Lisinopril and hydrochlorothiazide Pensà

Italy
Brand name Lisinopril and hydrochlorothiazide Pensà
Form tablets
Active substance / Dosage
LISINOPRIL DIHYDRATE
HYDROCHLOROTHIAZIDE
Prescription type Prescription only
ATC code
C09BA03
Registration number 039003
Manufacturer TOWA PHARMACEUTICAL S.P.A.

Table of Contents

Package leaflet: Information for the patient

LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA 20 mg + 12.5 mg tablets

Lisinopril and hydrochlorothiazide
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
    Contents of this leaflet:
    1. What LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA is and what it is used for
    2. What you need to know before taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA
    3. How to take LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA
    4. Possible side effects
    5. How to store LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA
    6. Contents of the pack and other information

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

LISINOPRIL E IDROCLOROTIAZIDE PENSA contains the active substances: lisinopril and hydrochlorothiazide.
Lisinopril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors), which work by reducing blood pressure through widening of the blood vessels.
Hydrochlorothiazide belongs to a group of medicines called diuretics, which work by increasing the production and elimination of urine, thereby lowering blood pressure.
LISINOPRIL E IDROCLOROTIAZIDE PENSA is indicated for the treatment of high blood pressure (essential hypertension) in patients whose blood pressure is not adequately controlled by lisinopril alone.

2. What you should know before taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA

Do not take LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA

  • if you are allergic to lisinopril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to medicines similar to hydrochlorothiazide (sulfonamide-related drugs) or to medicines similar to lisinopril (ACE inhibitors);
  • if you are not passing urine (anuria);
  • if you have previously experienced swelling of the hands, feet, ankles, face, lips, tongue and/or throat (angioedema) caused by prior treatment with ACE inhibitors;
  • if someone in your family has had a severe allergic reaction of unknown cause. This may indicate a condition called hereditary angioedema and may make you more susceptible to the symptoms described above;
  • if you suffer from idiopathic angioedema (without evident cause);
  • if you have severe kidney problems (creatinine clearance ≤ 30 ml/min);
  • if you have severe liver problems;
  • if you are more than three months pregnant (see section “Pregnancy and breastfeeding”);
  • 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 LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA”).

Warnings and precautions
Talk to your doctor or pharmacist before taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA
if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure within the eye and may occur from a few hours to several weeks after taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA. This may lead to permanent vision loss if untreated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing such reactions.
if you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, consult a doctor immediately.

Do not take this medicine if:

  • you have a narrowing (stenosis) of the aortic valve (a heart artery) or of the renal artery;
  • you have hypertrophic cardiomyopathy (a condition characterized by thickening of the heart muscle), or if you have narrowing of heart valves (mitral valve), or other obstructions to outflow from your left ventricle;
  • you have problems with diarrhea or vomiting;
  • you suffer from gout (a disease causing joint pain);
  • you have liver problems;
  • you have kidney problems;
  • you are undergoing dialysis (a medical treatment to clean the blood when you have severe kidney disease);
  • you have had a kidney transplant;
  • you have undergone kidney transplantation;
  • you are on a low-salt diet;
  • you are taking medicines for treating allergies, for example after insect stings;
  • you or someone in your family has previously had allergic reactions with swelling of the hands, feet or ankles, face, lips, tongue and/or throat accompanied by difficulty breathing (see section “Possible side effects”);
  • you need to undergo plasmapheresis (a procedure to separate certain components of blood);
  • you suffer from hypotension (low blood pressure, which may manifest as weakness or dizziness);
  • you have marked sugar intolerance or suffer from diabetes;
  • you are taking any of the following medicines used to treat high blood pressure:
    o An “angiotensin II receptor antagonist” (AIIRA), also known as sartans (e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
    o Aliskiren;
  • you have previously had skin cancer or are developing unexpected skin lesions 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 rays while taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.

  • if changes in blood cell counts (white blood cells, red blood cells, and platelets) occur during treatment with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA;
  • if you experience a marked decrease in certain types of white blood cells leading to increased susceptibility to infections and severe general symptoms (agranulocytosis).

Alteration of blood salt levels (electrolyte imbalance)
Due to the diuretic component in LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, levels of sodium and potassium in the blood may decrease. This may cause dry mouth, thirst, weakness, drowsiness, irritability, fatigue, muscle pain, hypotension, nausea, rapid heartbeat, and stomach and/or intestinal disturbances.
The diuretic may also cause decreased levels of chloride and magnesium, while possibly increasing calcium levels.
Therefore, your doctor may prescribe blood tests to monitor your electrolyte levels.

Cough
During treatment, you may develop a dry, persistent cough.
This cough resolves upon discontinuation of treatment.
If you need to undergo tests to evaluate respiratory function during treatment, inform your doctor that you are taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA.

Sudden drop in blood pressure
The initial dose may cause a sudden drop in blood pressure greater than that seen later during continued treatment. You may therefore experience weakness or dizziness; lying down may help in such cases. If symptoms persist, consult your doctor.

Anaesthesia
If you are admitted to hospital, you must inform medical staff that you are being treated with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, and particularly the anaesthetist (the doctor responsible for anaesthesia) if undergoing surgery. You should also inform your dentist if anaesthetics are administered for dental procedures.

Ethnicity
If you are of Black origin, you may be more likely to develop “angioedema” (characterized by swelling of the face, lips, tongue, throat, or sudden breathing difficulty).

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

Children and adolescents
The safety and efficacy of LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA in children and adolescents has not been established; therefore, this medicine is not recommended for children and adolescents.

Other medicines and LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, before starting treatment with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, inform your doctor if you are taking:

  • other diuretics (including a type of diuretics known as “potassium-sparing diuretics”), as they may enhance the effect of this medicine when taken together;
  • other antihypertensive medicines (for treating high blood pressure) known as sartans (e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems or diabetes;
  • other antihypertensive medicines (for treating high blood pressure), including those containing aliskiren (for treating high blood pressure), as they may enhance the effect of this medicine when taken together. In particular, do not take LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA if you are taking aliskiren and have kidney problems or diabetes (see section “Do not take LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA”);
  • indometacin (an analgesic, medicine for pain and inflammation) or other medicines for treating joint inflammation or muscle pain;
  • lithium (used to treat mental illnesses);
  • injectable gold (for treating rheumatoid arthritis, a chronic inflammation of the joints);
  • NSAIDs (Non-Steroidal Anti-Inflammatory Drugs, medicines for pain and inflammation), as they may reduce the effectiveness of this medicine when taken together. Additionally, if you have reduced kidney function, these medicines may further impair your kidney function;
  • allopurinol (for treating gout, a disease causing joint pain), as co-administration with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA may increase the risk of leukopenia (reduced number of white blood cells in the blood);
  • cytostatic agents (used to reduce tumor growth) such as cyclophosphamide or methotrexate, as co-administration with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA may increase the risk of leukopenia;
  • immunosuppressants (medicines that reduce immune response), which when taken together with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA may increase the risk of leukopenia;
  • procainamide and sotalol (medicines for heart rhythm disorders, antiarrhythmics);
  • medicines for treating diabetes (including insulin), as your doctor may need to adjust the dose of your diabetes medicine if you have diabetes;
  • potassium supplements or potassium-containing salt substitutes, or other medicines that increase potassium levels in the blood (e.g., heparin, co-trimoxazole);
  • salicylic acid derivatives, used to treat various types of pain (e.g., headache, menstrual pain, muscle or bone pain), to reduce fever, and to treat inflammatory diseases;
  • calcium or vitamin D supplements;
  • vasodilators, nitroglycerin, and other nitrates (used to lower blood pressure and/or treat heart problems);
  • medicines to relax muscles during general anaesthesia and intensive care therapy (including tubocurarine chloride and anaesthetics);
  • medicines for treating mood disorders, such as tricyclic antidepressants and antipsychotics;
  • sympathomimetics (medicines acting mainly on the sympathetic nervous system, which controls internal organs, particularly blood circulation and the heart);
  • amphotericin B (administered intravenously), for treating fungal infections;
  • carbenoxolone (for treating ulcers or inflammation of the esophagus or around the mouth);
  • corticotropin (a hormone);
  • stimulant laxatives (medicines for treating constipation);
  • digoxin (for treating heart problems, including heart rhythm issues);
  • medicines for treating high cholesterol levels such as cholestyramine and colestipol;
  • trimethoprim (for treating bacterial infections);
  • medicines to prevent organ rejection after transplantation such as cyclosporine;
  • medicines with anti-inflammatory activity (corticosteroids), as they increase the excretion of certain salts normally dissolved in blood and body fluids, particularly potassium;
  • medicines such as adrenaline (a medicine that stimulates the heart), as their effect may be reduced;
  • barbiturates and narcotics (substances that reduce brain activity), as they may cause excessive lowering of blood pressure when standing;
  • diazoxide (used to lower blood sugar levels);
  • amantadine (used to treat viral infections), as there may be increased drug toxicity.

LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA with alcohol
Avoid drinking alcoholic beverages during treatment with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, as they may cause excessive lowering of blood pressure when standing (see section “Driving and use of machines”).

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

Pregnancy
The use of LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA is not recommended during the first 3 months of pregnancy.
Do not take LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA after the first 3 months of pregnancy (see section “Do not take LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA”).
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant).
Treatment with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA should not be initiated during pregnancy.
Your doctor will usually advise you to stop taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine unless continued therapy with an ACE inhibitor is considered essential.
LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA is not recommended in early pregnancy, as there may be a slight increased risk of fetal toxicity.
LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA must not be taken if you are more than three months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy (see section “Do not take LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA”).
If exposure to an ACE inhibitor occurs after the first trimester of pregnancy, your doctor will recommend an ultrasound examination to assess fetal kidney and skull function, and the newborn will subsequently be monitored for the risk of hypotension (low blood pressure).

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding of newborns (first weeks after birth), and especially of premature infants, is not recommended while taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA. Your doctor will evaluate the benefits for you and the risks for the infant associated with taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA during breastfeeding and may recommend an alternative treatment if you wish to breastfeed.

Driving and use of machinery
During treatment with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, you may experience dizziness or fatigue.
Therefore, avoid driving or operating machinery requiring special attention until you know how you tolerate this medicine.

3. How to take LISINOPRIL E IDROCLOROTIAZIDE PENSA

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Adults and elderly
The recommended dose is 1 tablet once daily. Generally, if the desired effect is not achieved after 2–4 weeks, your doctor may increase the dosage up to 2 tablets taken together as a single daily dose.
If you have reduced kidney function (renal insufficiency)
If you suffer from renal insufficiency, your doctor may decide not to prescribe LISINOPRIL E IDROCLOROTIAZIDE PENSA for initial treatment of hypertension, as this medicine may be ineffective. When used alone, the recommended initial dose of lisinopril in renal insufficiency is 5–10 mg.
If previously treated with diuretics (medicines that work by increasing the amount of urine produced by the kidneys)
If you have previously been treated with diuretics, you may experience symptomatic hypotension (low blood pressure causing symptoms such as nausea, weakness, headache, drowsiness, mental confusion) at the beginning of treatment with LISINOPRIL E IDROCLOROTIAZIDE PENSA. This is especially likely if you have reduced blood volume (hypovolemia) and/or low blood sodium levels due to prior diuretic therapy.
If you are taking diuretics, your doctor will usually discontinue them for 2–3 days before starting treatment with LISINOPRIL E IDROCLOROTIAZIDE PENSA. If this is not possible, your doctor will start treatment with lisinopril alone at a dose of 5 mg.
Use in children and adolescents
The safety and efficacy of LISINOPRIL E IDROCLOROTIAZIDE PENSA in children and adolescents have not been established; therefore, this medicine is not recommended for use in children and adolescents.
How to take
Take the tablets with a glass of water at the same time each day, preferably early in the morning.
If you take more LISINOPRIL E IDROCLOROTIAZIDE PENSA than you should
In case of accidental overdose, contact your doctor or the nearest hospital immediately.
If you take too much of this medicine, you may experience the following symptoms: low blood pressure, syncope (fainting), electrolyte imbalances (levels of sodium, potassium and other electrolytes in the blood), kidney problems, rapid and deep breathing, fast heartbeat, palpitations, slow heartbeat, dizziness, anxiety, cough, increased urination, seizures, paresis, irregular heartbeat, and severe kidney problems.
If you forget to take LISINOPRIL E IDROCLOROTIAZIDE PENSA
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose.
If you stop taking LISINOPRIL E IDROCLOROTIAZIDE PENSA
Do not stop treatment because you feel better, unless your doctor tells you to.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA is generally well tolerated.
If, during treatment with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, you experience any of the following side effects, contact your doctor immediately, who will STOP treatment with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA:

  • allergic reactions. Signs may include: swelling of the face, hands, feet, ankles, lips, tongue and/or throat (angioedema) (see section “Warnings and precautions”);
  • jaundice (yellowing of the skin and whites of the eyes);
  • marked increase in liver enzymes (detected by blood tests). Elevated liver enzymes are signs of impaired liver function: hepatitis (inflammation of the liver), liver failure (serious liver disease). If, during treatment, you experience the following side effect, contact your doctor immediately:
  • severe eye pain accompanied by redness and sudden blurred vision. If left untreated, this condition could lead to permanent vision loss.
    Additionally, the following side effects have been observed and reported during treatment with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, with the following frequencies:
    Common (may affect up to 1 in 10 people):
  • dizziness
  • headache
  • paresthesia (tingling)
  • orthostatic effects, including hypotension (reduction in blood pressure upon standing, accompanied by symptoms such as dizziness/light-headedness)
  • syncope (fainting)
  • cough
  • diarrhea
  • nausea
  • vomiting
  • rash (skin eruptions)
  • muscle cramps
  • inability to achieve an erection (impotence)
  • fatigue
  • asthenia (weakness)
  • changes in blood tests assessing kidney function (increased urea and creatinine)
  • changes in blood tests assessing liver function (increased liver enzymes)
  • changes in blood tests assessing hemoglobin (decreased hemoglobin)

Uncommon (may affect up to 1 in 100 people):

  • gout (a disease causing joint pain)
  • depressive symptoms
  • palpitations (sensation of increased heartbeat)
  • dry mouth
  • chest tightness
  • alteration in laboratory test: decreased hematocrit (a test measuring the amount of red blood cells in the blood)

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

  • anemia (reduction in hemoglobin in the blood, the substance that carries oxygen)
  • inadequate production of a hormone that reduces the amount of urine produced by the kidneys, called “antidiuretic hormone”
  • increased blood sugar levels (hyperglycemia)
  • decreased potassium levels in the blood (hypokalemia)
  • increased uric acid levels in the blood (hyperuricemia)
  • increased potassium levels in the blood (hyperkalemia)
  • disturbances in smell
  • pancreatitis (inflammation of the pancreas, a gland located near the stomach)
  • muscle weakness
  • increased bilirubin (a substance produced by the body, whose increase may be due to liver disorder) in the blood

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

  • bone marrow depression (reduced activity of the bone marrow, where blood cells are produced)
  • hemolytic anemia (a disease due to destruction of certain blood cells, red blood cells)
  • thrombocytopenia (reduction in the number of platelets in the blood)
  • leukopenia (reduction in the number of white blood cells in the blood)
  • agranulocytosis (reduction in the number of granulocytes in the blood, a type of blood cell)
  • intestinal angioedema (swelling of the intestinal walls which may cause severe abdominal pain, vomiting and diarrhea)
  • cutaneous pseudolymphoma (a disease manifesting with a complex clinical picture that may include one or more of the following: fever, vasculitis (inflammation of blood vessels), myalgia (muscle pain), arthralgia/arthritis (joint pain/inflammation), positive laboratory tests for certain immune responses (positive antinuclear antibodies, ANA), elevated erythrocyte sedimentation rate (ESR, a laboratory marker of inflammation), eosinophilia and leukocytosis (increased blood levels of eosinophils and leukocytes, two types of blood cells), rash (skin eruptions), photosensitivity (sensitivity to sunlight), and other skin manifestations)

Other side effects reported with other medicines containing the same active substances as LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA (hydrochlorothiazide and lisinopril), and which may therefore also potentially occur with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA:

Possible side effects with hydrochlorothiazide
Frequency not known (cannot be estimated from available data)

  • anorexia (loss of appetite)
  • gastric irritation (inflammation of the stomach)
  • constipation
  • sialadenitis (inflammation of the salivary glands)
  • vertigo
  • xanthopsia (visual disturbance characterized by yellow vision of white objects)
  • aplastic anemia (inadequate production of all types of blood cells by the bone marrow)
  • purpura (a condition where the skin turns red due to abnormal blood accumulation)
  • photosensitivity (sensitivity to sunlight)
  • urticaria (red, itchy skin rashes)
  • inflammation of blood vessels (necrotizing angiitis: vasculitis, cutaneous vasculitis)
  • fever
  • exanthema (skin eruption with pustules, vesicles and blisters, typical of some childhood diseases)
  • breathing difficulties including pneumonia and pulmonary edema (accumulation of fluid in the lungs)
  • glycosuria (presence of sugar in the urine)
  • electrolyte imbalances including hyponatremia (decreased sodium levels in the blood), hypomagnesemia (decreased magnesium levels in the blood)
  • agitation, depression, dizziness, sleep disturbances
  • kidney disorders (renal dysfunction and interstitial nephritis)
  • activation or worsening of lupus symptoms (an autoimmune disease manifesting with fatigue, joint pain, skin rashes, swelling, flushing, weight gain or loss, etc.)
  • toxic epidermal necrolysis and Stevens-Johnson syndrome (serious skin reactions characterized by skin irritation, blistering and skin detachment)
  • hypochloremic alkalosis (loss of chloride from the body)
  • increased cholesterol and triglyceride levels in the blood
  • hypercalcemia (increased calcium levels in the blood); if you experience increased calcium levels, your doctor will prescribe tests to evaluate for a condition called “hyperparathyroidism” (a disorder in the production of a hormone regulating blood calcium levels)
  • cardiac arrhythmias (abnormal heart rhythm, i.e. change in beats per minute)
  • acute myopia (vision disorder affecting distance vision)
  • acute angle-closure glaucoma (a severe form of glaucoma, i.e. an eye disease caused by increased pressure of the fluid inside the eye)
  • sudden-onset reduction in distance vision (acute myopia), decreased vision or eye pain due to elevated 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)

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

  • Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion)

Possible side effects with lisinopril
Common (may affect up to 1 in 10 people):

  • kidney dysfunction

Uncommon (may affect up to 1 in 100 people):

  • taste disturbances
  • sleep disorders
  • mood changes
  • myocardial infarction (heart attack) or cerebrovascular event (stroke), possibly due, in predisposed individuals, to excessive reduction in blood pressure
  • tachycardia (increased heart rate per minute)
  • Raynaud's syndrome (pain in fingers and toes which first turn pale, then bluish, then reddish)
  • rhinitis (irritation or inflammation of nasal mucosa)
  • stomach ache (abdominal pain and indigestion)
  • pruritus (itching)

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

  • mental confusion
  • alopecia (hair loss)
  • urticaria (red, itchy skin rashes)
  • psoriasis (chronic inflammatory, non-infectious, non-contagious skin disease)
  • uremia (presence of urea in the blood)
  • acute renal failure (serious kidney disease)
  • gynecomastia (breast enlargement in men)
  • low sodium levels in the blood

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

  • lymphadenopathy (enlargement of lymph nodes, organs of the body's defense system)
  • autoimmune disease (disorder of the body's immune system)
  • low blood sugar levels (hypoglycemia)
  • sinusitis (inflammation of the sinuses)
  • bronchospasm (narrowing of the bronchi causing severe breathing difficulty due to reduced airflow)
  • breathing difficulties caused by an allergic reaction including allergic alveolitis/eosinophilic pneumonia
  • severe skin disorders including pemphigus (a blistering skin disease), toxic epidermal necrolysis and Stevens-Johnson syndrome (serious skin reactions characterized by erythema, blistering and skin detachment), and erythema multiforme (a condition characterized by red spots on the skin with "target-like" appearance, associated with itching)
  • diaphoresis (excessive sweating)
  • oliguria/anuria (reduced or absent urine output)

Frequency not known (cannot be estimated from available data):

  • hot flushes
  • visual and/or auditory hallucinations (perception of non-existent things and/or voices)

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 LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.” The expiry date refers to the last day of that month.
Store the medicine in the original packaging to protect it from light.
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 LISINOPRIL E IDROCLOROTIAZIDE PENSA contains

  • The active substances are lisinopril dihydrate and hydrochlorothiazide. One tablet contains 21.8 mg of lisinopril dihydrate (equivalent to 20 mg of anhydrous lisinopril) and 12.5 mg of hydrochlorothiazide.
  • The other components are mannitol, dibasic calcium phosphate dihydrate, corn starch, pregelatinized starch, magnesium stearate.

Description of the appearance of LISINOPRIL E IDROCLOROTIAZIDE PENSA and contents of the
pack
Pack containing 14 or 28 tablets.
Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Manufacturer
Special Product's Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)