Fosinopril Zentiva: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

FOSINOPRIL ZENTIVA 20 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to 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, contact your
doctor or pharmacist. See section 4.
Contents of this leaflet:

What Fosinopril Zentiva is and what it is used for
What you need to know before taking Fosinopril Zentiva
How to take Fosinopril Zentiva
Possible side effects
How to store Fosinopril Zentiva
Contents of the pack and other information

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

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

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

if you have high blood pressure (hypertension);
if you have a heart condition known as symptomatic heart failure, when the heart is unable to pump blood properly throughout the body.

This medicine must not be given to children.

2. WHAT YOU SHOULD KNOW BEFORE TAKING FOSINOPRIL ZENTIVA

Do not take Fosinopril Zentiva:

if you are allergic to fosinopril or to any of the other ingredients of this medicine (listed in section 6);
if you have previously had swelling of the legs, arms, face, mucous membranes or tongue (angioedema) during treatment with ACE inhibitors or due to an unknown cause, or if anyone in your family has had angioedema (this condition may be hereditary);
if you are taking or have taken sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults. Inform your doctor or pharmacist if you are currently taking, have recently taken, or may take sacubitril/valsartan;
if you are more than 3 months pregnant (it is better to avoid using Fosinopril Zentiva even in early pregnancy – see section “Pregnancy”);
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

When taking the first dose of Fosinopril Zentiva, the medicine may cause a more pronounced drop in blood pressure than may occur during continued treatment. You may experience dizziness or a sensation of emptiness in the head; in such cases, lying down may be helpful. If you are concerned about this, consult your doctor.

Stop taking Fosinopril Zentiva and contact your doctor immediately if you experience allergic reactions such as: difficulty breathing, with or without swelling of the face, lips, tongue and throat, which may lead to difficulty swallowing; severe itching of the skin (with swelling or puffiness).

Consult your doctor or pharmacist before taking Fosinopril Zentiva if:

You have kidney disease.
You have heart conditions (such as narrowing of certain blood vessels in the heart or thickening of the heart muscle).
You have:

low blood pressure – in this case, you may feel dizzy;
a sensation of emptiness in the head, especially when standing up;
kidney disease, or if you are undergoing haemodialysis;
liver disease;
high blood sugar levels (diabetes);
blood vessel disease (cerebrovascular disease);
diarrhoea or vomiting.

If you are on a low-salt diet, or if you are taking potassium supplements.

If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, e.g. in the throat) is increased: sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs), or neprilysin inhibitors (NEP) (such as racecadotril – a medicine used to treat diarrhoea).

If you are undergoing a procedure to remove bad cholesterol from the blood (LDL apheresis).

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 (e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes, or aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the section "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 during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy”).

Desensitisation treatment
If you are taking this medicine during desensitisation treatment, you may occasionally develop a more severe allergic reaction. If this applies to you, speak with your doctor.

If you are undergoing surgery
Inform your doctor or dentist that you are taking Fosinopril Zentiva before being given local or general anaesthesia, as there is a risk that your blood pressure may become very low during anaesthesia.

Blood tests
Fosinopril Zentiva may interfere with the results of certain blood tests, particularly digoxin levels and parathyroid function tests. In such cases, inform your doctor that you are taking Fosinopril Zentiva.

Cough
Cough may occur with the use of ACE inhibitors. Cough induced by ACE inhibitors should be considered in the differential diagnosis of cough.

Ethnic differences
Like other ACE inhibitors, Fosinopril Zentiva may be less effective in lowering blood pressure in black patients compared to patients of other ethnicities.

Other medicines and Fosinopril Zentiva
Inform 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 started treatment with any of the following medicines. Your doctor may need to adjust your dose and/or take other precautions:

sacubitril/valsartan – a medicine used to treat a type of chronic heart failure in adults (see also section "Do not take Fosinopril Zentiva");
diuretics (water tablets), including potassium-sparing diuretics such as spironolactone, triamterene or amiloride;
other medicines for treating high blood pressure (antihypertensives), such as beta-blockers or nitrates;
an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take Fosinopril Zentiva" and "Warnings and precautions");
non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin or high doses of acetylsalicylic acid (> 3 grams per day), used to treat arthritis and muscle pain;
medicines used to treat 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 co-trimoxazole, also known as trimethoprim/sulfamethoxazole);
medicines for treating diabetes such as insulin or oral antidiabetic medicines that lower blood sugar levels;
medicines that stimulate the central nervous system (sympathomimetics), including ephedrine, pseudoephedrine and salbutamol. These may be found in some decongestants (medicines for cough/cold and asthma);
medicines that suppress the body's immune response (immunosuppressants), treatment with allopurinol (for gout) or procainamide (for irregular heart rhythm);
antacids (used to neutralise stomach acidity, relieve indigestion and heartburn);
medicines to dissolve blood clots or low-dose acetylsalicylic acid (to prevent blood clot formation);
medicines to kill cancer cells;
corticosteroids taken orally or by injection (used e.g. as anti-inflammatory agents, to suppress immune response, or for hormone replacement therapy);
racecadotril (a medicine used to treat diarrhoea);
medicines usually used to prevent rejection of transplanted organs (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, as it may increase the blood pressure-lowering effect of Fosinopril Zentiva.

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

Pregnancy
You must inform 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 becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Fosinopril Zentiva is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Fosinopril Zentiva is not recommended for women who are breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
It is unlikely that Fosinopril Zentiva will affect your ability to drive or use machines. However, do not engage in activities requiring special attention, as adverse effects such as dizziness, low blood pressure and vertigo may interfere with driving or operating 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 exactly as your doctor has told you. If you have any doubts,
consult your doctor or pharmacist.
Dosage
The starting dose and maintenance dose depend on:

your health status;
whether you are taking other medicines.

Starting dose
The usual starting dose is 10 mg once daily.

Maintenance dose
The normal maintenance dose ranges from 10 mg to a maximum of 40 mg once daily.

How to take Fosinopril Zentiva
The tablet should be swallowed with water. You may take Fosinopril Zentiva with or without food. Always try to take the tablets at the same time each day.
Please remember that the first dose of Fosinopril Zentiva may cause a more pronounced drop in blood pressure than later doses during ongoing treatment. You may experience dizziness or a sensation of emptiness in the head; in such cases, lying down may be helpful. If this concerns you, consult your doctor as soon as possible.

If you take more Fosinopril Zentiva than you should
If you have taken more than the prescribed amount (overdose), contact your doctor or the nearest hospital immediately, especially if you experience any of 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;
increased breathing rate;
fast heartbeat;
slow heartbeat;
palpitations;
dizziness;
anxiety;
cough.

If you forget to take Fosinopril Zentiva
If you forget to take a dose, do not take a double dose to make up for the missed dose. Simply continue taking the medicine as you normally do.

If you stop taking Fosinopril Zentiva
Do not stop taking the tablets even if you feel better. It is important that you continue taking Fosinopril Zentiva for the entire duration prescribed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Stop taking Fosinopril Zentiva and contact your doctor immediately if you experience allergic reactions such as:

difficulty breathing, with or without swelling of the face, lips, tongue, and throat, which may lead to difficulty swallowing;
severe skin itching (with swelling or swellings).

Fosinopril Zentiva may reduce the number of white blood cells in the blood and decrease resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of your general health condition, or fever with signs of local infection such as sore throat/pharynx/mouth or urinary problems, you must contact your doctor immediately. A blood test will be required to check for a possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about this medicine.

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

headache, dizziness
rapid heartbeat, low blood pressure, dizziness when standing up quickly
feeling unwell, nausea, vomiting, diarrhoea
cough
skin redness, angioedema (swelling), dermatitis (skin disease)
chest pain (not heart-related), weakness
changes in laboratory tests (increased levels of alkaline phosphatase, bilirubin, LDH, and transaminases)

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

changes in blood tests (temporary decrease in haemoglobin levels, reduced haematocrit, increased levels of urea and creatinine)
decreased appetite, mood changes, confusion
cerebrovascular events (cerebral infarction), tingling sensation (altered sensitivity), drowsiness, stroke, syncope (transient loss of consciousness), taste disturbances, tremor, sleep disorders
vision disturbances, earache, ringing in the ears (tinnitus), vertigo
heart diseases
high blood pressure, shock, temporary reduction in blood supply to specific organs
shortness of breath, runny nose (rhinitis), inflammation of the nasal septum, breathing difficulties
constipation, dry mouth, flatulence
sticky skin, itching, urticaria
muscle pain
kidney diseases
sexual dysfunction
fever, swelling of limbs, sudden death, chest pain
weight gain
gout (painful joint inflammation due to deposition of urate crystals in joints)
increased potassium levels in blood

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

difficulty speaking, memory loss, disorientation
difficulty swallowing, tongue swelling
redness, bleeding, peripheral vascular disease
difficulty breathing, nosebleeds, hoarseness or loss of voice, lung infection (pneumonia), lung congestion
oral cavity lesions
inflammation of the pancreas or liver
skin bruising, arthritis (joint inflammation)
prostate disorders
weakness (loss of strength) in one arm and/or leg
stomach distension
increased haemoglobin levels or decreased sodium levels in blood

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

loss of white blood cells (agranulocytosis)
intestinal swelling (intestinal angioedema)
severe stomach pain with swelling, intestinal cramps, and vomiting [(sub)ileus]
kidney or liver disorders (failure)

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

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse 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 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 medicines via wastewater 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 Fosinopril Zentiva contains
The active substance is fosinopril sodium. Each tablet contains 20 mg of fosinopril.
The other ingredients are: monohydrate lactose, sodium croscarmellose, pregelatinized starch
(maize), microcrystalline cellulose and glyceryl dibehenate.

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

Blister packs containing 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets
Tablet containers containing 50, 100, 250 and 500 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l. - Viale Bodio, 37/b, 20158 Milano, Italy

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

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy, Portugal: Fosinopril Zentiva