Fositens Plus 20 mg / 12.5 mg tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Fositens Plus 20 mg/12.5 mg tablets

Fosinopril sodium/Hydrochlorothiazide

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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Fositens Plus 20 mg/12.5 mg tablets are and what they are used for
2. What you need to know before taking 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. How to store Fositens Plus 20 mg/12.5 mg tablets
6. Contents of the pack and other information

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

This medicine contains the combination of fosinopril and hydrochlorothiazide. Fosinopril belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which act by relaxing and thereby dilating blood vessels. Hydrochlorothiazide is a diuretic that lowers blood pressure by increasing the renal elimination of salt and water.

Fositens Plus is indicated for the treatment of hypertension in patients for whom combination therapy is appropriate. In patients in whom blood pressure reduction achieved with fosinopril alone is insufficient, administration of Fositens Plus provides improved blood pressure control due to the additive effects of fosinopril and hydrochlorothiazide.

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

Do not take Fositens Plus:

• If you are allergic to fosinopril or other medicines in the same class and/or to other drugs derived from sulfonamides (e.g., thiazides), or to any of the other ingredients of this medicine (listed in section 6).
• If you have reduced or absent ability to urinate (anuria).
• 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 Plus during the first months of pregnancy (See section “Pregnancy”).
• If you have diabetes or renal insufficiency 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 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 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 taking Fositens Plus:

• If you are taking any of the following medicines, 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 treatment 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 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).
• If you have had skin cancer or 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 non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Fositens Plus.
• If you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking Fositens Plus. If untreated, this may lead to vision loss. A previous history of allergy to penicillin or sulfonamides may increase the risk.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe 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) at regular intervals.

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

Before undergoing anesthesia 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 Plus 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 “Pregnancy”).

Children and adolescents

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

Taking Fositens Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 Plus, you must inform your doctor.

This is especially important if you are also taking:

• Medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Barbiturates or narcotics, calcium salts, lithium salts, other diuretics, antihypertensive medicines, carbamazepine, salt substitutes, and medicines used in surgery, potassium supplements or potassium-containing salt substitutes, and other drugs that may 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 concomitant treatment with Fositens Plus and antacids, doses should be separated by at least two hours. Colestipol hydrochloride or cholestyramine 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.
• Dosage adjustments may be needed for medicines used to treat diabetes and gout.

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

Taking Fositens Plus with food, drinks, and alcohol

You should inform your doctor when consuming or planning to consume alcohol, due to possible interactions.

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive test in anti-doping controls.

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 Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.

Use of Fositens Plus 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.

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 an alternative 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 Plus on the ability to drive or use machines.

Fositens Plus contains lactose

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

Fositens Plus 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 Plus 20 mg/12.5 mg tablets

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the appropriate dose of Fositens Plus based on your individual characteristics. Do not change your dose unless instructed 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed:

Frequent (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 breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from the 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, disorders of libido, sleep, numbness/tingling, decreased sensitivity, fainting, stroke, visual disturbances, tinnitus (ringing in the ears), dizziness, heart rhythm disorders, angina pectoris, myocardial infarction, hypotension (low blood pressure), intermittent claudication (pain in muscle groups), necrotizing vasculitis (inflammation of blood vessels), redness, sinus congestion, difficulty breathing, pneumonitis (inflammation around the lungs), pulmonary edema, bronchospasm, nausea, vomiting, diarrhea, abdominal pain, dyspepsia, inflammation of the mucosa of the stomach/esophagus, pancreatitis, altered sense of taste, hepatitis, yellowing of the skin and/or mucous membranes, angioedema, rash, Stevens-Johnson syndrome (severe skin rash affecting skin and mucous membranes), purpura, pruritus, urticaria, photosensitivity reactions, myalgia, muscle spasms, arthralgia, changes in urinary frequency and painful or difficult urination, renal failure, sexual dysfunction, edema (fluid retention), chest pain, asthenia (lack of energy), fever, abnormal liver function test results (elevated transaminases, increased blood lactate dehydrogenase, increased alkaline phosphatase, and increased blood bilirubin); abnormal blood levels of electrolytes, uric acid, glucose, magnesium, cholesterol, triglycerides, and calcium; skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, 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 Plus 20 mg/12.5 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 refers to 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 located in 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 Plus 20 mg/12.5 mg tablets

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

Appearance of the product and contents of the pack

Fositens Plus is presented in the form of tablets. Each pack 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. Przemysłowa 235-105 Rzeszów, Poland

Further information on this medicinal product is available 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 most recent revision of this leaflet: December 2021.

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