FOSINOPRIL 20 mg Tabletki

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1. FOSINOPRIL ZENTIVA 20 mg tablets
   1. WHAT IS FOSINOPRIL ZENTIVA AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING FOSINOPRIL ZENTIVA
   3. HOW TO TAKE FOSINOPRIL ZENTIVA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FOSINOPRIL ZENTIVA

FOSINOPRIL ZENTIVA 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 their
symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or
pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS FOSINOPRIL ZENTIVA AND WHAT IS IT USED FOR

What is Fosinopril Zentiva
Fosinopril Zentiva belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).
Fosinopril Zentiva works by widening blood vessels. This helps to lower blood pressure and makes it easier for the heart to pump blood to all parts of the body.

What is Fosinopril Zentiva used for
Your doctor has prescribed Fosinopril Zentiva for one of the following conditions:

• if you have high blood pressure (hypertension);
• if you suffer from a heart condition known as symptomatic heart failure, when the heart does not pump blood into your body as it should.

This medicine should not be given to children.

2. WHAT YOU NEED TO KNOW BEFORE TAKING FOSINOPRIL ZENTIVA

Do not take Fosinopril Zentiva:

• if you are allergic to fosinopril or any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced swelling of the legs, arms, face, mucous membranes or tongue (angioedema) while taking ACE inhibitors or for another unknown reason, or if someone in your family has suffered from angioedema (this condition may be hereditary);
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults. Tell your doctor or pharmacist if you are taking, have recently taken or might take sacubitril/valsartan;
• if you are pregnant for more than 3 months (it is best to avoid using Fosinopril Zentiva even at the beginning of pregnancy - see the section “Pregnancy”).
• 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. Warnings and precautionsWhen you take the first dose of Fosinopril Zentiva, the medicine may cause a more significant lowering of blood pressure than may occur with continued therapy. You may experience dizziness or a feeling of lightheadedness, in which case it may be helpful to lie down. If this condition worries you, consult your doctor. Stop taking Fosinopril Zentiva and contact your doctor immediately if you have allergic reactions such as:difficulty breathing, with or without swelling of the face, lips, tongue and throat that can lead to difficulty swallowing; intense skin itching (with swelling or swelling). Consult your doctor or pharmacist before taking Fosinopril Zentiva:If you suffer from kidney disease. If you suffer from heart conditions (narrowing of some blood vessels of the heart or an enlargement of the heart muscle). If you suffer from:
• low blood pressure. In this case, you may experience dizziness;
• a feeling of lightheadedness, especially when getting up;
• kidney disease, or if you are on hemodialysis;
• liver disease;
• high blood sugar (diabetes);
• blood vessel disease (cerebrovascular disease);
• diarrhea or vomiting. If you are following a low-salt diet, if you are taking potassium supplements. If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is greater: sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to prevent organ rejection after transplantation) or neprilysin inhibitors (NEP) (such as racecadotril - a medicine used to treat diarrhea). If you are undergoing a procedure that removes bad cholesterol from the blood (LDL apheresis). If you are taking one 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.

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g., potassium) in your blood at regular intervals.
See also what is reported under the heading "Do not take Fosinopril Zentiva”.
If you think you may be pregnant (or if there is a possibility of becoming pregnant).
Fosinopril Zentiva is not recommended at the beginning of pregnancy and should not be taken
if you are pregnant for more than 3 months, as it can cause serious harm to the baby if
taken during this period (see section “Pregnancy”).

Desensitization treatment
If you are taking this medicine during treatment, you may sometimes experience a more severe allergic reaction. If this applies to you, you should talk to your doctor.

If you are going to have surgery
Tell your doctor or dentist if you are taking Fosinopril Zentiva before you are
given a local or general anesthetic because there is a risk that your blood pressure
may become very low during anesthesia.

Blood test
Fosinopril Zentiva may interfere with the results of some blood tests, particularly with the
measurement of digoxin and with the parathyroid function test. In this case, you should tell
your doctor that you are taking Fosinopril Zentiva.

Cough
With the use of ACE inhibitors, a cough may occur. ACE inhibitor-induced cough should
be considered as part of the differential diagnosis of cough.

Ethnic differences
As with other ACE inhibitors, Fosinopril Zentiva may be less effective in lowering
blood pressure in people of black ethnicity compared to people of other ethnicities.

Other medicines and Fosinopril Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, it is important that your doctor knows if you have already started treatment with any
of the following medicines. Your doctor may need to adjust the dose and/or take
other precautions:

• sacubitril/valsartan - a medicine used to treat a type of long-term (chronic) heart failure in adults (see also what is reported under the heading "Do not take Fosinopril Zentiva");
• diuretics (water pills), which include potassium-sparing medicines such as spironolactone, triamterene or amiloride;
• other medicines for the treatment of high blood pressure (antihypertensives), such as beta-blockers or nitrates;
• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also what is reported under the heading "Do not take Fosinopril Zentiva" and "Warnings and precautions");
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as indomethacin or high doses of acetylsalicylic acid (> 3 grams per day), used for the treatment of arthritis and muscle pain;
• medicines used in the treatment of mental disorders such as lithium, antipsychotics and tricyclic antidepressants;
• potassium tablets or salt substitutes containing potassium, or other products associated with increased potassium levels in the blood (e.g., heparin and cotrimoxazole also known as trimethoprim/sulfamethoxazole);
• medicines for the treatment of diabetes such as insulin or oral medicines that lower blood sugar levels;
• medicines that stimulate the nervous system (sympathomimetics). These include ephedrine, pseudoephedrine and salbutamol. They may be present in some decongestants (medicines for the treatment of cough/cold and asthma);
• medicines that suppress the body's immune response (immunosuppressants), treatment with allopurinol (for gout) or procainamide (for irregular heartbeat);
• antacids (used to neutralize stomach acid, relieve indigestion and heartburn);
• medicines to dissolve blood clots or a low dose of acetylsalicylic acid (to prevent blood clot formation);
• medicines to kill cancer cells;
• corticosteroids taken by mouth or by injection (used, for example, as anti-inflammatory drugs, to suppress the immune response or for hormone replacement therapy).
• Racecadotril (a medicine used against diarrhea)
• medicines usually used to prevent organ rejection after transplantation (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Fosinopril Zentiva with food, drinks and alcohol
You should avoid drinking alcohol during treatment because it can increase the blood pressure-lowering effect of Fosinopril Zentiva.

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 using this medicine.

Pregnancy
You should tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will advise you to stop taking Fosinopril Zentiva before
a pregnancy or as soon as you are certain you are pregnant and will advise you to take another
medicine instead of Fosinopril Zentiva. Fosinopril Zentiva is not recommended at the beginning of
pregnancy and should not be taken if you are pregnant for more than 3 months, as it can
cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding.
Fosinopril Zentiva is not recommended for women who are breastfeeding and your doctor may
choose another treatment if you wish to breastfeed, especially if the baby is newborn or is
premature.

Driving and using machines
It is unlikely that Fosinopril Zentiva will affect your ability to drive vehicles or use machines.
However, do not engage in activities that require special attention because adverse reactions such as
dizziness, low blood pressure and lightheadedness may interfere with driving or using
machinery.

Fosinopril Zentiva contains lactose monohydrate and sodium
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”.
When the recommended dose is less than 20 mg, an alternative medicine based on manidipine should be used.

3. HOW TO TAKE FOSINOPRIL ZENTIVA

Take this medicine following exactly the instructions of your doctor. If you have any doubts,
consult your doctor or pharmacist.

Dosage
The initial dose and the maintenance dose depend on:

• your state of health;
• whether you are taking other medicines. Initial doseThe usual initial dose is 10 mg to be taken once a day. Maintenance doseThe normal maintenance dose ranges from 10 mg to a maximum of 40 mg taken once a day. How to take Fosinopril ZentivaThe tablet must be swallowed with water. You can take Fosinopril Zentiva with or without food. Always try to take the tablets at the same time each day. Remember that the first dose of Fosinopril Zentiva may cause a more pronounced drop in blood pressure than may occur with continued therapy. You may feel dizzy or lightheaded, in which case it may be helpful to lie down. If this condition worries you, consult your doctor as soon as possible.

If you take more Fosinopril Zentiva than you should
If you have taken more than you should (overdose), contact your doctor or the nearest hospital
immediately, especially if you experience the following symptoms:

• low blood pressure;
• circulatory shock (inadequate blood flow through the body);
• electrolyte disturbances (imbalance of certain ionized salts in the blood);
• kidney failure;
• faster breathing rate;
• fast heartbeat;
• slowed heartbeat;
• palpitations;
• dizziness;
• anxiety;
• cough. If you forget to take Fosinopril ZentivaIf you forget to take a dose, do not take a double dose to make up for the missed dose. Simply continue taking it as you normally do. If you stop taking Fosinopril ZentivaDo not stop taking the tablets even if you feel better. It is important that you continue to take Fosinopril Zentiva for the entire period prescribed by your 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 everybody gets them.
Stop taking Fosinopril Zentiva and contact your doctor immediately if you have allergic reactions such as:

• difficulty breathing, with or without swelling of the face, lips, tongue and throat which may lead to difficulty swallowing;
• intense itching of the skin (with swelling or lumps). Fosinopril Zentiva may cause a decrease in the number of white blood cells in the blood and decrease resistance to infections. If you have an infection with symptoms such as fever and a significant worsening of your general health, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, you should see your doctor immediately. You will need a blood test to check for a possible decrease in white blood cells (agranulocytosis). It is important to inform your doctor about the medicine.

The following side effects may occur:
Common side effects(may affect up to 1 in 10 people):

• headache, dizziness
• fast heartbeat, low blood pressure, dizziness when getting up quickly
• feeling unwell, vomiting, diarrhea
• cough
• skin rash, angioedema (swelling), dermatitis (skin disease)
• chest pain (not related to the heart), weakness
• changes in laboratory tests (increased levels of alkaline phosphatase, bilirubin, LDH and transaminases). Uncommon side effects(may affect up to 1 in 100 people):
• changes in blood tests (temporary decrease in hemoglobin values, reduced hematocrit, increased levels of urea, creatinine)
• loss of appetite, mood changes, confusion
• cerebral accidents (stroke), tingling sensation (altered sensitivity), drowsiness, stroke, syncope (temporary loss of consciousness), altered taste, tremor, sleep disorders
• vision problems, earache, ringing in the ears, vertigo
• heart disease
• high blood pressure, shock, temporary decrease in blood supply to specific organs
• shortness of breath, runny nose (rhinitis), inflammation of the nasal septum, difficulty breathing
• constipation, dry mouth, flatulence
• sticky skin, itching, hives
• muscle pain
• kidney disease
• sexual dysfunction
• fever, swelling of the limbs, sudden death, chest pain
• weight gain
• gout (painful inflammation of the joints due to the deposition of uric acid crystals in the joints)
• increased levels of potassium in the blood. Rare side effects(may affect up to 1 in 1,000):
• difficulty speaking, memory loss, disorientation
• difficulty swallowing, swelling of the tongue
• redness, bleeding, peripheral vascular disease
• difficulty breathing, nosebleeds, hoarseness or loss of voice, lung infection (pneumonia), congestion of the lungs

A complex of symptoms including fever, muscle and joint pain, rash, sensitivity to sunlight and changes in blood has been reported.

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
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 FOSINOPRIL ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date which is stated on the packaging/blister after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6CONTENTS OF THE PACK AND OTHER INFORMATION
What Fosinopril Zentiva contains
The active ingredient is fosinopril sodium. Each tablet contains 20 mg of fosinopril.
The other ingredients are: lactose monohydrate, sodium croscarmellose, pregelatinized starch
(corn), microcrystalline cellulose and dibeenate glycerol.

Description of the appearance of Fosinopril Zentiva and contents of the pack
Fosinopril Zentiva 20 mg tablets are round, whitish in color, with the inscription
"FL20".
Fosinopril Zentiva is available in:

• Blisters in packs of 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets
• Tablet containers in packs of 50, 100, 250 and 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l. - Viale Bodio, 37/b, 20158 Milan

Manufacturer
Balkanpharma Dupnitsa AD - 3 Samokovsko Shose Str., Dupnitsa 2600, Bulgaria

This medicinal product is authorised in the Member States of the European Economic
Area under the following denominations:
Italy, Portugal Fosinopril Zentiva