LISINOPRIL 20 mg /12,5 Mg Tabletki

Treść ulotki

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

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

Lisinopril and hydrochlorothiazide

Generic medicine

Read this leaflet carefully before you start 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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What LISINOPRIL E IDROCLOROTIAZIDE PENSA is and what it is used for
• 2. What you need to know before you take LISINOPRIL E IDROCLOROTIAZIDE PENSA
• 3. How to take LISINOPRIL E IDROCLOROTIAZIDE PENSA
• 4. Possible side effects
• 5. How to store LISINOPRIL E IDROCLOROTIAZIDE PENSA
• 6. Contents of the pack and other information

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

LISINOPRIL E IDROCLOROTIAZIDE PENSA contains the active ingredients: lisinopril and hydrochlorothiazide. Lisinopril belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors), which work by reducing blood pressure by dilating blood vessels.
Hydrochlorothiazide belongs to a group of medicines called diuretics which work by promoting the
production and elimination of urine, which causes a lowering of 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 need to 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 (sulphonamides) or to medicines similar to lisinopril (ACE inhibitors);
• if you do not produce urine (anuria);
• if you have previously suffered from swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema) caused by a previous 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 an obvious cause)
• if you suffer from severe kidney problems (creatinine clearance ≤ 30 ml/min);
• if you suffer from severe liver problems
• if you are pregnant for more than three months (see section “Pregnancy and breastfeeding”).
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren (see section “Other medicines and LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA”);

Warnings and precautions
Talk to your doctor or pharmacist before taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA
if you have blurred vision or eye pain. These could 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 LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater risk of developing it
if you have had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If, after taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, you experience shortness of breath or severe difficulty breathing, consult a doctor immediately.
Do not take this medicine if:

• if you suffer from a narrowing (stenosis) of the aortic valve (an artery of the heart) or of the renal artery
• if you suffer from hypertrophic cardiomyopathy (a condition characterized by an increase in the thickness of the heart muscle) or if the heart valves are narrowed (mitral valve), or if there are other obstacles to the outflow from your left ventricle if you suffer from problems with diarrhea or vomiting
• if you suffer from gout (a disease that causes joint pain)
• if you suffer from liver problems
• if you suffer from kidney problems
• if you are undergoing dialysis (medical treatment to clean the blood when you suffer from severe kidney disease)
• if you have had a kidney transplant
• if you have been on a low-salt diet
• if you are taking medicines to treat allergies, for example for insect bites
• if you or someone in your family has had allergic reactions in the past with swelling of the hands, feet or ankles, face, lips, tongue and/or throat with difficulty breathing (see section “Possible side effects”)
• if you need to undergo apheresis (a procedure to separate some components of the blood)
• if you suffer from hypotension (low blood pressure that can manifest as a feeling of weakness or dizziness)
• if you have a reduced tolerance to sugars or if you suffer from diabetes.
• if you are taking one of the following medicines used to treat high blood pressure: o An “angiotensin II receptor antagonist” (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes. o Aliskiren
• if you have had skin cancer in the past or are developing an unexpected skin lesion during treatment. Long-term use of hydrochlorothiazide, especially at high doses, can increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA

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

• if changes occur in the number of blood cells (white blood cells, red blood cells and platelets) during treatment with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA
• if you have a significant decrease in certain types of white blood cells with the development of susceptibility to infections and severe general symptoms (agranulocytosis)

Changes in blood salt levels (electrolyte imbalance)
Due to the diuretic present in LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, levels of sodium and potassium in the blood may decrease. This can cause dry mouth, thirst, weakness, drowsiness, irritability, fatigue or muscle pain, hypotension, rapid heartbeat and stomach and/or intestinal disorders.
The diuretic may also cause a decrease in the levels of chloride and magnesium; while it may cause an increase in calcium levels.
The doctor may therefore prescribe blood tests to check your salt levels.

Cough
You may experience a dry, persistent cough during treatment.
This cough resolves with discontinuation of treatment.
If you need to undergo tests to assess respiratory function during treatment, tell 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 which occurs subsequently with continued treatment. You may therefore experience a feeling of weakness or dizziness; in these cases, lying down may help. If symptoms persist, consult your doctor.

Anesthesia
If you are to be hospitalized, you must inform the medical staff of the ongoing treatment with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA and, in particular, the anesthesiologist (the doctor responsible for anesthesia) in case of surgery. It is also advisable to inform your dentist if an anesthetic is administered for dental care.

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

For those who play sports
The use of the drug without a therapeutic need constitutes doping and may still result in a positive 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
Tell 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, tell your doctor if you are taking:

• other diuretic medicines (including a type of diuretics called “potassium-sparing diuretics”), as if taken simultaneously with LISINOPRIL AND HYDROCHLOROTHIAZIDE PENSA, they can increase the effect of this medicine
• other antihypertensive medicines (for the treatment of high blood pressure) known as sartans (e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems or diabetes
• other antihypertensive medicines (for the treatment of high blood pressure), including those containing aliskiren (for the treatment of high blood pressure), as if taken simultaneously with

LISINOPRIL E IDROCLOROTIAZIDE PENSA may increase the effect of this medicine.

In particular, do not take LISINOPRIL E IDROCLOROTIAZIDE PENSA if you are taking aliskiren and
have kidney problems or have diabetes (see section “Do not take LISINOPRIL E
IDROCLOROTIAZIDE PENSA”)

• indometacin (pain reliever, medicine for pain and inflammation) or other medicines for the treatment of joint inflammation or muscle pain
• lithium (used for the treatment of mental illnesses)
• injectable gold (for the treatment of rheumatoid arthritis, a chronic inflammation of the joints)
• NSAIDs (Non-Steroidal Anti-Inflammatory Drugs, medicines for pain and inflammation), as if taken at the same time as LISINOPRIL E IDROCLOROTIAZIDE PENSA they may decrease the effect of this medicine. Furthermore, if you have reduced kidney function, these medicines may cause a further reduction in your kidney function
• allopurinol (for the treatment of gout, a disease that causes joint pain), as if taken together with LISINOPRIL E IDROCLOROTIAZIDE PENSA it may increase the risk of leucopenia (reduction in the number of white blood cells in the blood)
• cytostatic agents (used to reduce tumor growth) e.g. cyclophosphamide or methotrexate, as if taken together with LISINOPRIL E IDROCLOROTIAZIDE PENSA they may increase the risk of leucopenia
• immunosuppressants (medicines that reduce the immune response), which if taken together with LISINOPRIL E IDROCLOROTIAZIDE PENSA may increase the risk of leucopenia
• procainamide and sotalol (medicines for heart rhythm abnormalities, antiarrhythmics)
• medicines for treating diabetes (including insulin), as if you suffer from diabetes, your doctor may need to adjust the dose of the medicine you are taking
• potassium supplements or salt substitutes containing potassium or other medicines that increase potassium levels in the blood (e.g. heparin, co-trimoxazole)
• salicylic acid derivatives, used in the treatment of various forms of pain (e.g.: headache, menstrual pains, muscle or bone pains), to lower fever and in the treatment of inflammatory diseases
• calcium or vitamin D supplements
• vasodilators, nitroglycerin and other nitrates (used to reduce blood pressure and/or to treat heart problems)
• medicines for relaxing muscles in case of general anesthesia and in intensive care (including tubocurarine chloride and anesthetics)
• medicines for treating mood disorders, such as tricyclic antidepressants and antipsychotics
• sympathomimetics (medicines that act mainly on the sympathetic nervous system, the system that controls internal organs, mainly blood circulation and heart)
• amphotericin B (administered intravenously), for the treatment of fungal infections
• carbenoxolone (for the treatment of ulcers or inflammation of the esophagus or around the mouth)
• corticotropin (a hormone)
• stimulant laxatives (medicines for treating constipation)
• digoxin (for the treatment of heart problems, including heart rhythm problems)
• medicines for treating high cholesterol levels such as colestyramine and colestipol
• trimethoprim, for the treatment of bacterial infections
• medicines to prevent organ rejection after transplantation such as cyclosporine
• medicines with anti-inflammatory activity (corticosteroids), as they increase the elimination of some salts normally dissolved in the blood and fluids of the body, in particular potassium
• medicines such as adrenaline (a medicine that stimulates the heart), as their effect may decrease
• barbiturates and narcotics (substances that reduce brain activity), as they may cause an excessive decrease in blood pressure when in an upright position
• diazoxide (used to treat high blood sugar levels)
• amantadine (used for the treatment of viral infections), as there is an increase in toxicity
• medicine)

LISINOPRIL E IDROCLOROTIAZIDE PENSA with alcohol
Avoid drinking alcoholic beverages during treatment with LISINOPRIL E IDROCLOROTIAZIDE PENSA
as they may cause an excessive decrease in blood pressure when in an upright position
(see section “Driving and using machines”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of LISINOPRIL E IDROCLOROTIAZIDE PENSA is not recommended during the first 3
months of pregnancy.
Do not take LISINOPRIL E IDROCLOROTIAZIDE PENSA after the first 3 months of pregnancy
(see section “Do not take LISINOPRIL E IDROCLOROTIAZIDE PENSA”).
You should inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy).
Therapy with LISINOPRIL E IDROCLOROTIAZIDE PENSA should not be started during
pregnancy.
Normally your doctor will advise you to stop taking LISINOPRIL E
IDROCLOROTIAZIDE PENSA before starting a pregnancy or as soon as you become
aware that you are pregnant and will advise you to take another medicine unless it is considered essential to continue therapy with an ACE inhibitor.
LISINOPRIL E IDROCLOROTIAZIDE PENSA is not recommended in early pregnancy,
as there is a slight increase in the risk of toxicity to the fetus.
LISINOPRIL E IDROCLOROTIAZIDE PENSA should not be taken if you are in
pregnancy for more than three months, as it can cause serious harm to the baby if taken after the
third month of pregnancy (see section “Do not take LISINOPRIL E IDROCLOROTIAZIDE
PENSA”).
If exposure to an ACE inhibitor occurs after the first trimester of
pregnancy, your doctor will recommend an ultrasound check of kidney function and the fetal skull, and then monitor the newborn for the risk of
hypotension (low blood pressure).
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Breastfeeding of newborns
(first weeks after birth) and especially premature babies is not recommended while taking LISINOPRIL E IDROCLOROTIAZIDE PENSA. The doctor will assess the benefits for you and the risks
for the newborn related to taking LISINOPRIL E IDROCLOROTIAZIDE PENSA during
breastfeeding, and may advise you on alternative treatment if you wish to breastfeed.

Driving and using machines
During treatment with LISINOPRIL E IDROCLOROTIAZIDE PENSA you may experience dizziness or
fatigue.
Therefore, avoid driving vehicles or using machines that require particular attention, at least until
your tolerance to this medicine is known.

3. How to take LISINOPRIL E IDROCLOROTIAZIDE PENSA

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
doubts, ask your doctor or pharmacist.

Adults and the elderly
The recommended dose is 1 tablet once a day. In general, if after 2-4 weeks you do not obtain
the desired effect, your doctor may increase the dosage up to 2 tablets to be taken
simultaneously in a single daily dose.

If you have reduced kidney function (renal insufficiency)
If you suffer from renal insufficiency, your doctor, after evaluating your kidney function, may not
prescribe LISINOPRIL E IDROCLOROTIAZIDE PENSA in the initial treatment of hypertension, in
as much as this medicine may prove to be inactive. When used alone, the initial dose of
lisinopril recommended in renal insufficiency is 5-10 mg.

In case of previous treatment with diuretics(medicines that work by increasing the amount of urine
produced by the kidneys)
If before treatment with LISINOPRIL E IDROCLOROTIAZIDE PENSA, you have undergone therapy with
diuretics, at the beginning of therapy with LISINOPRIL E IDROCLOROTIAZIDE PENSA you may have
symptomatic hypotension (reduction of blood pressure that manifests with symptoms such as for example
nausea, weakness, headache, drowsiness, mental confusion). This can happen especially if you are in
a condition in which you have a reduced blood volume (hypovolemia) and/or a reduced amount of
sodium in the blood caused by a previous therapy with diuretics.
If you are taking diuretics, your doctor will suspend for 2-3 days the therapy with the diuretics you are taking,
before starting the therapy with LISINOPRIL E IDROCLOROTIAZIDE PENSA. If this is not possible,
your doctor will start the 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
has not been established, therefore this medicine is not recommended for children and adolescents.

How
Take the tablets with a little water at the same time of day, preferably early in the morning.

If you take more LISINOPRIL E IDROCLOROTIAZIDE PENSA than you should
In case of accidental intake of doses higher than the recommended one, immediately contact your
doctor or the nearest hospital.
In case of taking an excessive dose of medicine, you may have the following symptoms: reduction of
blood pressure, syncope (fainting), alterations of the electrolyte balance (amount of sodium, potassium and
others in the blood), kidney problems, rapid and deep breathing, accelerated heartbeat, perception of
heartbeats, slowed heartbeat, dizziness, anxiety, cough, increased diuresis, convulsions, paresis,
irregular heartbeats and serious kidney problems.

If you forget to take LISINOPRIL E IDROCLOROTIAZIDE PENSA
In case you forget to take a dose, it is advisable to take it as soon as possible. Two doses must not
be taken at the same time.
Do not take a double dose to make up for the missed dose.

If you stop taking LISINOPRIL E IDROCLOROTIAZIDE PENSA
Improvement of health status should not lead to interruption of treatment, unless
requested by the doctor.
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 will experience them.
The following side effects may occur:
LISINOPRIL E IDROCLOROTIAZIDE PENSA is generally well tolerated.
If you experience the following side effects during treatment with LISINOPRIL E IDROCLOROTIAZIDE PENSA, contact your doctor immediately, who will STOP the treatment with LISINOPRIL E
IDROCLOROTIAZIDE 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);
• a marked increase in liver enzymes (evaluated with a blood test). Increased liver enzyme values are symptoms of impaired liver function: hepatitis (liver inflammation), hepatic failure (severe liver disease). If you experience the following side effect during treatment, contact your doctor immediately:
• severe eye pain accompanied by redness and sudden blurred vision. If left untreated, this condition may cause permanent vision loss. Furthermore, the following side effects have been observed and reported during treatment with LISINOPRIL E IDROCLOROTIAZIDE PENSA with the following frequencies: Common (may affect up to 1 in 10 people):
• dizziness
• headache
• paresthesia (tingling)
• orthostatic effects, including hypotension (reduction of blood pressure when reaching an upright position accompanied by symptoms such as dizziness/lightheadedness)
• syncope (fainting)
• cough
• diarrhea
• nausea
• vomiting
• rash (skin eruptions)
• muscle cramps
• inability to achieve an erection (impotence)
• fatigue
• asthenia (tiredness)
• changes in blood tests to check kidney function (increased urea and creatinine)
• changes in blood tests to check liver function (increased liver enzymes)
• changes in blood tests to assess hemoglobin (decreased hemoglobin). Uncommon (may affect up to 1 in 100 people):
• gout (disease that causes joint pain)
• depressive symptoms
• palpitations (sensation of increased heartbeat)
• dry mouth
• feeling of chest tightness
• alteration of a laboratory test: decrease in hematocrit (test that measures the amount of red blood cells in the blood). Rare (may affect up to 1 in 1000 people):
• anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood)
• inadequate production of a hormone that reduces the amount of urine produced by the kidneys, called “antidiuretic hormone”
• increased blood sugar levels (hyperglycemia)
• reduced potassium levels in the blood (hypokalemia)
• increased uric acid levels in the blood (hyperuricemia)
• increased potassium levels in the blood (hyperkalemia)
• disturbances of 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 a 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 (disease due to the destruction of some 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 (increased number of granulocytes in the blood, a type of blood cell)
• intestinal angioedema (swelling of the intestinal walls that can cause severe abdominal pain, with vomiting and diarrhea)
• cutaneous pseudolymphoma (disease that manifests with a complex symptomatology that may include one or more of the following effects: fever, vasculitis (inflammation of blood vessels), myalgia (muscle pain), arthralgia/arthritis (joint pain/inflammation), positive laboratory values for the measurement of certain immune reactions (positive antinuclear antibodies, ANA), increased erythrocyte sedimentation rate (ESR, high laboratory value for measuring inflammation), eosinophilia and leukocytosis (increase in the blood of eosinophils and leukocytes, two types of blood cells), rash (skin eruptions), photosensitivity (sensitivity to sunlight) and other manifestations concerning the skin. Other side effects that have been reported with other medicines containing the same active ingredients as LISINOPRIL E IDROCLOROTIAZIDE PENSA (hydrochlorothiazide and lisinopril), and which therefore may be potential side effects also of LISINOPRIL E IDROCLOROTIAZIDE 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
• sialoadenitis (inflammation of the glands that produce saliva)
• vertigo
• xanthopsia (visual disturbance consisting of seeing objects white as yellow)
• aplastic anemia (insufficient production of all types of blood cells by the bone marrow)
• purpura (disease in which the skin takes on a reddish color due to abnormal accumulation of blood)
• photosensitivity (sensitivity to sunlight)
• urticaria (reddening of the skin accompanied by itching)
• inflammation of blood vessels (necrotizing angiitis: vasculitis, cutaneous vasculitis)
• fever
• exanthem (skin eruption of pustules, vesicles and blisters, typical of some childhood diseases)
• difficulty breathing including pneumonia and pulmonary edema (increased fluid in the lungs)
• glycosuria (presence of sugars in the urine)
• electrolyte imbalances including hyponatremia (decrease in the amount of sodium in the blood), hypomagnesemia (decrease in the amount of magnesium in the blood)
• agitation, depression, dizziness, sleep disturbances
• kidney disorders (renal dysfunction and interstitial nephritis)
• activation or increase of symptoms of lupus (disease of the immune system that manifests with fatigue, joint pain, skin rashes, swelling, redness, weight gain or loss, etc.)
• toxic epidermal necrolysis and Stevens-Johnson syndrome (severe skin lesions characterized by skin irritation, blistering lesions with areas of skin detachment)
• hypochloremic alkalosis (loss of chlorine from the body)
• increased levels of cholesterol and triglycerides in the blood
• hypercalcemia (increased calcium in the blood); if you should have an increase in calcium in the blood, your doctor will prescribe tests to assess the presence of a disease called “hyperparathyroidism” (alteration in the production of a hormone that regulates the amount of calcium in the blood)
• cardiac arrhythmias (alteration of the heart rate, i.e. the number of beats per minute)
• acute myopia (distance vision disorder)
• acute angle-closure glaucoma (severe form of glaucoma, i.e. eye disease caused by an increase in the pressure of the liquid contained within the eye)
• rapid onset of distance vision impairment (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) Very rare (may affect up to 1 in 10,000 people):
• 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):

• renal dysfunction. Uncommon (may affect up to 1 in 100 people):
• alteration of taste
• sleep disorders
• mood changes
• myocardial infarction (heart attack) or cerebrovascular event (stroke), possibly due to, in predisposed subjects, an excessive reduction in blood pressure
• tachycardia (increased heart rate per minute)
• Raynaud's syndrome (pain in the fingers of the hands and feet that become first white, then bluish and finally reddish)
• rhinitis (irritation or inflammation of the nasal mucous membranes)
• stomach pain (abdominal pain and indigestion)
• pruritus. Rare (may affect up to 1 in 1000 people):
• mental confusion
• alopecia (hair loss)
• urticaria (reddening of the skin accompanied by itching)
• psoriasis (chronic inflammatory skin disease, non-infectious and non-contagious)
• uremia (presence of urea in the blood)
• acute renal failure (severe kidney disease)
• gynecomastia (development of the breasts in men)
• low levels of sodium in the blood. Very rare (may affect up to 1 in 10,000 people):
• lymphadenopathy (swelling of the lymph nodes (organs of the body's defense system))
• autoimmune disease (alteration of the body's defense system)
• low blood sugar levels (hypoglycemia)
• sinusitis (inflammation of the nose)
• bronchospasm (narrowing of the bronchi that causes severe breathing difficulties due to reduced air passage)
• difficulty breathing caused by an allergic reaction including allergic alveolitis/eosinophilic pneumonia
• severe skin alterations including pemphigus (blistering skin disease), toxic epidermal necrolysis and Stevens-Johnson syndrome (severe skin lesions characterized by erythema, blistering lesions with areas of skin detachment) and erythema multiforme (condition characterized by the appearance of red spots on the skin with a "bull's eye" appearance associated with itching)
• diaphoresis (excessive sweating)
• oliguria/anuria (reduced/absent urine output). Frequency not known (cannot be estimated from available data)
• hot flashes
• visual and/or auditory hallucinations (perception of things and/or voices that do not exist in reality).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 contribute to providing more information on the safety of
this medicine.

5. How to store LISINOPRIL E IDROCLOROTIAZIDE PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.” The expiry date refers to the last day of that month.
Store the medicine in its original packaging to protect it from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LISINOPRIL E IDROCLOROTIAZIDE PENSA contains

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

Description of the appearance of LISINOPRIL E IDROCLOROTIAZIDE PENSA and pack contents
Pack of 14 or 28 tablets.

Marketing Authorisation 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)