Presartan

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Presartan, 50 mg, film-coated tablets
Presartan, 100 mg, film-coated tablets
Losartanum kalicum
Please read this leaflet carefully before 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 personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Presartan is and what it is used for
2. What you need to know 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 known as angiotensin II receptor antagonists. Angiotensin II
is a substance produced in the body that binds to receptors in the walls of blood vessels,
causing them to narrow. This leads to increased blood pressure. Losartan prevents angiotensin II
from binding to these receptors, resulting in relaxation of the blood vessels and consequently lowering
blood pressure. Losartan slows down the worsening of kidney function in patients with high
blood pressure and type 2 diabetes.
Presartan is used:

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

2. IMPORTANT INFORMATION BEFORE USING PRESARTAN

When not to use 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 impairment.
• After the 3rd month of pregnancy (it is also advisable to avoid taking Presartan in early pregnancy - see "Pregnancy and breastfeeding").
• If the patient has diabetes or kidney function impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Presartan, discuss this with your doctor.
Inform your doctor:

• if the patient has ever experienced angioedema – swelling of the face, lips, throat and/or tongue (see also section 4 "Possible side effects");
• if the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Presartan, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Presartan on your own initiative;
• if the patient is taking diuretics (medicines that increase the amount of fluid excreted by the kidneys) or a low-salt diet leading to excessive loss of fluids and salts from the body (see section 3 "Dosage in special patient groups");
• if the patient has narrowing or blockage of the blood vessels leading to the kidneys or has recently undergone a kidney transplant;
• if the patient has liver function impairment (see sections 2 "When not to use Presartan" and 3 "Dosage in special patient groups");
• if the patient has heart failure, with or without kidney function impairment, or life-threatening arrhythmias. Particular caution is required when treating concomitantly with β-blockers;
• if the patient has diseases affecting heart valves or heart muscle;
• if the patient has 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 the patient has primary hyperaldosteronism (a syndrome associated with increased excretion of the hormone aldosterone by the adrenal glands due to adrenal gland abnormalities);
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, ramipril, particularly if the patient has kidney problems related to diabetes,
• aliskiren;
• if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant. Presartan is not recommended in early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").

The treating physician may monitor kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading "When not to use Presartan".
Presartan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Particular caution is required when using the following medicines during treatment with Presartan:

• other medicines that lower blood pressure, as they may further reduce the patient's blood pressure. If another blood pressure-lowering medicine is added to losartan treatment, the doctor may decide that monitoring of kidney function is necessary. Blood pressure may also be reduced by the following medicines/groups of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• potassium-sparing agents or agents 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 drugs such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used adjunctively to relieve pain), as they may weaken the blood pressure-lowering effect of losartan. In patients with impaired kidney function, concomitant use of these medicines may lead to worsening of kidney function. Do not use lithium-containing medicines concomitantly with losartan without strict medical supervision. Special precautions may be required (e.g. blood tests).

The treating physician may need to adjust the dose and/or take other precautions if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Presartan" and "Warnings and precautions").
Presartan with food and drink
Presartan may be taken independently of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Your doctor will usually recommend discontinuing Presartan before planned pregnancy or immediately after pregnancy is confirmed, and will recommend taking another medicine instead of Presartan. Presartan is not recommended in early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Presartan is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. Your doctor may recommend using another medicine.
Children and adolescents
Studies on the use of losartan in children have not been conducted. For further information, consult your doctor.
Driving and operating machinery
Studies on the effect of the medicine on the ability to drive motor vehicles and operate mechanical equipment have not been conducted. It is unlikely that Presartan will affect the ability to drive motor vehicles and operate mechanical equipment. However, as with many medicines used to lower blood pressure, losartan may cause dizziness or drowsiness in some individuals.
If dizziness or drowsiness occurs, consult your doctor before engaging in such activities.
Presartan contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking the medicine.
Presartan contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. HOW TO USE PRESARTAN

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Your doctor will decide the appropriate dose of Presartan based on your condition and other
medicines you are taking. To maintain consistent blood pressure control, it is important to continue
taking Presartan for as long as your doctor recommends.

Patients with high blood pressure
Treatment is usually started at a dose of 50 mg losartan (e.g. one tablet of Presartan 50 mg) once daily.
The maximum blood pressure-lowering effect should occur within 3 to 6 weeks after starting treatment.
In some patients, the dose may then be increased to 100 mg losartan (e.g. two tablets of Presartan
50 mg or one tablet of Presartan 100 mg) once daily.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Patients with high blood pressure and type 2 diabetes
Treatment is usually started at a dose of 50 mg losartan (e.g. one tablet of Presartan 50 mg) once daily.
The dose may then be increased to 100 mg losartan (e.g. two tablets of Presartan 50 mg or one tablet of
Presartan 100 mg) once daily, depending on changes in blood pressure.
Tablets containing losartan may be used together with other blood pressure-lowering medicines (e.g.
diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally-acting agents), as well as with
insulin and other commonly used hypoglycaemic medicines (e.g. sulfonylureas, glitazones, and
alpha-glucosidase inhibitors).

Patients with heart failure
Treatment is usually started at a dose of 12.5 mg losartan once daily. This dose should usually be
gradually increased at weekly intervals (i.e. 12.5 mg once daily during the first week, 25 mg once daily
during the second week, 50 mg once daily during the third week) until the usual maintenance dose of
50 mg (e.g. one tablet of Presartan 50 mg) once daily 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 improve its function) and (or) beta-blockers.

Reduction of stroke risk in patients with hypertension and echocardiographically documented left
ventricular hypertrophy
Treatment is usually started at a dose of 50 mg losartan once daily. Depending on changes in blood
pressure, a low dose of hydrochlorothiazide may be added and (or) the dose may be increased to
100 mg losartan once daily.

Dosage in special patient groups
Your doctor may recommend a lower dose, especially at the beginning of treatment, for certain patients
such as those taking high-dose diuretics, patients with impaired liver function, or patients over 75 years
of age. Losartan should not be used in patients with severe hepatic impairment (see section "When not
to use Presartan").

Administration
The tablets should be swallowed with a glass of water. Try to take the daily dose at the same time each
day. It is important to continue taking Presartan unless your doctor advises otherwise.

Taking more Presartan than prescribed
If you accidentally take too many tablets or if a child swallows several tablets, contact your doctor
immediately. Symptoms of overdose include low blood pressure, increased heart rate (bradycardia may
also occur).

Missed dose of Presartan
If you accidentally miss a dose, take the next dose as usual. Do not take a double dose to make up for
the missed tablet.

Stopping Presartan
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur, stop taking the tablets
containing losartan and immediately consult a doctor or go to the nearest hospital:

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

These are serious, but less common adverse reactions (occurring in more than 1 in 10,000
patients, but in fewer than 1 in 1,000 patients). They may require urgent medical intervention
or hospitalization.
The following adverse reactions have been reported with the use of losartan:

Common (occurring in fewer than 1 in 10 people):

• reduction in red blood cells (anaemia),
• central dizziness, labyrinthine dizziness,
• 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 blood (hyperkalaemia),
• increased blood urea levels,
• increased serum creatinine levels,
• decreased blood sugar levels (hypoglycaemia).

Uncommon (occurring in fewer than 1 in 100 people):

• drowsiness,
• headache,
• sleep disorders,
• sensation of increased heart activity (palpitations),
• chest pain (angina pectoris),
• shortness of breath,
• cough,
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• urticaria,
• itching (pruritus),
• rash,
• oedema.

Rare (occurring in fewer than 1 in 1,000 people):

• hypersensitivity reactions,
• allergy (anaphylactic reactions),
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• sensation of numbness or tingling (paraesthesia),
• fainting,
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke,
• hepatitis,
• increased alanine aminotransferase (AlAT) activity in blood, usually resolving after discontinuation of treatment,
• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Not known (frequency cannot be estimated from available data):

• reduction in platelet count (thrombocytopenia),
• depression,
• migraine,
• taste disturbances,
• ringing, buzzing or clicking in the ears (tinnitus),
• pancreatitis,
• liver function disorders,
• photosensitivity,
• muscle pain,
• joint pain,
• skeletal muscle breakdown accompanied by pain and dark-coloured urine, which may lead to kidney failure (rhabdomyolysis),
• erectile dysfunction/impotence,
• general malaise,
• back pain,
• urinary tract infections,
• influenza-like symptoms,
• decreased sodium levels in blood (hyponatraemia).

Adverse reactions occurring in children are similar to those observed in adults.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in
this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. HOW TO STORE PRESARTAN

Store below 30°C.
Keep the medicine 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Presartan contains
The active substance is losartan potassium.
Each Presartan tablet, 50 mg contains 50 mg of losartan potassium.
Each Presartan tablet, 100 mg contains 100 mg of losartan potassium.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, sodium carboxymethyl starch (type A), magnesium stearate; coating Opadry White 20A18334 consisting of: 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 as white, round, biconvex film-coated tablets with a score line on one side.
Presartan 100 mg is available as white, round, biconvex film-coated tablets with a score line on one side.
Packaging for Presartan 50 mg and 100 mg contains 3 opaque blisters made of PVC/PE/PVDC/Al with 10 film-coated tablets each, in a cardboard carton.

Marketing Authorisation 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