Sacubitril and valsartan Doc Generici

Patient Information Leaflet

SACUBITRIL AND VALSARTAN DOC 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 this leaflet carefully before 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

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

Do not take SACUBITRIL AND VALSARTAN DOC:

• 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 currently taking an ACE inhibitor, wait 36 hours after taking the last dose before starting SACUBITRIL AND VALSARTAN DOC (see "Other medicines and SACUBITRIL AND VALSARTAN DOC").
• 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) while 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").
• 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 and consult your doctor.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before or while taking SACUBITRIL AND VALSARTAN DOC:

• if you are being treated with an angiotensin receptor blocker (ARB) or aliskiren (see "Do not take SACUBITRIL AND VALSARTAN DOC").
• if you have ever had angioedema (see "Do not take SACUBITRIL AND VALSARTAN DOC" and section 4 "Possible side effects").
• if, after taking SACUBITRIL AND VALSARTAN DOC, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking SACUBITRIL AND VALSARTAN DOC 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 are experiencing 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 sleep patterns while taking SACUBITRIL AND VALSARTAN DOC.
• 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.
Your doctor may check your blood potassium and sodium levels regularly during treatment with SACUBITRIL AND VALSARTAN DOC. Additionally, your doctor may monitor your blood pressure at the beginning 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, other pharmaceutical forms of medicines containing sacubitril/valsartan are more suitable; consult your doctor or pharmacist.
Other medicines and SACUBITRIL AND VALSARTAN DOC
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 discontinue one of these medicines. This is particularly important for the following medicines:

• ACE inhibitors. Do not take SACUBITRIL AND VALSARTAN DOC 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 (see "Do not take SACUBITRIL AND VALSARTAN DOC"). If you stop taking SACUBITRIL AND VALSARTAN DOC, wait 36 hours after taking the last dose 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 AND VALSARTAN DOC").
• 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 of the type known as non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. If you are taking any of these, your doctor may want to monitor your kidney function when starting or adjusting treatment (see "Warnings and precautions").
• lithium, a medicine used to treat certain psychiatric disorders.
• 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.
Pregnancy and breastfeeding
If you are pregnant, suspect you may 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 an alternative medicine instead of SACUBITRIL AND VALSARTAN DOC.
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 child if taken after the third month of pregnancy.
Breastfeeding
SACUBITRIL AND VALSARTAN DOC 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. 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 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 97 mg/103 mg dose, i.e., essentially 'sodium-free'.

3. How to take SACUBITRIL AND VALSARTAN DOC

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or
pharmacist.
Adults
You will usually start with a dose of 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 decide the exact starting dose based on the medicines you were
previously taking and your blood pressure. Your doctor will then adjust your dose every 2–4 weeks, depending
on your response to treatment, until the most suitable dose for you is found.
The usual recommended optimal dose is usually 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)
Your doctor (or your child’s doctor) will decide the starting dose based on body weight and other factors,
including previously taken medicines. Your doctor will adjust the dose every 2–4 weeks until the optimal dose
has been identified.
SACUBITRIL AND VALSARTAN DOC should be given twice daily (one tablet in the morning and one tablet in
the evening).
SACUBITRIL AND VALSARTAN DOC film-coated tablets are not intended for use in children weighing less
than 40 kg. For these patients, medicines containing sacubitril/valsartan in other pharmaceutical forms are
available.
Patients treated with SACUBITRIL AND VALSARTAN DOC may develop low blood pressure (dizziness,
feeling of emptiness in the head), high levels of potassium in the blood (detected when your doctor performs a
blood test), or reduced kidney function. If this occurs, your doctor may reduce the dose of any medicine you are
taking, temporarily reduce the dose of SACUBITRIL AND VALSARTAN DOC, or completely stop treatment
with SACUBITRIL AND VALSARTAN DOC.
Swallow the tablets with a glass of water. You may take SACUBITRIL AND VALSARTAN DOC with or
without food. Splitting or crushing the tablets is not recommended.
If you take more SACUBITRIL AND VALSARTAN DOC than you should
If you have accidentally taken too many SACUBITRIL AND VALSARTAN DOC 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
It is recommended to take the medicine at the same time every 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 a forgotten dose.
If you stop taking SACUBITRIL AND VALSARTAN DOC
Stopping treatment with SACUBITRIL AND VALSARTAN DOC may cause your condition to worsen. Do not
stop taking this medicine unless your doctor tells you to.
If you have any questions about using 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 can be serious.

• Stop taking SACUBITRIL AND VALSARTAN DOC 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 get worse, inform your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)

• low blood pressure which may cause symptoms of dizziness and lightheadedness (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, lightheadedness) when moving from a sitting or lying position to a standing position
• gastritis (stomach pain, nausea)
• sensation of dizziness (vertigo)
• low blood sugar levels shown by a blood test (hypoglycaemia)

Uncommon (may affect up to 1 in 100 people)

• allergic reaction with rash and itching (hypersensitivity)
• dizziness when moving 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 effect, 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

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 storage temperature.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if the packaging is damaged or shows any signs of tampering.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer
required. This will help protect the environment.

6. Package contents and other information

What SACUBITRIL AND VALSARTAN DOC contains

• The active substances are sacubitril and valsartan.
  o Each 24 mg/26 mg film-coated tablet contains 24.3 mg of sacubitril and 25.7 mg of valsartan.
  o Each 49 mg/51 mg film-coated tablet contains 48.6 mg of sacubitril and 51.4 mg of valsartan.
  o Each 97 mg/103 mg film-coated tablet contains 97.2 mg of sacubitril and 102.8 mg of valsartan.
• The other components of the tablet core are microcrystalline cellulose (E460(i)), low-substituted hydroxypropylcellulose (E463), crospovidone, magnesium stearate and talc (E553b) (see end of section 2 under “SACUBITRIL AND VALSARTAN DOC contains sodium”).
• The coatings of the 24 mg/26 mg and 97 mg/103 mg tablets contain hypromellose, titanium dioxide (E171), talc (E553b), Macrogol (4000), red iron oxide (E172) and black iron oxide (E172).
• The coating of the 49 mg/51 mg tablet contains hypromellose, titanium dioxide (E171), talc (E553b), Macrogol (4000), yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of SACUBITRIL AND VALSARTAN DOC and contents of the pack
SACUBITRIL AND VALSARTAN DOC 24 mg/26 mg film-coated tablets are round, violet-white, film-coated tablets, biconvex, without break line, marked with “L” on one side and smooth on the other side.
Approximate tablet diameter: 6.0 mm.
SACUBITRIL AND VALSARTAN DOC 49 mg/51 mg film-coated tablets are oval, pale yellow, film-coated tablets, biconvex, without break line, with bevelled edges, marked with “I” on one side and smooth on the other side.
Approximate tablet dimensions: 13.1 mm x 5.2 mm.
SACUBITRIL AND VALSARTAN DOC 97 mg/103 mg film-coated tablets are oval, light pink, film-coated tablets, biconvex, without break line, with bevelled edges, marked with “H” on one side and smooth on the other side.
Approximate tablet dimensions: 15.1 mm x 6.0 mm.
The tablets are supplied in packs containing 28 and 56 tablets.
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

• Elpen Pharmaceutical Co. Inc., Marathonos Avenue 95, Pikermi, Attiki, 190 09, Greece.
• Elpen Pharmaceutical Co. Inc., Keratea Industrial Park, Zapani, Block 1048, Keratea, Attiki, 190 01, Greece.
• Pharmacare Premium Limited, HHF003 Hal Far Industrial Estate, Birzebbugia, BBG 3000, Malta.

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