Leaflet: information for the patient

Fositens 20 mg tablets

Fosinopril sodium

Read this leaflet carefully before you start taking 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 for you onlyand should not be given to others, 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 Fositens 20 mg tablets are and what they are used for

2. What you need to know before you start 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. Contents of the pack and additional information

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

Fositens 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).

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.

Do not take Fositens:

-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 had an allergy to any antihypertensive medication in the past. In this case, consult your doctor.

-If you are more than three months pregnant. It is also recommended to avoid using Fositens 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 aliskireno.

-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 Fositens:

-If you are taking 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 desensitization procedures for allergies to 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.

-aliskireno.

-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 the amount of potassium in the blood (for example, trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to dilute the blood to prevent clots).

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

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

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

Inform your doctor if you are pregnant or think you may be pregnant. Fositens is not recommended for use 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 section “Pregnancy”).

Children and adolescents

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

Taking Fositens with other medications

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 can be hazardous. If you are taking any other medication in addition to Fositens, you should 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, lithium salts, and other medications that can increase potassium levels in the body (such as heparin and cotrimoxazol, also known as trimetoprima/sulfametoxazol).

Fositens 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 adjust your dose and/or take other precautions:

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

Taking Fositens with food and drinks

No interaction has been demonstrated between Fositens 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

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

Fositens is not recommended for use 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.

Fositens is not recommended for use in breastfeeding women, and 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 Fositens on the ability to drive or operate machinery.

Fositens contains lactose

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

Fositens contains sodium

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

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

Your doctor will determine your suitable dose of Fositens according to your individual characteristics. Do not modify 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 your blood pressure stabilizes.

As a guideline, it is recommended to start with a 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 if hypertension cannot be controlled solely with Fositens.

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

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

If you take more Fositens 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 all people may 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 alterations, angina pectoris, hypotension (low blood pressure), cough, sinus disturbances, nausea, vomiting, diarrhea, abdominal pain, digestive disturbances, taste disturbances, rash, muscle pain (myalgia) and musculoskeletal pain, urinary disturbances, 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):neumonia, laryngitis, sinusitis, tracheobronchitis, lymphadenopathy (a disorder of the lymph nodes), decrease in white blood cells and/or platelets in the blood, increase in a type of white blood cell, gout, appetite disturbances, weight fluctuations, decreased appetite, increased potassium in plasma, depression, abnormal behavior, confusional state, cerebral infarction, transient ischemic attack, tremor, balance disturbances, memory disturbances, sleep disturbances, stroke, tinnitus, vertigo, ear pain, cardiac arrest, myocardial infarction, tachycardia, cardiorespiratory 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 that does not appear 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 on the safety of this medication.

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

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

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Fositens 20 mg tablets

• The active ingredient is fosinopril sodium.

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

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24 PPT3

Ireland

Responsible for manufacturing:

ICN Polfa Rzeszów S.A

2 Przemyslowa Street

35-959 Rzeszow, Poland

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

Zentiva Spain S.L.U.

Paseo Club Deportivo 1, Edif 4.

Pozuelo de Alarcón 28223 – Madrid, Spain

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

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