FOSITENS 20 MG TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fositens 20 mg tablets

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 only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 adverse effects
5. How to store Fositens 20 mg tablets
6. Contents of the pack and other 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 Inhibitors (ACE inhibitors). Its action results in 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 due to 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 in the same class, or to any of the other components of this medicine (listed in section 6).
• If you have previously had an allergic reaction to any antihypertensive medicine. In such case, you must consult your doctor.
• If you are more than three months pregnant. It is also advisable to avoid using Fositens during the first months of pregnancy (see section “Pregnancy”).
• If you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin in areas such as the throat) is high.
• If you are taking any of the following medicines, the 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 Fositens:

• If you are taking any of the following medicines, as the risk of angioedema (rapid swelling beneath the skin in areas such as 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, desensitization procedures for allergy to bee or wasp stings.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• 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 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 (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and 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 Fositens”.

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. Use of Fositens 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 “Pregnacy”).

Children and adolescents

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

Taking Fositens with other medicines

Tell 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 can be dangerous. If you are receiving any other medication in addition to Fositens, you must inform your doctor.

This is especially important if you are also taking:

• Medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitor class medicines). 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.

Fositens may interfere with certain laboratory tests. Specifically, treatment should be discontinued a few days before tests assessing 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 information under the headings “Do not take Fositens” and “Warnings and precautions”).

Taking Fositens with food and drink

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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will usually advise you to stop taking Fositens before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.

Use of Fositens 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.

Breast-feeding

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

Administration of Fositens is not recommended for breastfeeding women, and your doctor may choose another 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 Fositens on the ability to drive or operate machinery.

Fositens contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with your doctor before taking this medicine.

Fositens contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Fositens 20 mg tablets

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

Your doctor will determine the appropriate dose of Fositens 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 prior to starting Fositens treatment. 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 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. This dose may be increased up to 40 mg depending on the therapeutic response achieved. No additional therapeutic benefit is obtained with doses exceeding 40 mg daily.

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

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

Dosage adjustment of Fositens is not required in patients with any degree of renal or hepatic impairment.

If you take more Fositens than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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, ocular and visual disorders, 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, oedema (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, increase in a type of white blood cells, gout, appetite disorders, weight fluctuation, decreased appetite, increased potassium in plasma, depression, abnormal behaviour, confusional state, cerebral infarction, transient ischaemic attack, tremor, balance disorders, memory disorders, sleep disorders, stroke, 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, haemorrhage 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. 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should 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 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 Fositens 20 mg tablets

• The active substance is fosinopril sodium.

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

Appearance of the product and contents of the pack

Fositens is presented as scored tablets. Each pack 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. Przemysłowa 235-105 Rzeszów, Poland

For further information about this medicinal product, please contact 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 most recent review of this leaflet: October 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.