Enalapril and hydrochlorothiazide Doc Generici

Italy
Brand name Enalapril and hydrochlorothiazide Doc Generici
Form tablets
Active substance / Dosage
ENALAPRIL MALEATE
Prescription type Prescription only
ATC code
C09BA02
Registration number 037741
Manufacturer DOC GENERICI SRL
Enalapril and hydrochlorothiazide Doc Generici tablets

Table of Contents

Package leaflet: Information for the patient

ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics 20 mg + 12.5 mg tablets

Generic 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 others, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

ENALAPRIL E IDROCLOROTIAZIDE DOC Generici is a combination of two active substances: enalapril and hydrochlorothiazide.
Enalapril belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors. ACE inhibitors work by causing the relaxation of blood vessels, thereby facilitating blood flow through them. ACE inhibitors are used to treat high blood pressure (hypertension). Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It works by stimulating the kidneys to produce more urine (diuretic effect), thus reducing blood pressure (antihypertensive effect).
ENALAPRIL E IDROCLOROTIAZIDE DOC Generici 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 given alone.

2. What you should know before taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics

Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics

  • if you are allergic to the active substances (enalapril maleate and hydrochlorothiazide) or to other medicines derived from sulfonamides (chemically related to hydrochlorothiazide) or to any of the other ingredients of this medicine (listed in section 6);
  • if you have had an allergic reaction causing swelling of the hands, feet, ankles, or even of the face, lips, tongue, and/or throat, leading to difficulty swallowing or breathing (angioedema) after taking ACE inhibitors;
  • if you suffer from hereditary angioedema (due to a familial predisposition);
  • if you suffer from idiopathic angioedema, i.e. angioedema of unknown cause;
  • if you have 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 insufficiency);
  • if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren (see section “Other medicines and ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics”).
  • 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).

Warnings and precautions
Talk to your doctor or pharmacist before taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics.

  • In particular, consult your doctor or pharmacist before taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics if:
    • you experience a decrease in vision or pain in one or both eyes. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion), increased pressure inside the eye (glaucoma), or sudden significant reduction in vision (acute myopia), which may occur from a few hours to weeks after starting ENALAPRIL AND HYDROCHLOROTHIAZIDE. If left untreated, these conditions may lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may be at higher risk of developing this disorder. If any of these symptoms occur, stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics and contact your doctor immediately, as medical treatment may be necessary.
    • you are taking medicines that increase urine production (diuretics), are on a low-salt diet, or have experienced vomiting or diarrhoea. In these cases, you are at risk of excessive drop in blood pressure (hypotension), which may manifest as weakness or dizziness. Your doctor will prescribe regular monitoring of electrolyte levels in your blood.
    • you have disorders affecting blood flow to the heart (ischaemic heart disease) or brain (ischaemic cerebrovascular disease), or other heart problems, with or without kidney problems. In these cases, a significant drop in blood pressure may be particularly dangerous. If you experience symptoms of hypotension during treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics, lie down and contact your doctor immediately;
    • 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 monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics”.
    • you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics.
    • you are taking any of the following medicines, as the risk of angioedema (rapid subcutaneous swelling, e.g. in the throat) is increased:
      • Racecadotril, a medicine used to treat diarrhoea.
      • Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
      • Vildagliptin, a medicine used to treat diabetes.
    • you are at risk of increased potassium levels in the blood (hyperkalemia) due to:
      • renal failure, worsening kidney function, age over 70 years, diabetes, dehydration, acute heart failure (where the heart does not pump blood adequately throughout the body), or increased acid levels in the blood (metabolic acidosis);
      • concomitant use of medicines that promote urine elimination while preserving potassium (potassium-sparing diuretics, e.g. spironolactone, eplerenone, triamterene or amiloride), potassium supplements, potassium-containing salt substitutes, or other medicines that may affect blood potassium levels, such as heparin (an anticoagulant) (see section “Other medicines and ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics”). In such cases, your doctor will frequently monitor your blood potassium levels;
    • you suffer from narrowing (stenosis) of the aortic artery or have thickening of the heart walls (hypertrophic cardiomyopathy);
    • you suffer from severe heart problems (severe heart failure);
    • you have kidney problems, such as 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 closely monitor your kidney function;
    • you have recently undergone a kidney transplant. In this case, 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 an alternative treatment (see section “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics”);
    • 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 AND HYDROCHLOROTHIAZIDE DOC Generics” and “Stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics and inform your doctor if”);
    • you have chronic degenerative liver disease (hepatic cirrhosis), produce large amounts of urine, do not take adequate oral electrolytes, or are being treated with corticosteroids or adrenocorticotropic hormone (hormonal medicines). In such cases, the risk of low blood potassium levels (hypokalemia) is highest;
    • you suffer from a connective tissue disease affecting blood vessels, are taking immunosuppressive medicines (which suppress the immune system), suffer from gout or are taking allopurinol (used to treat gout) or procainamide (used to treat heart rhythm disorders), or have a combination of these risk factors, especially if you also have kidney problems. In this case, severe infections may occur that may not respond to antibiotic therapy. If you need to take ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics under these conditions, your doctor will prescribe specific blood tests. Report any signs or symptoms of infection to your doctor;
    • you have diabetes and are taking oral antidiabetic medicines or insulin. In this case, your doctor will advise blood tests to monitor glucose levels, especially during the first month of treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics, and may adjust the dose of your antidiabetic medicines;
    • you are taking lithium (a medicine for treating mood disorders) (see section “Other medicines and ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics”);
    • you are of Black race. ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics may 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 time after starting treatment with an ACE inhibitor;
    • if you have a history of allergies or bronchial asthma, as sensitivity reactions may occur with the use of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics;
    • if you suffer from a disorder called systemic lupus erythematosus (an autoimmune disease), which may develop or worsen with the use of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics.

If you are about to undergo any of the following procedures, inform your doctor that you are taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics:

  • any surgical procedure or anaesthesia;
  • a treatment called LDL (low-density lipoprotein) apheresis with dextran sulfate, to remove cholesterol from the blood using machines. Your doctor may temporarily stop treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics to prevent a possible allergic reaction;
  • a treatment to reduce the effects of an allergy, for example due to an insect sting (desensitization therapy). If you take ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics during this treatment, you may experience a severe allergic reaction; therefore, temporary interruption of therapy is advisable;
  • tests to assess parathyroid gland function. Consult your doctor, who will advise you to stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics before undergoing this test.

Stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics and inform your doctor if you experience:

  • swelling of the hands, feet, ankles, or of the face, lips, tongue and/or throat, causing difficulty in swallowing or breathing (angioedema);
  • yellowing of the skin and whites of the eyes (jaundice), indicating liver problems or increased levels of transaminases (liver enzymes) in the blood;
  • increased levels of nitrogen and creatinine in the blood, which may suggest renal artery stenosis;
  • increased calcium levels in the blood (hypercalcemia).

During treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics, an electrolyte imbalance may occur, manifesting with signs and symptoms such as:

  • dry mouth, thirst, weakness, pathological state of deep sleep (lethargy), drowsiness, restlessness, muscle pain or cramps, muscle fatigue, low blood pressure, reduced urine output, increased heart rate (tachycardia), and gastrointestinal disturbances such as nausea and vomiting. In such cases, contact your doctor promptly. This medicine must be used under regular medical supervision. Therefore, strictly follow all laboratory tests and check-ups as prescribed by your doctor.

Children and adolescents
The use of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics is not recommended in children due to lack of safety and efficacy data.

Other medicines and ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, consult your doctor or pharmacist if you are taking:

  • an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also section “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics” 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, as excessive reduction in blood pressure may occur;
  • lithium, used to treat certain mood disorders, as excessive lithium concentration in the blood and lithium toxicity may occur;
  • potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clot formation);
  • medicines that promote diuresis (diuretics), such as thiazides or loop diuretics, as they may cause a reduction in blood pressure;
  • anaesthetics, antipsychotics, and tricyclic antidepressants (used to treat mental disorders), as further reduction in blood pressure may occur;
  • medicines acting on the autonomic nervous system (sympathomimetics) such as ephedrine, pseudoephedrine, salbutamol, found in some nasal decongestants, cough and cold medicines, asthma treatments, treatments for low blood pressure, and heart conditions. These medicines may reduce the antihypertensive effects of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics;
  • insulin or other oral antidiabetic medicines. Blood glucose levels should be closely monitored, especially during the first weeks of treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics 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:
    • gold-containing medicines administered by injection, e.g. sodium aurothiomalate, as they may cause facial flushing, nausea, vomiting, and low blood pressure when taken with ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics;
    • non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, as they may reduce the effectiveness of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics, increase potassium levels in the blood, and worsen kidney function;
  • carbenoxolone (a medicine used to treat stomach problems such as ulcers), kaliuretic diuretics (e.g. furosemide), or excessive use of laxatives. Use of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics with these medicines may further reduce potassium and/or magnesium levels in the blood;
  • tubocurarine, used to relax muscles during surgery (muscle relaxant), as ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics may enhance 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 relieve pain. These medicines may worsen dizziness upon standing due to a drop in blood pressure (orthostatic hypotension);
  • medicines used to reduce blood fat levels, such as cholestyramine or colestipol resins, as they may reduce the absorption of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics;
  • medicines used to treat irregular heartbeat (antiarrhythmics such as quinidine, procainamide, amiodarone, sotalol), as they may cause heart rhythm problems (torsades de pointes);
  • medicines used to treat heart failure (digitalis preparations);
  • corticosteroids (which modulate anti-inflammatory responses) and adrenocorticotropic hormone (ACTH), used to assess adrenal gland function, as they may further reduce blood salt levels, particularly potassium (hypokalemia);
  • pressor amines (e.g. noradrenaline), as ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics may reduce their effects;
  • cancer treatments such as cyclophosphamide or methotrexate, as ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics may increase their toxicity;
  • medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”;
  • medicines for treating gout, such as allopurinol (see section “Warnings and precautions”);
  • immunosuppressive medicines;
  • mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus), as concomitant administration may increase the risk of an allergic reaction called angioedema (see section “Stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics and inform your doctor if”).

ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics and alcohol
ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics should not be taken with alcohol, as this may cause excessive lowering of blood pressure.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy (see section “Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics”). Inform your doctor if you think you may be pregnant (or are planning a pregnancy). Your doctor will advise you to stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics immediately before becoming pregnant or as soon as you become aware of pregnancy, and will recommend an alternative medicine.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics is not recommended for women who are breastfeeding, particularly if the baby was born prematurely or during the first few weeks after delivery.

Driving and using machines
ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics may cause side effects such as dizziness or fatigue, which may occasionally affect your ability to drive or operate machinery. Therefore, exercise caution when driving or using machinery.

ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

It is advisable to start therapy with half a tablet per day.
The recommended dose may then be increased to 1 tablet per day. If necessary, your doctor may increase the dose up to a maximum of 2 tablets once daily.

Prior diuretic therapy
If you are already taking another medicine that increases urine production (diuretic), taking enalapril contained in ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici may cause an excessive drop in blood pressure. In such cases, if your doctor considers treatment with ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici necessary, you will be instructed to stop taking the diuretic for a few days before starting ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici. If this is not possible, your doctor may decide to start therapy with lower doses of enalapril, using separate tablets containing the same active substances found in ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici (enalapril and hydrochlorothiazide). ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici may be used at a later stage, once your doctor has determined that you require the fixed dose combination of enalapril and hydrochlorothiazide provided in the tablet.

Patients with kidney problems (renal impairment)
Do not use ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici if you have severe kidney problems (see section "Do not take ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici").
If you have kidney problems, your doctor will monitor your kidney function and determine the appropriate dose of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici.

Use in children and adolescents
The use of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici is not recommended in children.

Use in the elderly
Dosage adjustment is not required in elderly patients.

If you take more ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici than you should
If you accidentally take too much ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici, contact your doctor immediately or go to the nearest hospital emergency department and stop taking the medicine.
Symptoms of overdose may include: feeling faint or dizzy due to excessive lowering of blood pressure; severe 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 (hypokalemia), chloride (hypochloremia), and sodium (hyponatremia) in the blood; dehydration due to excessive diuresis.

If you forget to take ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici
Do not take a double dose to make up for a forgotten tablet. If in doubt, contact your doctor.

If you stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici
Do not stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici unless instructed by your doctor.

If you have any questions about how to use this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics and consult 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 face, lips, tongue and/or throat, leading to difficulty swallowing or breathing (angioedema).

The side effects observed with the use of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generics 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)

  • decrease in blood potassium levels (hypokalaemia) or increase in blood potassium levels (hyperkalaemia); increase in cholesterol, triglycerides, uric acid (hyperuricaemia), and creatinine levels in blood;
  • headache (cephalalgia), depression, temporary loss of consciousness (syncope), altered taste;
  • low blood pressure (hypotension), drop in blood pressure following sudden change from sitting or lying down to standing (orthostatic hypotension), heart rhythm disturbances, chest pain with a sensation of tightness and pressure (angina pectoris), increased heart rate (tachycardia);
  • difficulty breathing (dyspnoea);
  • diarrhoea, 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 (anaemia, including aplastic and haemolytic anaemia);
  • low blood sugar (hypoglycaemia), decrease in blood magnesium levels (hypomagnesaemia), joint pain and swelling (gout);
  • confusion, drowsiness, insomnia, nervousness, tingling sensation in legs, arms or other parts of the body (paraesthesia), sensation of dizziness (vertigo);
  • reduced sexual desire; impotence;
  • unpleasant sensation of ringing or buzzing in the ears (tinnitus);
  • redness and sensation of warmth, mainly in the face (flushing), awareness of irregular or forceful heartbeat (palpitations), heart attack (myocardial infarction) or stroke (cerebrovascular accident), possibly secondary to a sudden drop in blood pressure in high-risk patients (see section “Warnings and precautions”);
  • runny nose (rhinorrhoea), sore throat (laryngodynia) and hoarseness, sensation of chest tightness making breathing difficult and noisy (bronchospasm), asthma;
  • reduced intestinal movements (ileus), inflammation of the pancreas (pancreatitis), vomiting, difficulty in digestion (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, urticaria, hair loss (alopecia);
  • joint pain (arthralgia);
  • impaired kidney function, kidney failure, presence of protein in urine (proteinuria);
  • malaise, fever;
  • increased blood urea levels (uraemia), low sodium concentration in blood (hyponatraemia).

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

  • decrease in the number of certain white blood cells (neutropenia, leucopenia and agranulocytosis), haemoglobin levels, total volume of red blood cells (low haematocrit), blood platelets (thrombocytopenia), or all types of blood cells (pancytopenia), bone marrow suppression (when bone marrow fails to produce sufficient blood cells), swelling of glands called lymph nodes (lymphadenopathy), disorders of the immune system (autoimmune diseases);
  • increased blood sugar levels;
  • abnormal dreams, sleep disturbances, partial reduction in motility (paresis, due to hypokalaemia);
  • reduced blood flow to fingers of hands and feet causing redness and pain (Raynaud's phenomenon);
  • lung problems (including pulmonary infiltrates, severe respiratory failure (respiratory distress syndrome), inflammation (pneumonitis), and fluid accumulation in the lungs (pulmonary oedema), allergic (hypersensitivity) reaction in the lungs (allergic alveolitis), lung disease (eosinophilic pneumonia);
  • irritation or inflammation of the nose (rhinitis);
  • inflammation of the mouth mucosa (stomatitis), with ulcerations or aphthae, inflammation of the tongue (glossitis);
  • liver problems such as liver failure, liver damage (hepatic necrosis, potentially fatal), inflammation of the liver or bile ducts (hepatitis hepatocellular or cholestatic), yellowing of the skin and whites of the eyes (jaundice), inflammation of the gallbladder (cholecystitis, particularly in patients with pre-existing gallstones);
  • severe skin diseases with blistering, redness and peeling, including erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, purpura, cutaneous lupus erythematosus (an autoimmune disease causing skin inflammation), pemphigus and erythroderma (skin redness);
  • reduced urine output (oliguria), kidney disease (interstitial nephritis);
  • breast enlargement in men (gynaecomastia);
  • increased liver enzymes, increased bilirubin levels in blood (bilirubinaemia).

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

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

Not known (frequency cannot be estimated from the available data)

  • syndrome of inappropriate antidiuretic hormone secretion (SIADH);
  • skin and lip cancer (non-melanoma skin cancer); decreased vision or eye pain (possible signs of acute angle-closure glaucoma).

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 body cavities such as chest and abdomen), vasculitis (inflammation of blood vessels), muscle pain or muscle inflammation (myalgia/myositis), joint pain or joint inflammation (arthralgia/arthritis), positive test for antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), increased white blood cell count (eosinophilia, leucocytosis), skin rash, skin sensitivity to light (photosensitivity), and other skin problems;
  • eye and vision problems such as “yellow vision” and blurred vision, decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or of myopia or acute angle-closure glaucoma (increased pressure inside the eye)).

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 AND HYDROCHLOROTHIAZIDE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after “Exp.”. The expiry date refers to the last day of that month.
Do not store above 30 °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 AND HYDROCHLOROTHIAZIDE DOC Generici contains

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

Description of the appearance of ENALAPRIL AND HYDROCHLOROTHIAZIDE DOC Generici and contents of the
pack
Pack of 14 or 28 tablets in divisible blister PA-Alu-PVC/Alu.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan.
Manufacturers
FAMAR ITALIA S.p.A. – Via Zambeletti, 25 – 20021 Baranzate (MI).
Lachifarma S.r.l. Laboratorio Chimico Farmaceutico Salentino - S.S. 16 Zona Industriale - 73010 Zollino (LE).
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A. - Via Grignano, 43 - 24041 Brembate (BG)