FOSINOPRIL 10 mg Coated Tablets

Зміст інструкції

1. Fosinopril Aurobindo 10 mg tablets, 20 mg tablets
   1. What is Fosinopril Aurobindo and what is it used for
   2. What you need to know before taking Fosinopril Aurobindo
   3. How to take Fosinopril Aurobindo
   4. Possible side effects
   5. How to store Fosinopril Aurobindo
   6. Contents of the pack and other information

Fosinopril Aurobindo 10 mg tablets, 20 mg tablets

Generic medicine

Read this leaflet carefully before using this medicinebecause 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, because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Fosinopril belongs to a group of medicines called angiotensin converting enzyme inhibitors (ACE inhibitors). Fosinopril binds to ACE in the body, thus inhibiting the formation of angiotensin II, a substance that increases blood pressure. Angiotensin II also has a vasoconstrictor effect that narrows blood vessels. By inhibiting this substance, there is a reduction in pressure inside the blood vessels and the function of the heart can improve. Fosinopril Aurobindo is prescribed if you have high blood pressure and if your heart is not working efficiently enough; this is known as “heart failure”.

2. What you need to 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 had hypersensitivity reactions in the past such as skin reactions and sudden build-up of fluid in the skin and mucous membranes (e.g. throat or tongue), difficulty breathing and/or itching and skin rashes (known as angioedema) after taking an ACE inhibitor, or without any apparent cause, or if there is a history of these types of reactions in your family;
• in cases of hereditary angioedema or angioedema of unknown cause;
• if you are pregnant for more than 3 months (it is best to avoid the use of Fosinopril Aurobindo 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 precautions
The initial dose of 10 mg has not been studied in patients over 75 years of age undergoing
treatment for heart failure, or in patients with severe heart failure of class IV NYHA.
At the beginning of treatment with fosinopril 10 mg, a severe drop in blood pressure
or hyperkalemia (too much potassium in the blood) may occur in:

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

You must inform your doctor if you think you are (or may become) pregnant. Fosinopril is not
recommended at the beginning of pregnancy and must not be taken if you are pregnant for more than 3 months, as
it can cause serious harm to your baby if used at this stage (see the section on pregnancy).

Talk to your doctor or pharmacist before taking Fosinopril Aurobindo:

• If you have experienced an excessive drop in blood pressure. Although rare, this can happen after the first dose, if you are dehydrated (e.g. due to vomiting, poor salt intake, dialysis, diarrhea or diuretic therapy), or if you have a certain type of high blood pressure (known as severe renin-dependent hypertension). An excessive drop in blood pressure can also occur if you suffer from heart failure. This risk is increased if you have severe heart failure, for which you are using high doses of loop diuretics (a type of diuretic), if your sodium levels in the blood are too low (hyponatremia) or if your kidney function is reduced. If you are at higher risk of experiencing an excessive drop in blood pressure, you should be carefully monitored at the beginning of treatment and whenever the dosage is changed. This also applies to you if you have ischemic heart failure (a type of heart disease) or disorders affecting the blood vessels in the brain (cerebrovascular disorders). In this case, treatment should be administered with particular caution, as a massive drop in blood pressure could lead to a heart attack or stroke.
• If your blood pressure should drop too much. In this case, you should be placed in a lying position and, if necessary, given physiological saline solution for infusion. This does not mean that the treatment will have to be stopped. Once the blood volume and blood pressure have been restored, treatment can be resumed, possibly at a lower dose, or continued as before.
• If you suffer from heart failure and your blood pressure is low or normal. A further reduction in pressure may occur. If this persists, it may be necessary to reduce the dose or stop treatment.
• If you have stenosis of the aorta (a narrowing of the main artery of the body), stenosis of the mitral valve (a narrowing in the heart) or hypertrophic cardiomyopathy (a thickening of the heart muscle wall). In this case, you should use fosinopril with caution.
• If you have poor kidney function, the initial dose does not need to be adjusted. In this case, potassium and creatinine levels in the blood should be monitored regularly.
• If you suffer from heart failure. A sudden drop in blood pressure caused by the use of fosinopril can lead to poor kidney function and even acute kidney failure (which is generally temporary).
• If you have stenosis of the renal artery (a narrowing of one or both of the arteries to the kidneys), fosinopril can cause an increase in certain substances in the blood (e.g. the levels of so-called urea and creatinine may increase), especially if you suffer from poor kidney function.
• If you suffer from renovascular hypertension (high blood pressure due to a narrowing of the artery leading to the kidneys) you are at increased risk of experiencing a severe drop in blood pressure and poor kidney function. In this case, treatment should therefore be administered under strict medical supervision with low doses and dose increases carried out with caution. In addition, any treatment with diuretics should be stopped. Kidney function should be monitored during the first few weeks of treatment.
• Because in some patients with high blood pressure without renovascular disease (kidneys) fosinopril can cause an increase in certain substances in the blood (e.g. the levels of so-called urea and creatinine may increase). Such increases are generally minor and temporary, especially if fosinopril is administered simultaneously with a diuretic. If this happens, treatment should be stopped. If necessary, treatment can be resumed later at a reduced dose. The risk of developing these side effects is greater in patients with pre-existing kidney disease.
• In patients with pre-existing kidney dysfunction, proteinuria (protein excretion in the urine) may occur in rare cases. If these exceed 1 g per day, fosinopril can 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 reactions and sudden build-up of fluid 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 should immediately stop fosinopril, appropriate measures should be taken and you should be kept under close observation until the symptoms have completely disappeared. If the swelling affects the tongue, throat or larynx, the airways may become blocked, especially if you have undergone any surgery on the airways. In these cases, emergency therapy must be administered immediately. If you have had angioedema in the past while using any other medicine, you may be at increased risk of developing angioedema again.
• If you are of Afro-Caribbean origin. In fact, 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, the use of a different type of dialysis membrane or a different class of antihypertensive agents (for blood pressure reduction) should be considered.
• During LDL-apheresis (a type of treatment for removing cholesterol from the blood) with dextran sulfate. In fact, life-threatening hypersensitivity reactions may occur in rare cases. These can be avoided by temporarily suspending treatment with fosinopril before each session of apheresis.
• If this treatment is administered simultaneously with a therapy to make you less allergic to insect venom (desensitization therapy, for example against wasp and bee stings). In fact, life-threatening hypersensitivity reactions may occur. These can be avoided by temporarily suspending treatment with fosinopril.
• Because this treatment has been associated with liver abnormalities that have sometimes caused death. If you develop jaundice or detect a marked increase in certain specific liver substances in the blood, the use of fosinopril must be stopped and appropriate follow-up treatment started.
• Because blood abnormalities can occur. Blood abnormalities that can occur as a result of the use of fosinopril include a decrease in the number of platelets, accompanied by bruising and a tendency to bleed (thrombocytopenia), changes in the number of red blood cells, possibly accompanied by anemia, a reduction in the number of certain white blood cells with sudden high fever, severe sore throat and ulcers in the mouth (agranulocytosis) and a deficiency of white blood cells accompanied by increased susceptibility to infections (neutropenia). Treatment should be stopped if neutropenia occurs or is suspected.
• If you suffer from a connective tissue disorder (e.g. lupus erythematosus, a disease of the skin, internal organs, joints, kidneys and heart similar to an 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 poor kidney function. In fact, in some cases, serious infections have developed, which sometimes have not responded to antibiotic treatment. Patients are advised to check their white blood cell count periodically and to report any symptoms indicating an infection.
• During treatment with fosinopril, a dry cough may occur, which disappears when treatment is stopped.
• If you are to undergo major surgery and/or anesthesia. In these cases, an excessive drop in blood pressure may occur. Before any surgery, you should therefore inform the anesthesiologist (responsible for administering the anesthetic) that you are using fosinopril.
• If you have poor kidney function, if you have diabetes mellitus, if you are also using potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other

medicines that increase potassium in the blood, or if you are elderly. In these cases, fosinopril can
increase the amount of potassium in the blood. This can occur even without any apparent cause. If you need to use one or more of the aforementioned medicines, it is recommended to check
the amount of potassium in the blood regularly.

• If you have diabetes and are being treated with so-called oral antidiabetics (by mouth) or insulin (some agents used to treat diabetes), as fosinopril can affect the control of blood sugar levels. For this reason, you (or your doctor) should monitor the dosage of insulin and/or the oral antidiabetic (by mouth) and, if necessary, adjust it during the first month of treatment with fosinopril.
• If you are taking 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 blocker" (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 drugs, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors (used to prevent organ rejection after transplantation).

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in the blood at regular intervals.
See also what is stated in 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
Tell 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 that
you will use in the near future.
The effects of fosinopril may be increased if used simultaneously with:

• DiureticsThis may cause a (excessive) drop in blood pressure which may make you feel dizzy or faint. Your doctor may decide to stop the diuretic before starting you on therapy with fosinopril.
• Other medicines for high blood pressure, nitroglycerin and other nitrates
• Medicines used for the treatment of depression (tricyclic antidepressants), medicinesused for psychiatric disorders, some narcotics
• Alcohol

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

• So-called sympathomimetic agents (ephedrine, noradrenaline or adrenaline): These medicines have an effect on some parts of the nervous system.
• AntacidsAntacids (e.g. aluminium hydroxide, magnesium hydroxide, and simethicone) may reduce the absorption of fosinopril. For this reason, you should allow an interval of at least 2 hours between the administration of the two medicines.

Fosinopril may affect the use of other medicines:

• Medicines that increase potassium levels or that contain potassium:

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

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

Other medicines that have an effect on fosinopril:

• Anti-inflammatory drugs (NSAIDs) including acetylsalicylic acid 3 g per dayLong-term use of these anti-inflammatory agents such as indometacin, ibuprofen and aspirin may reduce the antihypertensive effect (blood pressure lowering). In addition, the amount of potassium in the blood is increased by the combination of these medicines, likely causing a worsening of kidney function. These effects usually disappear when the treatment is stopped.
• Medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

The doctor may need to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also
what is stated under “Do not take Fosinopril Aurobindo” and “Warnings and precautions”).

Fosinopril Aurobindo with food, beverages and alcohol
Some people may experience dizziness as a result of an excessive drop in blood
pressure, particularly at the beginning of treatment, with each increase in dose or when changing
medicine or in association with the effects of alcohol.

Pregnancy and breastfeeding
Pregnancy
You should tell your doctor if you think you are (or might 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
advise you to take another medicine instead of fosinopril. Fosinopril is not recommended
in early pregnancy, and must not be taken if you are pregnant for more than 3 months, as it can cause
serious harm to your baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to breastfeed. Fosinopril is not recommended
in breastfeeding mothers and your doctor may choose another treatment if you wish to breastfeed, in
particular if your baby is newborn or premature.

Driving and operating machinery
Some people may experience dizziness as a result of an excessive drop in blood
pressure, particularly at the beginning of treatment, with each increase in dose or when changing
medicine or in association with the effects of alcohol. Check if this applies to you before
starting to drive or operate machinery.

Fosinopril Aurobindo contains lactose:
Fosinopril Aurobindo tablets contain lactose. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Fosinopril Aurobindo

Take this medicine always exactly as your doctor has instructed. 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 cardiac
insufficiency of class IV NYHA or in patients over 75 years of age treated for cardiac
insufficiency.
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 cardiac
insufficiency (class IV NYHA), patients over 75 years of age treated for cardiac insufficiency,
patients with severe renal and/or hepatic impairment and patients undergoing treatment with diuretics.
If Fosinopril Aurobindo is administered to you for high blood pressure, you will usually start
with a 10 mg tablet once a day. The doctor will determine whether the effect of Fosinopril
Aurobindo is sufficient. Some users will need a lower or even higher dose (from 10 to 40 mg per
day). If necessary, the doctor will adjust the dose.
If you are using a diuretic, this will normally need to be stopped 2-3 days before
treatment with fosinopril. If this is not possible, treatment should be started at a dose of 10
mg and it is recommended that treatment with fosinopril sodium tablets is started for a few hours
under medical supervision until blood pressure is stable.
If Fosinopril Aurobindo is administered to you for heart failure, you will start (in most
cases) with a 10 mg tablet once a day. Treatment must be started
under strict medical supervision. Depending on the results, the doctor will then gradually increase the
dose to 40 mg once a day. If your kidney, liver or heart function is very poor, the
doctor may decide to start with Fosinopril Aurobindo 5 mg.
The use of Fosinopril Aurobindo is not recommended in children and adolescents. There is
limited experience in clinical studies on the use of fosinopril in hypertensive children aged 6 years or
older. The optimal dosage has not been determined in children in any age group.
An appropriate dosage is not available in children weighing less than 50 kg.

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

Duration of treatment
You will generally need to use Fosinopril Aurobindo for a long period. Carefully follow
your doctor's instructions. It is important that you continue to take your medicines, 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 using Fosinopril
Aurobindo. However, the desired effect will no longer occur; furthermore, there may be a risk of
complications due to high blood pressure, particularly in the heart, brain and kidneys.
You should not stop using 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 tablets of Fosinopril Aurobindo, contact your
doctor or pharmacist immediately. If you have taken too many tablets, you may feel dizzy or faint.

If you forget to take Fosinopril Aurobindo
Do not take a double dose to make up for a missed dose. For your treatment it is
important that you take the tablets prescribed by the doctor on a daily basis. If you happen to
forget to take the tablets, you can still take the missed dose unless it is already
time for the next dose.
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.
The following side effects have been reported with the approximate frequencies shown:

Common(may affect up to 1 in 10 people):

• upper respiratory tract infection, sore throat, inflammation of the nasal lining, viral infection;
• mood alteration, sleep disorders;
• dizziness, headache, tingling, taste alterations;
• eye disorders, visual impairment;
• fast heartbeat (tachycardia), heart rhythm disorders, palpitations, chest pain from the heart (angina pectoris), cough, nasal sinus disorders;
• nausea, vomiting, diarrhoea, stomach pain, indigestion;
• skin 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;
• urination disorders;
• impotence;
• low blood pressure;
• dizziness when getting up;
• chest pain (not related to the heart), weakness;
• effects on the liver.

Uncommon(may affect up to 1 in 1,000 people):

• changes in blood values, such as haemoglobin, haematocrit;
• decreased appetite, gout, excessively high concentrations of potassium in the blood (hyperkalaemia);
• depression, confusion;
• stroke, drowsiness, fainting, tremors;
• ear pain, ringing in the ears (tinnitus), vertigo;
• heart attack or cerebral haemorrhage (CVA), cardiac arrest, heart rhythm disorders, cardiac conduction disorders;
• high blood pressure (hypertension), shock, obstruction of blood flow to tissues (ischaemia);
• shortness of breath (dyspnoea), inflamed nasal sinuses (sinusitis), inflammation of the airways (tracheo-bronchitis);
• dry mouth, constipation, flatulence;
• itching, excessive sweating (hyperhidrosis), hives;
• kidney failure, increased protein excretion in the urine (proteinuria);
• fever, sudden death, chest pain (thorax);
• weight gain, changes in blood tests showing how well the liver and kidneys are working. Rare(may affect up to 1 in 10,000 people)
• changes in blood values, such as anaemia, an abnormality of the blood (deficiency of red blood cells) accompanied by increased susceptibility to infections (leucopenia and neutropenia), increased number of eosinophilic white blood cells (eosinophilia), disease of the lymph glands (lymphadenopathy), an abnormality of the blood (deficiency of platelets) accompanied by bruising and a tendency to bleed (thrombocytopenia);
• speech disorders (dysphasia), memory disorders, disorientation;
• hot flushes, bleeding (haemorrhage), peripheral vascular disorders;
• chest tightness caused by spasms of the respiratory muscles (bronchospasm), nosebleeds (epistaxis), inflammation of the larynx/hoarseness, pneumonia, lung disease (pulmonary congestion);
• ulcers in the mouth, inflamed pancreas (pancreatitis), swollen tongue, abdominal swelling, difficulty swallowing (dysphagia);
• liver inflammation (hepatitis);
• small blood spots on the skin (ecchymoses);
• joint pain;
• weakness of a limb.

Very rare(may affect less than 1 in 10,000 people)

• changes in blood values, such as agranulocytosis (a serious blood abnormality (deficiency of white blood cells) accompanied by high fever, severe sore throat or mouth ulcers);
• accumulation of fluid in the intestine (intestinal angioedema), complete (ileus) or partial (sub-ileus) intestinal obstruction;
• acute kidney failure;
• liver 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 interruption of heartbeat and breathing;
• highly elevated blood pressure;
• impaired voice, chest pain (pleuritic pain);
• muscle weakness;
• prostate diseases;
• pain;
• abnormal liver function test.

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

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 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 package and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
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.

6. Contents of the pack and other information

What Fosinopril Aurobindo contains

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

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

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
France FOSINOPRIL ARROW LAB 10 mg, divisible tablet
FOSINOPRIL ARROW LAB 20 mg, tablet
Italy Fosinopril Aurobindo
Malta Fosinopril Aurobindo 10mg/ 20 mg Tablets
Netherlands Fosinoprilnatrium Aurobindo 10 mg/ 20 mg, tablets
Romania Fosinopril Aurobindo 10 mg/ 20 mg Tablets
Spain FOSINOPRIL AUROBINDO 20 mg tablets
United Kingdom Fosinopril Sodium 10mg/ 20 mg Tablets