ENALAPRIL 20 mg /12.5 Mg Tablets

Зміст інструкції

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

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

enalapril maleate and hydrochlorothiazide

Generic medicine

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

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

ENALAPRIL E IDROCLOROTIAZIDE ALTER contains two active ingredients: enalapril maleate and
hydrochlorothiazide.
Enalapril belongs to a group of medicines known as angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors work by
relaxing the blood vessels, thereby facilitating the passage of blood 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) and in doing so reduces blood pressure (antihypertensive action).
ENALAPRIL E IDROCLOROTIAZIDE ALTER is used for the treatment of high blood pressure 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 ALTER

Do not take ENALAPRIL E IDROCLOROTIAZIDE ALTER

• if you are allergic to the active ingredients (enalapril maleate and hydrochlorothiazide) or to other medicines derived from sulfonamide (a chemically related substance

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to hydrochlorothiazide), or to any of the other ingredients of this medicine
(listed in section 6);

• 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, i.e. angioedema whose cause is unknown;
• if you suffer from severe kidney problems (severe renal failure);
• if you are unable to urinate (anuria);
• if you are in the second or third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• if you suffer from severe liver problems (severe hepatic failure);
• 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 ALTER”);
• if you are being treated with sacubitril/valsartan, a medicine for heart failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking ENALAPRIL E IDROCLOROTIAZIDE
ALTER:

• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, can increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking ENALAPRIL E IDROCLOROTIAZIDE ALTER.
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If shortness of breath or severe difficulty breathing occurs after taking Enalapril and Idroclorotiazide Alter, consult a doctor immediately
• In particular, talk to your doctor or pharmacist before taking ENALAPRIL E IDROCLOROTIAZIDE ALTER if:
• you are taking medicines that increase urine production (diuretics), are following a low-salt diet, or have experienced vomiting or diarrhea. In these cases you are at risk of excessive lowering of blood pressure (hypotension) which may manifest as weakness or dizziness. Your doctor will prescribe regular measurement of the amount of electrolytes in your blood;
• you have disturbances of blood flow to the heart (ischemic heart disease) or brain (cerebrovascular disease), or other heart problems associated 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 ALTER, lie down and contact your doctor;

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• tell your doctor 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, and racecadotril, used in patients with acute diarrhea;
• 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 ALTER”;
• you are at risk of an increase in potassium levels in your blood (hyperkalemia) due to:
• renal failure, worsening of 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 urine excretion 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 increase 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 ALTER”). In these 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, for example a narrowing (stenosis) of one or both renal arteries, as there is an increased risk of hypotension and renal failure. In this case, your doctor will keep you under close observation by 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 renal failure. In this case, your doctor will consider alternative treatment (see section “Do not take ENALAPRIL E IDROCLOROTIAZIDE ALTER”);
• 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 ALTER” and “Stop taking ENALAPRIL E IDROCLOROTIAZIDE ALTER 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

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medicines). In these cases, the risk of a lowering of potassium levels in the blood
(hypokalemia) is maximum;

• 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 ALTER in the presence of these conditions, your doctor will prescribe specific blood tests. Report any signs or symptoms of infection to your doctor;
• have diabetes and are taking oral or insulin antidiabetic medicines. In this case, your doctor will tell you to perform blood tests to check your glucose levels, especially during the first month of treatment with ENALAPRIL E IDROCLOROTIAZIDE ALTER 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 ALTER”);
• are of Black race. ENALAPRIL E IDROCLOROTIAZIDE ALTER may in fact be less effective in lowering blood pressure in patients of Black race compared to patients of non-Black race. In addition, you may have an increased risk of developing angioedema;
• have developed a persistent dry cough for a long period of time after starting treatment with an ACE inhibitor;
• if you have a history of allergies or bronchial asthma, as hypersensitivity reactions may occur with the use of ENALAPRIL E IDROCLOROTIAZIDE ALTER;
• suffer from a condition called systemic lupus erythematosus (an autoimmune disease), which may occur or worsen with the use of ENALAPRIL E IDROCLOROTIAZIDE ALTER;
• 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 can occur within a period ranging from a few hours to weeks after taking ENALAPRIL E IDROCLOROTIAZIDE ALTER. If left untreated, this increase can lead to permanent vision loss. If you have had an allergy to penicillins or sulfonamides in the past, you may have a higher risk of developing this disorder.

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

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

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• you need to perform tests to check the function of the parathyroid glands. Consult your doctor who will tell you to stop taking ENALAPRIL E IDROCLOROTIAZIDE ALTER before performing this test.

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

• swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat with resulting difficulty swallowing or breathing (angioedema);
• yellowing of the skin or the 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 possible stenosis of the renal artery;
• increased calcium levels in the blood (hypercalcemia).

During treatment with ENALAPRIL E IDROCLOROTIAZIDE ALTER, 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, inform 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 ALTER is not recommended in children,
due to the lack of data on safety and efficacy.

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

• an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported in the paragraph “Do not take ENALAPRIL E IDROCLOROTIAZIDE ALTER” and “Warnings and precautions”). Your doctor may need to adjust the 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 subsequent lithium toxicity may occur;
• medicines that promote urine elimination while preserving potassium (potassium-sparing diuretics, for example spironolactone, triamterene or amiloride), potassium supplements or salt substitutes containing potassium or other medicines that can increase blood potassium levels (e.g., heparin, [a medicine

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used to prevent blood clots], products containing trimethoprim such as
cotrimoxazole [medicines used to treat infections]) (see the
paragraph “Warnings and precautions”);

• medicines that promote diuresis (diuretics), such as thiazides or loop diuretics, because they may cause a reduction in blood pressure;
• anesthetics, antipsychotics and tricyclic antidepressants (used to treat 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 ALTER;
• insulin or other antidiabetic medicines taken by mouth. Blood glucose levels should be carefully monitored, especially during the first weeks of treatment with ENALAPRIL E IDROCLOROTIAZIDE ALTER 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, if taken with ENALAPRIL E IDROCLOROTIAZIDE ALTER;
• non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, because they can reduce the effectiveness of ENALAPRIL E IDROCLOROTIAZIDE ALTER, increase blood potassium levels and worsen kidney function;
• 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 ALTER with these medicines may further reduce potassium and/or magnesium levels in the blood;
• tubocurarine, used to relax muscles during surgery (muscle relaxant) because ENALAPRIL E IDROCLOROTIAZIDE ALTER can increase its effects;
• barbiturates, which have a sedative effect on the central nervous system, used for example to treat epilepsy, or opioid analgesics, medicines used to reduce pain. These medicines can worsen the feeling of dizziness when getting up, due to a drop in 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 ALTER;
• medicines for treating irregular heartbeat (antiarrhythmics such as quinidine, procainamide, amiodarone, sotalol) because they can cause heart rhythm problems (torsade de pointes);
• medicines used to treat heart failure (digitalis medicines);
• corticosteroids (which modulate anti-inflammatory reactions) and adrenocorticotropic hormone ACTH (used to check if the adrenal glands are functioning properly) because they can further reduce salt levels in the blood, especially potassium (hypokalemia);
• pressor amines (e.g., norepinephrine) because ENALAPRIL E IDROCLOROTIAZIDE ALTER can decrease their effects;

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• medicines for the treatment of cancer such as cyclophosphamide or methotrexate because ENALAPRIL E IDROCLORTIAZIDE ALTER can increase their toxicity;
• medicines to treat gout, such as allopurinol (see paragraph “Warnings and precautions”);
• medicines that suppress the immune system (immunosuppressants); mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) as concomitant administration may increase the risk of an allergic reaction called angioedema (see the paragraph “Stop taking ENALAPRIL E IDROCLOROTIAZIDE ALTER and tell your doctor if”).
• a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan) and racecadotril. The risk of angioedema (swelling of the face, lips, tongue or throat with difficulty swallowing or breathing) may be increased. See also the information contained in the paragraphs “Do not take Enalapril and Idroclorotiazide Alter” and “Warnings and precautions”.

ENALAPRIL E IDROCLOROTIAZIDE ALTER and alcohol
ENALAPRIL E IDROCLOROTIAZIDE ALTER should not be taken with alcohol,
as an excessive drop in blood pressure may occur.

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 using
this medicine.

Pregnancy
ENALAPRIL E IDROCLOROTIAZIDE ALTER is not recommended during pregnancy, and
should not be taken if you have been pregnant for more than 3 months, as it can
cause serious harm to the baby if taken after the third month of pregnancy (see
paragraph “Do not take ENALAPRIL E IDROCLOROTIAZIDE ALTER”).
You should tell your doctor if you think you are pregnant (or are
planning a pregnancy). Your doctor will tell you to stop taking ENALAPRIL E IDROCLOROTIAZIDE ALTER immediately before starting
pregnancy or as soon as you find out you are pregnant and will
advise you to take another medicine instead of ENALAPRIL E IDROCLOROTIAZIDE
ALTER.

Breastfeeding
Tell your doctor if you are breastfeeding or intend to breastfeed your baby.
ENALAPRIL E IDROCLOROTIAZIDE ALTER is not recommended in women
who are breastfeeding, especially if your baby was born prematurely and in the
first few weeks after delivery.

Driving and using machines
ENALAPRIL E IDROCLOROTIAZIDE ALTER can cause side effects that can
affect your ability to drive and operate machinery, such as dizziness or
fatigue, which may occur occasionally. Therefore, be careful when driving
and operating machinery.
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ENALAPRIL E IDROCLOROTIAZIDE ALTER contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact them before
taking this medicine.

For athletes
The use of the medicine without a therapeutic need constitutes doping and may still result in a positive doping test.

3. How to take ENALAPRIL E IDROCLOROTIAZIDE ALTER

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
It is advisable to start therapy with ½ tablet a day. Subsequently, the recommended dose is 1 tablet a day. If necessary, your doctor may increase the dose up to a maximum of 2 tablets, administered once a day.

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

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

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

Use in the elderly
No dosage adjustment is necessary in elderly patients.

If you take more ENALAPRIL E IDROCLOROTIAZIDE ALTER than you should
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In case of accidental intake of an excessive dose of ENALAPRIL E IDROCLOROTIAZIDE ALTER, immediately inform your doctor or go to the nearest hospital and stop treatment.
The symptoms of an overdose may include: feeling of lightheadedness or dizziness, due to excessive lowering of blood pressure, serious circulation 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 (hypokalemia), chlorine (hypochloremia) and sodium (hyponatremia) in the blood, dehydration due to excessive diuresis.

If you forget to take ENALAPRIL E IDROCLOROTIAZIDE ALTER
Do not take a double dose to make up for the missed tablet.
If in doubt, contact your doctor or pharmacist.

If you stop taking ENALAPRIL E IDROCLOROTIAZIDE ALTER
Do not stop treatment with ENALAPRIL E IDROCLOROTIAZIDE ALTER unless your doctor tells you to do so.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking ENALAPRIL and HYDROCHLOROTHIAZIDE ALTER and contact your doctor immediately if you experience symptoms of angioedema during 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 observed with the use of ENALAPRIL and HYDROCHLOROTHIAZIDE ALTER have been:

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

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

Common (may affect up to 1 in 10 people)

• lowering of the level of potassium in the blood (hypokalaemia) or increase of the level of potassium in the blood (hyperkalaemia) increase of the level of cholesterol, triglycerides, uric acid (hyperuricemia) and creatinine in the blood;

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• headache, depression, temporary loss of consciousness (syncope), altered taste;
• lowering of blood pressure (hypotension), decrease in blood pressure following the sudden transition from a sitting or lying position to an upright position (orthostatic hypotension), alterations in heart rhythm, pain accompanied by a sensation 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.

Uncommon (may affect up to 1 in 100 people)

• decrease in the number of red blood cells (anemia, including aplastic and hemolytic anemia);
• decrease in blood sugar (hypoglycemia), decrease in the level of magnesium in the blood (hypomagnesemia), pain and swelling in the joints (gout);
• confusion, drowsiness, insomnia, nervousness, tingling sensation in the legs, arms or other parts of the body (paresthesia), feeling of dizziness (vertigo);
• reduced sexual desire, impotence;
• annoying sensation of sounds or whistles in the ears (tinnitus);
• redness and sensation of heat mainly on the face (hot flashes), 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, feeling of tightness in the chest that makes breathing difficult and noisy (bronchospasm/asthma);
• reduction of intestinal movements (ileus), inflammation of the pancreas (pancreatitis), vomiting, difficulty digesting (dyspepsia), constipation, 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);
• malaise, fever;
• increases in the level of urea in the blood (uremia), low sodium concentration in the blood (hyponatremia).

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

• decrease in the number of some white blood cells (neutropenia, leukopenia and agranulocytosis), the amount of hemoglobin, the total volume of red blood cells (low hematocrit), platelets (thrombocytopenia) or all different types of blood cells (pancytopenia), depression of the bone marrow (when the bone marrow fails to produce a sufficient number of cells found in the blood), swelling of glands called lymph nodes (lymphadenopathy), autoimmune diseases;
• increased blood sugar levels;

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• abnormal dreams, sleep disorders, partial reduction of motility (paresis due to hypokalemia);
• reduced blood flow to the fingers of hands and feet causing redness and pain (Raynaud's phenomenon);
• lung problems including pulmonary 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 peeling, including erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus (an autoimmune disease that causes skin inflammation), pemphigus and erythroderma (redness of the skin);
• decreased urine output (oliguria), kidney disease (interstitial nephritis);
• growth of breast tissue in men (gynecomastia);
• increased liver enzymes, increased level of bilirubin in the blood (bilirubinemia).

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

• increased level of calcium in the blood (hypercalcemia);
• swelling of the intestinal mucosa (intestinal angioedema).
• Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated based on available data)

• syndrome of inappropriate secretion of antidiuretic hormone, SIADH;
• rapid-onset short-sightedness (acute myopia),
• decreased 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 inflammation of the muscles (myalgia/myositis) joint pain or inflammation of the joints (arthralgia/arthritis), positivity to the test for the presence of antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), increased number of white blood cells (eosinophilia, leukocytosis), skin rash, skin sensitivity to light (photosensitivity) and other skin problems.

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Reporting of side effects
If you get any side effects, even if 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 ALTER

Keep this medicine out of 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.
Do not store at a temperature above 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 to protect
the environment.

6. Contents of the pack and other information

What ENALAPRIL E IDROCLOROTIAZIDE ALTER 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: pregelatinized corn starch, sodium croscarmellose, lactose monohydrate, magnesium stearate, yellow iron oxide (E172), red iron oxide (E172), sodium bicarbonate.

Description of the appearance of ENALAPRIL E IDROCLOROTIAZIDE ALTER and pack contents
Pack of 14 divisible tablets.
Pack of 28 divisible tablets.

Marketing Authorisation Holder
Laboratori Alter S.r.l. Via Egadi, 7 – 20144 Milano

Manufacturer
Balkanpharma Dupnitsa AD - 3 Samokovsko Shosse Str.-Dupnitsa 2600 - Bulgaria
Teva Pharmaceutical Works Private Limited Company (TPW Debrecen) - 13 Pallagi
street – 4042 Debrecen - Hungary
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