Losartan Zentiva

Patient Information Leaflet

Losartan Zentiva 50 mg film-coated tablets

Equivalence medicine
Please read this leaflet carefully before you start taking this medicine, as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Losartan Zentiva is and what it is used for
2. What you need to know before taking Losartan Zentiva
3. How to take Losartan Zentiva
4. Possible side effects
5. How to store Losartan Zentiva
6. Package contents and other information

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

Losartan (the active substance in Losartan Zentiva) 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 blood vessels, causing the blood vessels to narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and a consequent reduction in blood pressure. Losartan slows the decline in renal function in patients with high blood pressure and type 2 diabetes.
Losartan Zentiva is indicated:

• for the treatment of patients with high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years;
• to protect the kidney in hypertensive patients with type 2 diabetes who have laboratory tests showing impaired kidney function and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormal amount of protein);
• for the treatment of patients with chronic heart failure when therapy with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) is not considered appropriate by the doctor. If your heart failure has been stabilised with ACE inhibitor therapy, you should not switch to losartan therapy;
• in patients with high blood pressure and thickening of the walls of the left ventricle, Losartan Zentiva has been shown to reduce the risk of stroke ("LIFE study indication").

2. WHAT YOU SHOULD KNOW BEFORE TAKING LOSARTAN ZENTIVA

Do not take Losartan Zentiva

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6);
• if you are more than 3 months pregnant (it is also preferable to avoid using Losartan Zentiva during the first trimester of pregnancy – see section “Pregnancy”);
• if you have severe impairment of liver function;
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking Losartan Zentiva.
You must inform your doctor if you think you are (or may become) pregnant. Losartan Zentiva is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby when used during this period (see section “Pregnancy”).
Before taking Losartan Zentiva, it is important that you tell your doctor:

• if you have a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4: “Possible side effects”);
• if you are experiencing excessive vomiting or diarrhoea, resulting in significant loss of body fluids and/or salts;
• if you are taking diuretics (medicines that increase the amount of water eliminated through the kidneys) or are on a low-salt diet, which may cause significant loss of body fluids and salt (see section 3: “Dosage in specific patient groups”);
• if you know you have narrowing or blockage of the blood vessels supplying the kidneys or if you have recently undergone a kidney transplant;
• if you have impaired liver function (see sections 2 “Do not take Losartan Zentiva” and 3 “Dosage in specific patient groups”);
• if you have heart failure, with or without impaired kidney function or life-threatening cardiac arrhythmias. Special caution is required if you are also taking a beta-blocker;
• if you have heart valve problems or heart muscle disease;
• if you suffer from coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood circulation to the brain);
• if you have primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland due to an abnormality within the gland);
• if you are taking any of the following medicines for high blood pressure: ✓ an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes; ✓ aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g., potassium) at regular intervals.
See also the information under the heading "Do not take Losartan Zentiva".
Children and adolescents
Losartan has been studied in children. For further information, consult your doctor.
Losartan Zentiva is not recommended for use in children with kidney or liver problems, as available data in these patient groups are limited. Losartan Zentiva is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.
Other medicines and Losartan Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention if you are taking any of the following medicines while on Losartan Zentiva. Your doctor may consider it necessary to adjust the dose and/or take additional precautions:

• other medicines to lower blood pressure, as they may further reduce your blood pressure. Blood pressure may also be lowered by any of the following drugs/classes of drugs: tricyclic antidepressants, antipsychotics, baclofen, amifostine;
• medicines that retain potassium or may increase potassium levels (e.g., potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin);
• non-steroidal anti-inflammatory drugs such as indometacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan;
• if your kidney function is impaired, concomitant use of these medicines may lead to worsening of kidney function;
• lithium-containing medicines should not be taken together with losartan without close medical monitoring. Appropriate precautionary measures may be required (e.g., blood tests);
• an ACE inhibitor or aliskiren (see also the sections “Do not take Losartan Zentiva” and “Warnings and precautions”).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you think you are pregnant (or could become pregnant), inform your doctor. Usually, your doctor will advise you to stop taking Losartan Zentiva before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Losartan Zentiva is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. The use of Losartan Zentiva is not recommended for breastfeeding mothers. Your doctor may choose an alternative treatment, especially if your baby is a newborn or was born prematurely.
Driving and using machines
No studies have been conducted on the effects on the ability to drive or operate machinery.
It is unlikely that Losartan Zentiva will affect your ability to drive or operate machinery.
However, like many other 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 engaging in such activities.
Losartan Zentiva contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Losartan Zentiva

Take this medicine exactly as prescribed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Losartan Zentiva based on your condition and any other medicines you may be taking. It is important to continue taking Losartan Zentiva for the entire duration prescribed by your doctor, as this will help maintain stable blood pressure control.

Adult patients with high blood pressure
Treatment usually starts with 50 mg of losartan (one Losartan Zentiva 50 mg tablet) once daily. The maximum blood pressure-lowering effect is achieved 3–6 weeks after starting treatment. In some patients, the dose may subsequently be increased to 100 mg of losartan (two Losartan Zentiva 50 mg tablets) once daily.
If you feel that the effect of losartan is too strong or too weak, contact your doctor or pharmacist.

Use in children and adolescents
Children under 6 years of age
Losartan Zentiva is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Children aged 6 to 18 years
The recommended starting dose for patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, administered once daily (up to a maximum of 25 mg of Losartan Zentiva). Your doctor may increase the dose if blood pressure is not adequately controlled.

Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg of losartan (one Losartan Zentiva 50 mg tablet) once daily. The dose may subsequently be increased to 100 mg of losartan (two Losartan Zentiva 50 mg tablets) once daily, depending on the blood pressure response to therapy.

Losartan Zentiva tablets can be administered together 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 commonly used glucose-lowering medicines (e.g. sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure
Treatment usually starts with 12.5 mg of losartan once daily.
In general, the dose should be gradually increased on a weekly basis (e.g. 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, 150 mg daily during the fifth week) up to the maintenance dose, as directed by your doctor. The maximum dose of 150 mg of losartan (three 50 mg Losartan Zentiva tablets) once daily may be used.

In the treatment of heart failure, losartan is usually given in combination with a diuretic (a medicine that increases the amount of fluid excreted by the kidneys), and/or digitalis (a medicine that helps strengthen and improve heart function), and/or a beta-blocker.

Dosing in specific patient groups
Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those receiving high-dose diuretics, patients with impaired liver function, or patients over 75 years of age.
The use of losartan is not recommended in patients with severe impairment of liver function (see section "Do not take Losartan Zentiva").

Administration
The tablets should be swallowed with a glass of water. Losartan Zentiva can be taken with or without food.
Try to take your daily dose at the same time each day. It is important to continue taking Losartan Zentiva unless your doctor tells you otherwise.

If you take more Losartan Zentiva than you should
If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose may include low blood pressure, increased heart rate, and possibly decreased heart rate.

If you forget to take Losartan Zentiva
If you accidentally miss a daily dose, take your next dose as usual.
Do not take a double dose to make up for the missed tablet. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Losartan Zentiva and consult your doctor immediately or go to the nearest hospital emergency department:
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing).
This is a serious but rare side effect, affecting up to 1 in 1,000 people. It may require urgent medical treatment or hospitalisation.

The following side effects have been reported with Losartan Zentiva:
Common (may affect up to 1 in 10 people):

• dizziness,
• low blood pressure (especially after excessive loss of fluid from the bloodstream, e.g. in patients with severe heart failure or those receiving high doses of diuretics),
• dose-related orthostatic effects such as low blood pressure occurring when rising from a lying or sitting position,
• weakness,
• fatigue,
• too low blood sugar (hypoglycaemia),
• too much potassium in the blood (hyperkalaemia),
• changes in kidney function including renal failure, reduced number of red blood cells (anaemia),
• increased blood urea, serum creatinine and serum potassium levels in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• urticaria,
• itching,
• rash,
• localized swelling (oedema),
• cough.

Rare (may affect up to 1 in 1,000 people):

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis including Henoch-Schönlein purpura),
• sensation of numbness or tingling (paraesthesia),
• fainting (syncope),
• very fast and irregular heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• inflammation of the liver (hepatitis),
• elevated blood levels of alanine aminotransferase (ALT), usually reversible upon discontinuation of treatment.

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

• reduced platelet count,
• migraine,
• abnormal liver function,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark urine (tea-coloured urine) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the blood (hyponatraemia),
• depression,
• general feeling of being unwell (malaise),
• hearing sounds, ringing, roaring or clicking in the ears (tinnitus),
• altered taste (dysgeusia).

Side effects in children are similar to those observed in adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losartan Zentiva

Keep this 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 that month. Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Losartan Zentiva contains
The active substance is losartan as losartan potassium.
Each Losartan Zentiva 50 mg film-coated tablet contains 50 mg of losartan potassium,
equivalent to 45.8 mg of losartan.
The other components are:
Tablet core:
monohydrate lactose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose,
magnesium stearate.
Coating:
hydroxypropylcellulose, hypromellose, titanium dioxide (E171), talc.

Description of the appearance of Losartan Zentiva and the contents of the pack
Losartan Zentiva 50 mg film-coated tablets are white to off-white in colour, oval-shaped, with a break-line on both sides.
The film-coated tablet can be divided into two equal doses.
Losartan Zentiva 50 mg tablets are available in blisters in pack sizes of 7, 14, 15, 21, 28, 30, 50, 56, 84, 90, 98, and 280 (10x28) tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l. Via P. Paleocapa 7, 20121 Milano

Manufacturers
Opella Healthcare Poland Sp. z o.o.
ul. Lubelska, 52 - 35-233 Rzeszów (Poland)

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
France: Losartan Zentiva Lab
Italy, Portugal: Losartan Zentiva