Losartan Krka

Package leaflet: Information for the user

Losartan Krka 12.5 mg film-coated tablets, 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine
losartan potassium
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What Losartan Krka 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 blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan blocks angiotensin II from binding to these receptors, resulting in relaxation of blood vessels and consequently lowering blood pressure. Losartan slows down the decline in kidney function in patients with high blood pressure and type 2 diabetes.

Losartan Krka is used:

• to treat patients with high blood pressure (hypertension) in adults and children and adolescents aged between 6 and 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes who have laboratory evidence of impaired kidney function and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormally high amount of protein).
• to treat patients with chronic heart failure when specific medicines, called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure), are not considered suitable by the doctor. If your heart failure has been stabilized with ACE inhibitor therapy, you should not switch to losartan therapy.
• in patients with high blood pressure and left ventricular hypertrophy, losartan has been shown to reduce the risk of stroke (“LIFE indication”).

2. What you should know before taking Losartan Krka

Do not take Losartan Krka:

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6);
• if your liver function is severely impaired;
• if you are more than 3 months pregnant. (It is advisable to avoid taking Losartan Krka even in early pregnancy – see also the section on pregnancy);
• 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 Krka.
You must inform your doctor if you think you are (or might become) pregnant.
Losartan Krka is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your unborn baby if used beyond the third month of pregnancy (see the section on pregnancy).
Before taking Losartan Krka, it is important that you inform 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 have excessive vomiting or diarrhoea causing significant loss of fluids and/or salts from your body;
• if you are taking diuretics (medicines that increase the amount of water excreted through the kidneys) or are on a low-salt diet causing significant fluid and salt loss (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 your liver function is impaired (see sections 2 "Do not take Losartan Krka" and 3 “Dosage in specific patient groups”);
• if you have heart failure, with or without impaired kidney function, or life-threatening concomitant 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 blood vessels of the heart) or cerebrovascular disease (caused by reduced blood flow 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 used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the information under the heading "Do not take Losartan Krka".

• if you are taking other medicines that may increase serum potassium levels (see section 2 “Other medicines and Losartan Krka”).

Children and adolescents
Losartan Krka has been studied in children. For further information, please speak with your doctor.
Losartan Krka is not recommended for use in children with kidney or liver problems due to limited data available in these patient groups. Losartan Krka 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 Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics such as amiloride, triamterene, spironolactone, or other medicines that may increase serum potassium (e.g. heparin, medicines containing trimethoprim), as concomitant use with Losartan Krka is not recommended.
Exercise particular caution if you are taking the following medicines while on Losartan Krka:

• 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;
• non-steroidal anti-inflammatory drugs such as indomethacin, 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.

Medicines containing lithium should not be taken in combination with losartan without close medical monitoring. Specific precautionary measures (e.g. blood tests) may be appropriate.
Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Losartan Krka" and "Warnings and precautions").

Losartan Krka with food and drink
Losartan Krka can be taken with or without food.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You must inform your doctor if you think you are pregnant (or might become pregnant). Your doctor will usually advise you to stop taking Losartan Krka before starting a pregnancy or, as soon as pregnancy is confirmed, will recommend switching to another medicine instead of Losartan Krka.
Losartan Krka is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the first three months of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or intend to breast-feed. Losartan Krka is not recommended for breastfeeding mothers, and if you wish to breast-feed, your doctor may choose an alternative treatment for you, especially if your baby is newborn or premature.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been conducted.
It is unlikely that Losartan Krka will affect your ability to drive or use machines. However, as with other medicines that lower blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you must consult your doctor before engaging in such activities.

Losartan Krka contains lactose
This medicinal product contains lactose. If your doctor has informed you of an intolerance to certain sugars, inform your doctor before taking this medicine.

3. How to take Losartan Krka

Always take this medicine exactly as described in this leaflet and as instructed by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure. Your doctor will determine the appropriate dose of Losartan Krka based on your condition and any other medicines you may be taking. It is important to continue taking Losartan Krka for the entire duration prescribed by your doctor in order to maintain stable control of your blood pressure.

Medicines containing potassium losartan are available in the following strengths: 12.5 mg, 25 mg, 50 mg and 100 mg.

High blood pressure in adults
Treatment usually starts with 50 mg of losartan (one Losartan Krka 50 mg tablet) once daily. The maximum effect in lowering blood pressure should be achieved within 3 to 6 weeks after starting treatment. In some patients, the dose may later be increased to 100 mg of losartan (two Losartan Krka 50 mg tablets or one Losartan 100 mg tablet) 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 Krka is not recommended for use in children under 6 years of age, as its efficacy has not been demonstrated in this age group.

Children and adolescents aged 6 to 18 years
The recommended starting dose in 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 Krka). Your doctor may increase the dose if blood pressure is not adequately controlled.

Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Adults with high blood pressure and type 2 diabetes
Treatment generally starts with 50 mg of losartan (one Losartan Krka 50 mg tablet) once daily. The dose may subsequently be increased to 100 mg of losartan (two Losartan Krka 50 mg tablets or one Losartan 100 mg tablet) once daily, depending on your blood pressure response.

Losartan tablets can be taken together with other antihypertensive medicines (e.g. diuretics, calcium channel blockers, 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).

Adults with heart failure
Treatment usually starts with 12.5 mg of losartan (one Losartan Krka 12.5 mg tablet) once daily. The dose should generally be increased gradually 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) until the maintenance dose established by your doctor is reached. A maximum daily dose of 150 mg of losartan may be used (e.g. three Losartan Krka 50 mg tablets, or one Losartan Krka 100 mg tablet plus one Losartan Krka 50 mg tablet).

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 make the heart stronger and more efficient) and/or beta-blockers.

Dosage 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 Krka").

Administration
The tablets should be swallowed with a glass of water. Try to take your daily dose at the same time each day. It is important to continue taking Losartan Krka for as long as your doctor instructs you to do so.

If you take more Losartan Krka than you should
If you accidentally take too many tablets, or if a child takes any, contact your doctor immediately. Symptoms of overdose may include low blood pressure, increased heart rate, or possibly decreased heart rate.

If you forget to take Losartan Krka
Do not take a double dose to make up for the missed dose. If you accidentally forget to take your daily dose, take the next tablet at your usual time.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the following side effects occur, stop taking losartan tablets and contact your doctor immediately or go to the nearest hospital emergency department:
A severe allergic reaction (skin 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 more than 1 in 10,000 but less than 1 in 1,000 patients. It may require urgent medical treatment or hospitalization.

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 fluid from the bloodstream, e.g. in patients with severe heart failure or 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 levels (hypoglycaemia)
• too much potassium in the blood (hyperkalaemia)
• changes in kidney function including kidney failure
• reduction in the 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
• skin 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 rapid and irregular heartbeat (atrial fibrillation)
• stroke (cerebrovascular accident)
• inflammation of the liver (hepatitis)
• elevated levels of alanine aminotransferase (ALT) in the blood, usually reversible upon discontinuation of treatment.

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

• reduced platelet count
• migraine
• liver function abnormalities
• muscle and joint pain
• influenza-like symptoms
• back pain and urinary tract infection
• increased sensitivity to sunlight (photosensitivity)
• unexplained muscle pain with dark-coloured (tea-coloured) urine (rhabdomyolysis)
• impotence
• inflammation of the pancreas (pancreatitis)
• low sodium levels in the blood (hyponatraemia)
• depression
• general feeling of being unwell
• ringing, buzzing, or other noise in the ears (tinnitus)
• taste disturbances (dysgeusia)

In children, side effects are similar to those observed in adults.

Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any side effect not mentioned in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losartan Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Container made of polyethylene (HDPE) with tamper-evident closure made of polypropylene (PP):
Losartan Krka 12.5 mg: use within 250 days after first opening of the container.
Losartan Krka 100 mg: use within 100 days after first opening of the container.
Medicines should not be disposed of 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 Krka contains

• The active substance is potassium losartan. Each film-coated tablet contains 12.5 mg, 25 mg, 50 mg, or 100 mg of potassium losartan, equivalent to 11.4 mg, 22.9 mg, 45.8 mg, and 91.5 mg of losartan, respectively.
• The other components of Losartan Krka 12.5 mg, 25 mg are: maize starch, pregelatinized maize starch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, and cellactose (a powder mixture of cellulose and monohydrate lactose) in the tablet core; and hypromellose, talc, propylene glycol, titanium dioxide (E171), and quinoline yellow (E104) in the film coating.
• The other components of Losartan Krka 50 mg, 100 mg are: maize starch, pregelatinized maize starch, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, and cellactose (a powder mixture of cellulose and monohydrate lactose) in the tablet core; and hypromellose, talc, propylene glycol, and titanium dioxide (E171) in the film coating.

See section 2 "Losartan Krka contains lactose".

Description of the appearance of Losartan Krka and contents of the pack

Losartan Krka 12.5 mg: film-coated tablets, oval, convex, yellow.
Losartan Krka 25 mg: film-coated, oval, convex, yellow tablets with a score line on one side. The tablets can be divided into two equal doses.
Losartan Krka 50 mg: film-coated, round, convex, white tablets with a score line on one side and bevelled edges. The score line is not intended to divide the tablet.
Losartan Krka 100 mg: film-coated, oval, convex, white tablets.

PVC/PVDC blisters with transparent lid, covered with an aluminium foil; box
Losartan Krka 12.5 mg: 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets.
Losartan Krka 25 mg: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets.
Losartan Krka 50 mg: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets.
Losartan Krka 100 mg: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 112 film-coated tablets.

Tablet container made of polyethylene (HDPE, white) with a polypropylene closure.
Desiccant in polyethylene filled with silica gel.
Losartan Krka 50 mg: 250 film-coated tablets in a box.

Tablet container made of polyethylene (HDPE, white) with tamper-evident closure in polypropylene (PP).
Losartan Krka 12.5 mg: 250 film-coated tablets in a box.
Losartan Krka 100 mg: 100 film-coated tablets in a box.

Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz Lohmann Strasse, D-27472 Cuxhaven, Germany

Local representative for Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: