LOSARTAN CINFA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

losartan cinfa 100 mg film-coated tablets EFG

potassium losartan

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

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

Losartan belongs to a group of medicines called angiotensin II receptor antagonists.

Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to narrow. This results in an increase in blood pressure.

Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, resulting in a decrease in blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan cinfa is used:

• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents from 6 to 18 years of age.
• to protect the kidney in hypertensive patients with type 2 diabetes and laboratory results that indicate kidney failure and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure, when your doctor considers that treatment with specific medications, called angiotensin-converting enzyme inhibitors (ACE inhibitors, medications used to lower high blood pressure), is not suitable. If your heart failure has been stabilized with an ACE inhibitor, you should not switch to losartan.
• in patients with high blood pressure and increased thickness of the left ventricle of the heart, losartan has been shown to reduce the risk of stroke (LIFE indication).

2. What you need to know before you take losartan cinfa

Do not take losartan cinfa

• If you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (It is also better to avoid losartan at the beginning of pregnancy (see section Pregnancy and breastfeeding).
• If your liver function is severely impaired.
• If you have diabetes or kidney failure 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 cinfa.

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

You should inform your doctor if you think you are pregnant (or might be). Losartan is not recommended at the beginning of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby (see section Pregnancy and breastfeeding).

Before taking losartan, it is important that you inform your doctor:

• If you have a history of angioedema (swelling of the face, lips, tongue, and/or throat) (see also section 4. Possible side effects).
• If you have excessive vomiting or diarrhea, which causes excessive loss of fluid and/or salt from your body.
• If you are taking diuretics (medicines that increase the amount of water that passes through your kidneys) or if you are on a low-salt diet that causes excessive loss of fluids or salt from your body (see section 3, Posology in special patient groups).
• If you know that you have narrowing or blockage of the blood vessels that supply your kidneys or if you have recently had a kidney transplant.
• If your liver function is impaired (see sections 2. Do not take losartan cinfa and 3. Posology in special patient groups).
• If you have heart failure with or without kidney impairment or potentially life-threatening heart rhythm disorders. Special attention is needed when you are being treated at the same time with a beta-blocker.
• If you have problems with the valves in your heart or with the heart muscle.
• If you have coronary heart disease (caused by reduced blood flow in the blood vessels of the heart) or cerebrovascular disease (caused by reduced blood circulation in the brain).
• 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:
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren

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 cinfa”.

Children and adolescents

Losartan has been studied in children. For more information, talk to your doctor.

Losartan is not recommended for use in children with kidney or liver problems, as there is limited data available in these patient groups. Losartan is not recommended for use in children under 6 years of age, as it has not been shown to work in this age group.

Taking losartan cinfa with other medicines

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, or potassium-sparing medicines such as certain diuretics (amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium levels (e.g., heparin, trimethoprim-containing medicines), as combination with losartan is not recommended.

While you are being treated with losartan, be particularly careful if you take any of the following medicines:

• Other medicines that lower blood pressure, as they may cause additional lowering of blood pressure. Blood pressure may also be lowered by some of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine.
• Non-steroidal anti-inflammatory medicines, such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and are used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan.

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 the information under the headings “Do not take losartan cinfa” and “Warnings and precautions”).

If your kidney function is impaired, concomitant use of these medicines may cause worsening of kidney function.

Medicines that contain lithium should not be used in combination with losartan without your doctor performing close monitoring. It may be appropriate to take special precautions (e.g., blood tests).

Taking losartan cinfa with food and drink

Losartan can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking losartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of losartan. Losartan is not recommended at the beginning of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you want to breastfeed. Especially if your baby is a newborn or was born prematurely.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Losartan is unlikely to affect your ability to drive or use machines. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before performing these activities.

Losartan cinfa contains lactose.

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

3. How to take losartan cinfa

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

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

Adult patients with high blood pressure

Normally, treatment starts with 50 mg of losartan (one losartan cinfa 50 mg tablet) once a day. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. After that, in some patients, the dose may be increased to 100 mg of losartan (two losartan cinfa 50 mg tablets or one losartan cinfa 100 mg tablet) once a day.

If you think the effect of losartan is too strong or too weak, please inform your doctor or pharmacist.

Use in children and adolescents

Children under 6 years of age

Losartan is not recommended for use in children under 6 years of age, as it has not been shown to work in this age group.

Children aged 6 to 18 years

The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, given once a day (up to 25 mg of losartan). Your doctor may increase the dose if blood pressure is not controlled.

Another pharmaceutical form of this medicine may be more suitable for children; ask your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes

Normally, treatment starts with 50 mg of losartan (one losartan cinfa 50 mg tablet) once a day. After that, the dose may be increased to 100 mg of losartan (two losartan cinfa 50 mg tablets or one losartan cinfa 100 mg tablet) once a day, depending on your blood pressure response.

Losartan can be given with other medicines that lower blood pressure (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other medicines frequently used to lower blood glucose levels (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure

Normally, treatment starts with 12.5 mg of losartan (one losartan cinfa 12.5 mg starting tablet) once a day. Normally, the dose is gradually increased weekly (i.e., 12.5 mg per day during the first week, 25 mg per day during the second week, 50 mg per day during the third week, 100 mg per day during the fourth week, 150 mg per day during the fifth week), up to a maintenance dose determined by your doctor. A maximum dose of 150 mg of losartan (e.g., 3 losartan cinfa 50 mg tablets or 1 losartan cinfa 100 mg tablet and 1 losartan cinfa 50 mg tablet) may be used once a day.

In the treatment of heart failure, losartan is normally combined with a diuretic (a medicine that increases the amount of water that passes through your kidneys) and/or digitalis (a medicine that helps your heart be stronger and more efficient) and/or a beta-blocker.

Posology in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those treated with high-dose diuretics, patients with liver failure, or patients over 75 years of age. Losartan is not recommended for use in patients with severe liver failure (see section "Do not take losartan cinfa").

Administration

The tablets should be swallowed whole with a glass of water. You should try to take your daily dose at approximately the same time each day. It is important that you keep taking losartan until your doctor tells you to stop.

If you take more losartan cinfa than you should

If you accidentally take too many tablets, contact your doctor immediately. The symptoms of overdose are low blood pressure, increased heart rate, and possibly decreased heart rate.

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 cinfa

If you accidentally miss a dose, simply take the next dose as normal. Do not take a double dose to make up for missed doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist or nurse.

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 tablets and inform your doctor immediately or go to the emergency department of your nearest hospital:

• A severe allergic reaction (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 that can affect up to 1 in 1,000 patients. You may need urgent medical attention or hospitalization.

Medicine adverse effects are classified as follows:

The following adverse effects have been reported with losartan:

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

• dizziness,
• low blood pressure (especially after excessive loss of water from the body within the blood vessels, for example in patients with severe heart failure or being treated with high doses of diuretics),
• dose-related orthostatic effects, such as a decrease in blood pressure that occurs after standing up from lying down or sitting,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• changes in liver function, including kidney failure,
• reduced number of red blood cells (anemia),

• increased urea, creatinine, and potassium levels in the blood in patients with heart failure.

Infrequent (may affect up to 1 in 100 patients)

• drowsiness
• headache
• sleep disorders
• feeling of very rapid heartbeats (palpitations)
• severe chest pain (angina pectoris)
• difficulty breathing (dyspnea),
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localized swelling (edema).
• cough

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

• hypersensitivity,
• angioedema,
• inflammation of the blood vessels (vasculitis, including Schonlein-Henoch purpura),
• numbness or tingling sensation (paresthesia),
• fainting (syncope),
• very rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebrovascular accident),
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves when treatment is discontinued.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known(cannot be estimated from available data)

• reduced number of platelets,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection.
• increased sensitivity to sunlight (photosensitivity),
• muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the blood (hyponatremia),
• depression,
• generally feeling unwell (malaise),
• ringing, buzzing, noise, or clicking in the ears (tinnitus),
• disturbance of taste (dysgeusia).

Adverse effects in children are similar to those observed in adults.

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 does not appear in this prospectus. You can also report them 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 Cinfa

Keep this medicine out of 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.

This medicine does not require special storage conditions.

Store in the original packaging.

Do not open the blister pack until you are ready to take the medicine.

Medicines should not be thrown away 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 way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan Cinfa

• The active ingredient is losartan potassium. Each film-coated tablet of losartan cinfa 100 mg contains 100 mg of losartan potassium.
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, hydroxypropylmethylcellulose, and titanium dioxide (E-171).

Losartan cinfa 100 mg contains potassium in the following amount: 8.48 mg (0.22 mEq).

Appearance of the Product and Package Contents

Losartan cinfa film-coated tablets are white and cylindrical.

Losartan cinfa is presented in aluminum-PVC/PVDC blister packs, in packs of 28 or 500 (clinical packaging) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – 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/67731/P_67731.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67731/P_67731.html