LOSARTAN/HYDROCHLOROTHIAZIDE CINFA 100 mg/12.5 mg FILM-COATED TABLETS

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Losartan/Hydrochlorothiazide cinfa and what is it used for
2. What you need to know before you take Losartan/Hydrochlorothiazide cinfa
3. How to take Losartan/Hydrochlorothiazide cinfa
4. Possible side effects
5. Storage of Losartan/Hydrochlorothiazide cinfa
6. Contents of the pack and other information

1. What is Losartan/Hydrochlorothiazide cinfa and what is it used for

Losartan/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 narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in the relaxation of blood vessels, which in turn lowers blood pressure. Hydrochlorothiazide causes the kidneys to eliminate more water and salts. This also helps to reduce blood pressure.

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

2. What you need to know before you take 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 (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, some antibacterials such as cotrimoxazole, ask your doctor if you are not sure).
• If you are more than 3 months pregnant. (It is also recommended to avoid losartan/hydrochlorothiazide during the first months of pregnancy (see section Pregnancy).
• If you have severe hepatic impairment.
• If you have severe renal impairment or your kidneys are not producing urine.
• If you have low levels of potassium or sodium, high levels of calcium that cannot be corrected with treatment.
• If you have gout.
• • If you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

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

Consult 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 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 pressure in the eye, and can occur within a few hours to a week after taking losartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be at greater risk if you have previously had an allergy to penicillin or sulfonamide.

Tell your doctor if you are pregnant (or think you may be). Losartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that time on (see section Pregnancy).

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

• If you have previously suffered from swelling of the face, lips, tongue, or throat.
• If you are taking diuretics (medicines to urinate).
• If you are on a low-salt diet.
• If you have had excessive vomiting and/or diarrhea.
• 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 that supply the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant.
• If you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to poor heart function).
• If you have narrowing of the aortic or mitral valve (valve narrowing) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves).
• If you are diabetic.
• If you have had gout.
• If you have had an allergic disorder, asthma, or a condition that causes joint pain, skin rash, and fever (systemic lupus erythematosus).
• If you have high levels of calcium or low levels of potassium, or if you are on a low-potassium diet.
• If you need to have anesthesia (even at the dentist) or before surgery, or if you are going to have tests to determine your parathyroid function, you should inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets.
• If you have primary hyperaldosteronism (a syndrome associated with high 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 (hypertension):
  • • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems
    • aliskiren.
• 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 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 experience severe shortness of breath or difficulty breathing after taking losartan/hydrochlorothiazide, 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 Losartan/Hydrochlorothiazide cinfa”.

Other medicines and Losartan/Hydrochlorothiazide cinfa

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

Diuretics like hydrochlorothiazide in losartan/hydrochlorothiazide may interact with other medicines. Preparations containing lithium should not be taken with losartan/hydrochlorothiazide without your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes that contain potassium, or potassium-sparing medicines, diuretics (water pills), some laxatives, medicines for gout, medicines to control heart rhythm or diabetes (oral or insulin), or other blood pressure-lowering medicines.

It is also important that your doctor knows if you are taking steroids, cancer medicines, painkillers, antifungal medicines, or medicines for arthritis, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills, or opioid medicines like morphine, "pressor amines" like adrenaline or other medicines in the same group; (oral diabetes medicines or insulins).

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Losartan/Hydrochlorothiazide cinfa” and “Warnings and precautions”).

Please, when taking losartan/hydrochlorothiazide, inform your doctor when you are scheduled to have a contrast medium with iodine.

Taking Losartan/Hydrochlorothiazide cinfa with food, drinks, and alcohol

It is recommended that you do not drink alcohol while taking these tablets: alcohol and losartan/hydrochlorothiazide tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of losartan/hydrochlorothiazide tablets.

Losartan/hydrochlorothiazide can be taken with or without food.

Grapefruit juice should be avoided while taking this medicine.

Pregnancy, fertility, and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or think you may be). Your doctor will normally advise you to stop taking losartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of losartan/hydrochlorothiazide. Losartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from that time on.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. The use of losartan/hydrochlorothiazide is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want 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 works as well and is as well tolerated by most elderly patients as by younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

When starting treatment with this medicine, you should not perform tasks that require special attention (e.g. driving a car or using hazardous machinery) until you know how your medicine affects you.

Losartan/Hydrochlorothiazide cinfa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Use in athletes

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

3. How to take Losartan/Hydrochlorothiazide cinfa

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will decide the appropriate dose of losartan/hydrochlorothiazide, depending on your condition and whether you are taking other medicines. It is important to keep taking losartan/hydrochlorothiazide while your doctor prescribes it to maintain constant control of your blood pressure.

High blood pressure

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

If you take more Losartan/Hydrochlorothiazide cinfa than you should

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

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 medicine and the amount taken.

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

If you forget to take Losartan/Hydrochlorothiazide cinfa

Try to take losartan/hydrochlorothiazide as prescribed. Do not take a double dose to make up for forgotten doses. Simply return to your usual schedule.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

This is a serious but rare side effect, affecting more than 1 patient in 10,000, but less than 1 patient in 1,000. You may need urgent medical attention or hospitalization.

The following side 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.
• High levels of potassium (which can cause an abnormal heart rhythm), decrease in 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 the hands and feet, and abdominal pain), bruising, reduced white blood cell count, blood clotting problems, low platelet count.
• Loss of appetite, high levels of uric acid or gout, high blood sugar levels, abnormal blood electrolyte levels.
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment.
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting.
• Blurred vision, eye irritation or itching, conjunctivitis, worsening of vision, seeing things in yellow.
• Ringing, buzzing, or other noises in the ears, dizziness.
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient stroke, "mini-stroke"), heart attack, palpitations.
• Inflammation of blood vessels that is often associated with a skin rash or bruising.
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion.
• Constipation, chronic constipation, gas, stomach disorders, stomach cramps, vomiting, dry mouth, inflammation of a salivary gland, toothache.
• Jaundice (yellowing of the eyes and skin), pancreatitis.
• Hives, itching, skin inflammation, skin rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss.
• Pain in the 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 desire, impotence.
• Swelling of the face, localized swelling (edema), fever.

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

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

Very rare (may affect up to 1 in 10,000 people):

• Acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

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

• Muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis),
• 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 effusion) or acute angle-closure glaucoma].

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 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 that appears on the packaging after CAD. The expiry date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan/Hydrochlorothiazide cinfa

• The active ingredients are losartan potassium and hydrochlorothiazide. Each tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
• The other ingredients 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 Package Contents

Film-coated tablets, cylindrical with a diameter of 10.5 mm, white in color, and marked with an "L" on one face. They are presented in PVC-PE-PVDC/AL blisters. Each package contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 Last Revision of this Leaflet:February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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