Losartan genoptim

Package leaflet: information for the patient

Losartan Genoptim, 50 mg, film-coated tablets
Losartanum kalicum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Losartan Genoptim is and what it is 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 Losartan Genoptim is and what it is 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 blood vessels and,
consequently, lowering of blood pressure. Losartan slows the progression of kidney damage in
patients with high blood pressure and type 2 diabetes.
Losartan Genoptim is used:

• for the treatment of high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years,
• to protect the kidneys in adult patients with high blood pressure and type 2 diabetes, laboratory-confirmed kidney function impairment, and proteinuria ≥0.5 g per day (a condition in which the urine contains an abnormal amount of protein),
• for the treatment of adult patients with chronic heart failure, when treatment with certain medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to lower high blood pressure) is not considered suitable by the physician – if heart failure has been stabilized with an ACE inhibitor, the treatment should not be switched to losartan,
• in adult patients with high blood pressure and left ventricular hypertrophy (thickening of the wall of the left ventricle of the heart), because it has been shown that losartan reduces the risk of stroke.

2. Important information before using Losartan Genoptim

When not to use Losartan Genoptim:

• if the patient has hypersensitivity to losartan or any of the other ingredients of this medicine (listed in section 6),
• after the 3rd month of pregnancy (use of Losartan Genoptim is also recommended to be avoided during the early stages of pregnancy – see "Pregnancy and breastfeeding"),
• if the patient has severe hepatic impairment,
• if the patient has diabetes or renal impairment and is being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Losartan Genoptim, discuss this with your doctor or
pharmacist.
Inform your doctor if you are pregnant or suspect or are planning pregnancy. Use of Losartan Genoptim is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may cause serious harm to the unborn child (see "Pregnancy and breastfeeding").
It is important to inform your doctor before taking Losartan Genoptim if:

• the patient has ever experienced angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 "Possible side effects"),
• the patient has severe vomiting or diarrhoea leading to excessive fluid and/or salt loss from the body,
• the patient is taking diuretics (medicines that increase the amount of water excreted by the kidneys) or a low-salt diet, resulting in excessive fluid and salt loss from the body (see "Dosage in special patient groups" in section 3),
• the patient has stenosis or blockage of the blood vessels supplying the kidneys or has recently undergone kidney transplantation,
• the patient has hepatic impairment (see section "When not to use Losartan Genoptim" in section 2 and "Dosage in special patient groups" in section 3),
• the patient has heart failure with or without renal impairment, or has severe, life-threatening cardiac arrhythmias – particular caution is required when treating concomitantly with β-blockers,
• the patient has heart valve disorders or myocardial disease,
• the patient has coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disorders (caused by reduced blood flow to the brain),
• the patient has primary hyperaldosteronism (a syndrome caused by excessive aldosterone secretion from the adrenal glands due to adrenal abnormalities),
• the patient is taking any of the following medicines used to treat high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors, e.g. enalapril, lisinopril, ramipril, particularly if the patient has renal impairment related to diabetes,
  • aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also "When not to use Losartan Genoptim".
If, after taking Losartan Genoptim, the patient experiences abdominal pain, nausea, vomiting, or diarrhoea, discuss this with your doctor. Your doctor will decide on further treatment. Do not make independent decisions to stop taking Losartan Genoptim.

Children and adolescents
Studies on the use of losartan in children have been conducted. For additional information, please consult your doctor.
The use of losartan is not recommended in children and adolescents with renal or hepatic impairment due to limited data in these patient groups. Losartan is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Losartan Genoptim and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Exercise particular caution when taking the following medicines during treatment with Losartan Genoptim:

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

Your doctor may recommend adjusting the dose and/or taking additional precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to use Losartan Genoptim" and "Warnings and precautions").

In patients with renal impairment, concomitant use of these medicines may lead to worsening of renal function.
Do not use lithium-containing medicines concomitantly with losartan without strict medical supervision. Special precautions (e.g. blood tests) may be required.

Taking Losartan Genoptim with food and drink
Losartan Genoptim may be taken independently of meals.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you are pregnant, suspect pregnancy, or are planning pregnancy. Your doctor will usually recommend discontinuing Losartan Genoptim before a planned pregnancy or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Use of Losartan Genoptim is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may cause serious harm to the unborn child.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Use of Losartan Genoptim is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm infant. Your doctor may recommend an alternative medicine.
Consult your doctor or pharmacist before taking this medicine.

Driving and operating machinery
No studies have been conducted on the effects of Losartan Genoptim on the ability to drive or operate machinery. It is unlikely that Losartan Genoptim would affect such abilities. However, as with many medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some individuals. If dizziness or drowsiness occurs, consult your doctor before engaging in such activities.

Important information about some of the ingredients of Losartan Genoptim
Losartan Genoptim contains monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Losartan Genoptim

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Losartan Genoptim depending on your condition and other medicines you are taking. It is important to take Losartan Genoptim for as long as your doctor has instructed, in order to maintain consistent blood pressure control.

Adult patients with high blood pressure
Treatment usually starts with a dose of 50 mg of losartan (one tablet of Losartan Genoptim 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 of losartan (two tablets of Losartan Genoptim 50 mg) once daily.
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 efficacy has not been demonstrated in this age group.

Children aged 6 to 18 years
The recommended starting dose for patients with a body weight between 20 kg and 50 kg is 0.7 mg of losartan per kg of body weight, given once daily (up to 25 mg of losartan – a dose which cannot be achieved with Losartan Genoptim, so your doctor may recommend using another medicine).
Your doctor may increase the dose if blood pressure is not controlled.
Another formulation of losartan may be more suitable for children. Please consult your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with a dose of 50 mg of losartan (one tablet of Losartan Genoptim 50 mg) once daily. The dose may then be increased to 100 mg of losartan (two tablets of Losartan Genoptim 50 mg) once daily, depending on achieved blood pressure values.
Losartan may be used together with other antihypertensive medicines (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. sulfonylurea derivatives, glitazones, and glucosidase inhibitors).

Adult patients with heart failure
Treatment usually starts with a dose of 12.5 mg of losartan once daily. Your doctor will usually recommend gradually increasing the dose at weekly intervals (i.e. 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), until the maintenance dose, as determined by your doctor, is reached. Doses of 12.5 mg and 25 mg cannot be achieved with Losartan Genoptim, so your doctor may recommend using another medicine. The maximum dose is 150 mg of losartan (e.g. three tablets of Losartan Genoptim 50 mg) once daily.
In the treatment of heart failure, losartan is usually used together with diuretics (medicines that increase the amount of water excreted by the kidneys) and (or) digitalis glycosides (medicines that increase the force of heart contractions and improve heart function) and (or) beta-blockers.

Dosing in special patient groups
Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those taking high-dose diuretics, patients with impaired liver function, or patients over 75 years of age. Losartan must not be used in patients with severe liver or kidney impairment (see "When not to take Losartan Genoptim").

Method of administration
Tablets should be swallowed with a glass of water. Try to take the dose at the same time each day. It is important to continue taking Losartan Genoptim unless your doctor advises otherwise.

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

Missing a dose of Losartan Genoptim
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed tablet.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, stop taking Losartan Genoptim and immediately consult a 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 in swallowing or breathing).

This is a serious, but rare adverse reaction, which may affect at least 1 in 10,000 patients but fewer than 1 in 1,000 patients. Immediate medical intervention or hospitalization may be necessary.
The following adverse reactions have been reported during treatment with losartan:
Common (may affect up to less than 1 in 10 people):

• dizziness,
• low blood pressure (especially after excessive fluid loss, e.g. in patients with severe heart failure or treated with high doses of diuretics),
• dose-dependent orthostatic symptoms such as reduction in blood pressure when standing up from lying or sitting position,
• weakness,
• fatigue,
• decreased blood sugar levels (hypoglycaemia),
• increased potassium levels in blood (hyperkalaemia),
• kidney function disorders, including kidney failure,
• reduced number of red blood cells (anaemia),
• increased levels of urea, creatinine and potassium in plasma in patients with heart failure.

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

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

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

• hypersensitivity,
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• sensation of numbness or tingling (paraesthesia),
• fainting,
• very fast 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.

Unknown frequency (cannot be estimated from available data):

• reduced platelet count,
• migraine,
• liver function disorders,
• muscle and joint pain,
• influenza-like symptoms,
• back pain and urinary tract infection,
• photosensitivity,
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in blood (hyponatraemia),
• depression,
• general malaise,
• ringing, buzzing, noise or clicking in the ears (tinnitus),
• taste disturbances.

Adverse reactions occurring in children are similar to those observed in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
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 authorization holder.
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store Losartan Genoptim

No special requirements.
Keep the medicine out of sight and reach of children.
Do not use Losartan Genoptim after the expiry date stated on the outer carton and blister pack: Expiry (EXP) and 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. Such measures 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, pregelatinized maize starch, magnesium stearate; coating: hydroxypropylcellulose, hypromellose, titanium dioxide (E171).
Losartan Genoptim contains potassium in the amount of 4.24 mg (0.108 mEq).

What Losartan Genoptim looks like and contents of the pack
White, round coated tablets with dimensions of 3.6 ±2 mm.
The following pack sizes of Losartan Genoptim are available:
PVC/PE/PVDC/Aluminium blisters in cardboard packaging containing 7, 10, 14, 15, 21, 28, 50, 56, 98, 100, 210 or 280 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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