Patient Information Leaflet

Eliten 20 mg tablets

Fosinopril sodium salt
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 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:

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

1. What Eliten is and what it is used for

The active substance of Eliten is fosinopril sodium, which belongs to a group of medicines called ACE
inhibitors (angiotensin-converting enzyme inhibitors).
Eliten is indicated for the treatment of the following conditions:
arterial hypertension (high blood pressure);
heart failure (a condition in which the heart is unable to pump enough blood to meet the body’s needs).

2. What you should know before taking Eliten

Do not take Eliten

if you are allergic to fosinopril or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to ACE inhibitors (medicines of the same type as Eliten);
if you have a history of angioedema (swelling of various body parts, especially eyes, lips, tongue, throat, genitals, hands and feet), with or without previous treatment with ACE inhibitors (medicines that lower blood pressure);
if you are anuric (you do not regularly eliminate urine);
if you are more than three months pregnant (see section “Pregnancy and breastfeeding”);
if you have diabetes (high blood sugar levels) or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren (see section “Other medicines and Eliten”);
to treat a child, as the use of Eliten in pediatric patients is not recommended;
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat);
if you are taking any of the following medicines, as the risk of angioedema may be increased:
- racecadotril, a medicine used to treat diarrhoea;
- medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus);
- vildagliptin, a medicine used to treat diabetes.

Warnings and precautions
Talk to your doctor or pharmacist before taking Eliten.
Exercise particular caution with Eliten:

If during treatment you experience swelling of the extremities, face, lips, mucous membranes, tongue or throat, or abdominal pain with or without nausea and vomiting, as cases of angioedema or intestinal angioedema (swelling due to fluid accumulation, including in the intestine) have been reported with ACE inhibitors, including fosinopril, especially after initial doses (rarely also observed after prolonged treatment). In such cases, stop treatment with this medicine immediately and contact your doctor or the nearest hospital for symptom management and replacement of Eliten with another antihypertensive medicine. Swelling of the tongue and/or throat may cause severe breathing difficulties (airway obstruction), which can be fatal.
If you are undergoing immunotherapy to reduce allergic reactions to insect stings (e.g. bees, wasps, etc.), due to the risk of severe and prolonged allergic (anaphylactoid) reactions, especially if you have previously experienced allergic reactions. In this case, you should be prescribed a different type of antihypertensive medicine.
If you are at risk of experiencing a significant drop in blood pressure (hypotension), especially after the first dose. Your risk is higher:
- if you are dehydrated (e.g. due to vomiting, low-salt diet, dialysis, diarrhoea or intensive diuretic therapy), or if you are undergoing renal dialysis. In such cases, restoration of electrolyte balance is required;
- if you have kidney problems (renal insufficiency);
- if you have severe heart problems (severe heart failure or congestive heart failure, with or without renal insufficiency), ischemic heart disease, or cerebrovascular disorders (altered blood flow to the brain). In such cases, your treatment should be closely monitored by a doctor, preferably in a hospital setting, to avoid potentially fatal complications;
- if you are elderly. At the beginning of treatment, your doctor may perform careful monitoring and assess kidney function;
- if you are taking medicines that increase urine production (diuretics). It may be necessary to discontinue or reduce the dose of diuretics;
- if you have low sodium levels in the blood. It may be necessary to discontinue or reduce the dose of diuretics. The effect of a pronounced blood pressure reduction is most evident during the first 2 weeks of treatment or with dose increases, then normalizes without loss of medicine efficacy.
If you are taking any of the following medicines for high blood pressure:
- an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
- “aliskiren”, as you are at increased risk of excessive blood pressure drop, high potassium levels and kidney failure (including severe). Concomitant use of these medicines is not recommended (see section “Other medicines and Eliten”); if administration is considered strictly necessary, you should take the medicines only under specialist supervision. Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals. In no case should you take these medicines together with Eliten if you have kidney problems caused by diabetes (diabetic nephropathy).
If you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling, e.g. in the throat) is increased:
- sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs).
If you discover you are pregnant during treatment with Eliten; in this case, stop treatment immediately and consult your doctor, as administration of ACE inhibitors (medicines like Eliten) during pregnancy has been associated with fetal harm or death.
If you have or have had kidney problems; you are at higher risk of severe drops in blood pressure and kidney dysfunction:
- if you have heart problems (congestive heart failure);
- if you have high blood pressure caused by reduced blood flow to one or both kidneys (renovascular hypertension);
- if you are severely dehydrated. Signs of kidney dysfunction include increased creatinine, nitrogen and potassium levels in the blood, protein in the urine and changes in urine volume, which resolve upon discontinuation of treatment. You may experience mild and transient increases in blood nitrogen and creatinine levels even if you appear to have no kidney function problems, especially if you are also taking diuretic medicines. In such cases, discontinuation of diuretic therapy or dose reduction, or discontinuation of Eliten, may be required due to the risk of acute kidney failure, potentially fatal.
If you have reduced liver function (e.g. severe liver insufficiency, alcoholic or biliary cirrhosis). If during treatment you develop symptoms of liver problems, such as yellowing of the skin or whites of the eyes (jaundice) or increased liver enzymes, stop treatment with Eliten immediately and contact your doctor or the nearest hospital, as in rare cases a severe, potentially fatal liver condition (fulminant hepatic necrosis) may occur.
If you are at risk of high potassium levels in the blood, for example if you have kidney or heart failure, diabetes mellitus, or if you are simultaneously taking potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes, or other medicines that may increase blood potassium levels, such as heparin (an anticoagulant) and co-trimoxazole (also known as trimethoprim/sulfamethoxazole). In these situations, regular monitoring of blood potassium levels is advisable.
If you are scheduled for surgery or anesthesia, as the use of Eliten may enhance the blood pressure-lowering effect. If discontinuation of Eliten is not possible, your doctor should carefully monitor your blood volume.
If you suffer from collagen vascular diseases such as Systemic Lupus Erythematosus (SLE) or scleroderma (both serious immune system disorders) and/or kidney failure, or if you are being treated with immunosuppressive medicines: you are at risk of severe reduction in white blood cell count (agranulocytosis) and bone marrow suppression (impaired blood cell production). In this case, you should have periodic white blood cell counts and immediately report any signs of infection (e.g. sore throat, fever) to your doctor, which may indicate low neutrophil levels (neutropenia).
If you develop a persistent dry cough; this symptom resolves upon discontinuation of treatment.
If you have an abnormally narrowed aortic valve (the main artery from the heart), as Eliten may reduce blood flow velocity to the heart.

Children
The efficacy and safety of Eliten in children have not yet been established; therefore, use of this medicine is not recommended in children.

Other medicines and Eliten
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Your doctor may need to adjust the dose and/or take additional precautions:
if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also “Do not take Eliten” and “Warnings and precautions”).
Inform your doctor especially if you are taking:

Diuretics (medicines that increase urine production): concomitant use may excessively lower blood pressure (especially in the first hours after administration), particularly if you have taken high doses of diuretics, are on a low-salt diet or are undergoing haemodialysis.
Medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other mTOR inhibitors). See section “Warnings and precautions”.
Potassium supplements (including salt substitutes), potassium-sparing diuretics (medicines that increase urine production without causing potassium loss, such as spironolactone, amiloride, triamterene and others) and other medicines that may increase blood potassium levels (such as trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting).
Medicines for stomach acidity (aluminium hydroxide, magnesium hydroxide, simeticone): may slightly reduce intestinal absorption of Eliten. Take Eliten at least two hours apart from these medicines.
Lithium (used to treat certain psychiatric disorders): concomitant use may increase lithium blood levels and cause symptoms of toxicity. If you are on lithium therapy, have frequent blood lithium level checks.
Anaesthetics (used in surgery): use of Eliten may enhance the blood pressure-lowering effect of some anaesthetics.
Narcotics (very strong painkillers) and antipsychotics (medicines for treating certain psychiatric disorders): concomitant administration may cause drops in blood pressure upon standing (orthostatic hypotension).
Medicines for diabetes (oral hypoglycaemics or insulin): concomitant use of Eliten may enhance blood sugar-lowering effects, increasing the risk of hypoglycaemia. The risk is higher especially during the first weeks of combined treatment and if you have reduced kidney function.
Indomethacin (used for inflammation and pain): reduces the effectiveness of medicines like Eliten, especially if you have high blood pressure with low levels of a kidney enzyme (low-renin hypertension).
Non-steroidal anti-inflammatory drugs (NSAIDs): concomitant administration may reduce the blood pressure-lowering effect of Eliten and increase the risk of worsening kidney function (including possible acute kidney failure and increased blood potassium levels), especially if you have kidney disease. If concomitant use cannot be avoided, exercise particular caution, especially if you are elderly. You should be adequately hydrated and your doctor should consider monitoring kidney function at the start of treatment.
Medicines that stimulate the nervous system (sympathomimetics): may reduce the blood pressure-lowering effect of Eliten.
Allopurinol (a medicine for gout), cytostatic agents or immunosuppressants (medicines to lower immune defences, e.g. before or after transplantation), systemic corticosteroids (anti-inflammatory medicines) or procainamide (a medicine for cardiac rhythm disorders): concomitant use of these medicines may increase the risk of leucopenia (low white blood cell count).

Interactions with laboratory tests
Eliten may interfere with certain laboratory tests measuring blood digoxin levels (a medicine used for cardiac rhythm disorders).
In addition, it is advisable to discontinue Eliten treatment a few days before undergoing parathyroid function tests.

Eliten and alcohol
If you consume alcohol during treatment with Eliten, your blood pressure may drop more than normal.

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

Pregnancy
Avoid use of this medicine during the first trimester of pregnancy, as it is not recommended.
Do not use this medicine during the second and third trimesters of pregnancy (see section “Do not take Eliten”), as it is contraindicated due to the risk of serious harm to the fetus (e.g. blood pressure problems, kidney problems, skull abnormalities and death).
Inform your doctor immediately if you become pregnant, as treatment with this medicine must be stopped immediately and, if appropriate, you should start alternative therapy.
Do not start treatment with this medicine during pregnancy. If you are planning a pregnancy, inform your doctor immediately so that alternative antihypertensive treatments with a proven safety profile in pregnancy can be prescribed, unless continuation of therapy with a medicine like this is considered essential. If an alternative therapy is not possible, your doctor will evaluate discontinuation of treatment together with you, informing you of the potential risks to the fetus and to yourself.

Breastfeeding
Do not take this medicine while breastfeeding, as there are insufficient data to establish its safety. This medicine may pass into breast milk and its effect on the infant has not been determined. Use alternative treatments with a proven safety profile during breastfeeding, especially if your baby is newborn or premature.

Driving and using machines
Although this medicine does not usually affect the ability to drive or operate machinery, very rarely adverse effects such as dizziness and visual disturbances may occur.

Eliten contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Eliten

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose and total duration of treatment will be determined by your doctor.
Recommended doses are:

Hypertension The recommended initial dose of Eliten is 10 mg once daily. Your daily dose may be adjusted by your doctor according to your response to treatment (blood pressure). The daily dose required to maintain stable blood pressure control ranges between 10–40 mg. Most patients achieve adequate blood pressure control with a single daily dose of 20 mg (1 tablet per day). In some patients receiving once-daily dosing, a reduction in antihypertensive effect may occur towards the end of the dosing interval. In such cases, your doctor should consider twice-daily dosing. If blood pressure is not adequately controlled with Eliten alone, your doctor may prescribe an additional diuretic medicine (which increases urine production).
Heart failure The recommended initial dose is 10 mg once daily. You must start therapy only under medical supervision. If the initial dose is well tolerated, your doctor may increase the dose, according to your response to treatment (carefully monitoring for excessive drops in blood pressure), up to a maximum of 40 mg (2 tablets) once daily.

Use in high-risk patients
If you are considered a high-risk patient, the first dose of an ACE inhibitor medicine
may cause a marked drop in blood pressure (see section “Warnings and
precautions”).
If you suffer from malignant hypertension or severe heart failure, initiation of therapy or dose adjustment should be performed in a hospital setting.
Use in children and adolescents
The use of Eliten in this age group is not recommended due to limited clinical experience.
Use in patients with impaired kidney or liver function
If you have severe renal or hepatic insufficiency, it is advisable to start therapy at the lowest dose of 10 mg under medical supervision; your doctor will subsequently adjust the dose according to your response to treatment.
If you take more Eliten than you should
In case of accidental ingestion or overdose of Eliten, contact your doctor immediately or go to the nearest hospital.
Cases of overdose with Eliten have not been reported. Symptoms of overdose with ACE inhibitors include: hypotension, shock, loss of consciousness, slowed heart rate, electrolyte imbalance, and renal failure.
If you forget to take Eliten
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
With Eliten, as with other ACE inhibitors, the following adverse reactions may occur:

Severe allergic reactions (anaphylactoid reactions) (see section “Warnings and precautions”)
Swelling of the skin and mucous membranes (angioedema)
Asthenia (weakness)
Tremors
Pain
Weakness, fever
Headache, dizziness, tingling (paraesthesia)
Chest pain
Muscle pain (myalgia), musculoskeletal pain
Syndrome including arthralgia/arthritis (joint inflammation)
Sleep disorders
Flushing (redness)
Viral infections
Depression, mood changes
Excessive sweating (hyperhidrosis)
Bruising (ecchymosis)
Peripheral edema (swelling of extremities)
Palpitations, changes in heart rhythm (arrhythmia)
Cardiac arrest, severe chest pain (angina), and heart attack
Excessive drop in blood pressure (hypotension), drop in blood pressure upon standing (orthostatic hypotension), and fainting (syncope)
Brain damage, hypertensive crisis, rapid heartbeat (tachycardia)
Stroke, transient ischaemic attack (lack of blood supply causing tissue damage in the brain)
Diseases of the veins in limbs (peripheral vasculopathies)
Inflammation of blood vessels (vasculitis)
Inflammation of a membrane (serositis)
Skin rash
Itching, dermatitis, and hives (urticaria)
Spotted skin irritation (erythema multiforme)
Loss of hair and body hair (alopecia)
Severe, potentially fatal skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Eye disorders, visual disturbances
Heartburn (dyspepsia)
Taste disturbances
Nausea and vomiting, diarrhoea, abdominal pain
Swelling of the tongue, difficulty swallowing (dysphagia), oral cavity lesions
Abdominal distension, changes in appetite/weight, constipation, gas in the intestine (flatulence)
Inflammation of the pancreas (pancreatitis), inflammation of the liver (hepatitis)
Yellowish skin discoloration due to liver dysfunction (cholestatic or hepatocellular jaundice)
Intestinal obstruction (paralytic ileus)
Dry mouth
Low white blood cell count (leucopenia, neutropenia, eosinophilia)
Deficiency of a type of white blood cells (agranulocytosis)
Reduction in the number of all blood cells (pancytopenia)
Excessive potassium concentration in the blood (hyperkalaemia)
Increased liver function tests (transaminases, blood lactate dehydrogenase, blood alkaline phosphatase, blood bilirubin)
Positive antinuclear antibodies (positive test for detecting immune system abnormalities)
Elevated erythrocyte sedimentation rate (ESR)
Gout (excess uric acid in the blood)
Gastrointestinal bleeding
Lymphatic system disorders (lymphadenopathy)
Balance disorders, memory disturbances, somnolence, confusion
Cough, sinus inflammation (sinusitis), infections of upper respiratory tract, nasal mucosa, throat and pharynx (rhinitis and pharyngitis)
Shortness of breath (dyspnoea), involuntary contraction of airway muscles (bronchospasm), lung inflammation (pneumonia, pulmonary congestion)
Laryngitis, hoarseness, nosebleeds
Inflammation of the trachea and bronchi (tracheobronchitis), lung pain
Syndrome characterised by cough, breathing difficulty, and low white blood cell count
Ringing in the ear (tinnitus), ear pain
Reduced kidney function (renal failure), prostate disorders
Sexual dysfunction
Urination disorders
Sudden death, cardio-respiratory arrest, shock

Additional adverse reactions in children
Safety data in children (paediatric population) treated with fosinopril are still limited. Only short-term exposure has been evaluated. During studies, the following adverse reactions were observed:

Headache
Low blood pressure (hypotension)
Cough
Increased potassium levels in the blood (hyperkalaemia)
Elevated serum creatinine levels (a waste product excreted in urine) and elevated serum creatine kinase levels (an enzyme that converts creatine). These elevated creatine kinase levels reported in this study differ from those observed in adults (even though transient and without clinical symptoms).

Following the instructions in the package leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Eliten

Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Eliten contains

The active substance is: fosinopril sodium. Each tablet contains 20 mg of fosinopril sodium.
The other components are: lactose, microcrystalline cellulose, crospovidone, povidone, sodium stearil fumarate.

What Eliten looks like and contents of the pack
Eliten is available in tablet form.
Each pack contains 14 tablets of 20 mg each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24 PPT3, Ireland

Manufacturer
ICN Polfa Rzeszów S.A., 2 Przemysłowa Street - 35-959 Rzeszów, Poland