FOSITENS PLUS 20 mg / 12.5 mg TABLETS

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

Do not take Fositens Plus:

• If you are allergic to fosinopril or other medications of the same family and/or to other drugs derived from sulfonamides (e.g., thiazides), or to any of the other components of this medication (listed in section 6).
• If you have reduced or eliminated urine production (anuria).
• If you have previously suffered an allergy to any antihypertensive medication. In that case, you should consult your doctor.
• If you are pregnant for more than three months. It is also preferable to avoid the use of Fositens Plus in the first months of pregnancy (see "Pregnancy" section).
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is high.
• If you are taking any of the following medications, the risk of suffering 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 medications 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 medications 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 taking or have recently taken potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that can increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to thin blood to prevent clots).
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Fositens Plus.
• If you experience vision loss or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a week after taking Fositens Plus. If left untreated, this can lead to vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.
• 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 kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.

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

Before being anesthetized or undergoing surgery, inform your doctor that you are taking this medication, as sudden hypotension may occur.

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

Children and Adolescents

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

Taking Fositens Plus with Other Medications

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

Never take a medication on your own initiative, as some combinations of medications can 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 also taking:

• Medications commonly used to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitor class medications). See "Warnings and Precautions" section.
• Barbiturates or narcotics, calcium salts, lithium salts, other diuretics, and antihypertensive medications, carbamazepine, regimen salts, and medications used in surgery, potassium supplements or salt substitutes containing potassium, and other medications that can increase potassium levels in the body (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole) should be administered with special caution.
• If you are receiving simultaneous treatment with Fositens Plus and antacids, the doses should be separated by at least two hours. Cholestyramine or colestipol hydrochloride should be administered at least one hour before or four to six hours after Fositens Plus.
• Indomethacin and other non-steroidal anti-inflammatory drugs (e.g., aspirin) may reduce the effects of Fositens Plus in some patients.
• Dose adjustments may be necessary for medications used to treat diabetes and gout.

Fositens Plus 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 modify 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 Plus" and "Warnings and Precautions").

Taking Fositens Plus with Food, Drinks, and Alcohol

You should inform your doctor when consuming or about to consume alcohol, due to possible interactions that may occur.

Use in Athletes

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

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 medication.

Pregnancy:

Normally, your doctor will advise 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.

The use of Fositens Plus is not recommended during the first months of pregnancy, and it should not be taken when you are pregnant for more than three months, as it may cause serious harm 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. The administration of Fositens Plus is not recommended in 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

No data are available on the effect of Fositens Plus on the ability to drive or use machines.

Fositens Plus Contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, 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".

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

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

Your doctor will determine the suitable dose of Fositens Plus for you 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been observed:

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

Very Rare(may affect up to 1 in 10,000 people): acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

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

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

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

Keep this medication out of sight and reach of children.

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

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

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fositens Plus 20 mg/12.5 mg Tablets

• The active ingredients are fosinopril sodium and hydrochlorothiazide.
• The other ingredients (excipients) are: lactose, sodium croscarmellose, povidone, sodium stearyl fumarate, red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the Product and Package Contents

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

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 medication 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 Package Leaflet:December 2021.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/.