Fosinopril Aurovitas 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fosinopril Aurovitas 20 mg tablets EFG

Fosinopril sodium

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine contains fosinopril, which belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Its action results in 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 due to heart failure.

2. What you need to know before taking Fosinopril Aurovitas

Do not take Fosinopril Aurovitas:

• If you are allergic to fosinopril or other medicines in the same class, or to any of the other ingredients of this medicine (listed in section 6).

• If you have previously had an allergic reaction to any antihypertensive medicine. In such case, you should consult your doctor.

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

• If you have diabetes or renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

  • If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, for example in the throat) is high.

• If you are taking any of the following medicines, your risk of developing angioedema may increase:

• Racecadotril, a medicine used to treat diarrhoea.

• 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

Talk to your doctor or pharmacist before taking fosinopril:

• If you are taking any of the following medicines, the risk of angioedema (rapid swelling beneath the skin, for example in the throat) increases: sirolimus, everolimus, and other medicines in the class of mTOR inhibitors (used to prevent rejection of transplanted organs).
• If you have renal or hepatic impairment, or congestive heart failure.
• If you are undergoing, or are scheduled to undergo, desensitisation treatment for allergy to bee or wasp stings.
• If you are taking any of the following medicines for high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as "sartans", for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren.
• If you are currently taking, have recently taken, or may need to take potassium supplements (including salt substitutes), potassium-sparing diuretics, or other medicines that may increase blood potassium levels (for example, trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).

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

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

Before undergoing anaesthesia or 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 might be pregnant. The use of fosinopril is not recommended during the first months of pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if used beyond 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 of age.

Other medicines and Fosinopril Aurovitas

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

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

This is especially important if you are also taking:

• Medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Potassium supplements or potassium-containing salt substitutes, potassium-sparing diuretics, dietary salt preparations, lithium salts, antacids, and other drugs that may 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. Specifically, treatment should be discontinued a few days before tests assessing parathyroid function are performed.

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 information under the headings “Do not take Fosinopril Aurovitas” and “Warnings and precautions”).

Taking Fosinopril Aurovitas with food and drinks

No interaction between fosinopril or its metabolites and food intake has been demonstrated.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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 recommend an alternative medicine.

Use of this medicine is not recommended during the first months of pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if used beyond the third month of pregnancy.

Breastfeeding

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

Fosinopril is not recommended for use in breastfeeding women. Your doctor may choose an alternative treatment if you wish to continue breastfeeding, especially if the baby is a neonate or was born prematurely.

Driving and using machines

There are no data available regarding the effect of fosinopril on the ability to drive or operate machinery.

Fosinopril Aurovitas contains lactose

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

Fosinopril Aurovitas contains sodium

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

3. How to take Fosinopril Aurovitas

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose of fosinopril based on your individual characteristics. Do not change your dose unless instructed by your doctor.

For the treatment of hypertension (high blood pressure), if you are being treated with a diuretic, withdrawal of the diuretic will be attempted 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 general guideline, an initial dose of half a tablet (10 mg) once daily is recommended, with a maintenance dose of one tablet (20 mg) daily. The dose may be increased up to 40 mg depending on the therapeutic response. Doses higher than 40 mg daily do not provide greater therapeutic effects.

Your doctor may add a diuretic or other antihypertensive medicines if hypertension cannot be controlled with fosinopril alone.

For the treatment of heart failure, the recommended initial dose of fosinopril is half a tablet (10 mg) once daily. Treatment must be initiated under strict medical supervision. If hypotension occurs after the initial dose, consult your doctor. Fosinopril should be used in combination with a diuretic.

Dosage adjustment of fosinopril is not 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause 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 alterations, sleep disorders, dizziness, headache, numbness/tingling, eye and visual disturbances, cardiac rhythm disturbances, angina pectoris, hypotension (low blood pressure), cough, sinus disorders, nausea, vomiting, diarrhea, abdominal pain, digestive disorders, taste disturbances, rash, muscle pain (myalgia) and musculoskeletal pain, urinary disorders, sexual dysfunction, fatigue (tiredness), chest pain, edema (swelling), asthenia (lack of energy).

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

Frequency not known (cannot be estimated from available data): pneumonia, laryngitis, sinusitis, tracheobronchitis, lymphadenopathy (a disorder of the lymph nodes), decreased white blood cells and/or platelets in blood, increased levels of a type of white blood cells, gout, appetite disorders, weight fluctuation, 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, vertigo, ear pain, cardiac arrest, myocardial infarction, accelerated heart rate, cardio-respiratory arrest, conduction disorders, hypertensive crisis and hypertension (high blood pressure), peripheral vascular disease, bleeding and redness.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Fosinopril Aurovitas Storage

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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This 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 components (excipients) are: lactose, microcrystalline cellulose, crospovidone, povidone (K-30), and stearic fumarate and sodium.

Appearance of the product and contents of the pack

Uncoated tablets, biconvex, round, white to off-white in colour, marked with an "X" on one side and "84" on the other.

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

Pack size: 28 tablets.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Date of the most recent review of this leaflet: February 2025

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