LOSARTAN PHARMACLAN 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan Pharmaclan50 mg film-coated tablets EFG

Losartan Pharmaclan100mg film-coated tablets EFG

potassium losartan

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Losartan Pharmaclan and what is it used for
2. What you need to know before taking Losartan Pharmaclan
3. How to take Losartan Pharmaclan
4. Possible side effects
5. Storage of Losartan Pharmaclan
6. Package Contents and Additional Information

1. What is Losartan Pharmaclan and what is it used for

Losartan belongs to a group of medications called angiotensin II receptor antagonists. 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, which causes the blood vessels to relax, thereby reducing blood pressure. Losartan reduces the worsening of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan 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 with clinical analyses indicating renal insufficiency and proteinuria ≥ 0.5 g per day (a disease in which the urine contains an abnormal amount of protein).
• to treat patients with chronic heart failure, when their 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 their heart failure has been stabilized with an ACE inhibitor, they should not be switched 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 taking Losartan Pharmaclan

Do not take Losartan Pharmaclan

• if you are allergic to losartan or any of the other ingredients of this medication (listed in section 6),
• if you are pregnant for more than 3 months (it is also best to avoid losartan at the beginning of pregnancy - see Pregnancy),
• if your liver function is severely impaired,
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure medication containing aliskiren.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

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 should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used at this stage (see section Pregnancy).

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

It is essential that you inform your doctor before taking losartan:

• 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 (medications that increase the amount of water that passes through your kidneys) or if you follow a low-salt diet that causes excessive loss of fluids and salt in your body (see section 3 "Posology in special patient groups"),
• if you know you have narrowing or blockage of the blood vessels that go to your kidneys or if you have recently undergone a kidney transplant,
• if your liver function is impaired (see sections 2 "Do not take Losartan Pharmaclan" and 3 "Posology in special patient groups"),
• if you have heart failure with or without kidney insufficiency or concomitant potentially life-threatening cardiac arrhythmias. Special attention is necessary when being treated at the same time with a beta-blocker,
• if you have problems with the valves of 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 medications 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 need to 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 Pharmaclan".

• if you are taking other medications that may increase serum potassium (see section 2 "Other medications and Losartan Pharmaclan").

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 be effective in this age group.

Other Medications and Losartan Pharmaclan

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

Tell your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics (e.g., amiloride, triamterene, spironolactone), or other medications that may increase serum potassium (e.g., heparin, trimethoprim-containing medications), as combination with losartan is not recommended.

While being treated with losartan, be particularly cautious if you take any of the following medications:

• other medications that lower blood pressure, as they may cause additional blood pressure reduction. Blood pressure may also be lowered by some of the following medications/classes of medications: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory medications, such as indomethacin, including COX-2 inhibitors (medications that reduce inflammation and can be 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 Pharmaclan" and "Warnings and Precautions").

If your kidney function is impaired, concomitant use of these medications may lead to worsening of kidney function.

Medications containing lithium should not be taken in combination with losartan without close monitoring by your doctor. Special precautions may be necessary (e.g., blood tests).

Taking Losartan Pharmaclan with Food and Drinks

Losartan can be taken with or without food.

Grapefruit juice should be avoided while taking losartan.

Pregnancy and Breastfeeding

Pregnancy

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

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to continue breastfeeding. Especially if your child is a newborn or premature.

Consult your doctor or pharmacist before using this medication.

Driving and Using Machines

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

It is unlikely that losartan will affect your ability to drive or use machines. However, like many medications 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 Pharmaclan Contains Lactose

Losartan Pharmaclan contains lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Losartan Pharmaclan

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, 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 medications. It is essential to continue taking losartan as prescribed by your doctor to maintain constant blood pressure control.

Adult patients with high blood pressure

Normally, treatment starts with 50 mg of losartan (one losartan 50 mg tablet) once a day. The maximum blood pressure-lowering effect should be 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 50 mg tablets or one losartan 100 mg tablet) once a day.

If you think the effect of losartan is too strong or too weak, 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 be effective in this age group.

Children between 6-18 years of age

The recommended starting dose in patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once a day (up to 25 mg of losartan, i.e., half of a 50 mg tablet). The doctor may increase the dose if blood pressure is not controlled.

Other forms of this medication may be more suitable for children; consult your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes

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

Losartan can be administered with other medications that lower blood pressure (e.g., diuretics, calcium antagonists, alpha or beta blockers, and centrally acting medications), as well as with insulin and other medications 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 12.5 mg tablet) once a day. Normally, the dose should be 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., three losartan 50 mg tablets or one losartan 100 mg tablet and one losartan 50 mg tablet) once a day can be used.

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

Dosage 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 insufficiency, or patients over 75 years of age. Losartan is not recommended for use in patients with severe liver insufficiency (see section "Do not take Losartan Pharmaclan").

Administration

The tablets should be swallowed with a glass of water. You should try to take your daily dose at approximately the same time each day. It is essential to continue taking losartan as prescribed by your doctor.

If You Take More Losartan Pharmaclan 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Losartan Pharmaclan

If you accidentally miss a daily dose, simply take the next dose as usual. Do not take a double dose to make up for missed doses. If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

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 the 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, affecting more than 1 in 10,000 patients, but less than 1 in 1,000 patients. You may need urgent medical attention or hospitalization.

The following adverse effects have been reported with losartan:

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

• dizziness,
• low blood pressure (especially after excessive loss of water from the body within the blood vessels, e.g., in patients with severe heart failure or on high doses of diuretics),
• dose-related orthostatic effects, such as decreased 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 renal function, including renal failure,
• reduced number of red blood cells (anemia),
• increased urea, creatinine, and potassium levels in the blood in patients with heart failure.

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

• 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 people):

• hypersensitivity,
• angioedema,
• inflammation of the blood vessels (vasculitis, including Schönlein-Henoch purpura),
• numbness or tingling sensation (paresthesia),
• fainting (syncope),
• very rapid and irregular heartbeats (atrial fibrillation),
• stroke (cerebral attack),
• inflammation of the liver (hepatitis),
• elevation of alanine aminotransferase (ALT) levels in the blood, which usually resolves upon discontinuation of treatment.
• intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• decrease in the number of platelets,
• migraine,
• abnormalities in liver function,
• 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 (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 is not listed in this leaflet. 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 Pharmaclan

• Keep this medicine out of the sight and reach of children.
• This medicine does not require special storage conditions.
• Do not use this medicine after the expiration date stated on the blister or bottle after "EXP". The expiration date is the last day of the month indicated.
• Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in your 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 Pharmaclan

The active ingredient is losartan potassium, available in 50 or 100 mg tablets.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose (E-460), low-substituted hydroxypropylcellulose (E-463), pregelatinized corn starch, magnesium stearate (E-572), hypromellose (E-464), macrogol 400 (E1521), and titanium dioxide (E-171).

Appearance of the Product and Package Contents

50 mg: film-coated tablets, white to off-white, oval, scored, and engraved with "1" and "17" on one side and nothing on the other side of the score. Without physical defects. The approximate dimensions of the tablet are 8.9 mm x 5.1 mm. The tablet can be divided into two equal doses.

100 mg: film-coated tablets, white to off-white, oval, engraved with "118" on one side and smooth on the other side. Without physical defects. The approximate dimensions of the tablet are 11.70 mm x 7.10 mm.

Package Details

50 mg:

PVC/PE/PVDC/Al blister pack with 28, 30, 90, or 98 tablets. High-density polyethylene (HDPE) bottle with 100 tablets.

100 mg:

PVC/PE/PVDC/Al blister pack with 28, 30, 90, 98, or 105 tablets. High-density polyethylene (HDPE) bottle with 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Pharmaclan S.R.O.

Trtinová 260/1, Cakovice

Prague 19600

Czech Republic

Manufacturer

Pharmazet Group S.R.O.

Trtinová 260/1,

Prague 19600

Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet

May 2025

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