Losartan/hydrochlorothiazide Cinfa 100 mg/25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

losartan/hydrochlorothiazide cinfa 100 mg/25 mg film-coated tablets EFG

potassium losartan and hydrochlorothiazide

Please read all of 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 only and must not be given to other people, 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 effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What losartan/hydrochlorothiazide cinfa is and what it is used for.
2. What you need to know before taking losartan/hydrochlorothiazide cinfa.
3. How to take losartan/hydrochlorothiazide cinfa.
4. Possible side effects.
5. How to store losartan/hydrochlorothiazide cinfa.

Pack contents and additional information.

1. What losartán/hidroclorotiazida cinfa is and what it is used for

losartán/hidroclorotiazida cinfa is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida). Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartán prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, thereby lowering blood pressure. Hidroclorotiazida causes the kidneys to eliminate increased amounts of water and salts. This also helps reduce blood pressure.

losartán/hidroclorotiazida cinfa is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before starting losartan/hydrochlorothiazide cinfa

Do not take losartan/hydrochlorothiazide cinfa

• If you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial medicines such as cotrimoxazole; ask your doctor if you are unsure).
• If you have severe liver impairment.
• If you have low levels of potassium or sodium, or high calcium levels that cannot be corrected with treatment.
• If you have gout.
• If you are more than 3 months pregnant. (It is also advisable to avoid losartan/hydrochlorothiazide cinfa in early pregnancy – see Pregnancy section.)
• If you have severe renal impairment or your kidneys are not producing urine.
• If you have diabetes or renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take losartan/hydrochlorothiazide cinfa.

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking losartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking losartan/hydrochlorothiazide on your own.

If you experience a decrease in vision or eye pain, these 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 weeks after taking losartan/hydrochlorothiazide. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.

Inform your doctor if you think you are pregnant (or could be). Use of losartan/hydrochlorothiazide is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your baby if used at this stage (see section Pregnancy).

It is important to inform your doctor before taking losartan/hydrochlorothiazide:

• if you have previously had swelling of the face, lips, tongue, or throat;

• if you are taking diuretics (medicines for increasing urine output);

• if you are on a low-salt diet;

• if you have or have had excessive vomiting and/or diarrhoea;

• if you have heart failure;

• if your liver function is impaired (see section 2 “Do not take losartan/hydrochlorothiazide cinfa”);

• if you have narrowed arteries leading to the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant;

• if you have narrowed arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function);

• if you have aortic or mitral valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a condition causing thickening of the heart muscle);

• if you are diabetic;

• if you have had gout;

• if you have or have had an allergic disorder, asthma, or a disease causing joint pain, skin rashes, and fever (systemic lupus erythematosus);

• if you have high calcium levels or low potassium levels, or if you are on a low-potassium diet;

• if you require anaesthesia (even at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, inform the doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets;

• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland);

• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;

• aliskiren.

• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking losartan/hydrochlorothiazide cinfa, seek medical attention immediately.

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

See also section 2 “Do not take losartan/hydrochlorothiazide cinfa”.

• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and losartan/hydrochlorothiazide cinfa”);
• 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 cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking losartan/hydrochlorothiazide.

Children and adolescents

There is no experience with the use of losartan/hydrochlorothiazide in children. Therefore, losartan/hydrochlorothiazide must not be given to children.

Other medicines and losartan/hydrochlorothiazide cinfa

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

Tell your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim), as combination with losartan/hydrochlorothiazide is not recommended.

Diuretics such as hydrochlorothiazide contained in losartan/hydrochlorothiazide may interact with other medicines.

Lithium-containing preparations must not be taken with losartan/hydrochlorothiazide unless your doctor performs careful monitoring.

Special precautions (e.g. blood tests) may be necessary if you are taking other diuretics (water tablets), certain laxatives, gout medications, medicines to control heart rhythm, or oral antidiabetic medicines or insulin.

It is also important that your doctor knows if you are taking:

• other medicines to lower your blood pressure,
• steroids,
• cancer treatment medicines,
• pain medicines,
• antifungal medicines,
• arthritis medicines,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping tablets;
• opioid medicines such as morphine,
• "pressor amines" such as adrenaline or other medicines in the same group,
• oral antidiabetic medicines or insulin.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also sections “Do not take losartan/hydrochlorothiazide cinfa” and “Warnings and precautions”).

If you are taking losartan/hydrochlorothiazide, inform your doctor if you are scheduled for a radiographic examination with iodinated contrast medium.

Taking losartan/hydrochlorothiazide cinfa with food, drinks and alcohol

You are advised not to drink alcohol while taking these tablets: alcohol and losartan/hydrochlorothiazide tablets may enhance each other's effects.

Excessive dietary salt intake may counteract the effect of losartan/hydrochlorothiazide tablets.

Losartan/hydrochlorothiazide may be taken with or without food.

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

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of losartan/hydrochlorothiazide is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Use of losartan/hydrochlorothiazide during breastfeeding is not recommended, and your doctor will choose an alternative treatment if you wish to breastfeed.

Use in elderly patients

Losartan/hydrochlorothiazide is equally effective and well tolerated by most elderly and younger patients. Most elderly patients require the same dose as younger patients.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce positive results in doping tests.

Driving and use of machines

When starting treatment with this medicine, do not perform tasks requiring special attention (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

losartan/hydrochlorothiazide cinfa contains lactose

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

3. How to take losartan/hydrochlorothiazide cinfa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the appropriate dose of losartan/hydrochlorothiazide based on your condition and whether you are taking other medications. It is important to keep taking losartan/hydrochlorothiazide as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure:

For most patients with high blood pressure, the recommended dose is 1 tablet of losartan/hydrochlorothiazide 50 mg/12.5 mg once daily to control blood pressure over 24 hours. The dose may be increased to 2 tablets of 50 mg losartan/12.5 mg hydrochlorothiazide daily or changed to 1 tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) daily. The maximum daily dose is 2 tablets of 50 mg losartan/12.5 mg hydrochlorothiazide daily or 1 tablet of 100 mg losartan/25 mg hydrochlorothiazide daily.

Administration

The tablets should be swallowed whole with a glass of water.

If you take more losartan/hydrochlorothiazide cinfa than you should

In case of overdose, contact your doctor immediately so you can receive immediate medical attention. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

In case of overdose or accidental ingestion, consult 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.

If you forget to take losartan/hydrochlorothiazide cinfa

Try to take losartan/hydrochlorothiazide every day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

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

If you experience the following, stop taking losartan/hydrochlorothiazide tablets immediately and contact your doctor or go to the nearest hospital emergency department:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing).

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported:

Common (may affect up to 1 in 10 patients):

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorder.
• Diarrhea, abdominal pain, nausea, indigestion.
• Muscle pain or cramps, leg pain, back pain.
• Insomnia, headache, dizziness.
• Weakness, fatigue, chest pain.
• Elevated potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels.
• Changes in kidney function including kidney failure.
• Low blood sugar (hypoglycemia).

Uncommon (may affect up to 1 in 100 patients):

• Anemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of hands and feet, and abdominal pain), bruising, reduced white blood cell count, blood clotting problems, and low platelet count.
• Loss of appetite, elevated uric acid levels or overt gout, elevated blood glucose levels, abnormal blood electrolyte levels.
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disturbances, drowsiness, memory impairment.
• Tingling or similar sensations, limb pain, tremor, migraine, fainting.
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow.
• Ringing, buzzing, noises, or crackling in the ears, dizziness.
• Low blood pressure which may be associated with postural changes (feeling dizzy or weak upon standing), angina (chest pain), abnormal heartbeats, stroke (transient ischemic attack, "mini-stroke"), heart attack, palpitations.
• Inflammation of blood vessels, often associated with a skin rash or bruising.
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nosebleeds, runny nose, congestion.
• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache.
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas.
• Hives, itching, skin inflammation, rash, skin redness, photosensitivity, dry skin, flushing, sweating, hair loss.
• Pain in arms, shoulders, hips, knees, or other joints, joint swelling, stiffness, muscle weakness.
• Frequent urination, even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased sexual appetite, impotence.
• Facial swelling, localized swelling (edema), fever.

Rare (may affect up to 1 in 1,000 patients):

• Hepatitis (liver inflammation), abnormal liver function tests.
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very rare:

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

Frequency not known (cannot be estimated from available data):

• Flu-like symptoms.
• Unexplained muscle pain with dark-colored urine (tea-colored) (rhabdomyolysis).
• Low sodium levels in blood (hyponatremia).
• General feeling of being unwell (malaise).
• Taste disturbance (dysgeusia).
• 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 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of losartan/hydrochlorothiazide cinfa

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

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.

Do not store above 30°C. Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of losartan/hydrochlorothiazide cinfa

• The active substances are losartan potassium and hydrochlorothiazide. Each tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.
• The other components are:

Tablet core: microcrystalline cellulose, monohydrate lactose, pregelatinized corn starch, and magnesium stearate.

Coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Film-coated tablets, cylindrical in shape and yellow in colour.

Presented in PVC-PE-PVDC/Aluminum blisters. Each pack contains 28 or 500 tablets (clinical pack) of film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo 19200

Azuqueca de Henares (Guadalajara), Spain

Date of the latest revision of this leaflet: February 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69056/P_69056.html

QR code link: https://cima.aemps.es/cima/dochtml/p/69056/P_69056.html