ENALAPRIL 5 mg Tablet

Зміст інструкції

1. ENALAPRIL ALMUS 5 mg tablets, 20 mg tablets
   1. What is ENALAPRIL ALMUS and what is it 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

ENALAPRIL ALMUS 5 mg tablets, 20 mg tablets

Generic medicine

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is ENALAPRIL ALMUS and what is it used for

ENALAPRIL ALMUS contains the active ingredient 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 provide an adequate amount of blood to the whole body
(heart failure). Furthermore, it is indicated for the prevention of heart failure in people
who present an abnormality of the heart (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 similar medicines (other ACE inhibitors) or to any of the other ingredients of this medicine (listed in section 6);
• if you have diabetes or your kidney function is impaired (glomerular filtration rate GFR < 60 ml/min/1.73 m²) and are being treated with a medicine that lowers blood pressure containing aliskiren (See sections “Warnings and precautions” and “Other medicines and ENALAPRIL ALMUS”);
• if you have taken or are 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 in areas such as the throat);
• if you experience swelling of the face, lips, throat and/or tongue (hereditary and/or idiopathic angioedema) causing difficulty swallowing and breathing or if you have suffered from it in the past when taking medicines similar to enalapril (ACE inhibitors); if you are in the second and 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 following a low-sodium diet (hyposodic);
• if you suffer from severe diarrhea and vomiting;
• if you suffer from heart problems (heart failure, cardiac decompensation, aortic or mitral valve stenosis, hypertrophic cardiomyopathy);
• if you have a heart condition called “ischemic 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 people with kidney problems and in hemodialysis”);
• if you experience problems with blood circulation to the kidneys (bilateral renal artery stenosis or stenosis of the artery of the only functioning kidney);
• if you have a collagen vascular 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 side effects (See section “Other medicines and ENALAPRIL ALMUS”). If your doctor believes you should take these medicines at the same time, they must monitor you closely and periodically monitor your kidney function, electrolyte levels and blood pressure;
• diuretics, which facilitate the elimination of urine;
• lithium, used to treat some mental disorders. In this case, unless absolutely necessary, the association with ENALAPRIL ALMUS is not recommended;
• immunosuppressant medicines, for the treatment of autoimmune diseases such as rheumatoid arthritis or following transplants;
• allopurinol, for the treatment of gout;
• procainamide, for treating heart rhythm abnormalities;
• antidiabetics or insulin, for the treatment of diabetes;
• medicines that increase potassium levels in the blood;
• medicines for the treatment of inflammation and allergies (corticosteroids) (See section “Other medicines and ENALAPRIL ALMUS”);
• sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to prevent organ rejection after transplantation), as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater.

In these cases, during treatment with ENALAPRIL ALMUS, your doctor will need to monitor the
functionality of your kidneys (creatinine clearance), blood pressure, potassium levels, blood sugar (glycemia) and liver enzymes.
Stop treatment with ENALAPRIL ALMUS and immediately inform your doctor if,
during therapy, you experience:

• swelling of the extremities, face, lips, throat, mouth or tongue (angioedema). This risk appears to be greater in people with black skin, compared to people with white skin and if you have suffered from it in the past (See section “Do not take ENALAPRIL ALMUS”);
• an infection (symptoms may include fever, sore throat). In this case, your doctor may deem it necessary for you to undergo blood tests to check your white blood cell count;
• a yellowing of the skin (cholestatic jaundice) or an alteration of the values of some blood tests (increased liver enzymes);
• a dry cough that persists for a long time.

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

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

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

Other medicines and ENALAPRIL ALMUS
Tell 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 side effects such as low blood pressure (hypotension), increased potassium levels in the blood (hyperkalemia) and reduced kidney function is greater (See sections “Do not take ENALAPRIL ALMUS” and “Warnings and precautions”);
• diuretics that facilitate the elimination of urine, called potassium-sparing diuretics such as spironolactone, eplerenone, triamterene or amiloride, potassium supplements (including salt substitutes) potassium-sparing diuretics and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent organ rejection; and heparin a medicine used to thin the blood and prevent the formation of clots) as they may cause an increase in potassium levels in the blood or an excessive lowering of blood pressure. If you need to take these medicines at the same time, your doctor will need to carefully monitor potassium levels in the blood (See section “Use in people undergoing therapy with medicines that facilitate the elimination of urine (“diuretic therapy”));
• other antihypertensive agents, which lower blood pressure, nitroglycerin, other nitrates and other vasodilators, used to treat some heart problems, as they may lower blood pressure excessively;
• tricyclic antidepressants, for the treatment of depression, antipsychotics for treating some mental disorders, anesthetics used to induce anesthesia during surgical interventions as they may increase the effects of ENALAPRIL ALMUS;
• non-steroidal anti-inflammatory drugs (NSAIDs) used to relieve pain and inflammation. In this case, a loss of efficacy of ENALAPRIL ALMUS, an increase in potassium levels in the blood and kidney problems that can sometimes be severe (acute renal failure) may occur, especially if you already suffer from kidney disorders or are elderly;
• sympathomimetics, used to increase blood pressure, because they may reduce the effectiveness of ENALAPRIL ALMUS;
• oral hypoglycemic agents and insulins, used to treat diabetes, because they may cause an excessive reduction in blood sugar (hypoglycemia), especially during the first weeks of treatment and if you have kidney problems (impaired kidney function);
• drugs commonly used to prevent organ rejection (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”;
• flushing of the face, nausea, vomiting and hypotension have been rarely reported in patients undergoing injectable gold therapy with the concomitant use of ACE inhibitors, including enalapril.

If you are taking any of the following medicines, the risk of angioedema may be
increased:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection 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 some mental
disorders, is not recommended as ENALAPRIL ALMUS may increase its toxicity.
However, if you need to take these medicines at the same time, your doctor must carefully monitor
lithium levels in the blood (See section “Warnings and precautions”).

ENALAPRIL ALMUS with 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 or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
If you are being treated with this medicine and it is confirmed that you are pregnant,
immediately stop treatment with this medicine and consult your doctor for
alternative therapy.
ENALAPRIL ALMUS is not recommended in early pregnancy and must not be taken if you
are in the second and third trimester of pregnancy, as it may cause serious harm to the baby if
taken during this period (See section “Do not take ENALAPRIL ALMUS”).
This medicine is not recommended during breastfeeding for premature babies and in
the first few weeks after delivery, due to the risk to blood circulation and
the kidneys. In the case of older babies, you may take this medicine during breastfeeding if your doctor considers it necessary. Your doctor will need to monitor your baby closely.

Driving and operating machinery
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 some sugars, contact them 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 always exactly as your doctor or pharmacist has told you.
If you have doubts, consult your doctor or pharmacist.
Before and during treatment with ENALAPRIL ALMUS, your doctor must carefully check your
blood pressure (arterial pressure), your kidney function and potassium levels in
your blood (See section “Warnings and precautions”).
The dose will be established by the doctor based on your health conditions and the 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, 1 time a
day.
If your blood pressure is only slightly above normal, the recommended initial dose is
5-10 mg per day.
If you suffer from kidney problems (renovascular hypertension), low levels of salt or fluids in the blood
(salt and/or volume-depleted), heart problems (heart failure) or severe hypertension, the doctor
must keep you under strict control and prescribe an initial dose of 5 mg or lower.
If you are taking medicines that facilitate the elimination of urine (diuretics) at high doses, it is
necessary to interrupt therapy 2-3 days before taking ENALAPRIL ALMUS, because an
excessive reduction in blood pressure (symptomatic hypotension) may occur. In this case as well, a
initial dose of 5 mg or lower is 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
the elimination of urine (diuretics) and, when possible, together with other medicines to treat
heart problems (digitalis, beta-blockers).
At the beginning of treatment, the recommended dose is 2.5 mg per day.
Subsequently, the dose must be gradually increased to the maintenance dose: 20 mg to be
taken in a single dose or in 2 divided doses.
The maximum dose is 40 mg per day, administered in 2 divided doses.

Use in people with kidney problems and in hemodialysis
If you suffer from kidney problems (reduced kidney function), the dose of ENALAPRIL ALMUS will be adjusted
based on the level of functioning of your kidneys (creatinine clearance).
If you undergo mechanical blood filtration (hemodialysis), the doctor will establish the dose to be
taken considering your response to the medicine.

Use in children
For children over 6 years of age, the dose to be taken for the treatment of high blood
pressure will be established by the doctor, based on the health conditions and weight of the child.

• 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 1 time per day.

This medicine is not recommended in newborns or children with kidney problems.

Use in the elderly
If you are elderly, the doctor must establish the dose based on your health conditions.

If you take more ENALAPRIL ALMUS than you should
Following the intake/assumption of an excessive dose of this medicine, the following
symptoms may occur:

• excessive lowering of blood pressure (marked hypotension);
• loss of consciousness (stupor);
• serious problems with circulation (circulatory shock);
• alteration of the levels of salts in the blood (electrolyte disturbances);
• serious kidney problems (renal failure);
• increased breathing rate (hyperventilation);
• increased or decreased heartbeats (tachycardia, bradycardia);
• increased perception of heartbeats (palpitations);
• dizziness;
• anxiety;
• cough.

In case of ingestion/assumption of an excessive quantity of this medicine, contact
immediately your doctor or the nearest hospital.

If you forget to take ENALAPRIL ALMUS
Do not take a double dose to make up for the forgotten dose. Take only the
next tablet, at the scheduled time.
If you have any doubts about the use of 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, depression;
• low blood pressure (hypotension) and a feeling of dizziness when getting up due to a drop in blood pressure (orthostatic hypotension), fainting with loss of consciousness (syncope), heart attack, chest pain, irregular heartbeat (arrhythmias), chest pain (angina pectoris), increased heart rate (tachycardia);
• difficulty breathing (dyspnea);
• diarrhea, abdominal pain, altered taste (dysgeusia);
• skin irritation (rash), allergic reactions including swelling of the extremities, face, lips, throat, mouth or tongue (angioedema);
• fatigue;
• changes in the results of some blood tests (hyperkalemia, increased serum creatinine).

Uncommon(may affect up to 1 in 100 people)

• reduced number of red blood cells in the blood (anemia, aplastic anemia, hemolytic anemia);
• reduced blood sugar levels (hypoglycemia);
• confusion, drowsiness, insomnia, nervousness, altered sensitivity of the limbs or other parts of the body (paresthesia), vertigo;
• feeling of dizziness when getting up due to a drop in blood pressure (orthostatic hypotension), increased awareness of heartbeats (palpitations), myocardial infarction or serious problems with brain circulation (cerebrovascular accident) (See section “Warnings and precautions”);
• runny nose (rhinorrhea), localized pain in the larynx (laryngodynia), altered voice (hoarseness), difficulty breathing (bronchospasm, asthma);
• intestinal disorders (ileus), inflammation of the pancreas (pancreatitis), vomiting, difficulty digesting food (dyspepsia), constipation, loss of appetite (anorexia), stomach irritation (gastric irritations), dry mouth, injury to the stomach or intestine (peptic ulcer);
• excessive sweating (diaphoresis), itching, skin irritation (urticaria), hair loss (alopecia);
• serious kidney problems (renal dysfunction, renal failure), presence of protein in the urine (proteinuria);
• fertility problems in men (impotence);
• muscle cramps, hot flashes, perception of ringing in the ears (tinnitus), malaise, fever;
• changes in the results of some blood tests (uremia, hyponatremia).

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

• serious blood problems (neutropenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, agranulocytosis, bone marrow depression, pancytopenia), swollen lymph nodes (lymphadenopathy), autoimmune diseases;
• sleep disorders (including altered dream activity);
• numbness and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon);
• lung problems (pulmonary infiltrates, allergic alveolitis/eosinophilic pneumonia), inflammation of the nasal cavities (rhinitis);
• inflammation and injury of the oral mucosa (stomatitis/aphthous ulcers), inflammation of the tongue (glossitis);
• serious liver problems (liver failure, hepatitis - hepatocellular or cholestatic, hepatitis including necrosis, cholestasis, including jaundice);
• serious skin diseases (erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma);
• poor urine production (oliguria);
• development of breast tissue in men (gynecomastia);
• changes in some blood test results (increased liver enzymes, increased bilirubinemia).

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

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

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

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 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 the medicine at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What ENALAPRIL ALMUS contains
ENALAPRIL ALMUS 5 mg tablets

• The active ingredient is enalapril maleate. 1 tablet contains 5 mg of enalapril maleate.
• The other ingredients are: lactose monohydrate, pregelatinized starch, corn starch, sodium bicarbonate, magnesium stearate.

ENALAPRIL ALMUS 20 mg tablets

• The active ingredient is enalapril maleate. 1 tablet contains 20 mg of enalapril maleate.
• The other ingredients are: lactose monohydrate, 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 Authorisation Holder
Almus S.r.l. - Via Cesarea 11/10 - 16121 Genova
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)