ENALAPRIL 20 mg /12.5 Mg Таблетки

Содержание инструкции

1. ENALAPRIL E IDROCLOROTIAZIDE PENSA 20 mg + 12,5 mg tablets
   1. What is ENALAPRIL E IDROCLOROTIAZIDE PENSA and what is it used for
   2. What you need to know before taking ENALAPRIL E IDROCLOROTIAZIDE PENSA
2. ENALAPRIL AND HYDROCHLOROTHIAZIDE PENSA may occasionally cause undesirable effects that
   1. How to take ENALAPRIL E IDROCLOROTIAZIDE PENSA
   2. Possible side effects
   3. How to store ENALAPRIL E IDROCLOROTIAZIDE PENSA
   4. Contents of the pack and other information

ENALAPRIL E IDROCLOROTIAZIDE PENSA 20 mg + 12,5 mg tablets

Enalapril maleate and hydrochlorothiazide

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

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

ENALAPRIL E IDROCLOROTIAZIDE PENSA contains two active ingredients: enalapril and hydrochlorothiazide.
Enalapril belongs to a group of medicines known as angiotensin converting enzyme inhibitors (ACE inhibitors). ACE inhibitors work by causing the blood vessels to relax, thus facilitating passage through them. ACE inhibitors are used for the treatment of high blood pressure (hypertension).
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It works by stimulating the kidneys to produce a greater quantity of urine (diuretic action) with a consequent reduction in blood pressure (antihypertensive action).
ENALAPRIL E IDROCLOROTIAZIDE PENSA is indicated for the treatment of high blood pressure (hypertension) and is indicated in patients whose blood pressure is not adequately controlled with enalapril maleate or hydrochlorothiazide administered alone.

2. What you need to know before taking ENALAPRIL E IDROCLOROTIAZIDE PENSA

Do not take ENALAPRIL E IDROCLOROTIAZIDE PENSA

• if you are allergic to the active ingredients (enalapril maleate and hydrochlorothiazide) or to other medicines derived from sulfonamides (a substance related to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal insufficiency);
• if you have severe liver problems (severe hepatic insufficiency);
• if you are unable to urinate (anuria);
• if you have had an allergic reaction that caused swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat with resulting difficulty swallowing or breathing (angioedema) after taking ACE inhibitors;
• if you suffer from hereditary angioedema (due to a family history);
• if you suffer from idiopathic angioedema, that is, angioedema whose cause is unknown;
• if you are in the second or third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren (see section “Other medicines and ENALAPRIL E IDROCLOROTIAZIDE PENSA”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ENALAPRIL E IDROCLOROTIAZIDE PENSA.
In particular, talk to your doctor or pharmacist before taking ENALAPRIL E IDROCLOROTIAZIDE
PENSA:

• if you are taking medicines that increase urine production (diuretics), are following a low-salt diet (hyposodic), or if you have had diarrhea or vomiting. In these cases you are at risk of an excessive drop in blood pressure (hypotension) which may manifest as a feeling of weakness or dizziness. Your doctor will prescribe that you regularly measure the amount of electrolytes in your blood.
• if you have disturbances of blood flow to the heart (ischemic heart disease) or brain (ischemic cerebrovascular disease), or other heart problems with or without kidney problems. In these cases, an excessive lowering of blood pressure can be particularly dangerous.
• If you experience symptoms of hypotension during treatment with ENALAPRIL E IDROCLOROTIAZIDE PENSA, lie down and contact your doctor;
• you are taking any of the following medicines used to treat high blood pressure:
• an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
• aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals. See also what is stated in the section “Do not take ENALAPRIL E IDROCLOROTIAZIDE PENSA”;
• you are at risk of an increase in potassium levels in the blood (hyperkalemia) due to:
• kidney failure, worsening kidney function, age over 70 years, diabetes, dehydration, acute heart failure due to which the heart does not pump blood adequately throughout the body, increased acidity in the blood (metabolic acidosis);
• concomitant use of medicines that facilitate the elimination of urine while preserving potassium (potassium-sparing diuretics, for example spironolactone, eplerenone, triamterene or amiloride), potassium supplements or salt substitutes containing potassium, or if you are taking other medicines that can affect potassium levels 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]) (see section “Other medicines and ENALAPRIL E IDROCLOROTIAZIDE PENSA”). In such cases, your doctor will frequently monitor potassium levels in your blood;
• you suffer from a narrowing (stenosis) of the aortic artery or have a thickening of the heart walls (hypertrophic cardiomyopathy);
• you suffer from severe heart problems (severe heart failure);
• you have kidney problems, such as a narrowing (stenosis) of one or both renal arteries, as there is an increased risk of hypotension and kidney failure. In this case, your doctor will keep you under close observation monitoring your kidney function;
• you have recently undergone a kidney transplant. In this case, the use of this medicine is not recommended;
• you are undergoing dialysis (blood purification therapy) due to kidney failure. In this case, your doctor will consider alternative treatment (see section “Do not take ENALAPRIL E IDROCLOROTIAZIDE PENSA”);
• you have liver problems or suffer from a disease that could lead to destruction of liver cells (progressive hepatopathy) (see sections “Do not take ENALAPRIL E IDROCLOROTIAZIDE PENSA” and “Stop taking ENALAPRIL E IDROCLOROTIAZIDE PENSA and tell your doctor if”);
• you have a chronic and degenerative liver disease (liver cirrhosis), present a marked production of

urine, do not take an adequate amount of electrolytes orally, are being treated with corticosteroids or
adrenocorticotropic hormone (hormonal medicines). In these cases, the risk of a decrease in the level of
potassium in the blood (hypokalemia) is maximum;

• you suffer from a connective tissue disease involving blood vessels, are taking medicines that suppress the immune defenses (immunosuppressants), suffer from gout or are taking allopurinol (used in the treatment of gout) or procainamide (used to treat heart rhythm abnormalities), or have a combination of these risk factors, especially if you also have kidney problems. In this case, serious infections may occur that may not respond to antibiotic therapy. If you need to take ENALAPRIL E IDROCLOROTIAZIDE PENSA in the presence of these conditions, your doctor will prescribe specific blood tests. Report to your doctor any sign or symptom of infection;
• you have diabetes and are taking oral antidiabetic medicines or insulin. In this case, your doctor will tell you to perform blood tests to check your glucose level, especially during the first month of treatment with ENALAPRIL E IDROCLOROTIAZIDE PENSA and will assess the need to adjust the dose of antidiabetic medicines;
• you are taking lithium (medicine for the treatment of mood disorders) (see section “Other medicines and ENALAPRIL E IDROCLOROTIAZIDE PENSA”);
• you are of black race. ENALAPRIL E IDROCLOROTIAZIDE PENSA may in fact be less effective in lowering blood pressure in black patients compared to non-black patients. In addition, you may have a higher risk of developing angioedema;
• you have developed a persistent dry cough for a long period of time after starting treatment with an ACE inhibitor;
• you have a history of allergies or bronchial asthma, as sensitivity reactions may occur with the use of ENALAPRIL E IDROCLOROTIAZIDE PENSA;
• you suffer from a disease called systemic lupus erythematosus (an autoimmune disease), which may occur or worsen with the use of ENALAPRIL E IDROCLOROTIAZIDE PENSA
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Long-term use of hydrochlorothiazide, especially at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking ENALAPRIL E IDROCLOROTIAZIDE PENSA
• If you have decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and may occur within hours or weeks after taking ENALAPRIL E IDROCLOROTIAZIDE PENSA.

Stop taking ENALAPRIL E IDROCLOROTIAZIDE PENSA and tell your doctor immediately if you experience:

• swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat with resulting difficulty breathing or swallowing (angioedema);.
• yellowing of the skin or whites of the eyes (jaundice) which indicates liver problems or an increase in liver enzyme levels (transaminases) in the blood;
• increased levels of nitrogen and creatinine in the blood, this circumstance may suggest a stenosis of the renal artery;
• increased levels of calcium in the blood (hypercalcemia).

If you are about to undergo any of the following procedures, tell your doctor that you are taking
ENALAPRIL E IDROCLOROTIAZIDE PENSA:

• any surgical intervention or if you are to undergo anesthetic therapy;
• a treatment called LDL (low-density lipoprotein) apheresis with dextran sulfate to remove cholesterol from the blood using machinery. Your doctor may interrupt the treatment with ENALAPRIL E IDROCLOROTIAZIDE PENSA to prevent a possible allergic reaction;
• a treatment to reduce the effects of an allergy, resulting for example from an insect sting (desensitization treatment). If you take ENALAPRIL E IDROCLOROTIAZIDE PENSA

while undergoing this treatment, you may experience a severe allergic reaction, so it is
advisable to temporarily interrupt therapy;

• you need to undergo tests to check the function of the parathyroid glands (parathyroid function). Consult your doctor who will tell you to stop taking ENALAPRIL E IDROCLOROTIAZIDE PENSA before undergoing this test.

During treatment with ENALAPRIL E IDROCLOROTIAZIDE PENSA, an electrolyte imbalance may occur which manifests with signs and symptoms that may include:

• dry mouth, thirst, weakness, deep sleepiness (lethargy), drowsiness, agitation, muscle pain or cramps, muscle fatigue, lowering of blood pressure, reduced urine production, increased heart rate (tachycardia) and gastrointestinal disorders, such as nausea and vomiting. In these cases, alert your doctor promptly. The use of this medicine must occur under regular medical supervision. Therefore, strictly follow the examinations and laboratory tests prescribed by your doctor.

Children and adolescents
The use of ENALAPRIL E IDROCLOROTIAZIDE PENSA is not recommended in children due to the
lack of data on safety and efficacy.

Other medicines and ENALAPRIL E IDROCLOROTIAZIDE PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor or pharmacist if you are taking:

• an angiotensin II receptor blocker (AIIRA) or aliskiren (see also the sections “Do not take ENALAPRIL E IDROCLOROTIAZIDE PENSA” and “Warnings and precautions”). Your doctor may need to adjust your dose and/or take other precautions;
• other medicines that lower blood pressure (antihypertensives), including vasodilators, nitroglycerin and other nitrates, because an excessive reduction in blood pressure may occur;
• lithium, used to treat some mood disorders, because an excessive increase in lithium concentration in the blood and consequent lithium toxicity may occur;
• medicines that promote diuresis (diuretics), such as thiazides or loop diuretics, because they may cause a reduction in blood pressure;
• medicines that facilitate the elimination of urine while preserving potassium (potassium-sparing diuretics, for example spironolactone, triamterene or amiloride), potassium supplements or salt substitutes containing potassium, medicines that can 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]), (see the section “Warnings and precautions”);
• anaesthetics, antipsychotics and tricyclic antidepressants (used to treat some mental disorders), because a further reduction in blood pressure may occur;
• medicines that act on the autonomic nervous system (sympathomimetics) such as ephedrine, pseudoephedrine, salbutamol found in some nasal decongestants, cough and cold medicines, for asthma, for the treatment of low blood pressure and for the treatment of heart problems. These medicines can reduce the antihypertensive effects of ENALAPRIL E IDROCLOROTIAZIDE PENSA;
• insulin or other oral antidiabetic medicines. Blood glucose levels should be carefully monitored, particularly during the first few weeks of treatment with ENALAPRIL E IDROCLOROTIAZIDE PENSA and in patients with kidney problems;
• medicines used to treat stiffness and inflammation associated with painful conditions, particularly those affecting muscles, bones and joints, including:
• medicines containing gold administered by injection, for example sodium aurothiomalate, because they can cause flushing of the face, feeling unwell (nausea), vomiting and low blood pressure;
• non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors because they can reduce the effectiveness of ENALAPRIL E IDROCLOROTIAZIDE PENSA, increase potassium levels in the blood and worsen kidney function;
• tubocurarine, used to relax muscles during surgery (muscle relaxant) because ENALAPRIL E IDROCLOROTIAZIDE PENSA can enhance its effects;
• carbenoxolone (a medicine used to treat stomach problems such as ulcers), kaliuretic diuretics (for example furosemide) or excessive use of laxatives. The use of ENALAPRIL E IDROCLOROTIAZIDE PENSA with these medicines may further reduce potassium and/or magnesium levels in the blood;
• barbiturates, which have a sedative effect on the central nervous system, used for example to treat epilepsy, or opioid analgesics used to reduce pain. These medicines can worsen the feeling of dizziness when getting up, due to a lowering of blood pressure (orthostatic hypotension);
• medicines used to reduce the amount of fat in the blood, such as cholestyramine or colestipol resins, because they can reduce the absorption of ENALAPRIL E IDROCLOROTIAZIDE PENSA;
• medicines for the treatment of irregular heartbeat (antiarrhythmics such as quinidine, procainamide, amiodarone, sotalol), because they can cause heart rhythm problems (torsades de pointes);
• medicines used to treat heart failure (digitalis);
• corticosteroids (which modulate anti-inflammatory reactions) and adrenocorticotropic hormone ACTH (used to check if the adrenal glands are working properly) because they can reduce salt levels in the blood, especially potassium (hypokalemia);
• pressor amines (e.g. noradrenaline) because ENALAPRIL E IDROCLOROTIAZIDE PENSA can decrease their effects;
• cancer medicines such as cyclophosphamide and methotrexate because ENALAPRIL E IDROCLOROTIAZIDE PENSA can increase their toxicity;
• medicines to treat gout, such as allopurinol (see section “Warnings and precautions”);
• medicines that suppress the body's defenses (immunosuppressants);
• mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) as concomitant administration may increase the risk of an allergic reaction called angioedema (see the section “Stop taking ENALAPRIL E IDROCLOROTIAZIDE PENSA and tell your doctor if”).

ENALAPRIL E IDROCLOROTIAZIDE PENSA with alcohol
ENALAPRIL E IDROCLOROTIAZIDE PENSA should not be taken with alcohol, as this may
cause an excessive lowering of blood pressure.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
ENALAPRIL E IDROCLOROTIAZIDE PENSA is not recommended during pregnancy and should not
be taken if you have been pregnant for more than three months, as it can cause serious harm to the baby
if taken after the third month of pregnancy (see section “Do not take ENALAPRIL E
IDROCLOROTIAZIDE PENSA”).
Tell your doctor if you think you may be pregnant (or are planning a pregnancy).
Your doctor will tell you to stop taking the medicine immediately and, if appropriate, will advise you to take
another medicine instead of ENALAPRIL E IDROCLOROTIAZIDE PENSA.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. ENALAPRIL E
IDROCLOROTIAZIDE PENSA is not recommended in women who are breastfeeding, particularly
if your baby was born prematurely and in the first few weeks after delivery.

Driving and using machines

ENALAPRIL AND HYDROCHLOROTHIAZIDE PENSA may occasionally cause undesirable effects that

may affect the ability to drive vehicles and operate machinery, such as dizziness and fatigue.
Therefore, use caution when driving and operating machinery.

ENALAPRIL AND HYDROCHLOROTHIAZIDE PENSA contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is essentially ‘sodium-free’.

For those who practice sports
The use of the medicine without therapeutic need constitutes doping and may still result in positive doping tests.

3. How to take ENALAPRIL E IDROCLOROTIAZIDE PENSA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended initial dose is half a tablet a day.
The recommended dose for the treatment of high blood pressure is 1 tablet once a day.
In cases where your doctor deems it necessary, the dose may be increased to 2 tablets once a
day.
This fixed-dose combination is generally not suitable for initiating therapy.

Previous diuretic therapy
If you are already taking another medicine that promotes diuresis, the use of enalapril, contained in
ENALAPRIL E IDROCLOROTIAZIDE PENSA, may cause an excessive reduction in
blood pressure. In such cases, if your doctor still considers the use of ENALAPRIL E
IDROCLOROTIAZIDE PENSA necessary, they will tell you to stop the diuretic a few days before taking
ENALAPRIL E IDROCLOROTIAZIDE PENSA. If this is not possible, your doctor will decide to start
therapy with lower doses of enalapril, i.e. with separate tablets of the same active ingredients as
ENALAPRIL E IDROCLOROTIAZIDE PENSA (enalapril and hydrochlorothiazide). ENALAPRIL E
IDROCLOROTIAZIDE PENSA may then be used later, when your doctor has established your need to take the dose of enalapril and hydrochlorothiazide present in the ENALAPRIL E
IDROCLOROTIAZIDE PENSA tablet.

Patients with kidney problems (renal insufficiency)
You must not use ENALAPRIL E IDROCLOROTIAZIDE PENSA if you suffer from severe kidney problems (see
the section “Do not take ENALAPRIL E IDROCLOROTIAZIDE PENSA”).
If you suffer from kidney problems, your doctor will check your kidney function and decide on the appropriate
dose of ENALAPRIL E IDROCLOROTIAZIDE PENSA.

Use in children and adolescents
The use of ENALAPRIL E IDROCLOROTIAZIDE PENSA is not recommended in children.

Use in the elderly
No dosage adjustments are necessary in the elderly.

If you take more ENALAPRIL E IDROCLOROTIAZIDE PENSA than you should
In case of ingestion/taking of an excessive amount of this medicine, seek immediate medical attention or go to the nearest
hospital.
Symptoms of an overdose may include:
feeling lightheaded or dizzy, due to an excessive lowering of blood pressure,
serious circulatory problems (circulatory shock), kidney failure, hyperventilation, increased
heart rate (tachycardia), palpitations, decreased heart rate
(bradycardia), anxiety, cough, electrolyte disturbances such as low levels of potassium (hypokalaemia), chlorine (hypochloraemia) and sodium (hyponatraemia) in the blood, dehydration due to excessive diuresis.

If you forget to take ENALAPRIL E IDROCLOROTIAZIDE PENSA
Do not take a double dose to make up for a missed dose. If you have any doubts about using
this medicine, consult your doctor or pharmacist.

If you stop taking ENALAPRIL E IDROCLOROTIAZIDE PENSA
Do not stop treatment with ENALAPRIL E IDROCLOROTIAZIDE PENSA unless your
doctor tells you to. If you have any doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking ENALAPRIL E IDROCLOROTIAZIDE PENSA and consult your doctor immediately if you experience symptoms of angioedemaduring treatment, such as:

• allergic reaction accompanied by swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat with resulting difficulty swallowing or breathing (angioedema).

The side effects reported with ENALAPRIL E IDROCLOROTIAZIDE PENSA are:

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

• blurred vision;
• dizziness;
• loss of strength (asthenia);
• cough;
• nausea.

Common(may affect up to 1 in 10 people)

• headache, depression, temporary loss of consciousness (syncope), altered taste;
• low blood pressure (hypotension), decrease in blood pressure when suddenly moving from a sitting or lying position to an upright position (orthostatic hypotension), changes in heart rhythm, pain accompanied by a feeling of constriction and oppression in the chest (angina pectoris), increased heart rate (tachycardia);
• difficulty breathing (dyspnea);
• diarrhea, abdominal pain;
• skin rash (exanthema);
• involuntary muscle contractions (muscle cramps);
• chest pain, fatigue;
• low potassium levels in the blood (hypokalaemia) or increased potassium levels in the blood (hyperkalaemia), increased levels of cholesterol, triglycerides, uric acid (hyperuricemia) and creatinine in the blood.

Uncommon(may affect up to 1 in 100 people)

• decreased number of red blood cells in the blood (anemia, including aplastic and hemolytic anemia);
• decreased blood sugar levels (hypoglycemia), decreased magnesium levels in the blood (hypomagnesemia), pain and swelling in the joints (gout);
• confusion, drowsiness, insomnia, nervousness, tingling sensation in the limbs or other parts of the body (paresthesia), ringing or whistling sounds in the ears (tinnitus);
• redness or feeling of warmth mainly in the face (hot flushes), perception of irregular or reinforced heartbeat (palpitations), heart attack (myocardial infarction) or stroke (cerebrovascular accident) possibly secondary to a drastic drop in pressure in high-risk patients (see section “Warnings and precautions”);
• runny nose (rhinorrhea), sore throat (laryngodynia) and hoarseness, a feeling of tightness in the chest that makes breathing difficult and noisy (bronchospasm/asthma);
• reduced bowel movements (ileus), inflammation of the pancreas (pancreatitis), vomiting, difficulty digesting food (dyspepsia), constipation (stipsis), loss of appetite (anorexia), stomach irritation, dry mouth, stomach lesions (peptic ulcer), increased production of intestinal gas (flatulence);
• increased sweating (diaphoresis), itching, hives, hair loss (alopecia);
• joint pain (arthralgia);
• impaired kidney function, kidney failure, presence of protein in the urine (proteinuria);
• decreased sexual desire, impotence;
• general feeling of being unwell, fever;
• increased urea levels in the blood (uremia), low sodium concentration in the blood (hyponatremia).

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

• decreased number of certain white blood cells (neutropenia, leukopenia and agranulocytosis), amount of hemoglobin, total volume of red blood cells (low hematocrit), platelets (thrombocytopenia), or all different types of blood cells (pancytopenia), bone marrow depression (when the bone marrow fails to produce a sufficient number of cells found in the blood), swollen lymph nodes (lymphadenopathy), diseases of the immune system (autoimmune diseases);
• abnormal dreams, sleep disturbances, partial loss of mobility (paresis due to hypokalaemia);
• reduced blood flow to the fingers of the hands and feet causing redness and pain (Raynaud's phenomenon);
• lung problems including lung infiltrates, severe respiratory failure (acute respiratory distress syndrome), inflammation (pneumonia) and fluid accumulation in the lungs (pulmonary edema), allergic reaction (hypersensitivity) in the lungs (allergic alveolitis), lung disease (eosinophilic pneumonia);
• irritation or inflammation of the nose (rhinitis);
• Inflammation of the oral mucosa (stomatitis) with ulcers or sores, inflammation of the tongue (glossitis);
• liver problems such as liver failure, liver damage (necrotic hepatitis, potentially fatal), inflammation of the liver or bile ducts (hepatocellular or cholestatic hepatitis), yellowing of the skin and whites of the eyes (jaundice), inflammation of the gallbladder (cholecystitis, especially in patients with pre-existing gallstones);
• severe skin diseases with blister formation, redness and scaling, including erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus (an autoimmune disease that causes skin inflammation), pemphigus and erythrodermia (redness of the skin).
• decreased urine production (oliguria), kidney disease (interstitial nephritis);
• breast enlargement in men (gynecomastia);
• increased liver enzymes, increased bilirubin levels in the blood (bilirubinemia).

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

• swelling of the intestinal mucosa (intestinal angioedema);
• increased calcium levels in the blood (hypercalcemia).

Not known(frequency cannot be estimated from available data)

• syndrome of inappropriate secretion of the antidiuretic hormone, SIADH;
• impaired vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• skin and lip cancer (non-melanoma skin cancer)

Other side effects
A complex disorder including one or more of the following symptoms has been reported, with unknown frequency:

• fever, serositis (inflammation of the membranes lining the body cavities, such as chest and abdomen), vasculitis (inflammation of blood vessels), muscle pain or muscle inflammation (myalgia/myositis), joint pain or inflammation (arthralgia/arthritis), positive test for the presence of antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), increased number of white blood cells (eosinophilia, leukocytosis), skin rash, sensitivity to light (photosensitivity) and other skin problems.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 E IDROCLOROTIAZIDE 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 label after “Exp.”. The expiry date
refers to the last day of that month.
This medicine does not require any particular storage conditions.
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 E IDROCLOROTIAZIDE PENSA contains

• The active ingredients are: enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: sodium bicarbonate, lactose monohydrate, yellow iron oxide, corn starch, pregelatinized starch, magnesium stearate.

Description of the appearance of ENALAPRIL E IDROCLOROTIAZIDE PENSA and pack contents
Pack of 14 tablets in aluminum blisters.
Pack of 28 tablets in aluminum blisters.

Marketing authorization holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milano

Manufacturer
Special Product’s Line S.p.A.
Strada Paduni, 240
03012 Anagni (FR)