PRESARTAN 100 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGING: 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 than recommended dose of Presartan
   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 PACK AND OTHER INFORMATION
   1. What Presartan contains
   2. What Presartan looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

LEAFLET INCLUDED IN THE PACKAGING: 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, 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 pack 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 blood vessel walls, causing them to narrow, resulting in increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to relax, which in turn lowers blood pressure. Losartan slows the progression of kidney disease 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 disease 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 suitable by the doctor. If heart failure has been stabilized with an ACE inhibitor, it should not be switched to 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 disease.
• After the 3rd month of pregnancy (it is also recommended to avoid taking Presartan during early pregnancy - see "Pregnancy and breastfeeding").
• If the patient has diabetes or kidney disease 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 are on a low-salt diet that leads to excessive loss of fluids and salts 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 have recently undergone a kidney transplant;
• if they have liver disease (see sections 2 "When not to take Presartan" and 3 "Dosage in special patient groups");
• if they have heart failure with or without kidney disease or concomitant severe life-threatening heart rhythm disorders. Particular caution is required when co-administering beta-blockers;
• if they have diseases affecting 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 secretion by the adrenal glands, caused by adrenal gland disorders);
• if they are taking any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme inhibitor (ACE), such as enalapril, lisinopril, ramipril, especially if the patient has kidney disease 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 early pregnancy and must not be taken after the 3rd month of pregnancy, 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 medicines that lower blood pressure, 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 medicines 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 disease, 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 baby, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy

The patient should inform their doctor if they suspect (or plan) pregnancy. The doctor will usually advise stopping Presartan before planned pregnancy or as soon as pregnancy is confirmed and recommend taking a different medicine instead of Presartan. Presartan should not be taken during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus.

Breastfeeding

The patient should inform their doctor if they are breastfeeding or plan to breastfeed. Presartan is not recommended during breastfeeding, especially in newborns or premature babies. The doctor may recommend a different 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.

If the patient experiences dizziness or drowsiness, they 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. If the patient has any doubts, they 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.

Patients with high blood pressure

Treatment usually starts with a dose of 50 mg of losartan (e.g., one 50 mg Presartan tablet) 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 50 mg Presartan tablets or one 100 mg Presartan tablet) once a day.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Patients with high blood pressure and type 2 diabetes

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

Losartan tablets can be taken with other blood pressure-lowering medicines (e.g., diuretics, calcium channel blockers, alpha- or beta-blockers) and with insulin and other commonly used medicines with a blood glucose-lowering effect (e.g., sulfonylurea derivatives, glitazones, and glucose inhibitors).

Patients 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 per day during the first week, 25 mg per day during the second week, 50 mg per day during the third week) until the usual maintenance dose of 50 mg (e.g., one 50 mg Presartan tablet) 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-blockers.

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 disease, or patients over 75 years of age, the doctor may recommend a dose reduction, especially during the initial treatment phase. Losartan should not be used in patients with severe liver disease (see "When not to take Presartan").

Administration

The 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 than recommended dose of Presartan

If the patient has accidentally taken too many tablets or a child has swallowed several tablets, they should contact their doctor immediately. Symptoms of overdose are low blood pressure, increased heart rate (decreased heart rate is possible).

Missing a dose of Presartan

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

Stopping treatment with Presartan

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

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

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

These are severe 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):

• decrease in red blood cell count (anemia),
• dizziness of central or peripheral 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,
• allergic reactions (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 discontinuation,
• angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• decrease in 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 the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, 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, more information can be collected on the safety of the medicine.

5. HOW TO STORE PRESARTAN

Store in a temperature below 30°C.

The medicine should be stored out of 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 they no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Presartan contains

The active substance of Presartan is losartan potassium.

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

Each 100 mg Presartan tablet 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 pack

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 packs contain 3 non-transparent blisters of PVC/PE/PVDC/Al, 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: