Package Insert: Information for the Patient

Fositens Plus 20 mg/12.5 mg Tablets

Fosinopril Sulfate/Hydrochlorothiazide

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.
-Keep this package insert, as you may need to refer to it again.
- If you have any questions, consult your doctor or pharmacist.
- This medication has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insertSee section 4.

1. What is Fositens Plus 20 mg/12.5 mg Tablets and what is it used for

2. What you need to know before starting to take Fositens Plus 20 mg/12.5 mg Tablets

3. How to take Fositens Plus 20 mg/12.5 mg Tablets

4. Possible adverse effects

5. Storage of Fositens Plus 20 mg/12.5 mg Tablets

6. Contents of the package and additional information

This medication contains the association of fosinopril and hydrochlorothiazide. Fosinopril belongs to a group of medications called Angiotensin-Converting Enzyme Inhibitors (ACEIs), whose action achieves the relaxation and subsequent dilation of blood vessels. Hydrochlorothiazide is a diuretic that reduces blood pressure by its eliminatory action of salt and water at the renal level.

Fositens Plus is indicated for the treatment of hypertension, in patients for whom combined treatment is appropriate. In patients in whom the reduction of blood pressure obtained with fosinopril alone is not sufficient, the administration of Fositens Plus allows, by the additive effects of fosinopril with hydrochlorothiazide, a greater and better control of blood pressure.

Do not take Fositens Plus:

-If you are allergic to fosinopril or other medications in its class and/or to other sulfonamide-derived drugs (e.g., thiazides), or to any of the other components of this medication (listed in section 6).

-If you have decreased or absent ability to urinate (anuria).

-If you have previously experienced an allergy to any antihypertensive medication. In this case, consult your doctor.

-If you are more than three months pregnant. It is also recommended to avoid the use of Fositens Plus in the first months of pregnancy (See section “Pregnancy”).

-If you have diabetes or renal insufficiency and are being treated with a medication to lower blood pressure 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 Plus:

-If you are using 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 renal or hepatic insufficiency, or congestive heart failure.

-If you are undergoing or will undergo desensitization procedures for allergy 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 renal 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 potassium levels in the blood (e.g., trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to dilute blood to prevent clots).

-If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The use of hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV rays while taking Fositens Plus.

-If you experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Fositens Plus. If left untreated, this can cause vision loss. If you have previously experienced an allergy to penicillin or sulfamide, you may be at higher risk.

-If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Fositens Plus, seek medical attention immediately.

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

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

Inform your doctor before being anesthetized or undergoing surgery that you are taking this medication, as it may cause sudden hypotension.

Inform your doctor if you are pregnant or think you may be pregnant. Fositens Plus is not recommended for use during the first months of pregnancy, and it should not be taken when pregnant for more than three months, as it may cause severe damage to the baby if used after the third month of pregnancy (See section “Pregnancy”).

Children and adolescents

Fositens Plus has not been established as effective and safe in children and adolescents under 18 years old.

Taking Fositens Plus 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 may be hazardous. If you are receiving any other medication in addition to Fositens Plus, you must inform your doctor.

This applies especially if you are taking:

• Medications used more frequently to prevent organ transplant rejection (sirolimús, everolimús, and other mTOR inhibitors). See section “Warnings and precautions”.
• Barbiturates or narcotics, calcium salts, lithium salts, other diuretics, and antihypertensive medications, carbamazepine, salt substitutes, and medications used in surgery, potassium supplements or salt substitutes that contain potassium, other medications that can increase potassium levels in the body (such as heparin and cotrimoxazol, also known as trimetoprima/sulfametoxazol).
• Anti-diarrheal medications, such as racecadotril.
• Anti-inflammatory medications, such as indometacina and other non-steroidal anti-inflammatory drugs (e.g., aspirin), which may reduce the effects of Fositens Plus in some patients.
• Medications used to treat diabetes and gout, which may require dose adjustments.

Fositens Plus 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 modify 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 Plus” and “Warnings and precautions”).

Taking Fositens Plus with food, drinks, and alcohol

You should inform your doctor when you ingest or plan to ingest alcohol, due to possible interactions.

Use in athletes

This medication contains hydrochlorothiazide, which may produce a positive result in doping control tests.

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 Plus before becoming pregnant or as soon as you know you are pregnant, and will indicate which medication to take instead of Fositens Plus.

Fositens Plus is not recommended for use during the first months of pregnancy, and it should not be taken when pregnant for more than three months, as it may cause severe damage to the baby if used after the third month of pregnancy.

Breastfeeding:

Fositens Plus is excreted in breast milk. Inform your doctor if you are breastfeeding. Fositens Plus 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 Plus on the ability to drive or operate machinery.

Fositens Plus 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 Plus 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. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine your suitable dose of Fositens Plus according to your individual characteristics. Do not modify your dose unless decided by your doctor. The usual dose of Fositens Plus is one tablet per day.

If you take more Fositens Plus 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 medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been observed:

Frequent (can affect up to 1 in 10 people):upper respiratory tract infection, headache, dizziness, cough, musculoskeletal pain, and fatigue (tiredness).

Very rare (can affect up to 1 in 10,000 people):acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency (cannot be estimated from available data): pharyngitis, rhinitis, sinusitis, lymphadenopathy (a disorder of the lymph nodes),decrease in white blood cells and/or platelets in blood, anemia, gout, decrease in potassium and/or sodium and/or chloride in plasma, depression, sexual dysfunction,sleep disturbances,numbness/tingling, decreased sensitivity, fainting, stroke, visual disturbances,tinnitus, vertigo, cardiac rhythm disturbances, angina pectoris, myocardial infarction, hypotension (low blood pressure), intermittent claudication (muscle pain in groups), necrotizing vasculitis (inflammation of blood vessels), flushing, sinus congestion, difficulty breathing, pneumonitis (inflammation around the lungs), pulmonary edema, bronchospasm, nausea, vomiting, diarrhea, abdominal pain, indigestion,inflammation of the mucous membrane of the stomach/esophagus, pancreatitis, alteration in taste, hepatitis, yellow discoloration of the skin and/or mucous membranes, angioedema, rash, Stevens-Johnson syndrome(severe skin rash affecting the skin and mucous membranes), purpura, pruritus, urticaria, photosensitivity reactions, myalgia, muscle spasms, arthralgia,alterations in urine frequency and painful or difficult urination, renal failure, sexual dysfunction, edema (fluid retention), chest pain, asthenia (apathy), fever, abnormal values in liver function tests (increased transaminases, increased lactate dehydrogenase, increased alkaline phosphatase, and increased bilirubin); abnormal values in blood electrolytes, uric acid, glucose, magnesium, cholesterol, triglycerides, and calcium; skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to high pressure[possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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. Deposit the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Fositens Plus 20 mg/12.5 mg tablets

-The active principles are fosinopril sodium and hydrochlorothiazide.

-The other components (excipients) are: lactose, sodium croscarmellose, povidone, stearic acid and sodium, iron oxide red (E-172) and iron oxide yellow (E-172).

Appearance of the product and contents of the packaging

Fositens Plus is presented in the form of tablets. Each package contains 28 tablets with 20 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide.

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:December 2021.

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/.