ENALAPRIL 5 mg Coated Tablet

Зміст інструкції

1. ENALAPRIL PENSA 5 mg tablets, 20 mg tablets
   1. What is ENALAPRIL PENSA 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

ENALAPRIL PENSA 5 mg tablets, 20 mg tablets

enalapril maleate

Generic medicine

Read 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, 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 PENSA is and what it is used for
• 2. What you need to know before you take 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 is ENALAPRIL PENSA and what it is used for

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

• to treat high blood pressure (hypertension)
• to treat heart failure (weakening of the heart's function). It can reduce the need to go to hospital and can help some patients to live longer - to prevent the signs of heart failure. The signs include: shortness of breath, fatigue after light activity such as walking, or swelling of the ankles and feet.

This medicine works by widening 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
will need several weeks of treatment before the best 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 components of this medicine (listed in section 6);
• if you experience swelling of the face, lips, tongue and/or throat (hereditary or idiopathic angioedema) which causes difficulty swallowing and breathing or if you have suffered from this in the past when taking medicines similar to enalapril (ACE inhibitors);
• if you suffer from diabetes or your kidney function is impaired (glomerular filtration rate GFR < 60 ml/min/1.73 m²) and you are being treated with a medicine that lowers your blood pressure, containing aliskiren (See sections “Warnings and precautions” and “Other medicines and ENALAPRIL PENSA”);
• if you are in the second and third trimester of pregnancy (See section “Pregnancy and breastfeeding”);
• 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). Do not take this medicine if you have any of the problems listed above. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking ENALAPRIL PENSA.
Tell your doctor about any illness or medical problem you have at the moment or have had in the past and about
any allergies.
Tell your doctor if:

• you suffer from heart disease;
• you have a condition involving blood vessels in the brain;
• you have a blood problem such as a low number or absence of white blood cells (neutropenia/agranulocytosis), a low number of platelets (thrombocytopenia) or a reduction in the number of red blood cells (anemia);
• you have diabetes. You need to carefully monitor if a lowering of blood glucose levels occurs, especially during the first month of treatment. The level of potassium in the blood may also be higher;
• you have liver problems;
• you have kidney problems (including kidney transplant). This can lead to an increase in potassium in the blood, which can be serious. Your doctor may need to adjust the dose of ENALAPRIL PENSA or monitor your blood potassium levels;
• you are on dialysis;
• you are following a low-sodium diet (hyposodic), are taking potassium supplements, potassium-sparing agents, salt substitutes containing potassium or other medicines that can increase potassium in the blood (e.g., heparin [a medicine used to prevent blood clots], products containing trimethoprim such as co-trimoxazole [medicines used to treat infections]);
• you are over 70 years of age;
• you suffer from or have recently suffered from severe vomiting and diarrhea;
• you have or have had allergies with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing. You should know that black patients are at higher risk for these types of reactions to ACE inhibitors;
• you have low blood pressure (you notice this condition if you feel faint or dizzy, especially when standing up);
• you have a collagen vascular disease (e.g., lupus erythematosus, rheumatoid arthritis or scleroderma), are undergoing immunosuppressive therapy, are taking allopurinol or procainamide, or their combinations;
• you are taking any of the following drugs, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ 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.
• if you are taking a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan), used in patients with heart failure
• 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 PENSA”). If your specialist believes that the simultaneous intake of these medicines is absolutely necessary,

they must be kept under strict and frequent control and your kidney function, salt (electrolyte) levels and blood pressure must be monitored periodically;

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

In these cases, your doctor may need to adjust the dose of ENALAPRIL PENSA.
If you are not sure if any of the above conditions apply to you, talk to your doctor or
pharmacist before taking this medicine.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). This medicine is not recommended in the early stages of pregnancy, and should not be taken if
you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see section Pregnancy).
Stop treatment with ENALAPRIL PENSA and immediately inform your doctor if, during
therapy, there is an obstruction of the airways. This risk is increased in patients who have been
undergone surgery to the airways.
If you are about to undergo any of the following procedures, tell your doctor (or dentist) that you are in
treatment with ENALAPRIL PENSA:

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

As with other medicines belonging to the same class, ENALAPRIL PENSA seems to be less
effective in lowering blood pressure in patients with black skin compared to patients with white 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).
In addition, this medicine is not recommended in newborns and children who have kidney problems (glomerular
filtration rate <30 ml/min/1.73 m²) (See section “Use in children”).
For more information, consult your doctor.

Other medicines and ENALAPRIL PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This includes herbal medicines. This is because ENALAPRIL PENSA can
interfere with the mechanism of action of some medicines. Also, some other medicines can interfere
with the mechanism of 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 (medicine for treating heart failure)
for an increased risk of angioedema (rapid swelling under the skin in areas such as the throat). See
section “Do not take ENALAPRIL PENSA”
Tell your doctor if you are taking:

• angiotensin II receptor antagonists or aliskiren, used to lower blood pressure, as, when taken together with ENALAPRIL PENSA, they can lead to an increased risk of side effects such as low blood pressure (hypotension), increased potassium levels in the blood (hyperkalaemia) and reduced kidney function (including acute renal failure). (See sections “Do not take ENALAPRIL PENSA” and “Warnings and precautions”);
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that could increase the amount of potassium in the blood (such as trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to

prevent organ rejection; and heparin, a medicine used to thin the blood and
prevent the formation of clots);

• other antihypertensive drugs, which lower blood pressure, as they may lower blood pressure excessively, especially if it is a diuretic;
• lithium salts, used to treat some mental disorders. In this case, lithium levels in the blood must be carefully monitored, as the elimination of lithium may be reduced during treatment with ENALAPRIL PENSA;
• some anesthetics used to induce anesthesia during surgery;
• tricyclic antidepressants, for the treatment of depression;
• antipsychotics to treat some mental disorders, as they can cause a further decrease in blood pressure;
• some medicines for cough and cold and weight-loss medicines that contain a so-called "sympathomimetic agent";
• some medicines for pain or arthritis including therapy with gold salts;
• an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus: medicines used to treat some types of cancer or to prevent the immune system of the body from rejecting a transplanted organ). See also the information contained in the section “Warnings and precautions”;
• racecadotril, a medicine used against diarrhea;
• non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors used to relieve pain and inflammation. In this case, there may be a reduction in the effect of ENALAPRIL PENSA, an increase in potassium levels in the blood and a worsening of kidney function. These effects are usually transient. Rarely, kidney problems (acute renal failure) may occur, especially in patients who already have impaired kidney function such as the elderly and dehydrated people;
• oral hypoglycemic agents, vildagliptin or insulin, used to treat diabetes, because their action may be increased and there is a risk of excessive lowering of blood sugar (hypoglycemia), especially during the first weeks of treatment and if you have kidney problems (impaired kidney 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 not sure if any of the above conditions apply to you, talk to 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 causes an excessive lowering of
blood pressure.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine.
Pregnancy:
ENALAPRIL PENSA is not recommended during the first trimester of pregnancy and should not be
taken during the second and third trimester of pregnancy as it can cause malformations in the baby
(risk of teratogenicity) if taken during this period (See section “Do not take ENALAPRIL
PENSA”).
Therapy with ENALAPRIL PENSA should not be started during pregnancy.
If you are being treated with this medicine and you are confirmed to be pregnant, stop
immediately taking this medicine and consult your doctor who, if appropriate, will prescribe
an alternative therapy.
Breastfeeding:
The use of ENALAPRIL PENSA in breastfeeding is not recommended for premature babies and in the first
weeks after birth, due to the possible risk of adverse effects on the heart, blood vessels and kidneys
and because there is not enough clinical experience.
In older babies, if deemed necessary for the mother, ENALAPRIL PENSA may be taken during
breastfeeding, but in this case the newborn must be monitored for the possible appearance of adverse effects.

Driving and using machines
When driving vehicles or using machines, it is necessary to take into account that dizziness and fatigue may occasionally occur.

ENALAPRIL PENSA contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him 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 always exactly as your doctor or pharmacist has told you. If you have
doubts, ask your doctor or pharmacist.
The dose will be established by the doctor based on your health conditions and considering any other medicines you
are taking.
ENALAPRIL PENSA must be taken every day, as prescribed by the doctor.
It is very important to continue taking ENALAPRIL PENSA until it is prescribed to you by
the doctor. Do not take more tablets than corresponding to 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, 1 time a day.
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 the start of therapy
must occur under strict medical control.
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 disorders (heart failure/asymptomatic left ventricular
dysfunction)
At the beginning of treatment, the recommended dose is generally 2.5 mg, 1 time a day.
The doctor will gradually increase the dose to reach the appropriate dose for each patient. Usually the maintenance dose is 20 mg to be taken 1 or 2 times a day.
The maximum dose is 40 mg per day, to be taken in two daily administrations.
It is necessary to pay particular attention when taking the first dose or when the dose is
increased. Immediately inform the doctor if you feel a sense of dizziness or lightheadedness.

Use in patients with kidney problems
The dose of the medicine will vary according to the function of your kidneys:

• moderate kidney problems - from 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 varied according to your blood pressure.

Use in the elderly
If you are elderly, the doctor will establish the dose after evaluating the function of your kidneys.

Use in children
Experience with the use of ENALAPRIL PENSA in children with high blood pressure is limited. In
children able to swallow the tablets, the doctor will establish the dose 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 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 1 time a day.

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

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

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

In case of lowering of blood pressure (hypotension) lay the patient on their back
(supine position).
In case of ingestion/intake of an excessive quantity of this medicine, immediately contact
your doctor or the nearest hospital. Bring with you the package of the medicine.

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

If you stop taking ENALAPRIL PENSA
Do not stop treatment with the medicine unless your doctor tells you to.
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.

Stop taking ENALAPRIL PENSA and contact a doctor immediately if you notice any of the following:

• swelling of the face, lips, tongue or throat which may cause difficulty with breathing or swallowing
• swelling of the hands, feet or ankles
• development of a skin rash with raised, red patches (urticaria). You should know that patients of Black race have a higher risk of developing this type of reactions. If you notice the appearance of any of these manifestations, stop taking 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)

• visual disturbances (blurred vision);
• dizziness;
• cough;
• nausea;
• weakness.

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• flushing;
• decrease in blood pressure (including low blood pressure when standing up quickly), fainting, heart attack or stroke, possibly secondary to excessive decrease in pressure in high-risk patients (See section “Warnings and precautions”);
• reduction in the number of red blood cells in the blood (anaemia, including aplastic and hemolytic anaemia);
• low blood sugar levels;
• confusion, drowsiness, insomnia, nervousness, tingling, vertigo;
• lowering of blood pressure when standing up quickly, increased perception of heartbeats (palpitations);
• runny nose (nasal secretion), sore throat, alteration of voice (hoarseness);
• asthma associated with chest tightness;
• blockage of the intestine (intestinal occlusion), inflammation of the pancreas (pancreatitis), vomiting, difficulty digesting, constipation, loss of appetite, irritation of the stomach, dry mouth, injury to the stomach or intestine (peptic ulcer);
• sweating, itching, skin rash (urticaria), hair loss;
• kidney problems (renal dysfunction, renal failure), presence of excess protein in the urine;
• impotence in men (erectile dysfunction);
• muscle cramps, hot flushes, perception of ringing inside the ear, malaise, fever;
• alteration of some 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 some white blood cells (neutrophils), decrease in hemoglobin, decrease in hematocrit, low levels of platelets, decrease in the number of a type of white blood cells (granulocytes), decreased bone marrow function, decrease in all types of cells present in the blood, enlarged lymph nodes, autoimmune diseases;
• altered dreams, sleep disorders;
• 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 wall of the nose (nasal mucosa);
• inflammation of the inner wall of the mouth (oral mucosa), aphthae, inflammation of the tongue;
• serious liver problems (liver failure, hepatitis - hepatocellular or cholestatic, hepatitis including necrosis, blockage of bile flow including jaundice);
• serious skin diseases (erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma);
• decreased amount of urine;
• breast enlargement in men (gynecomastia);
• alteration of some 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(the frequency of which cannot be estimated on the basis of available data)

• Overproduction of antidiuretic hormone, which causes fluid retention, resulting in weakness, fatigue or confusion.

A complex of symptoms has been reported that may include some or all of the following: fever,
inflammation of the serous membranes, inflammation of the blood vessels, pain/inflammation of the
muscles, pain/inflammation of the joints, alteration of some blood test results
(presence of ANA antibodies, high ESR levels, increased number of eosinophils and white
blood cells), skin irritation (rash), sensitivity to light (photosensitivity) and other skin
problems (dermatological manifestations).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 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 the medicine at a temperature not exceeding 25 °C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ENALAPRIL PENSA contains
ENALAPRIL PENSA 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 PENSA 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 (E-172), yellow iron oxide (E-172).

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

Marketing Authorisation 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)