Patient Information Leaflet

Fosinopril Aurobindo 10 mg tablets, 20 mg tablets

Equivalent medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Fosinopril Aurobindo is and what it is used for

Fosinopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Fosinopril binds to ACE in the body, thereby inhibiting the formation of angiotensin II, a substance that increases blood pressure. Angiotensin II also has a vasoconstrictive effect, narrowing the blood vessels. By inhibiting this substance, there is a reduction in pressure within the blood vessels and heart function may improve.
Fosinopril Aurobindo is prescribed if you have high blood pressure and if your heart is not functioning adequately; this is known as "heart dysfunction".

2. What you should know before taking Fosinopril Aurobindo

Do not take Fosinopril Aurobindo

if you are allergic to fosinopril sodium or to any of the other ingredients of this medicine (listed in section 6) or to other angiotensin-converting enzyme (ACE) inhibitors;
if you have previously experienced hypersensitivity reactions such as skin rashes and sudden fluid accumulation in the skin and mucous membranes (e.g. throat or tongue), difficulty breathing and/or itching and skin eruptions (known as angioedema) after taking an ACE inhibitor, or without any apparent cause, or if there is a history of such reactions in your family;
in cases of hereditary angioedema or angioedema of unknown cause;
if you are more than 3 months pregnant (it is best to avoid using Fosinopril Aurobindo 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
The initial dose of 10 mg has not been studied in patients over 75 years of age being treated
for heart failure, or in patients with severe NYHA class IV heart failure.
At the beginning of treatment with fosinopril 10 mg, a severe drop in blood pressure
or hyperkalemia (excess potassium in the blood) may occur in:

patients with severe heart failure (NYHA class IV)
elderly patients
patients with renal dysfunction treated for heart failure
patients with high blood pressure treated with diuretics

You must inform your doctor if you think you are (or could become) pregnant. Fosinopril is
not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as
it may cause serious harm to your baby if used at this stage (see section on pregnancy).
Talk to your doctor or pharmacist before taking Fosinopril Aurobindo:

If you have experienced excessive lowering of blood pressure. Although rare, this may occur after the first dose, if you are dehydrated (e.g. due to vomiting, low-salt diet, dialysis, diarrhoea or diuretic therapy), or if you have a certain type of high blood pressure (known as severe renin-dependent hypertension). Excessive lowering of blood pressure may also occur if you have heart failure. This risk is increased if you have severe heart failure and are using high doses of loop diuretics (a type of diuretic), if your blood sodium levels are too low (hyponatremia), or if your kidney function is reduced. If you are at higher risk of experiencing excessive lowering of blood pressure, you must be closely monitored at the beginning of treatment and whenever the dose is changed. This also applies if you have ischemic heart failure (a type of heart disease) or conditions affecting the blood vessels of the brain (cerebrovascular disorders). In such cases, treatment should be administered with particular caution, as a marked drop in blood pressure could lead to a heart attack or cerebral haemorrhage.
If your blood pressure drops too much. In this case, you should be placed in a supine position and, if necessary, given physiological saline solution by infusion. This does not mean that treatment must be discontinued. Once blood volume and blood pressure have been restored, treatment may be resumed, possibly at a lower dose, or continued as before.
If you have heart failure and your blood pressure is low or normal. A further reduction in blood pressure may occur. If this persists, it may be necessary to reduce the dose or discontinue treatment.
If you have aortic stenosis (narrowing of the main artery of the body), mitral valve stenosis (narrowing in the heart), or hypertrophic cardiomyopathy (thickening of the heart muscle wall). In such cases, you should use fosinopril with caution.
If you have impaired kidney function, no adjustment of the initial dose is necessary. In this case, potassium and creatinine levels in the blood should be monitored regularly.
If you have heart failure. A sudden drop in blood pressure caused by fosinopril may lead to poor kidney function and even acute kidney failure (which is usually temporary).
If you have renal artery stenosis (narrowing of one or both arteries leading to the kidneys), fosinopril may cause an increase in certain substances in the blood (e.g. so-called urea and creatinine levels may rise), especially if you have impaired kidney function.
If you have renovascular hypertension (high blood pressure due to narrowing of the artery leading to the kidneys), you are at increased risk of experiencing a severe drop in blood pressure and impaired kidney function. In this case, treatment should therefore be administered under close medical supervision, using low doses and cautious dose increases. In addition, any treatment with diuretics should be discontinued. Kidney function should be monitored during the first weeks of treatment.
Since in some patients with high blood pressure without renovascular disease (kidneys), fosinopril may cause an increase in certain substances in the blood (e.g. so-called urea and creatinine levels may rise). These increases are usually minor and temporary, particularly if fosinopril is administered concurrently with a diuretic. If this occurs, treatment should be discontinued. If necessary, treatment may be resumed later at a reduced dose. The risk of experiencing these adverse effects is higher in patients with pre-existing kidney disease.
In patients with pre-existing kidney dysfunction, proteinuria (excretion of protein in the urine) may rarely occur. If protein excretion exceeds 1 g per day, fosinopril may only be used after careful consideration of the benefits and risks and with regular monitoring of laboratory test results.
If you experience hypersensitivity reactions such as skin rashes and sudden fluid accumulation in the skin and mucous membranes (e.g. in the face, arms and/or legs, lips, tongue, throat or larynx), difficulty breathing and/or itching and skin rash (so-called angioedema). You must stop fosinopril immediately, appropriate measures must be taken, and you must be kept under close observation until symptoms have completely disappeared. If swelling involves the tongue, throat or larynx, the airways may become blocked, particularly if you have undergone any airway procedures. In such cases, emergency treatment must be administered immediately. If you have previously experienced angioedema while using any other medicine, you may be at increased risk of developing angioedema again.
If you are of Afro-Caribbean origin. Indeed, fosinopril may be less effective in some Afro-Caribbean patients. In addition, some Afro-Caribbean patients may be more prone to developing severe hypersensitivity reactions (angioedema, see previous warnings) compared to non-Afro-Caribbean patients.
If you are undergoing dialysis with high-flux membranes (e.g. AN 69). In this case, severe hypersensitivity reactions (anaphylactic reactions) may occur. For this reason, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agents (for blood pressure reduction).
During LDL apheresis (a type of treatment to remove cholesterol from the blood) with dextran sulfate. Indeed, rare but life-threatening hypersensitivity reactions may occur. These can be avoided by temporarily discontinuing fosinopril treatment before each apheresis session.
If this treatment is administered concurrently with therapy to reduce your allergy to insect venom (desensitisation therapy, e.g. against wasp and bee stings). Indeed, life-threatening hypersensitivity reactions may occur. These can be avoided by temporarily discontinuing fosinopril treatment.
Because this treatment has been associated with liver abnormalities that have occasionally led to death. If jaundice develops or a marked increase in specific liver substances in the blood is detected, fosinopril must be discontinued and appropriate follow-up treatment initiated.
Because blood abnormalities may occur. Blood abnormalities that may result from the use of fosinopril include a decrease in platelet count, accompanied by bruising and tendency to bleed (thrombocytopenia), changes in red blood cell count, possibly accompanied by anaemia, a reduction in certain white blood cells with sudden high fever, severe sore throat and mouth ulcers (agranulocytosis), and a deficiency of white blood cells accompanied by increased susceptibility to infections (neutropenia). Treatment must be discontinued if neutropenia develops or is suspected.
If you have a connective tissue disorder (e.g. systemic lupus erythematosus, a disease affecting the skin, internal organs, joints, kidneys and heart, similar to inflammation), if you are using medicines that suppress the immune system (immunosuppressants), or if you are being treated with allopurinol (a medicine for gout) or procainamide (used to treat heart rhythm disorders). You should use fosinopril with extreme caution, especially if you have impaired kidney function. In some cases, severe infections have developed, which sometimes did not respond to antibiotic treatment. Patients are advised to periodically check their white blood cell count and report any symptoms indicating infection.
During treatment with fosinopril, a dry cough may occur, which disappears when treatment is discontinued.
If you are scheduled for major surgery and/or anaesthesia. In such cases, excessive lowering of blood pressure may occur. Before any surgical procedure, you must therefore inform the anaesthetist (responsible for administering anaesthesia) that you are using fosinopril.
If you have impaired kidney function, if you have diabetes mellitus, if you are also using potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other

medicines that increase potassium in the blood, or if you are elderly. In these cases, fosinopril may
increase the amount of potassium in the blood. This may also occur without any apparent cause. If you need to use one or more of the above-mentioned medicines, regular monitoring of blood potassium levels is recommended.

If you have diabetes and are being treated with so-called oral antidiabetics (by mouth) or insulin (some agents used to treat diabetes), since fosinopril may affect blood sugar control. For this reason, you (or your doctor) should monitor the dosage of insulin and/or oral antidiabetic (by mouth) and, if necessary, adjust it during the first month of treatment with fosinopril.
If you are also using lithium (an antidepressant). Generally, the use of this combination is not recommended.
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.
aliskiren.
If you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling at sites such as the throat) is greater:
sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs).

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes
(e.g. potassium) in the blood at regular intervals.
See also the section "Do not take Fosinopril Aurobindo"
Consult your doctor if any of the above cases apply to you or have applied to you in the past.
Other medicines and Fosinopril Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Note: The following statements may also apply to medicines recently used or medicines you will use in the near future.
The effects of fosinopril may be increased if used concurrently with:

Diuretics This may cause a drop (excessive) in blood pressure leading to dizziness or fainting. Your doctor may decide to discontinue the diuretic before starting you on fosinopril therapy.
Other medicines for high blood pressure, nitroglycerin and other nitrates
Medicines used to treat depression (tricyclic antidepressants), medicines used for psychiatric disorders, some narcotics
Alcohol

The effects of fosinopril may be reduced if used concurrently with:

Sympathomimetic agents (ephedrine, noradrenaline or adrenaline): These medicines act on certain parts of the nervous system.
Antacids Antacids (e.g. aluminium hydroxide, magnesium hydroxide, and simeticone) may reduce the absorption of fosinopril. Therefore, at least a 2-hour interval should be maintained between the administration of the two medicines.

Fosinopril may affect the use of other medicines:

Medicines that increase potassium levels or contain potassium:

Some diuretics containing spironolactone, triamterene or amiloride may increase
potassium levels in the blood. This can harm the heart. The combination of these medicines with
fosinopril is not recommended. This also applies to certain dietary salt substitutes, heparin (a blood thinner) and cotrimoxazole (also known as trimethoprim/sulfamethoxazole). This is of
particular importance for people with impaired kidney or heart function and for diabetics.

Lithium: The amount of lithium (used in some forms of depression) in the blood may increase. This is particularly true if diuretics known as thiazide diuretics are also used. However, if a combination of fosinopril and lithium is still necessary, lithium levels must be closely monitored.
Medicines used in diabetes: The combined use of ACE inhibitors and antidiabetic medicines (insulin, oral hypoglycaemic tablets) may lead to a further reduction in blood sugar levels. This occurs at the beginning of combined treatment and in patients with impaired kidney function.
Immunosuppressants, cytostatic agents, systemic corticosteroids or procainamide, allopurinolo: The combination of fosinopril sodium and immunosuppressants and/or other medicines causing leucopenia (deficiency of white blood cells accompanied by increased susceptibility to infections) should be avoided.

Other medicines that affect fosinopril:

Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid  3 g per day Long-term use of these anti-inflammatory agents such as indomethacin, ibuprofen and aspirin may reduce the antihypertensive effect (blood pressure lowering). In addition, the combination of these medicines increases blood potassium levels, possibly leading to worsening of kidney function. These effects usually disappear when treatment is discontinued.
Medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Your doctor may consider it necessary to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also
section “Do not take Fosinopril Aurobindo” and “Warnings and precautions”).
Fosinopril Aurobindo with food, drinks and alcohol
Some people may experience dizziness as a result of excessive lowering of arterial pressure,
especially at the beginning of treatment, with each dose increase, when changing
medication or in combination with the effects of alcohol.
Pregnancy and breast-feeding
Pregnancy
You must inform your doctor if you think you are (or could become) pregnant. Normally your
doctor will advise you to stop taking fosinopril before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of fosinopril. Fosinopril is not recommended
in early pregnancy, and must not be taken if you are more than 3 months pregnant, as
it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Fosinopril is not recommended in
mothers who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed,
particularly if your baby is a newborn or was born prematurely.
Driving and using machines
Some people may experience dizziness as a result of excessive lowering of blood
pressure, especially at the beginning of treatment, with each dose increase or when changing
medication or in combination with the effects of alcohol. Check whether this applies to you before starting to
drive or operate machinery.
Fosinopril Aurobindo contains lactose:
Fosinopril Aurobindo tablets contain lactose. If your doctor has told you that you have
an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Fosinopril Aurobindo

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended initial dose of 10 mg has not been studied in patients with severe class IV NYHA heart failure or in patients over 75 years of age being treated for heart failure.
It is recommended to start treatment at a reduced dose (5 mg) in patients at increased risk of hypotension (excessively low blood pressure), such as patients with severe heart failure (NYHA class IV), patients over 75 years of age being treated for heart failure, patients with severe renal and/or hepatic impairment, and patients receiving diuretic therapy.
If Fosinopril Aurobindo is prescribed for you for high blood pressure, you will usually start with one 10 mg tablet once daily. Your doctor will determine whether the effect of Fosinopril Aurobindo is adequate. Some patients may require a lower or even higher dose (from 10 to 40 mg per day). If necessary, your doctor will adjust the dose accordingly.
If you are taking a diuretic, it should normally be discontinued 2–3 days before starting treatment with fosinopril. If this is not possible, treatment should be initiated at a dose of 10 mg, and it is recommended that treatment with fosinopril sodium tablets begin under medical supervision for several hours until blood pressure is stable.
If Fosinopril Aurobindo is prescribed for you for heart failure, treatment will usually start with one 10 mg tablet once daily. Treatment must be initiated under close medical supervision. Depending on the response, your doctor will gradually increase the dose to 40 mg once daily. If your renal, hepatic, or cardiac function is severely impaired, your doctor may decide to start treatment with Fosinopril Aurobindo 5 mg.
The use of Fosinopril Aurobindo is not recommended in children and adolescents. Clinical experience with fosinopril in hypertensive children aged 6 years and older is limited. The optimal dosage has not been established in children of any age group. An appropriate dosage is not available for children weighing less than 50 kg.

Instructions for use
Take the tablets with half a glass of water. You may take the tablets before, during, or after a meal. Take Fosinopril Aurobindo once daily, approximately at the same time each day.
The effect of the tablets lasts for 24 hours.

Duration of treatment
You will generally need to take Fosinopril Aurobindo for a long period. Follow your doctor’s instructions carefully. It is important that you continue taking your medicine, even if you do not feel any effect.

If you stop taking Fosinopril Aurobindo
You will not experience any withdrawal symptoms if you suddenly stop taking Fosinopril Aurobindo. However, the desired therapeutic effect will no longer occur; furthermore, there may be an increased risk of complications due to high blood pressure, particularly affecting the heart, brain, and kidneys.
Do not stop taking this medicine for any reason without consulting your doctor.

If you take more Fosinopril Aurobindo than you should
If you have taken or used too many Fosinopril Aurobindo tablets, contact your doctor or pharmacist immediately. If you have taken too many tablets, you may experience dizziness or fainting.

If you forget to take Fosinopril Aurobindo
Do not take a double dose to make up for the missed dose. It is important for your treatment that you take the prescribed tablets daily. If you forget to take a dose, you may still take it unless it is already time for the next dose.

If you have any questions 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 experiences them.
The following side effects have been reported at the approximate frequencies shown below:

Common (affects 1 to 10 users in 100):

Infection of the upper airways, sore throat, inflammation of the nasal lining, viral infection;
Mood changes, sleep disorders;
Dizziness, headache, tingling, taste disturbances;
Eye disorders, vision disturbances;
Rapid heartbeat (tachycardia), heart rhythm disorders, palpitations, chest pain of cardiac origin (angina pectoris), cough, nasal sinus disorders;
Nausea, vomiting, diarrhoea, stomach ache, indigestion;
Rash, sudden accumulation of fluid in the skin and mucous membranes (e.g. throat, tongue), difficulty breathing and/or itching and rash, usually due to an allergic reaction (angioedema), skin inflammation (dermatitis);
Bone, muscle and joint pain;
Urinary disorders;
Impotence;
Low blood pressure;
Dizziness upon standing;
Chest pain (not heart-related), weakness;
Effects on the liver.

Uncommon (affects 1 to 10 users in 1,000):

Changes in blood values such as haemoglobin, haematocrit;
Decreased appetite, gout, excessively high levels of potassium in the blood (hyperkalaemia);
Depression, confusion;
Stroke, drowsiness, fainting, tremors;
Ear pain, ringing in the ears (tinnitus), dizziness;
Heart attack or cerebral haemorrhage (CVA), cardiac arrest, heart rhythm disorders, disorders of cardiac conduction;
High blood pressure (hypertension), shock, obstruction of blood flow to tissues (ischaemia);
Shortness of breath (dyspnoea), inflamed sinuses (sinusitis), inflammation of the respiratory tract (tracheobronchitis);
Dry mouth, constipation, flatulence;
Itching, excessive sweating (hyperhidrosis), urticaria;
Renal failure, increased excretion of protein in urine (proteinuria);
Fever, sudden death, chest pain;
Weight gain, changes in blood tests showing how well the liver and kidneys are functioning.

Rare (affects 1 to 10 users in 10,000):

Changes in blood values, such as anaemia, a blood disorder (lack of red blood cells) accompanied by increased susceptibility to infections (leucopenia and neutropenia), increased number of eosinophil white blood cells (eosinophilia), lymph gland disease (lymphadenopathy), a blood disorder (lack of platelets) accompanied by bruising and tendency to bleed (thrombocytopenia);
Speech disorders (dysphasia), memory disorders, disorientation;
Hot flushes, bleeding (haemorrhage), peripheral vascular disorders;
Chest tightness caused by muscle spasms in the airways (bronchospasm), nosebleed (epistaxis), inflammation of the larynx/hoarseness, pneumonia, lung disease (pulmonary congestion);
Mouth ulcers, inflamed pancreas (pancreatitis), swollen tongue, abdominal swelling, difficulty swallowing (dysphagia);
Inflammation of the liver (hepatitis);
Small spots of blood under the skin (ecchymoses);
Joint pain;
Weakness in a limb.

Very rare (affects fewer than 1 user in 10,000):

Changes in blood values such as agranulocytosis (a serious blood disorder (lack of white blood cells) accompanied by sudden high fever, severe sore throat or mouth ulcers);
Accumulation of fluid in the intestine (intestinal angioedema), complete intestinal obstruction (ileus) or partial obstruction (sub-ileus);
Acute renal failure;
Hepatic failure;
Low levels of salt in the blood.

Not known (frequency cannot be estimated from the available data):

Appetite disorders, weight fluctuations;
Abnormal behaviour;
Balance disorders;
Sudden cessation of heartbeat and breathing;
Marked increase in blood pressure;
Voice impairment, chest pain (pleuritic pain);
Muscle weakness;
Prostate disorders;
Pain;
Abnormal liver function tests.

A syndrome complex has been reported, in which one or more of the following symptoms may occur: fever, inflamed blood vessels (vasculitis), muscle pain, joint pain (arthralgia/arthritis), certain blood abnormalities (including positive antinuclear antibodies (ANA), increased erythrocyte sedimentation rate (ESR), eosinophilia and leukocytosis), skin rash, photosensitivity or other skin disorders.

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

5. How to store Fosinopril Aurobindo

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Fosinopril Aurobindo contains

The active substance is fosinopril sodium. Each tablet contains 10 mg or 20 mg of fosinopril sodium.
The other ingredients are: anhydrous lactose, microcrystalline cellulose, crospovidone, sodium stearil fumarate and povidone (K30).

Description of the appearance of Fosinopril Aurobindo and package contents
Fosinopril Aurobindo 10 mg tablets:
Tablets from white to off-white, flat, capsule-shaped, uncoated, with a score line and notched edges on both sides, marked with "X" and "77" above and below the score line on one side and smooth on the other.
The tablet can be divided into two equal parts.
Fosinopril Aurobindo 20 mg tablets:
Tablets from white to off-white, round, biconvex, uncoated, marked with "X" on one side and "84" on the other.
The tablets are packaged in PVC/PE/PVDC/aluminum blisters or in plastic bottles made of high-density polyethylene (HDPE).
Pack sizes:
PVC/PE/PVDC/aluminum blisters: 10, 14, 20, 21, 28, 30, 42, 50, 56, 60, 98, 100 and 400 tablets.
HDPE bottles with polypropylene cap containing a silica gel sachet and a cotton wad: 28 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000 - Malta

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
France FOSINOPRIL ARROW LAB 10 mg, scored tablet
FOSINOPRIL ARROW LAB 20 mg, tablet
Italy Fosinopril Aurobindo
Malta Fosinopril Aurobindo 10mg/ 20 mg Tablets
Netherlands Fosinoprilnatrium Aurobindo 10 mg/ 20 mg, tabletten
Romania Fosinopril Aurobindo 10 mg/ 20 mg Comprimate
Spain FOSINOPRIL AUROBINDO 20 mg tablets
United Kingdom Fosinopril Sodium 10mg/ 20 mg Tablets