Losartan Genoptim

Package Leaflet: Information for the Patient

Losartan Genoptim, 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Losartan Genoptim 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. This results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing the blood vessels to relax and thereby lowering blood pressure. Losartan also slows the progression of kidney disease in patients with high blood pressure and type 2 diabetes.
Losartan Genoptim is used:

• to treat high blood pressure (hypertension) in adults and in children and adolescents from 6 to 18 years of age,
• to protect the kidneys in adult patients with high blood pressure and type 2 diabetes with laboratory evidence of kidney damage and proteinuria ≥0.5 g/day (a condition in which the urine contains an abnormal amount of protein),
• to treat adult patients with chronic heart failure, if 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, the medicine should not be switched to losartan,
• in adult patients with high blood pressure and left ventricular hypertrophy, as losartan has been shown to reduce the risk of stroke.

2. Important information before taking Losartan Genoptim

When not to take Losartan Genoptim:

• after the third month of pregnancy (it is also recommended to avoid taking Losartan Genoptim during the first trimester of pregnancy - see "Pregnancy and breastfeeding"),

Warnings and precautions

Before taking Losartan Genoptim, discuss it with your doctor or pharmacist.
Inform your doctor if you think you might be pregnant or are planning to become pregnant. It is not recommended to take Losartan Genoptim during the first trimester of pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy and breastfeeding").
It is important to inform your doctor before taking Losartan Genoptim if:

• you have ever had angioedema (swelling of the face, lips, throat and/or tongue) (see also section 4 "Possible side effects"),
• you have had severe vomiting or diarrhea leading to excessive loss of fluids and/or electrolytes,
• you are taking diuretics (medicines that increase the amount of water excreted by the kidneys) or are on a low salt diet leading to excessive loss of fluids and electrolytes (see "Dosage in special patient groups" in section 3),
• you have narrowing or blockage of the blood vessels leading to the kidneys or have recently had a kidney transplant,
• you have liver disease (see "When not to take Losartan Genoptim" in section 2 and "Dosage in special patient groups" in section 3),
• you have heart failure with kidney problems or without kidney problems, or co-existing serious life-threatening heart rhythm problems - special caution is required when co-administering beta-blockers,
• you have problems with your heart valves or heart muscle,
• you have coronary heart disease (caused by reduced blood flow in the blood vessels supplying the heart) or cerebrovascular disease (caused by reduced blood flow in the blood vessels supplying the brain),
• you have primary hyperaldosteronism (a condition caused by excessive production of aldosterone by the adrenal glands, caused by adrenal gland problems),
• you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme inhibitor (ACE inhibitor), such as enalapril, lisinopril, ramipril), particularly if you have kidney problems associated with diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g. potassium).
See also "When not to take Losartan Genoptim".
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Losartan Genoptim, discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Losartan Genoptim on your own.

Children and adolescents

Studies have been conducted on the use of losartan in children. For more information, consult your doctor.
Losartan is not recommended for children and adolescents with kidney or liver disease due to limited data in these patient groups. Losartan is not recommended for children under 6 years of age, as its effect in this age group has not been established.

Losartan Genoptim and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Be particularly cautious when taking the following medicines during treatment with Losartan Genoptim:

• other medicines that lower blood pressure, as they may cause additional lowering of blood pressure. Blood pressure may also be lowered by the following medicines/groups of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine.
• medicines that retain potassium or may increase potassium levels in the blood (e.g. potassium supplements, salt substitutes containing potassium, or potassium-sparing diuretics such as amiloride, triamterene, spironolactone) or heparin.
• non-steroidal anti-inflammatory medicines, such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and are used to relieve pain), as they may weaken the blood pressure-lowering effect of losartan.

Your doctor may recommend changing the dose and/or taking other precautions:

In patients with kidney disease, concomitant use of these medicines may lead to worsening of kidney function.
Without close medical supervision, do not take medicines containing lithium in combination with losartan. Special precautions may be necessary (e.g. blood tests).

Taking Losartan Genoptim with food and drink

Losartan Genoptim can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
Inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Your doctor will usually recommend stopping Losartan Genoptim before planned pregnancy or as soon as possible after confirmation of pregnancy, and will recommend taking a different medicine instead of Losartan Genoptim. It is not recommended to take Losartan Genoptim during the first trimester of pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Losartan Genoptim during breastfeeding, especially during breastfeeding of a newborn or premature baby. Your doctor may recommend taking a different medicine.
Before taking this medicine, consult your doctor or pharmacist.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. It is unlikely that Losartan Genoptim will affect the ability to drive and use machines. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness. If you experience dizziness or drowsiness, consult your doctor before performing such activities.

Important information about some of the ingredients of Losartan Genoptim

Losartan Genoptim contains lactose monohydrate. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Losartan Genoptim

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Your doctor will determine the appropriate dose of Losartan Genoptim based on your condition and the medicines you are taking. It is important to take Losartan Genoptim for as long as your doctor recommends, in order to maintain constant blood pressure control.
Adult patients with high blood pressure
Treatment usually starts with a dose of 50 mg of losartan (one 50 mg Losartan Genoptim tablet) once a day. The maximum effect on lowering blood pressure should occur within 3 to 6 weeks after starting treatment. In some patients, the dose may be subsequently increased to 100 mg of losartan (two 50 mg Losartan Genoptim tablets) once a day.
If you feel that the effect of losartan is too strong or too weak, consult your doctor or pharmacist.
Use in children and adolescents
Children under 6 years of age
Losartan Genoptim is not recommended for children under 6 years of age, as its effect in this age group has not been established.
Children from 6 to 18 years of age
The recommended initial dose for patients with a body weight of 20 kg to 50 kg is 0.7 mg of losartan per kg of body weight, given once a day (up to 25 mg of losartan - this dose cannot be achieved with Losartan Genoptim, so your doctor may recommend taking a different medicine).
Your doctor may increase the dose if blood pressure is not controlled.
A different formulation of losartan may be more suitable for children. Consult your doctor or pharmacist.

Dosage in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those taking high doses of diuretics, patients with liver disease, or patients over 75 years of age. Do not take losartan in patients with severe liver and kidney disease (see "When not to take Losartan Genoptim").

Method of administration

Swallow the tablets with a glass of water. Try to take your dose at the same time each day. It is important to continue taking Losartan Genoptim unless your doctor tells you to stop.

Overdose of Losartan Genoptim

If you accidentally take too many tablets, contact your doctor or go to the emergency department of your nearest hospital immediately. Symptoms of overdose are low blood pressure, rapid heartbeat, and possibly slow heartbeat.

Missed dose of Losartan Genoptim

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

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 Losartan Genoptim and consult your doctor or go to the emergency department of your nearest hospital immediately:

• 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, which may affect between 1 in 10,000 and 1 in 1,000 patients. Immediate medical attention or hospitalization may be required.
The following side effects have been reported with losartan:

Common (may affect up to 1 in 10 people):

• dizziness,
• low blood pressure (especially after excessive loss of water from the body, e.g. in patients with severe heart failure or those treated with high doses of diuretics),
• dose-dependent orthostatic effects, such as low blood pressure when standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• high potassium levels in the blood (hyperkalemia),
• kidney problems, including kidney failure,
• low red blood cell count (anemia),
• increased levels of urea, creatinine, and potassium in the blood in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath,
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching (pruritus),
• rash,
• localized swelling,
• cough.

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

• hypersensitivity,
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• fainting,
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke,
• hepatitis,
• increased levels of alanine aminotransferase (ALT) in the blood, usually reversible after stopping treatment,
• 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):

• low platelet count,
• migraine,
• liver problems,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• sensitivity to sunlight,
• unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• general feeling of being unwell,
• ringing, buzzing, noise, or cracking in the ears (tinnitus),
• taste disorders.

Side effects in children are similar to those observed in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losartan Genoptim

No special precautions.
Keep the medicine out of the sight and reach of children.
Do not take Losartan Genoptim after the expiry date stated on the carton and blister after: Expiry date (EXP) and EXP. The expiry date refers to the last day of the month stated.
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 pack and other information

What Losartan Genoptim contains

The active substance is losartan potassium.
Each tablet contains 50 mg of losartan potassium.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, maize starch, magnesium stearate; coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E171).
Losartan Genoptim contains 4.24 mg of potassium (0.108 mEq).

What Losartan Genoptim looks like and contents of the pack

White, round, film-coated tablets, 3.6 ± 2 mm in diameter.
Losartan Genoptim is available in the following pack sizes:

Blisters PVC/PE/PVDC/Aluminum in a carton box containing 7, 10, 14, 15, 21, 28, 50, 56, 98, 100, 210, or 280 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Tel: 607 696 231

Manufacturer

Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

Date of last revision of the leaflet: