Losartan/hydrochlorothiazide Cinfa 100 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartan/Hydrochlorothiazide cinfa 100 mg/12.5 mg film-coated tablets EFG

Read all of this 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. Do not give it to other people, even if they have the same symptoms as you, because it may 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.

Contents of the leaflet

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
6. Contents of the pack and other information

1. What Losartán/Hidroclorotiazida cinfa is and what it is used for

Losartán/hydrochlorothiazide is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

Angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to constrict. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Hydrochlorothiazide causes the kidneys to eliminate increased amounts of water and salts. This also helps reduce blood pressure.

Losartán/hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartán/Hidroclorotiazida cinfa

Do not take Losartán/Hidroclorotiazida 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 (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial agents such as cotrimoxazole; ask your doctor if you are unsure).
• If you are more than 3 months pregnant. (It is also advisable to avoid losartan/hydrochlorothiazide during the first months of pregnancy (see Pregnancy section)).
• If you have severe liver failure.
• If you have severe renal failure or your kidneys do not produce urine.
• If you have low levels of potassium or sodium, or high levels of calcium that cannot be corrected with treatment.
• If you have gout.
  • If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with losartan/hydrochlorothiazide.

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

If you experience vision changes or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to one week 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 are pregnant (or suspect you might be). The use of losartan/hydrochlorothiazide is not recommended during early pregnancy, and you must not take it after the third month of pregnancy as it may cause serious harm to your baby when used from that point onward (see Pregnancy section).

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

• If you have previously experienced swelling of the face, lips, tongue, or throat.
• If you are taking diuretics (medicines to increase urination).
• If you are on a low-salt diet.
• If you have or have had excessive vomiting and/or diarrhea.
• If you have heart failure.
• If your liver function is impaired (see section 2. Do not take Losartán/Hidroclorotiazida cinfa).
• If you have narrowed arteries supplying 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 have diabetes.
• If you have had gout.
• If you have or have had an allergic disorder, asthma, or a condition causing joint pain, skin rash, 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 anesthesia (even at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, you must inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets.
• If you have primary hyperaldosteronism (a syndrome associated with excessive aldosterone hormone secretion by the adrenal gland due to gland dysfunction).
  • If you are taking any of the following medicines for high blood pressure (hypertension):
    • 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 had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun and UV radiation while taking this medicine.
• 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 losartan/hydrochlorothiazida, 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 the information under the heading “Do not take Losartán/Hidroclorotiazida cinfa”.

Other medicines and Losartán/Hidroclorotiazida cinfa

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

Diuretics such as hydrochlorothiazide contained in losartan/hydrochlorothiazide may interact with other medicines. Lithium-containing preparations should not be taken with losartan/hydrochlorothiazide without careful monitoring by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate if you are taking potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines, diuretics (water tablets), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral antidiabetics or insulin). It is also important that your doctor knows if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, 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, or 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 information under the headings “Do not take Losartán/Hidroclorotiazida cinfa” and “Warnings and precautions”).

Please inform your doctor if you are scheduled to receive an iodinated contrast agent while taking losartan/hydrochlorothiazide.

Taking Losartán/Hidroclorotiazida cinfa with food, drinks, and alcohol

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

Excessive dietary salt intake may reduce the effectiveness of losartan/hydrochlorothiazide tablets.

Losartan/hydrochlorothiazide may be taken with or without food.

Grapefruit juice should be avoided while taking this medicine.

Pregnancy, fertility, and breastfeeding

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. 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 from that stage.

Breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Use in children and adolescents

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

Use in elderly patients

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

Driving and using 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.

Losartán/Hidroclorotiazida cinfa contains lactose

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

Use in athletes

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

3. How to take Losartán/Hidroclorotiazida cinfa

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

Your doctor will determine the appropriate dose of losartán/hidroclorotiazida based on your condition and whether you are taking other medications. It is important to continue taking losartán/hidroclorotiazida 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 losartán/hidroclorotiazida 50 mg/12.5 mg once daily to control blood pressure over 24 hours. This dose may be increased to 2 film-coated tablets of losartán/hidroclorotiazida 50 mg/12.5 mg daily or changed to 1 film-coated tablet of losartán/hidroclorotiazida 100 mg/25 mg (a stronger dose) once daily. The maximum daily dose is 2 tablets of 50 mg losartán/12.5 mg hydrochlorothiazide daily or 1 tablet of 100 mg losartán/25 mg hydrochlorothiazide daily.

If you take more Losartán/Hidroclorotiazida cinfa than you should

In case of overdose, contact your doctor immediately or go directly to the hospital to receive immediate medical attention.

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.

Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to take Losartán/Hidroclorotiazida cinfa

Try to take losartán/hidroclorotiazida every day as prescribed. Do not take a double dose to make up for missed doses. Simply return to your regular schedule.

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 people):

• Cough, respiratory 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 people):

• 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 cells, bleeding disorders, reduced 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 disorders, somnolence, 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 when standing up), 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), nosebleed, runny nose, congestion.
• Constipation, chronic constipation, flatulence, 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, skin rash, redness of the skin, 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 people):

• 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 (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 available data):

• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis).
• 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 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.

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

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide cinfa

• The active substances are potassium losartan and hydrochlorothiazide. Each tablet contains 100 mg of potassium losartan and 12.5 mg of hydrochlorothiazide.
• The other components are:

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

Coating: hypromellose, titanium dioxide (E-171) and macrogol.

Appearance of the product and contents of the pack

Film-coated tablets, cylindrical, 10.5 mm in diameter, white in colour and marked with an "L" on one side. The product is presented in PVC-PE-PVDC/AL blisters. Each pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain

or

Laboratorios Liconsa S.A.
Avda. Miralcampo, 7; Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara (Spain)

Date of the most recent revision of this leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) at http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89223/P_89223.html

QR code to: https://cima.aemps.es/cima/dochtml/p/89223/P_89223.html