FOSINOPRIL AUROVITAS 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Fosinopril Aurovitas 20 mg Tablets EFG

Fosinopril Sodium

Read all of thisleaflet 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

This medicine contains fosinopril, which belongs to a group of medicines called ACE inhibitors (ACEIs). Its action achieves relaxation and consequent dilation of blood vessels.

Fosinopril is indicated for the treatment of high blood pressure (hypertension). It can 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.

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

Do not take Fosinopril Aurovitas:

• If you are allergic to fosinopril or other medicines of the same family, or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously suffered an allergy to any antihypertensive medicine. In that case, you should consult your doctor.
• If you are more than three months pregnant. It is also preferable to avoid the use of this medicine during the first months of pregnancy (see section “Pregnancy”).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (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 medicines, the risk of suffering angioedema may increase:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine 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 medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) increases: sirolimus, everolimus, and other medicines of the mTOR inhibitor class (used to prevent organ transplant rejection).
• If you have kidney or liver failure, or congestive heart failure.
• If you are undergoing, or are going to undergo, desensitization procedures for bee or wasp stings.
• If you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARA) (also known as "sartans", e.g., valsartan, telmisartan, irbesartan), particularly if you have diabetes-related kidney problems.
• aliskiren.
• If you are taking, have recently taken, or may need to take potassium supplements (including salt substitutes), diuretics (water pills, especially potassium-sparing ones), dietary salts, lithium salts, antacids, and other medicines that can increase potassium levels in the body (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole).

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

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

Before being anesthetized or undergoing surgery, inform your doctor that you are taking this medicine, as sudden hypotension may occur.

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

Children and adolescents

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

Other medicines and Fosinopril Aurovitas

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

Never take a medicine on your own initiative, as some combinations of medicines can be dangerous. If you are receiving any other medication in addition to fosinopril, you must inform your doctor.

This applies especially if you are also taking:

• Medicines used more frequently to prevent organ transplant rejection (sirolimus, everolimus, and other medicines of the mTOR inhibitor class). See section “Warnings and precautions”.
• Potassium supplements or salt substitutes that contain potassium, diuretics (especially potassium-sparing ones), dietary salts, lithium salts, antacids, and other medicines that can increase potassium levels in the body (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole) should be used with caution and under medical supervision.

Fosinopril may interfere with certain laboratory tests. In particular, treatment should be discontinued a few days before performing tests to assess parathyroid function.

Your doctor may need to adjust 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

It has not been demonstrated that fosinopril or its metabolites interact with food intake.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Normally, your doctor will advise you to stop taking fosinopril before you become pregnant or as soon as you know you are pregnant, and will advise you on which medicine to take instead of fosinopril.

The use of this medicine is not recommended during the first months of pregnancy, and it should not be taken when you are more than three months pregnant, as it can cause serious harm 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.

The administration of fosinopril is not recommended in breastfeeding women; your doctor may choose another treatment if you wish to continue breastfeeding, especially if the baby is a newborn or was born prematurely.

Driving and using machines

No data are available on the effects of fosinopril on the ability to drive or use machines.

Fosinopril Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Fosinopril Aurovitas contains sodium

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

3. How to take Fosinopril Aurovitas

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the adequate 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 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, an initial dose of half a tablet (10 mg) per day and a maintenance dose of one tablet (20 mg) per day are recommended, 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 antihypertensive medicines when blood pressure cannot be controlled with fosinopril alone.

In the treatment of heart failure, the recommended initial dose of fosinopril is half a tablet (10 mg) once a day. Treatment should be started under strict medical supervision. If hypotension occurs 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 impairment.

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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed:

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

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

Frequency not known(cannot be estimated from the available data):pneumonia, laryngitis, sinusitis, tracheobronchitis, lymphadenopathy (a disorder of the lymph nodes), decreased white blood cells and/or platelets in blood, increased white blood cells, gout, appetite disorders, weight fluctuations, decreased appetite, increased potassium in plasma, depression, abnormal behavior, confusional state, cerebral infarction, transient ischemic attack, tremor, balance disorders, memory disorders, sleep disorders, stroke, tinnitus, ear pain, cardiac arrest, myocardial infarction, accelerated heart rate, cardio-respiratory arrest, conduction disorders, hypertensive crises, and hypertension (high blood pressure), peripheral vascular disease, hemorrhage, and flushing.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosinopril Aurovitas

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Fosinopril Aurovitas

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

Appearance of the product and contents of the pack

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

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

Package size: 28 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

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

Date of last revision of this leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)