling of the throat blocks the airways) when taking an ACE inhibitor or an angiotensin receptor blocker (ARB) (such as valsartan, telmisartan, or irbesartan).
• if you have a history of hereditary angioedema or angioedema of unknown cause (idiopathic).
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren (see "Other medicines and SACUBITRIL AND VALSARTAN DOC Generics").
• if you have severe liver disease.
• if you are more than 3 months pregnant (see "Pregnancy and breastfeeding").

If any of these apply to you, do not take SACUBITRIL AND VALSARTAN DOC Generics and consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before or when taking SACUBITRIL AND VALSARTAN DOC Generics:

• if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren (see "Do not take SACUBITRIL AND VALSARTAN DOC Generics").
• if you have ever had angioedema (see "Do not take SACUBITRIL AND VALSARTAN DOC Generics" and section 4 "Possible side effects").
• if after taking SACUBITRIL AND VALSARTAN DOC Generics you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking SACUBITRIL AND VALSARTAN DOC Generics on your own.
• if you have low blood pressure or are taking any other medicine to lower blood pressure (for example, a medicine that increases urine production (diuretic)), or if you have vomiting or diarrhoea, especially if you are 65 years of age or older, or if you have kidney disease and low blood pressure.
• if you have kidney disease.
• if you are dehydrated.
• if you have narrowing of a renal artery.
• if you have liver disease.
• if you experience hallucinations, paranoia, or changes in your sleep pattern while taking SACUBITRIL AND VALSARTAN DOC Generics.
• if you have hyperkalaemia (high levels of potassium in the blood).
• if you suffer from heart failure classified as NYHA class IV (unable to perform any physical activity without discomfort and may experience symptoms even at rest).

If any of these apply to you, inform your doctor, pharmacist, or nurse before taking SACUBITRIL AND VALSARTAN DOC Generics.

Your doctor may check your blood potassium and sodium levels at regular intervals during treatment with SACUBITRIL AND VALSARTAN DOC Generics. In addition, your doctor may monitor your blood pressure at the start of treatment and when doses are increased.

Children and adolescents

Do not give this medicine to children under 1 year of age, as it has not been studied in this age group. For children aged 1 year and older with body weight below 40 kg, this medicine will be given as granules (instead of tablets).

Other medicines and SACUBITRIL AND VALSARTAN DOC Generics

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. It may be necessary to adjust the dose, take additional precautions, or even stop taking one of these medicines. This is particularly important for the following medicines:

• ACE inhibitors. Do not take SACUBITRIL AND VALSARTAN DOC Generics with ACE inhibitors. If you are being treated with an ACE inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting SACUBITRIL AND VALSARTAN DOC Generics (see "Do not take SACUBITRIL AND VALSARTAN DOC Generics"). If you stop taking SACUBITRIL AND VALSARTAN DOC Generics, wait 36 hours after taking the last dose before starting an ACE inhibitor.
• other medicines used to treat heart failure or to lower blood pressure, such as angiotensin receptor blockers or aliskiren (see "Do not take SACUBITRIL AND VALSARTAN DOC Generics").
• certain medicines known as statins, used to lower elevated cholesterol levels (for example 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 known as non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. If you are taking one of these, your doctor may want to monitor kidney function when starting or adjusting treatment (see "Warnings and precautions").
• lithium, a medicine used to treat certain types of psychiatric illness.
• furosemide, a medicine belonging to the diuretic class used to increase urine production.
• nitroglycerin, a medicine used to treat angina pectoris.
• certain types of antibiotics (rifamycin group), cyclosporine (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 these apply to you, inform your doctor or pharmacist before taking SACUBITRIL AND VALSARTAN DOC Generics.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of SACUBITRIL AND VALSARTAN DOC Generics.

This medicine is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.

Breastfeeding

SACUBITRIL AND VALSARTAN DOC Generics is not recommended for breastfeeding mothers.

Inform your doctor if you are breastfeeding or planning to breastfeed.

Driving and using machines

Before driving a vehicle, operating tools or machinery, or performing other activities requiring concentration, you should be aware of how you react to SACUBITRIL AND VALSARTAN DOC Generics. If you feel dizzy or very tired while taking this medicine, do not drive, ride a bicycle, or operate tools or machinery.

SACUBITRIL AND VALSARTAN DOC Generics contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially "sodium-free".

3. How to take SACUBITRIL AND VALSARTAN DOC Generics

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
You will usually start by taking either 24 mg/26 mg or 49 mg/51 mg tablets twice daily (one tablet in the morning and one tablet in the evening). Your doctor will determine the exact starting dose based on the medications you were previously taking and your blood pressure. Your doctor will then adjust the dose every 2–4 weeks according to your response to treatment until the most appropriate dose for you is found.
The usual recommended optimal dose is 97 mg/103 mg twice daily (one tablet in the morning and one tablet in the evening).

Children and adolescents (from one year of age onwards)
Your doctor (or your child’s doctor) will determine the starting dose based on body weight and other factors, including previously taken medications. The doctor will adjust the dose every 2–4 weeks until the optimal dose has been identified.
SACUBITRIL AND VALSARTAN DOC Generics should be given twice daily (one tablet in the morning and one tablet in the evening).
SACUBITRIL AND VALSARTAN DOC Generics film-coated tablets are not intended for use in children weighing less than 40 kg. Granules of sacubitril/valsartan are available for these patients.

Patients treated with SACUBITRIL AND VALSARTAN DOC Generics may develop low blood pressure (dizziness, lightheadedness), high potassium levels in the blood (detected during blood tests performed by the doctor), or reduced kidney function. If this occurs, your doctor may reduce the dose of any concomitant medication you are taking, temporarily reduce the dose of SACUBITRIL AND VALSARTAN DOC Generics, or discontinue treatment completely.

Swallow the tablets with a glass of water. You may take SACUBITRIL AND VALSARTAN DOC Generics with or without food. Splitting or crushing the tablets is not recommended.

If you take more SACUBITRIL AND VALSARTAN DOC Generics than you should
If you have accidentally taken too many SACUBITRIL AND VALSARTAN DOC Generics tablets, or if someone else has taken your tablets, contact your doctor immediately. If you experience severe dizziness and/or fainting, inform your doctor as soon as possible and lie down.

If you forget to take SACUBITRIL AND VALSARTAN DOC Generics
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.

If you stop taking SACUBITRIL AND VALSARTAN DOC Generics
Stopping treatment with SACUBITRIL AND VALSARTAN DOC Generics may cause your condition to worsen. Do not stop taking this medicine unless instructed by your doctor.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some side effects may be serious.

• Stop taking SACUBITRIL AND VALSARTAN DOC Generici and seek immediate medical help if you notice any swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing. These may be signs of angioedema (an uncommon side effect that may affect up to 1 in 100 people).

Other possible side effects:
If any of the side effects listed below worsen, inform your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)

• low blood pressure which may cause symptoms such as dizziness and a feeling of emptiness in the head (hypotension)
• high levels of potassium in the blood, shown by a blood test (hyperkalaemia)
• reduced kidney function (renal impairment)

Common (may affect up to 1 in 10 people)

• cough
• dizziness
• diarrhoea
• low levels of red blood cells in the blood, shown by a blood test (anaemia)
• tiredness (fatigue)
• sudden inability of the kidney to function properly (renal failure)
• low levels of potassium in the blood, shown by a blood test (hypokalaemia)
• headache
• fainting (syncope)
• weakness (asthenia)
• feeling unwell (nausea)
• low blood pressure (dizziness, feeling of emptiness in the head) when changing from a sitting or lying position to a standing position
• gastritis (stomach pain, nausea)
• sensation of dizziness (vertigo)
• low levels of sugar in the blood, shown by a blood test (hypoglycaemia)

Uncommon (may affect up to 1 in 100 people)

• allergic reaction with rash and itching (hypersensitivity)
• dizziness when changing from a sitting to a standing position (postural dizziness)
• low levels of sodium in the blood, shown by a blood test (hyponatraemia)

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

• seeing, hearing or sensing things that are not there (hallucinations)
• changes in the way of sleeping (sleep disorders)

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

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

Not known (frequency cannot be estimated from the available data)

• sudden involuntary muscle twitch (myoclonus)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SACUBITRIL E VALSARTAN DOC Generici

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 after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to protect the
medicine from moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer used. This will help protect the environment.

6. Package contents and other information

What SACUBITRIL AND VALSARTAN DOC Generici contains

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

Description of the appearance of SACUBITRIL AND VALSARTAN DOC Generici and package contents
SACUBITRIL AND VALSARTAN DOC Generici 24 mg/26 mg film-coated tablets (tablets) are white, biconvex, oval-shaped film-coated tablets, marked with “S7V” on one side and “L1” on the other. Approximate tablet dimensions: 13 mm x 5 mm.
SACUBITRIL AND VALSARTAN DOC Generici 49 mg/51 mg film-coated tablets (tablets) are pink, biconvex, oval-shaped film-coated tablets, marked with “S7V” on one side and “M2” on the other. Approximate tablet dimensions: 12 mm x 5 mm.
SACUBITRIL AND VALSARTAN DOC Generici 97 mg/103 mg film-coated tablets (tablets) are pink, biconvex, oval-shaped film-coated tablets, marked with “S7V” on one side and “H3” on the other. Approximate tablet dimensions: 16 mm x 6 mm.
SACUBITRIL AND VALSARTAN DOC Generici 24 mg/26 mg is available in packs containing 28 film-coated tablets in blisters.
SACUBITRIL AND VALSARTAN DOC Generici 49 mg/51 mg are available in packs containing 28 or 56 film-coated tablets in blisters.
SACUBITRIL AND VALSARTAN DOC Generici 97 mg/103 mg are available in packs containing 56 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy.

Manufacturers

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Sacubitril/Valsartan DOC Generici 24 mg/26 mg, filmomhulde tabletten
Sacubitril/Valsartan DOC Generici 49 mg/51 mg, filmomhulde tabletten
Sacubitril/Valsartan DOC Generici 97 mg/103 mg, filmomhulde tabletten
Italy: SACUBITRIL AND VALSARTAN DOC Generici