LOSARTAN/HYDROCHLOROTHIAZIDE CINFA 100 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

losartan potassium and hydrochlorothiazide

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 and other information

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. Storing losartan/hydrochlorothiazide cinfa.

Contents of the pack and further information.

1. What is losartan/hydrochlorothiazide cinfa and what is it used for

losartan/hydrochlorothiazide cinfa is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to narrow. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, resulting in the blood vessels relaxing, which in turn lowers the blood pressure. Hydrochlorothiazide causes the kidneys to remove more water and salts. This also helps to lower blood pressure.

losartan/hydrochlorothiazide cinfa 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 to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial drugs such as cotrimoxazole; ask your doctor if you are not sure).
• If you have severe hepatic impairment.
• If you have low levels of potassium or sodium, or high levels of calcium that cannot be corrected by treatment.
• If you have gout.
• If you are more than 3 months pregnant. (It is also better to avoid losartan/hydrochlorothiazide at the beginning of pregnancy – see section Pregnancy).
• 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 a blood pressure medicine that contains aliskiren.

Warnings and precautions

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

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 an increase in pressure in the eye, and can occur within hours to weeks 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.

You should inform your doctor if you think you are pregnant (or might become pregnant). 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. It is not recommended to take losartan/hydrochlorothiazide at the start of pregnancy, and in no case should it be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage.

It is important that you 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 (water tablets);
• 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 narrow 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 stenosis) 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 disease that causes joint pain, skin rashes, 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 to undergo 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 an alteration 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 had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking losartan/hydrochlorothiazide cinfa, seek medical attention immediately.

Your doctor may check 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 levels (see section 2 “Other medicines and losartan/hydrochlorothiazide cinfa”);
• 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 exposure 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 should not be given to children.

Other medicines and losartan/hydrochlorothiazide cinfa

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

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

Diuretics like hydrochlorothiazide in losartan/hydrochlorothiazide may interact with other medicines.

Preparations containing lithium should not be taken with losartan/hydrochlorothiazide without close monitoring by your doctor.

Special precautions may be necessary (e.g. blood tests) if you are taking other diuretics (water tablets), certain laxatives, medicines for treating gout, medicines for controlling heart rhythm, or for diabetes (oral medicines or insulins).

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

• other medicines to lower your blood pressure,
• corticosteroids,
• medicines to treat cancer,
• medicines for pain relief,
• medicines to treat fungal infections,
• medicines for arthritis,
• cholesterol-lowering medicines such as colestyramine,
• muscle relaxants,
• sleeping tablets;
• opioid medicines such as morphine,
• "pressor amines" such as adrenaline or other medicines of the same group,
• oral medicines for diabetes 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 sections “Do not take losartan/hydrochlorothiazide cinfa”and “Warnings and precautions”).

When taking losartan/hydrochlorothiazide, inform your doctor if you are to undergo a radiographic examination with an iodine-containing contrast medium.

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.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you are pregnant (or think you might be). Your doctor will usually 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. It is not recommended to take losartan/hydrochlorothiazide at the start of pregnancy, and in no case should it be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to take losartan/hydrochlorothiazide during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

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.

Use in athletes

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

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 the 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, contact them before taking this medicine.

3. How to take losartan/hydrochlorothiazide cinfa

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. 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 continue taking losartan/hydrochlorothiazide as long as 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 over 24 hours. This can be increased to 2 tablets of 50 mg losartan/12.5 mg hydrochlorothiazide 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 losartan/12.5 mg hydrochlorothiazide per day or 1 tablet of 100 mg losartan/25 mg hydrochlorothiazide per day.

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 for medical attention. Overdose may cause a drop in 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take losartan/hydrochlorothiazide cinfa

Try to take losartan/hydrochlorothiazide at the prescribed time every day. 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 all people suffer from 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 adverse effect, affecting more than 1 patient in 10,000, but less than 1 patient in 1,000. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported:

Frequent (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.
• High levels of potassium (which can cause an abnormal heart rhythm), decrease in hemoglobin levels.
• Changes in renal function, including renal failure.
• Low blood sugar (hypoglycemia).

Infrequent (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 the hands and feet, and abdominal pain), hematoma, reduced white blood cell count, coagulation problems, and reduced platelet count.
• Lack of appetite, high levels of uric acid or gout, high blood glucose 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, tremors, migraine, fainting.
• Blurred vision, itching or burning in the eyes, conjunctivitis, worsening vision, seeing things in yellow.
• Ringing, buzzing, noises, or clicking in the ears, vertigo.
• Low blood pressure that 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 hematoma.
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nasal bleeding, runny nose, congestion.
• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache.
• Jaundice (yellowish color 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 renal function, including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased sexual appetite, impotence.
• Swelling of the face, 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 that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very Rare:

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

Frequency Not Known (cannot be estimated from the available data):

• Flu-like symptoms.
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis).
• Low sodium levels in the blood (hyponatremia).
• Generally feeling 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 that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. 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 25 mg of hydrochlorothiazide.
• The other excipients are:

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

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

Appearance of the Product and Package Contents

Film-coated tablets, cylindrical, and yellow in color.

They are presented in PVC-PE-PVDC/Aluminum blisters. Each package contains 28 or 500 (clinical package) film-coated tablets.

Only some package 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 Last Revision of this Prospectus: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 prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69056/P_69056.html

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