FOSITENS 20 mg TABLETS

Introduction

Patient Information Leaflet

Fositens 20 mg Tablets

Fosinopril Sodium

Read this leaflet 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What Fositens 20 mg Tablets are and what they are used for
2. What you need to know before taking Fositens 20 mg Tablets
3. How to take Fositens 20 mg Tablets
4. Possible side effects
5. Storage of Fositens 20 mg Tablets
6. Package contents and additional information

1. What Fositens 20 mg Tablets are and what they are used for

This medicine contains fosinopril, which belongs to a group of medicines called Angiotensin-Converting Enzyme (ACE) Inhibitors. Its action achieves relaxation and subsequent dilation of blood vessels.

Fositens 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).

Fositens 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 taking Fositens 20 mg Tablets

Do not take Fositens:

• If you are allergic to fosinopril or other medicines of the same family, or to any of the other components of this medicine (listed in section 6).
• If you have previously suffered an allergy to any antihypertensive medicine. In this case, you should consult your doctor.
• If you are more than three months pregnant. It is also preferable to avoid the use of Fositens during the first months of pregnancy (see the "Pregnancy" section).
• 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 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

Talk to your doctor or pharmacist before starting to take Fositens:

• 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 will 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 kidney problems related to diabetes.
• Aliskiren.
• If you are taking or have recently taken potassium supplements (including salt substitutes), potassium-sparing diuretics, or other medicines that can increase potassium levels in the blood (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole).

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

See also the information under the heading "Do not take Fositens".

Before being anesthetized or undergoing surgery, inform your doctor that you are taking this medicine, as it may cause a sudden drop in blood pressure.

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

Children and adolescents

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

Taking Fositens with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may 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 Fositens, you should 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 the "Warnings and precautions" section.
• Potassium supplements or salt substitutes that contain potassium, diuretics (especially potassium-sparing ones), 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.

Fositens 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 Fositens" and "Warnings and precautions").

Taking Fositens with food and drinks

It has not been shown that Fositens 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

The use of Fositens 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 may cause serious harm to the baby if used after the third month of pregnancy.

Breastfeeding

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

The administration of Fositens is not recommended in breastfeeding women, and your doctor may choose an alternative 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 effect of Fositens on the ability to drive or use machines.

Fositens contains lactose

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

Fositens contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Fositens 20 mg Tablets

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

Your doctor will determine the appropriate dose of Fositens for you based on your individual characteristics. Do not change your dose unless your doctor decides to do so.

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 Fositens. If this is not possible, it is recommended to start treatment with half a tablet of Fositens (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 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 Fositens alone.

In the treatment of heart failure, the recommended initial dose of Fositens 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. Fositens should be used with a diuretic.

No dose adjustment of Fositens is necessary in patients with any degree of kidney or liver failure.

If you take more Fositens 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 taken.

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 changes, sleep disorders, dizziness, headache, numbness/tingling, eye and vision disorders, heart rhythm changes, 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 the blood, increased white blood cells, gout, appetite disorders, weight fluctuations, decreased appetite, increased potassium in plasma, depression, abnormal behavior, confusion, stroke, transient ischemic attack, tremor, balance disorders, memory disorders, sleep disorders, cerebrovascular accident, tinnitus, vertigo, ear pain, cardiac arrest, myocardial infarction, increased heart rate, cardio-respiratory arrest, conduction disorders, hypertensive crises, and hypertension (high blood pressure), peripheral vascular disease, hemorrhage, and flushing.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storage of Fositens 20 mg Tablets

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

Do not store above 25°C. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Fositens 20 mg Tablets

• The active ingredient is fosinopril sodium.

The other ingredients (excipients) are: lactose, microcrystalline cellulose, crospovidone, povidone, and sodium stearyl fumarate.

Appearance of the product and package contents

Fositens is presented in the form of scored tablets. Each package contains 28 tablets with 20 mg of fosinopril sodium.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24 PPT3

Ireland

Manufacturer:

ICN Polfa Rzeszów S.A

ul. Przemyslowa 235-105 Rzeszow, Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Paseo Club Deportivo 1, Edif 4.

Pozuelo de Alarcón 28223 – Madrid, Spain

Date of the last revision of this leaflet:October 2020.

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