Losartan Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan Sandoz 12.5 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before using 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. What Losartan Sandoz 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 the blood vessels to constrict.
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 consequently lowering blood pressure.
Losartan slows the decline in renal function in patients with high blood pressure and type 2 diabetes.
Losartan Sandoz is used

• to treat high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• To protect the kidneys in hypertensive patients with type 2 diabetes who have laboratory tests showing kidney impairment 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 therapy with specific medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors, medicines used to lower high blood pressure) is not considered appropriate by the physician. If your heart failure has been stabilized by ACE inhibitor therapy, you should not be switched to losartan therapy.
• in patients with high blood pressure and thickening of the walls of the left ventricle, Losartan Sandoz has been shown to reduce the risk of stroke ("LIFE study indication").

2. What you need to know before taking Losartan Sandoz

Do not take Losartan Sandoz

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6.1)
• if you have severe impairment of liver function
• if you are more than three months pregnant. (It is advisable to avoid Losartan Sandoz even in the early stages of pregnancy – see 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 Sandoz.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Losartan Sandoz 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 during this period (see section 'Pregnancy').
Before taking Losartan Sandoz, 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 have severe vomiting or diarrhoea causing significant loss of body fluids and/or salts,
• if you are taking diuretics (medicines that increase the amount of water excreted by the kidneys) or are on a low-salt diet leading to significant loss of body fluids and salts (see section 3 'Dosage in particular 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 Sandoz' and 3 'Dosage in particular patient groups'),
• if you suffer from 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 blood vessels of the heart) or cerebrovascular disease (caused by reduced blood circulation in 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 levels of electrolytes (e.g. potassium) at regular intervals. See also information under “Do not take Losartan Sandoz”.

Children and adolescents
Losartan Sandoz has been studied in children. For further information, consult your doctor.
Losartan Sandoz is not recommended for use in children with kidney or liver problems, or in children under 6 years of age, due to limited data available in these patient groups.

Other medicines and Losartan Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention if you are taking the following medicines while on Losartan Sandoz:

• 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 medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• medicines that retain potassium or may increase potassium levels in the blood (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. Medicines containing lithium should not be taken together with losartan without close monitoring by your doctor. Appropriate precautionary measures may be required (e.g. blood tests).

Your doctor may consider it necessary to adjust the dose and/or take other precautions:
if you are taking an ACE inhibitor or aliskiren (see also information under “Do not take Losartan Sandoz” and “Warnings and precautions”).

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

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Losartan Sandoz before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine.
Losartan Sandoz 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 after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or intend to start breast-feeding. Losartan Sandoz is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is newborn or was born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
It is unlikely that Losartan Sandoz 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 Sandoz contains lactose monohydrate
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Losartan Sandoz

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Losartan Sandoz based on your condition and any other medicines you may be taking. It is important to continue taking Losartan Sandoz for the full duration prescribed by your doctor, as this will ensure stable control of your blood pressure.

Adult patients with high blood pressure
Treatment usually starts with 50 mg of losartan (4 tablets of Losartan Sandoz 12.5 mg) once daily. The maximum blood pressure-lowering effect is reached 3 to 6 weeks after starting treatment. In some patients, the dose may later be increased to 100 mg of losartan (8 tablets of Losartan Sandoz 12.5 mg) 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 (aged 6 to 18 years)
The recommended initial dose for patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, given once daily (up to a maximum of 25 mg of Losartan Sandoz). 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 (4 tablets of Losartan Sandoz 12.5 mg) once daily. The dose may later be increased to 100 mg of losartan (8 tablets of Losartan Sandoz 12.5 mg) once daily, depending on the blood pressure response to therapy.

Losartan tablets may be administered 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. sulfonylureas, glitazones, and alpha-glucosidase inhibitors).

Adult patients with heart failure
Treatment usually starts with 12.5 mg of losartan (1 tablet of Losartan Sandoz 12.5 mg) once daily. 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) until the maintenance dose determined by your doctor is reached.
A maximum dose of 150 mg of losartan (12 tablets of Losartan Sandoz 12.5 mg) once daily may be used.

In the treatment of heart failure, losartan is usually given together 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 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 Sandoz").

Method of 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 Sandoz unless your doctor tells you otherwise.

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

If you forget to take Losartan Sandoz
If you accidentally miss a daily dose, take the next tablet at the usual time on the following day. Do not take a double dose to make up for the missed tablet. If you have any questions about the use of this product, 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 effects, stop taking losartan tablets immediately and consult your doctor 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
swallowing or breathing).
This is a serious but rare side effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000.
It may require urgent medical treatment or hospitalisation.

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

• dizziness,
• low blood pressure (especially after excessive loss of fluid from the blood vessels, e.g. in patients with severe heart failure or those treated with high doses of diuretics),
• dose-related orthostatic effects such as low blood pressure occurring when standing up 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 kidney failure,
  • reduction in red blood cell count (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 rapid and irregular heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• inflammation of the liver (hepatitis),
• elevated blood levels of alanine aminotransferase (ALT [a laboratory test to assess liver function]), usually reversible upon discontinuation of treatment.

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

• reduced platelet count,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to light (photosensitivity), possibly with skin redness after sun exposure,
• unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the blood (hyponatraemia),
• depression,
• general malaise,
• ringing, buzzing, 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, talk to your doctor or
pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Losartan Sandoz

Keep out of the reach and sight of children.
Do not use Losartan Sandoz after the expiry date stated on the pack after "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the medicine in the outer packaging to protect it from light.
Do not open the blister pack until ready to take the medicine.
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. Package contents and other information

What Losartan Sandoz contains
The active substance is losartan potassium.
Each Losartan Sandoz 12.5 mg tablet contains 12.5 mg of losartan potassium.
The other components are: microcrystalline cellulose, macrogol 4000, povidone K25, colloidal silicon dioxide,
magnesium stearate, lactose monohydrate, hypromellose, titanium dioxide, sodium starch glycolate (type A), indigo carmine,
aluminum lake.
Losartan Sandoz 12.5 mg contains the following amount of potassium: 1.06 mg (0.027 mEq).
Losartan Sandoz 12.5 mg film-coated tablets also contain titanium dioxide (E171), indigo carmine (E132), aluminum lake.

Description of the appearance of Losartan Sandoz and contents of the pack
Losartan Sandoz 12.5 mg film-coated tablets
blue, oval, embossed with "1".

Losartan Sandoz is supplied in the following packaging:
PVC/PVDC/Aluminum blisters
Losartan Sandoz is available in the following pack sizes:
Losartan Sandoz 12.5 mg film-coated tablets
Blister packs:
7-21 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben (Germany)
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen (Germany)
LEK Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana (Slovenia)
LEK S.A., Ul. Podlipie 16, 95-010 Stryków (Poland)
with manufacturing site at Ul. Domaniewska 50 C, 02-672 Warsaw (Poland)
Lek Pharmaceuticals d.d. – Trimlini 2D – 9220 Lendava (Slovenia)

This medicinal product has been authorized in the EEA member states under the following names:
Germany: Losagrün 12.5 mg Film Tablets
Italy: Losartan Sandoz 12.5 mg film-coated tablets

This patient information leaflet was last approved

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan Sandoz 50 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before using 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. What Losartan Sandoz 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 the blood vessels to constrict.
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 Sandoz is used:

• to treat high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes who have laboratory tests showing kidney impairment 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 treatment with specific medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors, medicines used to lower high blood pressure) is considered inadequate by the physician. If your heart failure has been stabilized by treatment with an ACE inhibitor, you should not be switched to treatment with losartan.
• in patients with high blood pressure and thickening of the walls of the left ventricle, Losartan Sandoz has been shown to reduce the risk of stroke ("LIFE study indication").

2. What you need to know before taking Losartan Sandoz

Do not take Losartan Sandoz

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6.1)
• if you have severe impairment of liver function
• if you are more than three months pregnant. (It is advisable to avoid Losartan Sandoz even in the early stages of pregnancy (see section '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 Sandoz.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Losartan Sandoz is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby when taken during this period (see section 'Pregnancy').
Before taking Losartan Sandoz, 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 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 causing significant loss of body fluids and salts (see section 3 'Dosage in particular 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 Sandoz" and 3 'Dosage in particular patient groups'),
• if you have heart failure, with or without impaired kidney function, or life-threatening 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 circulation in 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), 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 section “Do not take Losartan Sandoz”.

Children and adolescents
Losartan Sandoz has been studied in children. For further information, consult your doctor.
Losartan Sandoz is not recommended for use in children with kidney or liver problems, or in children under 6 years of age, as limited data are available in these patient groups.

Other medicines and Losartan Sandoz
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 the following medicines while on Losartan Sandoz:

• 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 medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• medicines that retain potassium or may increase potassium levels in the blood (e.g. potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics such as 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.
Medicines containing lithium should not be taken together with losartan without close medical monitoring. Appropriate precautionary measures (e.g. blood tests) may be required.
Your doctor may consider it necessary to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also sections: “Do not take Losartan Sandoz” and “Warnings and precautions”).

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

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Losartan Sandoz before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
Losartan Sandoz is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan Sandoz is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.

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

Losartan Sandoz contains lactose monohydrate
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Losartan Sandoz

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Losartan Sandoz based on your condition and any other medicines you may be taking. It is important to continue taking Losartan Sandoz for the full 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 tablet of Losartan Sandoz 50 mg) once daily. The maximum effect in lowering blood pressure is achieved 3 to 6 weeks after starting treatment. In some patients, the dose may subsequently be increased to 100 mg of losartan (two tablets of Losartan Sandoz 50 mg) 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 (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 Sandoz). 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 tablet of Losartan Sandoz 50 mg) once daily. The dose may subsequently be increased to 100 mg of losartan (two tablets of Losartan Sandoz 50 mg) once daily, depending on the blood pressure response to therapy.

Losartan tablets may be administered 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. sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure
Treatment usually starts with 12.5 mg of losartan (one tablet of Losartan Sandoz 12.5 mg) once daily. 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 determined by your doctor.
A maximum dose of 150 mg of losartan (three tablets of Losartan Sandoz 50 mg) once daily may be used.

*To achieve these lower doses, tablets containing 12.5 mg (scored tablets) of losartan per tablet are available.

In the treatment of heart failure, losartan is usually given in combination with a diuretic (a medicine that increases the amount of fluid removed 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 aged over 75 years. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Losartan Sandoz").

Method of 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 Sandoz unless your doctor tells you otherwise.

Instructions for splitting Losartan Sandoz 50 mg film-coated tablets
Film-coated tablets may be divided into two equal halves.

If you take more Losartan Sandoz 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, or possibly decreased heart rate.

If you forget to take Losartan Sandoz
If you accidentally miss a dose, take the next tablet at your usual time the following day. Do not take a double dose to make up for the missed tablet. If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following effects, stop taking losartan tablets immediately and consult your doctor 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 patients but less than 1 in 1,000. It may require urgent medical treatment or hospitalization.

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

• dizziness,
• low blood pressure (especially after excessive loss of fluid in 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 kidney failure,
  • reduction in red blood cell count (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 blood levels of alanine aminotransferase (ALT [a laboratory test to assess liver function]), usually reversible upon discontinuation of treatment.

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

• reduced platelet count,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to light (photosensitivity), possibly with skin redness after sun exposure,
• unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the blood (hyponatraemia),
• depression,
• general malaise,
• ringing, buzzing, roaring or clicking in the ears (tinnitus),
  • alteration of taste sensation.

Side effects in children are similar to those observed in adults.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losartan Sandoz

Keep out of the reach and sight of children.
Do not use Losartan Sandoz after the expiry date stated on the packaging after the word "EXP". The expiry date refers to the last day of that month.
Keep the medicine in its outer packaging to protect it from light.
Do not open the blister pack until you are ready to take the medicine.
Medicines must 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. OTHER INFORMATION

What Losartan Sandoz contains
The active substance is losartan potassium.
Each Losartan Sandoz 50 mg tablet contains 50 mg of losartan potassium.
The other components are: microcrystalline cellulose, macrogol 4000, povidone K25, colloidal silicon dioxide,
magnesium stearate, monohydrate lactose, hypromellose, titanium dioxide, sodium starch glycolate (type A), indigo carmine.
Losartan Sandoz 50 mg contains the following amount of potassium: 4.24 mg (0.108 mEq).
Losartan Sandoz 50 mg film-coated tablets also contain titanium dioxide (E171).

Description of the appearance of Losartan Sandoz and contents of the pack
Losartan Sandoz 50 mg film-coated tablets
white, oval, with a break line on both sides and the number 3 in relief.
The film-coated tablets can be divided into two equal parts.
Losartan Sandoz is supplied in the following packaging:
PVC/PVDC/Aluminum blister
Losartan Sandoz is available in the following pack sizes:
Losartan Sandoz 50 mg film-coated tablets
Blister:
28 film-coated tablets
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben (Germany)
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen (Germany)
LEK Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana (Slovenia)
LEK S.A., Ul. Podlipie 16, 95-010 Stryków (Poland)
with manufacturing site at Ul. Domaniewska 50 C, 02-672 Warsaw (Poland)
Lek Pharmaceuticals d.d. – Trimlini 2D – 9220 Lendava (Slovenia)

This medicinal product has been authorized in EEA member states under the following names:
Germany: Losagrün 50 mg Film Tablets
Italy: Losartan Sandoz 50 mg film-coated tablets

This patient information leaflet was last approved on