LISINOPRIL 5 mg Tablet

Зміст інструкції

1. LISINOPRIL ZENTIVA 5 mg tablets, 20 mg tablets
   1. What Lisinopril Zentiva is and what it is used for
   2. What you need to know before taking Lisinopril Zentiva
   3. How to take Lisinopril Zentiva
   4. Possible side effects
   5. How to store LISINOPRIL ZENTIVA
   6. Contents of the pack and other information

LISINOPRIL ZENTIVA 5 mg tablets, 20 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lisinopril Zentiva is and what it is used for

Lisinopil Zentiva contains an active substance called lisinopril, which belongs to a group of
medicines called ACE inhibitors. Lisinopril Zentiva works by dilating blood
vessels, improving circulation and lowering blood pressure.
Lisinopril Zentiva is indicated for the following conditions:

• to treat high blood pressure (hypertension);
• to treat a heart condition called heart failure, in which the heart does not pump blood effectively to various parts of the body;
• to treat a recent heart attack (myocardial infarction);
• to treat kidney problems caused by type 2 diabetes in subjects with high blood pressure.

2. What you need to know before taking Lisinopril Zentiva

Do not take Lisinopril Zentiva

• if you are allergic to lisinopril, or to any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction to another ACE inhibitor with swelling of the lips, tongue or throat and with difficulty swallowing or breathing (angioedema);
• if a member of your family has had a serious allergic reaction (angioedema) to an ACE inhibitor or if you have had a similar reaction without a known reason (idiopathic angioedema);
• if you are in the second and third trimester of pregnancy (See section Pregnancy, breastfeeding and fertility);
• 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;
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat). Tell your doctor or the

pharmacist if you are taking, have recently taken or might take
sacubitril/valsartan.
If you are taking any of the following medicines, the risk of angioedema may be
increased:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus) and other drugs belonging to the class of mTOR inhibitors;
• vildagliptin, a medicine used to treat diabetes. Warnings and precautionsTalk to your doctor or pharmacist before taking Lisinopril Zentiva.

Use this medicine with caution and tell your doctor if you have any of the following conditions:

• if you have heart problems (heart failure, heart attack);
• if you have a narrowing of the aorta (aortic stenosis), a narrowing of some heart valves (aortic and mitral valve) or if you have a thickening of the heart muscle (hypertrophic cardiomyopathy);
• if you have a narrowing (stenosis) of the renal artery;
• if you have kidney problems or are on dialysis;
• if you have high levels of cholesterol in your blood and are undergoing a treatment called "LDL apheresis";
• if you have liver problems;
• if you have problems with blood vessels (collagen vascular disease);
• if you are of Black race as you have a greater risk of developing angioedema, a serious allergic reaction;
• if you have or are at risk of having high levels of potassium in your blood;
• if you have diabetes;
• if 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 suffer from kidney problems related to diabetes;
• aliskiren.
• if you are taking any of the following medicines used to prevent organ transplantation (sirolimus, everolimus, temsirolimus).
• if you are taking a neprilysin inhibitor (NEP) (such as racecadotril - a medicine for the treatment of diarrhea).
• if you are taking a medicine that can cause angioedema. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals.

Be particularly careful if you are undergoing or are about to start treatment to reduce the effects of an allergy such as that for insect stings (desensitizing treatment).
Tell your doctor if you develop a persistent dry cough after starting treatment with
this medicine.
If you are going to have surgery (including dental surgery) tell your doctor or
dentist that you are taking Lisinopril Zentiva.

Children and adolescents
Lisinopril has been studied in children. For more information, please consult your doctor. Lisinopril
Zentiva is not recommended in children under 6 years of age or in children with severe
kidney problems.

Other medicines and Lisinopril Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Lisinopril Zentiva can affect the mechanism of action of other medicines and some medicines
can have an effect on Lisinopril Zentiva.
In particular, tell your doctor or pharmacist if you are taking, have recently taken or
might take any of the following medicines:
potassium supplements (including salt substitutes), potassium-sparing diuretics and other
medicines that may increase the amount of potassium in your blood (such as
trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, a
immunosuppressant medicine used to prevent rejection of transplanted organs; and
heparin, a medicine used to thin the blood and prevent the formation of clots)

• sacubitril / valsartan - a medicine used to treat a type of long-term (chronic) heart failure in adults (see also the information under the heading "Do not take Lisinopril Zentiva");
• other medicines that lower blood pressure (antihypertensives);
• medicines that promote the elimination of urine (diuretics, especially those so-called potassium-sparing);
• ;
• medicines for depression (tricyclic antidepressants);
• medicines used for mental health problems (antipsychotics), including lithium;
• drugs used to relieve pain and inflammation (NSAIDs);
• gold salts, such as sodium aurothiomalate, used for the treatment of arthritis;
• medicines used to treat diabetes (insulins and oral medicines);
• medicines used to treat asthma and colds (sympathomimetic medicines);
• medicines used to reduce platelet aggregation (acetylsalicylic acid);
• medicines to dissolve blood clots (thrombolytics);
• medicines used for some heart rhythm disorders (beta-blockers);
• medicines for heart problems (nitrates);
• allopurinol (medicine for gout);
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may be increased:
• racecadotril, a medicine used to treat diarrhea (see also "Warnings and Precautions");
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus) and other drugs belonging to the class of mTOR inhibitors (used to prevent organ rejection);
• sacubitril/valsartan - a medicine used to treat a type of long-term (chronic) heart failure in adults (see also “Do not take Lisinopril Zentiva”);
• vildagliptin, a medicine used to treat diabetes.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
Tell your doctor if you think you may be (or might become) pregnant. Usually your doctor will advise
you to stop taking Lisinopril Zentiva before you start trying to become pregnant or as soon as you know you
are pregnant and will advise you to take another medicine instead of Lisinopril Zentiva. The use of
this medicine is not recommended in the first months of pregnancy and must not be taken
after the first trimester of pregnancy, as it can cause serious problems for the baby if used
after the third trimester of pregnancy.

Breastfeeding
The use of this medicine is not recommended if you are breastfeeding, especially if
the baby is newborn or premature.

Driving and using machines
When driving vehicles or using machines, you should consider that
dizziness or fatigue may occasionally occur.

Lisinopril Zentiva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”

3. How to take Lisinopril Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take the dose once a day, approximately at the same time each day. It is not
important whether Lisinopril Zentiva is taken before or after meals.
The doctor will adjust the dosage and duration of treatment based on your needs and your
response to treatment.

Treatment of high blood pressure: the initial dose is usually 10 mg once a
day. The maintenance dose is usually 20 mg once a day. Your doctor
may gradually increase the dose until obtaining the best possible control of your
blood pressure, up to 80 mg per day.

Treatment of heart failure: lisinopril can be used in addition to other
medicines (e.g. diuretics, digitalis or beta-blockers) prescribed to treat this disease
of the heart: the recommended initial dose is 2.5 mg once a day which can be increased
gradually, usually up to 35 mg per day, to obtain the best control of blood
pressure.

Treatment in people who have had a heart attack: lisinopril can be used in addition
to other medicines prescribed to treat this heart disease; treatment is started
with an initial dose of 5 mg, within 24 hours of the attack, and 5 mg after 24 hours, 10 mg after 48 hours
and then 10 mg once a day. A lower daily dose of 2.5 mg may be administered
for those with low blood pressure or kidney problems.
The maintenance dose is usually 10 mg once a day for at least 6 weeks.

Treatment of kidney problems caused by diabetes:the recommended dose is 10 mg
once a day which can be increased, if necessary, up to 20 mg per day.

Use in people with kidney problems and in the elderly
If you are elderly, have kidney problems or are taking diuretic medicines, your doctor may prescribe
a lower dose based on your kidney function.

Use in children and adolescents (from 6 to 16 years of age) with high blood pressure
The doctor will prescribe the correct dose for the child based on weight and kidney function. For
children weighing between 20 Kg and 50 Kg, the recommended initial dose is 2.5 mg once a day.
For children weighing over 50 Kg, the recommended initial dose is 5 mg per day.

If you take more Lisinopril Zentiva than you should
In case of overdose, you may experience the following symptoms: lowering of blood
pressure (hypotension) even severe, which may lead to shock, serious kidney
problems (renal failure), breathing rate (hyperventilation), perception of the heartbeat
(palpitations) and increase or decrease in the number of heartbeats (bradycardia or tachycardia),
dizziness, anxiety, cough, alteration of some blood tests (electrolyte disturbances).
If you ingest/take an excessive dose of this medicine consult
immediately your doctor or go to the nearest hospital.
If you forget to take Lisinopril Zentiva
If you forget to take a dose, take it as soon as you remember. However, if the next
dose is approaching, skip the forgotten dose.
Do not take a double dose to make up for the missed dose.

If you stop taking Lisinopril Zentiva
Do not stop taking the tablets, even if you feel well, unless your
doctor tells you to.
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.

Stop treatment with Lisinopril Zentivaand see your doctor immediatelyif you experience any of the following side effects:

• severe allergic reactions that cause swelling of the face, lips, tongue or throat, with difficulty swallowing and breathing, severe or sudden swelling of hands, feet and ankles, a feeling of intense itching, even with the appearance of blisters on the skin (hypersensitivity/angioedema). These situations are rare.
• severe skin disorders, such as a sudden and unexpected redness or burning, or peeling (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, cutaneous pseudolymphoma). These situations are very rare;
• infection with fever and worsening of general health conditions and with local symptoms such as sore throat or mouth or reduced amount of urine produced during the day (oliguria/anuria). These situations are very rare. Other possible side effects are:

Common(may affect up to 1 in 10 people)

• headache;
• feeling of dizziness or lightheadedness, especially when getting up quickly, caused by a sudden drop in blood pressure (orthostatic hypotension);
• vomiting and diarrhea;
• cough;
• kidney problems.

Uncommon(may affect up to 1 in 100 people)

• mood changes;
• dizziness;
• finger pain; change in the color of the fingers of the hands or feet (bluish color followed by redness) or numbness or tingling in the fingers of the hands or feet, caused by a problem with blood circulation (Raynaud's phenomenon);
• altered taste;
• sleep disturbances;
• stroke;
• fast heartbeat (tachycardia);
• perception of heartbeat (palpitations);
• runny nose (rhinitis);
• feeling unwell (nausea), stomach pain or indigestion;
• difficulty having an erection (impotence);
• feeling tired or weak (asthenia and fatigue);
• skin rash and itching;
• alteration of kidney and liver function, which is evident from blood tests;
• heart attack (myocardial infarction);
• hallucinations.

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

• mental confusion;
• change in the perception of smells (olfactory disorders);
• itchy skin rash (urticaria);
• dry mouth;
• hair loss (alopecia);
• psoriasis (skin disease);
• development of breasts in men (gynecomastia);
• alteration of some blood tests (decrease in hemoglobin, decrease in hematocrit, increase in bilirubin);
• alteration of the production of a type of hormone called antidiuretic hormone (SIADH);
• low levels of sodium in the blood (hyponatremia).

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

• reduction of white blood cells (agranulocytosis, leukopenia, neutropenia), red blood cells (anemia, hemolytic anemia) and platelets (thrombocytopenia);
• reduction of bone marrow activity (bone marrow depression);
• immune diseases (lymphadenopathy, autoimmune diseases);
• reduction of blood sugar levels (hypoglycemia);
• inflammation of the sinuses (sinusitis);
• shortness of breath due to bronchial obstruction (bronchospasm);
• inflammation of the lungs (allergic alveolitis, eosinophilic pneumonia);
• yellowing of the skin and the white of the eyes with dark coloration of the urine (jaundice);
• skin problems with peeling and blister formation (pemphigus);
• decreased urine production (oliguria);
• liver problems (liver failure, hepatocellular or cholestatic hepatitis);
• inflammation of the pancreas (pancreatitis).

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

• symptoms of depression;
• fainting (syncope).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system
at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store LISINOPRIL ZENTIVA

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 pack 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 protect the environment.

6. Contents of the pack and other information

What LISINOPRIL ZENTIVA contains
LISINOPRIL ZENTIVA 5 mg tablets

• The active ingredient is lisinopril (as lisinopril dihydrate). Each tablet contains 5 mg of lisinopril.
• The other ingredients are: mannitol, dibasic calcium phosphate dihydrate, pregelatinized maize starch, sodium croscarmellose, magnesium stearate.

LISINOPRIL ZENTIVA 20 mg tablets

• The active ingredient is lisinopril (as lisinopril dihydrate). Each tablet contains 20 mg of lisinopril.
• The other ingredients are: mannitol, dibasic calcium phosphate dihydrate, pregelatinized maize starch, sodium croscarmellose, magnesium stearate, red iron oxide, black iron oxide and yellow iron oxide.

Description of the appearance of LISINOPRIL ZENTIVA and contents of the pack
The score line on the tablet is to facilitate breaking it to make it easier to swallow and not to divide it into equal doses.
Packs of 14 tablets in blisters.

Marketing Authorisation Holder
Zentiva Italia S.r.l. – Via P. Paleocapa 7, 20121 Milano – Italy

Manufacturer
S.C. Zentiva S.A.
50 Theodor Pallady Bvd
3 district - 032266 Bucharest – Romania