LAKEA 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Lakea, 50 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
3. What Lakea is and what it is used for
4. Important information before taking Lakea
   1. When not to take Lakea
   2. Warnings and precautions
   3. Before taking Lakea, tell your doctor or pharmacist if:
   4. Children and adolescents
   5. Lakea and other medicines
   6. Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
   7. Lakea with food, drink, and alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Lakea contains lactose
5. How to take Lakea
   1. Dosing in special patient groups
   2. Method of administration
   3. Taking more than the recommended dose of Lakea
   4. Missing a dose of Lakea
   5. Stopping treatment with Lakea
6. Possible side effects
   1. If you experience any of the following symptoms, stop taking Lakea and immediately contact your doctor or go to the emergency department of the nearest hospital:
   2. Reporting side effects
7. How to store Lakea
8. Contents of the pack and other information
   1. What Lakea contains
   2. What Lakea looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the Patient

Lakea, 50 mg, Film-Coated Tablets

Losartan Potassium

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

• 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 only. 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What Lakea is and what it is used for

Lakea contains losartan, which 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. As a result, blood pressure increases.
Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to widen and, as a result, lowering blood pressure. Losartan slows the progression of kidney disease in patients with high blood pressure and type 2 diabetes.
Lakea tablets are used:

• to treat patients with high blood pressure (hypertension);
• in patients with high blood pressure and left ventricular hypertrophy, where the drug reduces the risk of stroke;
• to protect the kidneys in patients with type 2 diabetes and high blood pressure, in whom laboratory tests have confirmed kidney function disorders and proteinuria ≥0.5 g/day (a condition in which the urine contains an abnormal amount of protein);
• to treat patients with chronic kidney disease, when in the doctor's opinion the use of angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to lower high blood pressure) is not appropriate. If heart failure has been stabilized with ACE inhibitors, treatment should not be switched to losartan.

2. Important information before taking Lakea

When not to take Lakea

if you are allergic (hypersensitive) to losartan or any of the other ingredients of the medicine (listed in section 6);
if you are in the second or third trimester of pregnancy (you should also avoid taking Lakea in early pregnancy - see section "Pregnancy and breastfeeding");
if you have severe liver function disorders;
if you have diabetes or kidney function disorders and are taking a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before taking Lakea, tell your doctor or pharmacist if:

you are allergic (hypersensitive) to acetylsalicylic acid and/or penicillin, ACE inhibitors;
you have a history of angioedema (swelling of the face, lips, throat, and/or tongue), see also section 4 "Possible side effects";
you are taking high doses of diuretics, are on a low-salt diet, or have severe vomiting or diarrhea, leading to excessive fluid and/or salt loss;
you have liver disease;
you have severe kidney disease;
you have narrowing or obstruction of the blood vessels leading to the kidneys or have recently undergone a kidney transplant;
you have ischemic heart disease and cerebrovascular disease;
you have heart failure with kidney function disorders (with or without kidney function disorders) or with severe, life-threatening heart rhythm disorders. Particular caution is required when taking beta-adrenergic blockers;
you have aortic or mitral stenosis or a heart condition called hypertrophic cardiomyopathy;
you have primary hyperaldosteronism (a disease related to increased aldosterone hormone secretion by the adrenal glands).
you are taking one of the following medicines for high blood pressure:

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney disease caused by diabetes
• aliskiren

Your doctor may regularly check your kidney function, blood pressure, and electrolyte levels (e.g., potassium).
See also the information in the section "When not to take Lakea".
Tell your doctor if you suspect (or plan) pregnancy. It is not recommended to take Lakea in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see section "Pregnancy and breastfeeding").

Children and adolescents

Studies have been conducted on the use of losartan in children. For more information, consult your doctor.
Lakea should not be used in children and adolescents with kidney or liver function disorders, as well as in children under 6 years of age.

Lakea and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

It is especially important to inform your doctor about taking:
other blood pressure-lowering medicines, as they may cause additional blood pressure lowering. Blood pressure may also be lowered by the following medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine;
potassium-sparing medicines or medicines that may increase potassium levels in the blood (e.g., potassium preparations, salt substitutes containing potassium, or potassium-sparing diuretics, e.g., some diuretics [amiloride, triamterene, spironolactone] or heparin);
non-steroidal anti-inflammatory medicines, such as indomethacin, as well as COX-2 inhibitors (medicines that reduce inflammation and are used to relieve pain), as they may weaken the blood pressure-lowering effect of losartan.
In patients with kidney function disorders, taking these medicines may lead to worsening kidney function.
aliskiren or ACE inhibitors, such as perindopril, enalapril, ramipril (medicines used to lower blood pressure), as their concurrent use with losartan should be limited to individual cases. In such cases, the doctor will closely monitor the patient's kidney function.
Do not take medicines containing lithium in combination with losartan without close medical supervision. The doctor may recommend special precautions (e.g., blood tests).
The doctor may change the dose of the medicine and/or recommend other precautions if you are taking an ACE inhibitor or aliskiren (see also the information in the sections "When not to take Lakea" and "Warnings and precautions").
If you are in doubt about what these medicines are, consult your doctor.

Lakea with food, drink, and alcohol

The medicine can be taken with or without food.
Excessive amounts of salt may weaken the blood pressure-lowering effect of Lakea.
It is not recommended to drink alcohol while taking Lakea tablets. Alcohol and the medicine may enhance each other's effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.
Pregnancy
Tell your doctor if you suspect (or plan) pregnancy. The doctor will usually recommend stopping Lakea before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Lakea. It is not recommended to take Lakea in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Lakea during breastfeeding, especially when breastfeeding a newborn or premature baby. The doctor may recommend another medicine.

Driving and using machines

Dizziness and drowsiness have been reported in people taking losartan. If you experience these symptoms, do not drive or operate machinery.

Lakea contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Lakea

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the appropriate dose of Lakea based on your condition and the medicines you are taking. It is important to take Lakea for as long as your doctor recommends to maintain constant blood pressure control.
The tablets can be taken with or without food, with a glass of water.
Patient with high blood pressure
The usual starting dose is 50 mg of losartan (1 Lakea tablet) once a day.
Maximum effect is usually achieved within 3 to 6 weeks of treatment. In some patients, the doctor may increase the dose to 100 mg of losartan (2 Lakea tablets) once a day.
If you feel that the effect of losartan is too strong or too weak, consult your doctor or pharmacist.
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 per day in the first week, 25 mg per day in the second week, 50 mg per day in the third week) until a maintenance dose of 50 mg (1 Lakea tablet) is reached.
In the treatment of heart failure, losartan is usually used with a diuretic (a medicine that increases the amount of water excreted by the kidneys) and/or digitalis glycosides (medicines that increase the strength of heart contractions and improve its efficiency) and/or beta-adrenergic blockers.
Patient with high blood pressure and type 2 diabetes
The usual starting dose is 50 mg (1 Lakea tablet) once a day. The doctor may increase the dose to 100 mg (2 Lakea tablets) once a day, depending on the blood pressure response.
Lakea can be taken with other blood pressure-lowering medicines (e.g., diuretics, calcium antagonists, alpha- or beta-adrenergic blockers, and centrally acting agents), as well as with insulin and other commonly used antidiabetic medicines (e.g., sulfonylurea derivatives, glitazones, and glucosidase inhibitors).
* To administer this dose, the doctor will use another medicine containing the appropriate amount of losartan.

Dosing in special patient groups

Your doctor may recommend a lower dose (especially at the start of treatment) for certain patients, such as those taking high doses of diuretics, patients with liver function disorders, or patients over 75 years of age. It is not recommended to take losartan in patients with severe liver function disorders (see section "When not to take Lakea").

Method of administration

Swallow the tablets with a glass of water. Try to take the medicine at the same time every day. It is important to continue taking Lakea until your doctor tells you to stop.

Taking more than the recommended dose of Lakea

If you (or someone else) have taken a large number of tablets or if you suspect that a child has taken some tablets, immediately contact the emergency department of the nearest hospital or your doctor. Overdose may cause low blood pressure and lead to disorders (acceleration or slowing) of heart function. Bring this leaflet, the remaining tablets, and the package with you.

Missing a dose of Lakea

If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet.

Stopping treatment with Lakea

If you plan to stop treatment, always consult your doctor first.
Continuation of treatment may be necessary even if you feel better.
If you have any further questions about taking this medicine, ask 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 symptoms, stop taking Lakea and immediately contact your doctor or go to the emergency department of the nearest hospital:

severe allergic reaction(rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing)
This is a severe but rare side effect that may occur less often than in 1 in 1000 people. It may require emergency treatment or hospitalization.
The following side effects have been reported during treatment with losartan:
Common(may occur less often than in 1 in 10 people):
dizziness
increased potassium levels in the blood (which may cause heart rhythm disorders)
weakness, fatigue
low blood pressure, orthostatic hypotension (low blood pressure that may be associated with changes in body position, e.g., feeling dizzy or weak when standing up from a lying or sitting position)
decreased hemoglobin levels (anemia)
increased urea and creatinine levels in the blood (which may indicate kidney function disorders)
kidney function disorders, kidney failure
low blood sugar levels (hypoglycemia)
Uncommon(may occur less often than in 1 in 100 people):
drowsiness
sleep disorders
rapid and strong heartbeat (palpitations), angina pectoris (chest pain)
rash
abdominal pain
constipation
edema, headache
shortness of breath
cough
diarrhea
nausea
vomiting
hives
itching
Rare(may occur less often than in 1 in 1000 people):
vasculitis (including Henoch-Schönlein purpura)
increased alanine aminotransferase (AlAT) activity, a liver enzyme, detected in laboratory tests, which check liver function)
hepatitis
numbness or tingling sensation
fainting
atrial fibrillation
stroke
Frequency not known(frequency cannot be estimated from the available data):
decreased platelet count
depression
migraine
taste disorders
ringing, buzzing, or noise in the ears (tinnitus)
pancreatitis
liver function disorders
increased skin sensitivity to light
muscle pain
joint pain
unexplained muscle pain and dark (tea-colored) urine (breakdown of striated muscle - rhabdomyolysis)
erectile dysfunction or impotence
general malaise
low sodium levels in the blood (hyponatremia)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lakea

Keep the medicine out of the sight and reach of children.
Store in a temperature not exceeding 25°C.
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.
Store in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lakea contains

The active substance is losartan potassium. Each tablet contains 50 mg of losartan potassium.
The other ingredients are: microcrystalline cellulose, pregelatinized starch, lactose monohydrate, magnesium stearate, colloidal anhydrous silica
Coating: hypromellose, hydroxypropylcellulose, macrogol 400, titanium dioxide, talc.

What Lakea looks like and contents of the pack

Lakea tablets are biconvex, with a score line on one side.
The tablets can be divided into two halves.
The medicine is available in aluminum/aluminum blisters in a cardboard box, containing 30 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
For more information, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel: 22 209 70 00
Date of last revision of the leaflet:04/2022
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