Enalapril Almus

Package leaflet: Information for the patient

ENALAPRIL ALMUS 5 mg tablets, 20 mg tablets

Equivalent medicine
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 questions, ask your doctor or pharmacist.
• 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 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 ENALAPRIL ALMUS is and what it is used for
2. What you need to know before taking ENALAPRIL ALMUS
3. How to take ENALAPRIL ALMUS
4. Possible side effects
5. How to store ENALAPRIL ALMUS
6. Contents of the pack and other information

1. What ENALAPRIL ALMUS is and what it is used for

ENALAPRIL ALMUS contains the active substance enalapril, which belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors), used to dilate blood vessels and reduce blood pressure.
ENALAPRIL ALMUS is indicated for the treatment of high blood pressure (hypertension) and when the heart is unable to pump an adequate amount of blood to the body (heart failure). It is also indicated for the prevention of heart failure in people who have a heart abnormality (asymptomatic left ventricular dysfunction with ejection fraction ≤ 35%).

2. What you need to know before taking ENALAPRIL ALMUS

Do not take ENALAPRIL ALMUS

• if you are allergic to enalapril, to medicines similar to it (other ACE inhibitors), or to any of the other ingredients of this medicine (listed in section 6);
• if you have diabetes or impaired kidney function (glomerular filtration rate GFR < 60 ml/min/1.73 m²) and are being treated with a blood pressure-lowering medicine containing aliskiren (See sections “Warnings and precautions” and “Other medicines and ENALAPRIL ALMUS”);
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat);
• if you experience swelling of the face, lips, throat, and/or tongue (hereditary and/or idiopathic angioedema) causing difficulty in swallowing or breathing, or if you have had such episodes in the past when taking medicines similar to enalapril (ACE inhibitors);
• if you are in the second or third trimester of pregnancy (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ENALAPRIL ALMUS.
Avoid taking this medicine if you have recently undergone a kidney transplant or if you have severe problems with blood circulation (cardiogenic shock, significant hemodynamic obstruction).
Take this medicine with caution and inform your doctor:

• if you are on a low-sodium diet (low-sodium diet);
• if you have severe diarrhea and vomiting;
• if you have heart problems (heart failure, cardiac decompensation, aortic or mitral valve stenosis, hypertrophic cardiomyopathy);
• if you suffer from a heart disease called “ischaemic heart disease”, which reduces blood flow to the heart;
• if you have a disease that reduces blood flow to the brain (cerebrovascular disease);
• if you have kidney problems (impaired kidney function with creatinine clearance < 80 ml/min) or are undergoing mechanical blood filtration (hemodialysis with high-flux membranes) (See section “Use in patients with kidney problems and in hemodialysis”);
• if you have impaired blood circulation to the kidneys (bilateral renal artery stenosis or stenosis of the artery of the only functioning kidney);
• if you have a vascular collagen disease such as systemic lupus erythematosus;
• if you have diabetes;
• if you are taking:
• other medicines that lower high blood pressure (aliskiren, angiotensin II receptor antagonists). This combination is not recommended, as it increases the risk of adverse effects (See section “Other medicines and ENALAPRIL ALMUS”). If your doctor considers it necessary to take these medicines together, you must be closely monitored and your kidney function, electrolyte levels, and blood pressure must be checked regularly;
• diuretics, which help eliminate urine;
• lithium, used to treat certain mental disorders. In this case, except when strictly necessary, the combination with ENALAPRIL ALMUS is not recommended;
• immunosuppressive medicines, used to treat autoimmune diseases such as rheumatoid arthritis or following organ transplants;
• allopurinol, used to treat gout;
• procainamide, used to treat heart rhythm abnormalities;
• antidiabetic medicines or insulin, used to treat diabetes;
• medicines that increase potassium levels in the blood;
• medicines used to treat inflammation and allergies (corticosteroids) (See section “Other medicines and ENALAPRIL ALMUS”);
• sirolimus, everolimus, and other drugs belonging to the mTOR inhibitor class (used to prevent rejection of transplanted organs), as the risk of angioedema (rapid subcutaneous swelling, for example in the throat) is higher.

In these cases, during treatment with ENALAPRIL ALMUS, your doctor should monitor your kidney function (creatinine clearance), blood pressure, potassium levels, blood sugar (glucose), and liver enzymes.
Stop treatment with ENALAPRIL ALMUS and inform your doctor immediately if, during treatment, you experience:

• swelling of the extremities, face, lips, throat, mouth, or tongue (angioedema). This risk appears to be higher in people with black skin compared to those with lighter skin, and if you have experienced such episodes in the past (See section “Do not take ENALAPRIL ALMUS”);
• an infection (symptoms may include fever, sore throat). In this case, your doctor may consider it necessary to perform blood tests to check your white blood cell count;
• yellowing of the skin (cholestatic jaundice) or changes in certain blood test values (elevated liver enzymes);
• a persistent dry cough.

If you are about to undergo any of the following procedures, inform your doctor that you are being treated with ENALAPRIL ALMUS:

• any surgical procedure or if you need to take anesthetics;
• a treatment called LDL apheresis, to remove cholesterol from the blood using machines;
• a desensitization treatment, to reduce the effect of an allergy to bee or wasp stings.
  Please be aware that this medicine may be less effective in lowering blood pressure in people with black skin compared to those with lighter skin.

Children
Due to lack of data on safety and efficacy, ENALAPRIL ALMUS is not recommended in children under 6 years of age and for conditions other than the treatment of high blood pressure (hypertension).
Furthermore, this medicine is not recommended in newborns and children with kidney problems (glomerular filtration rate <30 ml/min/1.73 m²) (See section “Use in children”).

Other medicines and ENALAPRIL ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use caution and inform your doctor if you are taking:

• angiotensin II receptor antagonists or aliskiren, used to lower blood pressure, as the risk of adverse effects such as low blood pressure (hypotension), increased potassium levels in the blood (hyperkalemia), and reduced kidney function is higher (See sections “Do not take ENALAPRIL ALMUS” and “Warnings and precautions”);
• potassium-sparing diuretics such as spironolactone, eplerenone, triamterene, or amiloride, potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clot formation), as they may cause increased potassium levels or excessive lowering of blood pressure. If it is necessary to take these medicines together, your doctor must carefully monitor your blood potassium levels (See section “Use in patients on medicines that promote urine elimination (“previous diuretic therapy”)”);
• other antihypertensive agents that lower blood pressure, nitroglycerin, other nitrates, and other vasodilating agents, used to treat certain heart conditions, as they may excessively lower blood pressure;
• tricyclic antidepressants, used to treat depression, antipsychotics used to treat certain mental disorders, and anesthetics used to induce anesthesia during surgery, as they may enhance the effects of ENALAPRIL ALMUS;
• non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and inflammation. In this case, a loss of effectiveness of ENALAPRIL ALMUS, increased potassium levels in the blood, and kidney problems (sometimes severe, such as acute renal failure) may occur, especially if you already have kidney function disorders or are elderly;
• sympathomimetics, used to increase blood pressure, as they may reduce the effectiveness of ENALAPRIL ALMUS;
• oral hypoglycemic agents and insulin, used to treat diabetes, as they may cause excessive lowering of blood sugar (hypoglycemia), especially during the first weeks of treatment and if you have kidney problems (impaired kidney function);
• medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, and other drugs belonging to the mTOR inhibitor class). See section “Warnings and precautions”;
• flushing, nausea, vomiting, and hypotension have been reported rarely in patients receiving injectable gold salts while concomitantly taking ACE inhibitors, including enalapril.

The risk of angioedema may be increased if you are taking any of the following medicines:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

The combination of this medicine with medicines containing lithium, used to treat certain mental disorders, is not recommended, as ENALAPRIL ALMUS may increase its toxicity.
However, if you need to take these medicines together, your doctor must carefully monitor your blood lithium levels (See section “Warnings and precautions”).

ENALAPRIL ALMUS and alcohol
Avoid drinking alcoholic beverages during treatment with ENALAPRIL ALMUS, as excessive lowering of blood pressure may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are being treated with this medicine and pregnancy is confirmed, stop treatment immediately and consult your doctor for an alternative therapy.
ENALAPRIL ALMUS is not recommended during early pregnancy and must not be taken during the second and third trimesters of pregnancy, as it may cause serious harm to the unborn child if taken during this period (See section “Do not take ENALAPRIL ALMUS”).
This medicine is not recommended during breastfeeding for preterm infants and during the first few weeks after delivery, due to the risk it may pose to blood circulation and the kidneys. For older infants, if your doctor considers it necessary, you may take this medicine during breastfeeding. Your doctor must closely monitor your baby.

Driving and using machines
Avoid driving vehicles or operating machinery during treatment with ENALAPRIL ALMUS, as this medicine may cause dizziness and fatigue.

ENALAPRIL ALMUS contains lactose and sodium
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
ENALAPRIL ALMUS contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take ENALAPRIL ALMUS

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Before and during treatment with ENALAPRIL ALMUS, your doctor must carefully monitor your
blood pressure (arterial pressure), kidney function, and blood potassium levels
(See section “Warnings and precautions”).
Your doctor will determine the dose based on your health condition and response to therapy.

Treatment of high blood pressure (hypertension)
At the beginning of treatment, the recommended dose is 5 mg, up to a maximum of 20 mg, once daily.
If your blood pressure is only slightly above normal, the recommended initial dose is 5–10 mg per day.
If you have kidney problems (renovascular hypertension), low levels of salt or fluids in the blood
(hypovolemia and/or hyponatremia), heart problems (heart failure), or severe hypertension, your doctor must closely monitor you and prescribe an initial dose of 5 mg or lower.
If you are taking medicines that increase urine elimination (diuretics) at high doses, diuretic therapy should be stopped 2–3 days before starting ENALAPRIL ALMUS, as excessive reduction in blood pressure (symptomatic hypotension) may occur. In this case, an initial dose of 5 mg or lower is also recommended.
Once your blood pressure is under control, the usual maintenance dose ranges from 20 mg to a maximum of 40 mg per day.

Treatment of heart disorders
In patients with heart problems (heart failure/asymptomatic left ventricular dysfunction), ENALAPRIL ALMUS is usually used together with medicines that increase urine elimination (diuretics) and, when appropriate, with other medicines for treating heart conditions (digitalis, β-blockers).
At the beginning of treatment, the recommended dose is 2.5 mg per day.
Subsequently, the dose should be gradually increased to the maintenance dose: 20 mg taken as a single dose or in two divided doses.
The maximum dose is 40 mg per day, administered in two divided doses.

Use in patients with kidney problems and in haemodialysis
If you have kidney problems (reduced renal function), the dose of ENALAPRIL ALMUS will be adjusted according to your kidney function (creatinine clearance).
If you are undergoing mechanical blood filtration (haemodialysis), your doctor will determine the dose based on your response to the medicine.

Use in children
For children over 6 years of age, the dose for treatment of high blood pressure will be determined by the doctor based on the child's health condition and body weight.

• Children weighing between 20 kg and 50 kg: the recommended initial dose is 2.5 mg, up to a maximum of 20 mg per day;
• Children weighing more than 50 kg: the initial dose is 5 mg, up to a maximum of 40 mg per day. ENALAPRIL ALMUS is taken once daily.

This medicine is not recommended for neonates or children with kidney problems.

Use in elderly patients
If you are elderly, your doctor will determine the dose based on your health condition.

If you take more ENALAPRIL ALMUS than you should
Taking an excessive dose of this medicine may cause the following symptoms:

• excessive lowering of blood pressure (marked hypotension);
• loss of consciousness (stupor);
• severe circulatory problems (circulatory shock);
• changes in blood electrolyte levels (electrolyte disturbances);
• severe kidney problems (renal failure);
• increased breathing rate (hyperventilation);
• increased or decreased heart rate (tachycardia, bradycardia);
• increased awareness of heartbeats (palpitations);
• dizziness;
• anxiety;
• cough.

If you have taken too much of this medicine, contact your doctor or the nearest hospital immediately.

If you forget to take ENALAPRIL ALMUS
Do not take a double dose to make up for the missed dose. Take only the next tablet at the scheduled time.
If you have any doubts 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 everybody gets them.
The following side effects may occur:

Very Common (may affect more than 1 in 10 people)

• vision disorders (blurred vision);
• dizziness;
• cough;
• nausea;
• weakness (asthenia).

Common (may affect up to 1 in 10 people)

• headache (cephalalgia), depression;
• low blood pressure (hypotension) and dizziness upon standing due to a drop in blood pressure (orthostatic hypotension), fainting with loss of consciousness (syncope), heart attack, chest pain, heart rhythm problems (arrhythmias), chest pain (angina pectoris), increased heart rate (tachycardia);
• difficulty breathing (dyspnoea);
• diarrhoea, abdominal pain, altered taste (dysgeusia);
• skin irritation (rash), allergic reactions including swelling of the extremities, face, lips, throat, mouth or tongue (angioneurotic oedema);
• fatigue (fatigability);
• changes in results of certain blood tests (hyperkalaemia, increased serum creatinine).

Uncommon (may affect up to 1 in 100 people)

• reduction in the number of red blood cells in the blood (anaemia, aplastic anaemia, haemolytic anaemia);
• reduction in blood sugar levels (hypoglycaemia);
• confusion, drowsiness, insomnia, nervousness, altered sensation in limbs or other body parts (paraesthesia), vertigo;
• dizziness upon standing due to a drop in blood pressure (orthostatic hypotension), increased awareness of heartbeats (palpitations), myocardial infarction or severe problems with brain circulation (cerebrovascular accident) (See section “Warnings and precautions”);
• runny nose (rhinorrhoea), pain localized in the larynx (laryngodynia), voice changes (hoarseness), difficulty breathing (bronchospasm, asthma);
• intestinal disorders (ileus), inflammation of the pancreas (pancreatitis), vomiting, digestive difficulties (dyspepsia), constipation (stipsis), loss of appetite (anorexia), stomach irritation (gastric irritation), dry mouth, stomach or intestinal lesions (peptic ulcer);
• excessive sweating (diaphoresis), itching (pruritus), skin irritation (urticaria), hair loss (alopecia);
• severe kidney problems (renal dysfunction, renal failure), presence of protein in urine (proteinuria);
• male fertility problems (impotence);
• muscle cramps, hot flushes, perception of ringing in the ear (tinnitus), malaise, fever;
• changes in results of certain blood tests (uraemia, hyponatraemia).

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

• severe blood disorders (neutropenia, decreased haemoglobin, decreased haematocrit, thrombocytopenia, agranulocytosis, bone marrow depression, pancytopenia), swollen lymph nodes (lymphadenopathy), immune system disorders (autoimmune diseases);
• sleep disorders (including changes in dream activity);
• tingling and pain in fingers, followed by sensation of heat and pain (Raynaud's phenomenon);
• lung problems (pulmonary infiltrates, allergic alveolitis/eosinophilic pneumonia), inflammation of nasal cavities (rhinitis);
• inflammation and lesions of the mucosa of the mouth (stomatitis/aphthous ulcers), inflammation of the tongue (glossitis);
• severe liver problems (hepatic failure, hepatitis – hepatocellular or cholestatic, including necrosis, cholestasis, including jaundice);
• severe skin diseases (erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma);
• reduced urine output (oliguria);
• development of breasts in men (gynaecomastia);
• changes in certain blood test results (increased liver enzymes, increased bilirubinaemia).

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

• swelling due to fluid accumulation in the intestine (intestinal angioedema).

Frequency not known (cannot be estimated from the available data)

• condition characterized by fever, inflammation of veins (vasculitis), inflammation or disorders of muscles (myalgia), joint pain or inflammation (arthralgia/arthritis), changes in certain blood test values (positive ANA test, increased ESR, eosinophilia, leucocytosis), skin irritations (rash), light sensitivity (photosensitivity) and other skin problems (dermatological manifestations);
• syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 ENALAPRIL ALMUS

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 packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not store this medicine above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ENALAPRIL ALMUS contains
ENALAPRIL ALMUS 5 mg tablets

• The active substance is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.
• The other ingredients are: monohydrate lactose, pregelatinized starch, corn starch, sodium bicarbonate, magnesium stearate.

ENALAPRIL ALMUS 20 mg tablets

• The active substance is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other ingredients are: monohydrate lactose, pregelatinized starch, corn starch, sodium bicarbonate, magnesium stearate, red iron oxide, yellow iron oxide.

Description of the appearance of ENALAPRIL ALMUS and contents of the pack
ENALAPRIL ALMUS 5 mg tablets
Packs of 28 tablets.
ENALAPRIL ALMUS 20 mg tablets
Packs of 14 tablets.

Marketing Authorization Holder
Almus S.r.l. - Via Cesarea 11/10 - 16121 Genoa
E-mail: [email protected]

Manufacturers
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A., Via di Fossignano, 2 - 04011 Aprilia (LT)
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)