Enalapril Pensa

Package leaflet: Information for the patient

ENALAPRIL PENSA 5 mg tablets, 20 mg tablets

enalapril maleate
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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ENALAPRIL PENSA contains an active substance called enalapril maleate. This active substance
belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors).
ENALAPRIL PENSA is used:

• to treat high blood pressure (hypertension)
• to treat heart failure (weakening of heart function). It may reduce the need for hospitalisation and may help some patients live longer
• to prevent the signs of heart failure. These signs include: shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet.

This medicine works by dilating your blood vessels. This lowers your blood pressure.
The medicine usually starts to work within one hour, and the effect lasts for at least 24 hours. Some people
may require several weeks of treatment before the full effect on blood pressure can be seen.

2. What you need to know before taking ENALAPRIL PENSA

Do not take ENALAPRIL PENSA

• if you are allergic to enalapril maleate, to similar medicines (other ACE inhibitors), or to any of the other ingredients of this medicine (listed in section 6);
• if you have experienced swelling of the face, lips, tongue and/or throat (hereditary 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 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 PENSA”);
• if you are in the second or third trimester of pregnancy (See section “Pregnancy and breastfeeding”);
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat). Do not take this medicine if you have any of the conditions listed above. If you are unsure, speak with your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking ENALAPRIL PENSA.
Inform your doctor about any current or past medical conditions or diseases and any allergies.
Inform your doctor if:

• you have heart disease;

• you have a condition affecting blood vessels in the brain;

• you have a blood disorder such as low number or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anemia);

• you have diabetes. Close monitoring for hypoglycemia (low blood sugar levels) is necessary, especially during the first month of treatment. Blood potassium levels may also be higher;

• you have liver problems;

• you have kidney problems (including kidney transplant). This may lead to increased blood potassium levels, which can be serious. Your doctor may need to adjust your dose of ENALAPRIL PENSA or monitor your blood potassium levels;

• you are on dialysis;

• you are on a low-sodium (low-salt) diet, taking potassium supplements, potassium-sparing agents, potassium-containing salt substitutes, or other medicines that may increase blood potassium levels (e.g., heparin [a medicine used to prevent blood clots], products containing trimethoprim such as cotrimoxazole [medicines used to treat infections]);

• you are over 70 years of age;

• you are suffering from or have recently suffered from severe vomiting or diarrhea;

• you have or have had allergies with swelling of the face, lips, tongue and/or throat, with difficulty swallowing or breathing. Please note that black patients are at higher risk for these types of reactions to ACE inhibitors;

• you have low blood pressure (you may feel faint or dizzy, especially when standing up);

• you have a collagen vascular disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are undergoing immunosuppressive therapy, or are taking allopurinol, procainamide, or their combinations;

• you are taking any of the following medicines, as the risk of angioedema (rapid swelling under the skin, e.g., in the throat) is increased:

  • racecadotril, a medicine used to treat diarrhea;
  • medicines used to prevent organ transplant rejection and to treat cancer (such as temsirolimus, sirolimus, everolimus) and other drugs belonging to the class of mTOR inhibitors;
  • vildagliptin, a medicine used to treat diabetes;
  • a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan), used in patients with heart failure.

• 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 PENSA”). If your specialist doctor considers concomitant use absolutely necessary,

  they must monitor you closely and frequently, and periodically check your kidney function, electrolyte levels, and blood pressure;

  • diuretics, which increase urine elimination;
  • any other medicine for the treatment of other conditions or diseases (see section “Other medicines and ENALAPRIL PENSA”).

In these cases, your doctor may consider it necessary to adjust the dose of ENALAPRIL PENSA.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking this medicine.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). This medicine is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause severe harm to the unborn baby if taken during this period (see section “Pregnancy”).
Stop treatment with ENALAPRIL PENSA and contact your doctor immediately if you experience airway obstruction during treatment. This risk is increased in patients who have undergone surgery on the airways.
If you are about to undergo any of the following procedures, inform your doctor (or dentist) that you are being treated with ENALAPRIL PENSA:

• any surgical procedure or anesthesia (including dental procedures), as a sudden drop in blood pressure associated with anesthesia may occur;
• a therapy called LDL apheresis, to remove cholesterol from the blood using machines;
• a desensitization treatment to reduce the effects of an allergy to bee or wasp stings.

Like other medicines in the same class, ENALAPRIL PENSA appears to be less effective in lowering blood pressure in black patients compared to patients with lighter skin.

Children
ENALAPRIL PENSA has been studied in children. ENALAPRIL PENSA is not recommended in children for indications other than the treatment of high blood pressure (hypertension).
Furthermore, this medicine is not recommended in neonates and children with kidney problems (glomerular filtration rate <30 ml/min/1.73 m²) (See section “Use in children”).
For further information, consult your doctor.

Other medicines and ENALAPRIL PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This includes herbal medicines. This is because ENALAPRIL PENSA may interact with the mechanism of action of certain medicines. Likewise, certain other medicines may interfere with the action of ENALAPRIL PENSA. Your doctor may need to adjust the dose and/or take other precautions.

Do not take ENALAPRIL PENSA with sacubitril/valsartan (a medicine for treating heart failure) due to an increased risk of angioedema (rapid swelling under the skin, e.g., in the throat). See section “Do not take ENALAPRIL PENSA”.

Inform your doctor if you are taking:

• angiotensin II receptor antagonists or aliskiren, used to lower blood pressure, as their concomitant use with ENALAPRIL PENSA may increase the risk of adverse effects such as low blood pressure (hypotension), increased blood potassium levels (hyperkalemia), and reduced kidney function (including acute kidney injury) (See sections “Do not take ENALAPRIL PENSA” and “Warnings and precautions”);
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting);
• other antihypertensive medicines that lower blood pressure, as they may excessively lower blood pressure, especially if you are also taking a diuretic;
• lithium salts, used to treat certain mental disorders. In this case, blood lithium levels must be closely monitored, as lithium elimination may be reduced during treatment with ENALAPRIL PENSA;
• certain anesthetics used to induce anesthesia during surgery;
• tricyclic antidepressants, used to treat depression;
• antipsychotics used to treat certain mental disorders, as they may cause a further decrease in blood pressure;
• certain cough and cold medicines and weight-loss medicines containing a so-called "sympathomimetic agent";
• certain medicines for pain or arthritis, including gold therapy;
• an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus: medicines used to treat certain types of cancer or to prevent organ transplant rejection). See also information in section “Warnings and precautions”;
• racecadotril, a medicine used to treat diarrhea;
• non-steroidal anti-inflammatory drugs (NSAIDs) and selective COX-2 inhibitors used to relieve pain and inflammation. In this case, the effect of ENALAPRIL PENSA may be reduced, blood potassium levels may increase, and kidney function may worsen. These effects are usually temporary. Rarely, kidney problems (acute kidney injury) may occur, particularly in patients who already have impaired kidney function, such as elderly or dehydrated individuals;
• oral hypoglycemic agents, vildagliptin, or insulin, used to treat diabetes, as their effect may be enhanced, increasing the risk of excessive lowering of blood sugar (hypoglycemia), especially during the first weeks of treatment and if you have kidney problems (impaired renal function);
• sympathomimetics, used to increase blood pressure, as they may reduce the effect of ENALAPRIL PENSA;
• aspirin (acetylsalicylic acid);
• medicines used to dissolve blood clots (thrombolytics);
• alcohol. If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before taking ENALAPRIL PENSA.

ENALAPRIL PENSA with food, drinks, and alcohol
ENALAPRIL PENSA can be taken with or without food. Most people take ENALAPRIL PENSA with a glass of water.
During treatment with ENALAPRIL PENSA, alcohol may cause an excessive drop in blood pressure.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy:
ENALAPRIL PENSA is not recommended during the first trimester of pregnancy and must not be taken during the second and third trimesters of pregnancy, as it may cause fetal malformations (teratogenic risk) if taken during this period (See section “Do not take ENALAPRIL PENSA”).
Treatment with ENALAPRIL PENSA must not be initiated during pregnancy.
If you are being treated with this medicine and become pregnant, stop taking it immediately and consult your doctor, who will prescribe an alternative treatment if appropriate.

Breastfeeding:
The use of ENALAPRIL PENSA during breastfeeding is not recommended for premature infants and during the first weeks after birth, due to the potential risk of adverse effects on the heart, blood vessels, and kidneys, and because there is insufficient clinical experience.
In older infants, if considered necessary for the mother, ENALAPRIL PENSA may be taken during breastfeeding, but in this case the infant should be monitored for possible adverse effects.

Driving and using machines
When driving or operating machinery, bear in mind that dizziness and fatigue may occasionally occur.

ENALAPRIL PENSA contains lactose
If you have been diagnosed with an intolerance to certain sugars by your doctor, contact them before taking this medicine.

ENALAPRIL PENSA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take ENALAPRIL PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your dose will be determined by your doctor based on your health condition and taking into account any other
medicines you are taking.
ENALAPRIL PENSA must be taken every day as prescribed by your doctor.
It is very important to continue taking ENALAPRIL PENSA for as long as your doctor has prescribed it. Do not take more tablets than the prescribed dosage.

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.
Some patients may need to start treatment with a lower dose, and treatment initiation should occur under close medical supervision.
Once your blood pressure is under control, the usual maintenance dose is 20 mg. The maximum maintenance dose is 40 mg per day.

Treatment of heart problems (heart failure/asymptomatic left ventricular dysfunction)
At the beginning of treatment, the recommended dose is generally 2.5 mg, once daily.
Your doctor will gradually increase the dose until the appropriate dose for each patient is reached. Usually, the maintenance dose is 20 mg taken once or twice daily.
The maximum dose is 40 mg per day, taken in two daily doses.
Particular caution is required when taking the first dose or when the dose is increased. Inform your doctor immediately if you experience dizziness or lightheadedness.

Use in patients with kidney problems
The dose of this medicine will vary depending on the function of your kidneys:

• moderate kidney problems – 5 to 10 mg per day,
• severe kidney problems – 2.5 mg per day,
• if you are on dialysis – 2.5 mg per day. On days when you are not undergoing dialysis, the dose may be adjusted according to your blood pressure.

Use in elderly patients
If you are elderly, your doctor will determine the dose after evaluating your kidney function.

Use in children
Experience with the use of ENALAPRIL PENSA in children with high blood pressure is limited. In children able to swallow tablets, the doctor will determine the dose based on the child's health condition and 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 50 kg or more: the initial dose is 5 mg, up to a maximum of 40 mg per day. In children, ENALAPRIL PENSA is administered once daily.

The dose may be adjusted according to the child's needs:

• a maximum dose of 20 mg per day may be used in children weighing between 20 kg and 50 kg,
• a maximum dose of 40 mg per day may be used in children weighing more than 50 kg.

ENALAPRIL PENSA is not recommended in newborns and children with kidney problems (glomerular filtration rate less than 30 ml/min/1.73 m²).

ENALAPRIL PENSA tablets can be taken before, during, or after meals.
Most patients take ENALAPRIL PENSA with water.
The tablet may be divided into equal parts.

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

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

In case of low blood pressure (hypotension), lay the patient flat on their back (supine position).
If an excessive amount of this medicine has been ingested or taken by mistake, seek immediate medical advice from your doctor or the nearest hospital. Take the medicine packaging with you.

If you forget to take ENALAPRIL PENSA
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 how to use this medicine, consult your doctor or pharmacist.

If you stop taking ENALAPRIL PENSA
Do not stop treatment with this medicine unless instructed by your doctor.
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 everyone will experience them.
Stop treatment with ENALAPRIL PENSA and contact a doctor immediately if you notice
any of the following symptoms:

• swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing
• swelling of the hands, feet or ankles
• development of a skin rash with red raised areas (urticaria). You should know that black patients have a higher risk of developing these types of reactions. If you notice any of these symptoms, stop treatment with ENALAPRIL PENSA and contact your doctor immediately.

ENALAPRIL PENSA has generally been well tolerated.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

• vision disturbances (blurred vision)
• dizziness
• cough
• nausea
• weakness

Common (may affect up to 1 in 10 people)

• headache, depression
• fainting, chest pain, changes in heart rhythm, chest pain (angina pectoris), increased heart rate
• difficulty breathing
• diarrhoea, abdominal pain, altered taste
• skin redness, allergic reactions with swelling of the face, lips, tongue and/or throat, causing difficulty swallowing and breathing
• fatigue
• changes in certain blood test results (high potassium levels, increased serum creatinine)

Uncommon (may affect up to 1 in 100 people)

• flushing
• low blood pressure (including low blood pressure upon standing up quickly), fainting, heart attack or stroke, possibly secondary to excessive blood pressure reduction in high-risk patients (see section “Warnings and precautions”)
• reduction in the number of red blood cells (anaemia, including aplastic and haemolytic anaemia)
• low blood sugar levels
• confusion, drowsiness, insomnia, nervousness, tingling, dizziness
• drop in blood pressure upon standing up quickly, increased awareness of heartbeats (palpitations)
• runny nose (nasal discharge), sore throat, voice changes (hoarseness)
• asthma associated with chest tightness
• intestinal obstruction (intestinal occlusion), inflammation of the pancreas (pancreatitis), vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, stomach or intestinal damage (peptic ulcer)
• sweating, itching, skin rash (urticaria), hair loss
• kidney problems (renal dysfunction, renal failure), presence of excess protein in urine
• erectile dysfunction in men
• muscle cramps, hot flushes, ringing in the ears, malaise, fever
• changes in certain blood test results (increased urea, low sodium levels)
• ringing in the ears (tinnitus)

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

• low levels of certain white blood cells (neutrophils), reduced haemoglobin, reduced haematocrit, low platelet count, reduced number of a type of white blood cells (granulocytes), reduced bone marrow function, reduction in all types of blood cells, swollen lymph nodes, immune system disorders (autoimmune diseases)
• changes in dreams, sleep disturbances
• temporary interruption of blood flow to the fingers (or more rarely nose or ears) due to narrowing of blood vessels (Raynaud's phenomenon)
• lung problems (pulmonary infiltrates, allergic pneumonia), inflammation of the inner lining of the nose (nasal mucosa)
• inflammation of the inner lining of the mouth (oral mucosa), mouth ulcers, inflammation of the tongue
• severe liver problems (liver failure, hepatitis – hepatocellular or cholestatic, including necrosis, bile flow obstruction including jaundice)
• severe skin diseases (erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma)
• reduced urine output
• breast enlargement in men (gynaecomastia)
• changes in certain blood test results (increased liver enzymes, increased bilirubin)

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

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

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

• Excessive production of antidiuretic hormone, causing fluid retention, leading to weakness, fatigue or confusion.

A syndrome complex has been reported which may include some or all of the following symptoms: fever,
inflammation of serous membranes, inflammation of blood vessels, muscle pain/inflammation, joint pain/inflammation, changes in certain blood test results (presence of ANA antibodies, elevated ESR, increased eosinophils and white blood cells), skin rashes, light sensitivity (photosensitivity), and other skin problems (dermatological manifestations).

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 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 PENSA

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 “Expiry”.
The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 25 °C.
Do not dispose of any medicine 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 PENSA contains
ENALAPRIL PENSA 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 PENSA 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 (E-172), yellow iron oxide (E-172).

Description of the appearance of ENALAPRIL PENSA and package contents
ENALAPRIL PENSA 5 mg tablets
Pack containing 28 divisible tablets.
ENALAPRIL PENSA 20 mg tablets
Packs containing 14 or 28 divisible tablets.
Marketing Authorization Holder
Pensa Pharma S.p.A. – Via Ippolito Rosellini, 12 – 20124 Milan (MI)
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)