Prospect: information for the patient

Fosinopril Aurovitas 20 mg tablets EFG

Fosinopril sodium

Read the entireleaflet carefully before starting to take this medicine, as it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribedto youpersonally, and you must not give it to other people, even if they have the same symptomsas you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

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

2. What you need to know before starting to take Fosinopril Aurovitas

3. How to take Fosinopril Aurovitas

4. Possible side effects

5. Storage of Fosinopril Aurovitas

6. Contents of the pack and additional information

This medication contains fosinopril, which belongs to a group of medications called angiotensin-converting enzyme (ACE) inhibitors. Its action achieves relaxation and subsequent dilation of blood vessels.

Fosinopril is indicated for the treatment of high blood pressure (hypertension). It may be used alone or in combination with other antihypertensive agents (e.g. thiazide diuretics).

Fosinopril is also indicated for the treatment of heart failure in combination with a diuretic. In these patients, fosinopril improves symptoms and exercise tolerance, and reduces the frequency of hospitalization for heart failure.

Do not take Fosinopril Aurovitas:

-If you are allergic to fosinopril or any other medicine in its class, or to any of the other components of this medicine (listed in section 6).

-If you have previously experienced an allergy to any antihypertensive medication. In this case, consult your doctor.

-If you are more than three months pregnant. It is also recommended to avoid using this medicine in the first months of pregnancy (see section “Pregnancy”).

-If you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication that contains aliskiren.

• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

• If you are taking any of the following medications, the risk of angioedema may increase:

• Racecadotril, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.

Warnings and precautions

Consult your doctor or pharmacist before starting to take fosinopril:

-If you are using any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) increases: sirolimus, everolimus, and other mTOR inhibitors (used to prevent organ transplant rejection).

-If you have kidney or liver insufficiency, or congestive heart failure.

-If you are undergoing or will undergo allergy desensitization procedures for bee or wasp stings.

-If you are taking any of the following medications used to treat high blood pressure (hypertension):

-An angiotensin II receptor antagonist (ARA) (also known as "sartanes" for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

-Aliskiren.

-If you are taking, have taken recently, or may need to take potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that can increase blood potassium levels (e.g. trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to prevent blood clots).

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Fosinopril Aurovitas”.

Inform your doctor before being anesthetized or undergoing surgery that you are taking this medication, as it may cause sudden hypotension.

Inform your doctor if you are pregnant or think you may be pregnant. Fosinopril is not recommended during the first months of pregnancy, and it should not be taken when pregnant for more than three months, as it may cause severe damage to the baby if used after the third month of pregnancy (see section “Pregnancy”).

Children and adolescents

The efficacy and safety of fosinopril have not been established in children and adolescents under 18 years old.

Other medications and Fosinopril Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

You should never take a medication on your own initiative, as some combinations of medications may be hazardous. If you are receiving any other medication in addition to fosinopril, you must inform your doctor.

This applies especially if you are taking:

• Medications used more frequently to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Use potassium supplements or salt substitutes that contain potassium, diuretics (especially potassium-sparing diuretics), salt regimens, medications with lithium salts, antacids, and other medications that can increase potassium levels in the body (such as heparin and cotrimoxazol, also known as trimetoprima/sulfametoxazol).

Fosinopril may interfere with certain laboratory tests. Specifically, you should discontinue your treatment for a few days before undergoing tests to evaluate parathyroid function.

Your doctor may need to modify your dose and/or take other precautions:

If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Fosinopril Aurovitas” and “Warnings and precautions”).

Taking Fosinopril Aurovitas with food and drinks

No interaction has been demonstrated between fosinopril and its metabolites and the ingestion of food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will usually advise you to stop taking fosinopril before becoming pregnant or as soon as you know you are pregnant, and will indicate which medication to take instead of fosinopril.

Fosinopril is not recommended during the first months of pregnancy, and it should not be taken when pregnant for more than three months, as it may cause severe damage to the baby if used after the third month of pregnancy.

Breastfeeding

Fosinopril is excreted in breast milk. Inform your doctor if you are breastfeeding.

Fosinopril is not recommended for breastfeeding women. Your doctor may choose another treatment if you wish to continue breastfeeding, especially if the baby is a newborn or premature.

Driving and operating machinery

No data is available on the effect of fosinopril on the ability to drive or operate machinery.

Fosinopril Aurovitas contains lactose

This medication contains lactose. If your doctor has advised you that you have a certain sugar intolerance, consult with them before taking this medication.

Fosinopril Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine your suitable dose of fosinopril according to your individual characteristics. Do not modify your dose unless decided by your doctor.

In the treatment of hypertension (high blood pressure), if you are being treated with a diuretic, it will be attempted to withdraw it before starting treatment with fosinopril. If this is not possible, it is recommended to start treatment with half a tablet of Fosinopril Aurovitas (10 mg) under medical supervision until blood pressure stabilizes.

As a guideline, it is recommended to start with an initial dose of half a tablet (10 mg) per day and a maintenance dose of one tablet (20 mg) per day, which can be increased up to 40 mg according to the therapeutic response obtained. No better therapeutic effects are obtained with doses higher than 40 mg per day.

Your doctor may add a diuretic or other anti-hypertensive medications when hypertension cannot be controlled solely with fosinopril.

In the treatment of heart failurethe recommended initial dose of fosinopril is half a tablet (10 mg) per day. Treatment should be initiated under strict medical supervision. If hypotension appears after the initial dose, consult your doctor. Fosinopril should be used with a diuretic.

No dose adjustment of fosinopril is required in patients with any degree of renal or hepatic insufficiency.

If you take more Fosinopril Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been observed:

Frequent (may affect up to 1 in 10 people):upper respiratory tract infection, pharyngitis, rhinitis, viral infection, mood changes, sleep disturbances, dizziness, headache, numbness/tingling, eye and visual disturbances, heart rhythm changes, angina, low blood pressure, cough, sinus problems, nausea, vomiting, diarrhea, abdominal pain, digestive problems, taste disturbances, rash, muscle pain (myalgia) and musculoskeletal pain, urinary problems, sexual function disturbances, fatigue (fatigue), chest pain, edema (swelling), asthenia (apathy).

Rare (may affect up to 1 in 100 people):angioedema, fainting, shock.

Unknown frequency(cannot be estimated from available data):pneumonia, laryngitis, sinusitis, tracheobronchitis, lymphadenopathy (a lymph node disorder), decreased white blood cells and/or platelets in the blood, increased white blood cells, gout, appetite disturbances, weight fluctuations, decreased appetite, increased potassium in plasma, depression, abnormal behavior, confusion, cerebral infarction, transient ischemic attack, tremors, balance disturbances, memory disturbances, sleep disturbances, stroke, tinnitus, vertigo, ear pain, cardiac arrest, myocardial infarction, tachycardia, cardiac arrest, conduction disturbances, hypertensive crises and hypertension (high blood pressure), peripheral vascular disease, hemorrhage, and erythema.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Fosinopril Aurovitas

• The active ingredient is fosinopril sodium. Each tablet contains 20 mg of fosinopril sodium.
• The other components (excipients) are: lactose, microcrystalline cellulose, crospovidone, povidone (K-30) and stearate sodium.

Appearance of the product and content of the container

Uncoated tablets, biconvex, round, white to off-white in color, marked with “X” on one face and with “84” on the other.

Fosinopril Aurovitas tablets are available in PVC/PE/PVdC-Aluminum blisters.

Container size: 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Last review date of this leaflet: February 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)