PRESARTAN 50 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT
2. Presartan, 50 mg, film-coated tablets
3. Presartan, 100 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. WHAT IS PRESARTAN AND WHAT IS IT USED FOR
5. IMPORTANT INFORMATION BEFORE TAKING PRESARTAN
   1. When not to take Presartan
   2. Warnings and precautions
   3. Presartan and other medicines
   4. Presartan with food and drink
   5. Pregnancy and breastfeeding
   6. Children and adolescents
   7. Driving and using machines
   8. Presartan contains lactose monohydrate
   9. Presartan contains sodium
6. HOW TO TAKE PRESARTAN
   1. Dosage in special patient groups
   2. Administration
   3. Taking a higher dose of Presartan than recommended
   4. Missing a dose of Presartan
   5. Stopping treatment with Presartan
7. POSSIBLE SIDE EFFECTS
   1. Reporting side effects
8. HOW TO STORE PRESARTAN
9. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
   1. What Presartan contains
   2. What Presartan looks like and contents of the package
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Presartan, 50 mg, film-coated tablets

Presartan, 100 mg, film-coated tablets

Losartan potassium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Presartan and what is it used for
• 2. Important information before taking Presartan
• 3. How to take Presartan
• 4. Possible side effects
• 5. How to store Presartan
• 6. Contents of the package and other information

1. WHAT IS PRESARTAN 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 the blood vessel walls, causing them to narrow, which in turn increases blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing the blood vessels to relax, which in turn lowers blood pressure. Losartan slows down the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

Presartan is used:

• to treat patients with high blood pressure (hypertension)
• to protect the kidneys in patients with high blood pressure and type 2 diabetes with laboratory-confirmed kidney function impairment and proteinuria ≥ 0.5 g/day (a condition in which the urine contains an excessive amount of protein)
• to treat patients with chronic heart failure, when treatment with certain medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines used to lower high blood pressure) is not considered appropriate by the doctor. If heart failure has been stabilized with an ACE inhibitor, it should not be replaced with losartan
• in patients with high blood pressure and thickening of the left ventricular wall, as losartan has been shown to reduce the risk of stroke (the "LIFE indication").

2. IMPORTANT INFORMATION BEFORE TAKING PRESARTAN

When not to take Presartan

• If the patient is allergic to losartan or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe liver function disorders.
• After the 3rd month of pregnancy (it is also recommended to avoid taking Presartan in early pregnancy - see "Pregnancy and breastfeeding").
• If the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Presartan, the patient should discuss it with their doctor.

The patient should inform their doctor:

• if they have ever had angioedema - swelling of the face, lips, throat, and/or tongue (see also section 4 "Possible side effects");
• if they experience abdominal pain, nausea, vomiting, or diarrhea after taking Presartan, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Presartan on their own;
• if they are taking diuretics (medicines that increase the amount of water excreted by the kidneys) or a low-salt diet leading to excessive fluid and salt loss from the body (see section 3 "Dosage in special patient groups");
• if they have narrowing or blockage of the blood vessels leading to the kidneys or if they have recently undergone a kidney transplant;
• if they have liver function disorders (see sections 2 "When not to take Presartan" and 3 "Dosage in special patient groups");
• if they have heart failure with or without kidney function disorders or co-existing severe life-threatening heart rhythm disorders. Particular caution is required when treating with beta-adrenolityki;
• if they have diseases of the heart valves or heart muscle;
• if they have coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebral vascular disease (caused by reduced blood circulation in the brain);
• if they have primary hyperaldosteronism (a syndrome associated with increased aldosterone hormone excretion by the adrenal glands, caused by adrenal gland disorders);
• if they are taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme inhibitor (ACE), such as enalapril, lisinopril, ramipril, especially if the patient has kidney function disorders associated with diabetes,
• aliskiren;
• if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant. Presartan should not be taken during pregnancy, especially after the 3rd month, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.

See also the information under the heading "When not to take Presartan".

Presartan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Particular caution is required when taking the following medicines during treatment with Presartan:

• other blood pressure-lowering medicines, as they may further lower blood pressure. If another blood pressure-lowering medicine is added to losartan, the doctor may decide to monitor kidney function. Blood pressure may also be lowered by the following medicines/groups of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• potassium-sparing medicines or those that may increase potassium levels in the blood [e.g., potassium supplements, salt substitutes containing potassium, or potassium-sparing diuretics (such as amiloride, triamterene, spironolactone, eplerenone) or heparin],
• non-steroidal anti-inflammatory medicines such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used to reduce pain), as they may weaken the blood pressure-lowering effect of losartan. In patients with kidney function disorders, concomitant use of these medicines may lead to worsening of kidney function. Without close medical supervision, it is not recommended to take lithium-containing medicines in combination with losartan. It may be necessary to take special precautions (e.g., blood tests).

The doctor may need to adjust the dose and/or take other precautions if the patient is taking an ACE inhibitor or aliskiren (see also the information under the headings "When not to take Presartan" and "Warnings and precautions").

Presartan with food and drink

Presartan can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy

The patient should inform their doctor about suspected (or planned) pregnancy. The doctor will usually recommend stopping Presartan before planned pregnancy or as soon as pregnancy is confirmed and recommend taking another medicine instead of Presartan. Presartan should not be taken during pregnancy, especially after the 3rd month, as it may seriously harm the fetus.

Breastfeeding

The patient should inform their doctor about breastfeeding or intending to breastfeed. Presartan should not be taken during breastfeeding, especially in the case of breastfeeding a newborn or premature baby. The doctor may recommend taking another medicine.

Children and adolescents

No studies have been conducted on the use of losartan in children. For further information, the patient should consult their doctor.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive vehicles and operate machinery. It is unlikely that Presartan will affect the ability to drive vehicles and operate machinery. However, as with many blood pressure-lowering medicines, losartan may cause dizziness or drowsiness.

In case of dizziness or drowsiness, the patient should consult their doctor before performing such activities.

Presartan contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Presartan contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. HOW TO TAKE PRESARTAN

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

The doctor will decide on the appropriate dose of Presartan, depending on the patient's condition and other medicines being taken. To maintain consistent blood pressure control, it is essential to continue taking Presartan as long as the doctor recommends.

Patient with high blood pressure

Treatment usually starts with a dose of 50 mg of losartan (e.g., one tablet of Presartan 50 mg) once a day. The maximum blood pressure-lowering effect should occur 3 to 6 weeks after starting treatment. In some patients, the dose may be increased to 100 mg of losartan (e.g., two tablets of Presartan 50 mg or one tablet of Presartan 100 mg) once a day.

Patient with high blood pressure and type 2 diabetes

Treatment usually starts with a dose of 50 mg of losartan (e.g., one tablet of Presartan 50 mg) once a day. The dose may be increased to 100 mg of losartan (e.g., two tablets of Presartan 50 mg or one tablet of Presartan 100 mg) once a day, depending on blood pressure changes.

Tablets containing losartan can be taken together with other blood pressure-lowering medicines (e.g., diuretics, calcium channel blockers, alpha- or beta-adrenolityki) and with insulin and other commonly used hypoglycemic medicines (e.g., sulfonylurea derivatives, glitazones, and glucosidase inhibitors).

Patient with heart failure

Treatment usually starts with a dose of 12.5 mg of losartan once a day. This dose is usually increased gradually at weekly intervals (i.e., 12.5 mg/day during the first week, 25 mg/day during the second week, 50 mg/day during the third week) until the usual maintenance dose of 50 mg (e.g., one tablet of Presartan 50 mg) once a day is reached, depending on the patient's condition.

In the treatment of heart failure, losartan is usually combined with diuretics (medicines that increase the amount of water excreted by the kidneys) and/or digitalis glycosides (medicines that strengthen the heart and increase its efficiency) and/or beta-adrenolityki.

Reducing the risk of stroke in patients with high blood pressure and left ventricular hypertrophy confirmed by ECG

Treatment usually starts with a dose of 50 mg of losartan once a day. Depending on blood pressure changes, hydrochlorothiazide may be added in a low dose and/or the dose of losartan may be increased to 100 mg once a day.

Dosage in special patient groups

In some patients, such as those taking high doses of diuretics, patients with liver function disorders, or patients over 75 years of age, the doctor may recommend reducing the dose, especially during the initial treatment phase. Losartan should not be taken by patients with severe liver function disorders (see "When not to take Presartan").

Administration

Tablets should be swallowed with a glass of water. The patient should try to take their daily dose of Presartan at the same time every day. It is essential to continue taking Presartan unless the doctor recommends otherwise.

Taking a higher dose of Presartan than recommended

In case of accidental ingestion of too many tablets or swallowing of several tablets by a child, the patient should immediately contact their doctor. Symptoms of overdose are low blood pressure, increased heart rate (decreased heart rate is possible).

Missing a dose of Presartan

If the patient has accidentally missed a daily dose, they should take the next dose as usual. The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Presartan

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

In case of the following side effects, the patient should stop taking the tablets containing losartan and immediately consult their doctor or go to the nearest hospital:

• severe allergic reactions (rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing).

These are serious but rare side effects (occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients). They may require urgent medical attention or hospitalization.

The following side effects have been reported in connection with losartan:

Frequent (occurring in less than 1 in 10 patients):

• decreased red blood cell count (anemia),
• dizziness of central or labyrinthine origin,
• low blood pressure, including orthostatic hypotension occurring when standing up from a lying or sitting position,
• kidney function disorders and kidney failure,
• weakness,
• fatigue,
• increased potassium levels in the blood (hyperkalemia),
• increased urea levels in the blood,
• increased creatinine levels in the serum,
• decreased blood sugar levels (hypoglycemia).

Uncommon (occurring in less than 1 in 100 patients):

• drowsiness,
• headache,
• sleep disorders,
• increased heart rate (palpitations),
• chest pain (angina pectoris),
• shortness of breath,
• cough,
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching (pruritus),
• rash,
• edema.

Rare (occurring in less than 1 in 1,000 patients):

• hypersensitivity reactions,
• allergy (anaphylactic reactions),
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• fainting,
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke,
• hepatitis,
• increased alanine aminotransferase (ALT) activity in the blood, usually resolving after treatment is stopped,
• angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown (frequency cannot be estimated from the available data):

• decreased platelet count (thrombocytopenia),
• depression,
• migraine,
• taste disorders,
• ringing, buzzing, or clicking in the ears (tinnitus),
• pancreatitis,
• liver function disorders,
• photosensitivity,
• muscle pain,
• joint pain,
• muscle breakdown, which can lead to kidney failure (rhabdomyolysis),
• erectile dysfunction/impotence,
• general malaise,
• back pain,
• urinary tract infections,
• flu-like symptoms,
• decreased sodium levels in the blood (hyponatremia).

Side effects in children are similar to those in adults.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. HOW TO STORE PRESARTAN

Store in a temperature below 30°C.

Medicines should be kept out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Presartan contains

The active substance of Presartan is losartan potassium.

Each tablet of Presartan 50 mg contains 50 mg of losartan potassium.

Each tablet of Presartan 100 mg contains 100 mg of losartan potassium.

The other ingredients of the medicine are: microcrystalline cellulose, lactose monohydrate, maize starch, sodium carboxymethylcellulose (type A), magnesium stearate; coating Opadry White 20A18334 containing: hydroxypropylcellulose (E463), hypromellose 6cP (E464), and titanium dioxide (E171).

Presartan 50 mg and 100 mg contain potassium in the following amounts: 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.

What Presartan looks like and contents of the package

Presartan 50 mg is available in the form of white, round, biconvex film-coated tablets with a dividing line on one side.

Presartan 100 mg is available in the form of white, round, biconvex film-coated tablets with a dividing line on one side.

Presartan 50 mg and 100 mg packages contain 3 non-transparent blisters of PVC/PE/PVDC/Al foil, each containing 10 film-coated tablets, in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Tel: +48 17 865 51 00

Manufacturer

PharmaPath S.A.

28is Oktovriou 1

Agia Varvara, 123 51, Greece

Bausch Health Poland sp. z o.o.

ul. Przemysłowa 2

35-959 Rzeszów, Poland

Date of last revision of the leaflet: