Neo-Lotan

Package leaflet: Information for the user

NEO-LOTAN 12.5 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Losartan potassium
Please read all of 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Neo-lotan is and what it is used for

Losartan (Neo-lotan) 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 blood vessels, causing the blood vessels to narrow. 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.

Neo-lotan is used

• to treat adult patients and children and adolescents aged 6 to 18 years with high blood pressure (hypertension);
• to protect the kidney in hypertensive patients with type 2 diabetes who have laboratory tests showing impaired renal 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 treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) is not considered appropriate by the doctor. If your heart failure has been stabilized with 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, Neo-lotan has been shown to reduce the risk of stroke ("LIFE study indication").

2. What you should know before taking Neo-lotan

Do not take Neo-lotan:

• if you are allergic to losartan or to any of the excipients of this medicine (listed in section 6);
• if you are more than 3 months pregnant (it is also advisable to avoid taking Neo-lotan during the first trimester of pregnancy – see Pregnancy);
• if you have severe impairment of liver function;
• 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, pharmacist, or nurse before taking Neo-lotan.
You must inform your doctor if you think you are (or might become) pregnant. Neo-lotan is not recommended
during the first trimester of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may
cause serious harm to the unborn baby when used during this period (see section Pregnancy).
Before taking Neo-lotan, 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 are experiencing excessive vomiting or diarrhoea leading to significant fluid and/or salt loss in the body;
• if you are taking diuretics (medicines that increase the amount of water eliminated through the kidneys) or are on a low-salt diet causing substantial 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 you have impaired liver function (see sections 2 "Do not take Neo-lotan" and 3 "Dosage in specific patient groups");
• if you suffer from heart failure, with or without impaired kidney function, or have life-threatening cardiac arrhythmias. Special caution is required if you are also taking a beta-blocker;
• if you have heart valve problems or cardiomyopathy;
• if you suffer from coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood circulation 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 section "Do not take Neo-lotan".

Contact your doctor if, after taking Neo-lotan, you experience abdominal pain, nausea, vomiting, or
diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Neo-lotan
on your own.
Children and adolescents
Neo-lotan has been studied in children. For further information, consult your doctor.
Neo-lotan is not recommended in children with kidney or liver problems, as available data in this patient group are limited. Neo-lotan is not recommended in children under 6 years of age, as efficacy has not been demonstrated in this age group.
Other medicines and Neo-lotan
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 Neo-lotan:

• 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 (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.

Your doctor may consider it necessary to adjust the dose and/or take additional precautions: if you are
taking an ACE inhibitor or aliskiren (see also the sections “ Do not take Neo-lotan ” and " Warnings and precautions ”).
If your kidney function is impaired, concomitant use of these medicines may lead to worsening of kidney function.
Medicines containing lithium must not be taken together with losartan without close medical monitoring. Appropriate precautionary measures (e.g. blood tests) may be required.
Neo-lotan with food and drink
Neo-lotan can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop treatment with Neo-lotan before you become pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine to Neo-lotan. Neo-lotan is not recommended during the first trimester of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if used after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Neo-lotan is not recommended for nursing mothers, and your doctor may choose an alternative treatment if you wish to breast-feed. This is especially important if your baby is a newborn or a premature infant.
Consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No studies have been conducted on the effects on the ability to drive vehicles and use machines.
It is unlikely that Neo-lotan will affect the ability to drive vehicles 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.
Neo-lotan contains lactose
Neo-lotan 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 Neo-lotan

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Neo-lotan based on your condition and any other medicines you may be taking. It is important to continue taking Neo-lotan for the entire 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 Neo-lotan 50 mg tablet) once daily. The maximum effect on lowering blood pressure is reached 3–6 weeks after starting treatment. In some patients, the dose may later be increased to 100 mg of losartan (two Neo-lotan 50 mg tablets or one Neo-lotan 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
Neo-lotan is not recommended for children under 6 years of age, as its effectiveness has not been demonstrated in this age group.

Children 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, taken once daily (up to a maximum of 25 mg of Neo-lotan). Your doctor may increase the dose if blood pressure is not adequately controlled.

Another formulation of this medicine might 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 50 mg of losartan (one Neo-lotan 50 mg tablet) once daily. The dose may later be increased to 100 mg of losartan (two Neo-lotan 50 mg tablets or one Neo-lotan 100 mg tablet) once daily, depending on the blood pressure response to therapy.

Losartan tablets can 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 Neo-lotan 12.5 mg tablet) once daily. The dose should be gradually increased on a weekly basis (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), up to the maintenance dose established by your doctor. A maximum dose of 150 mg of losartan (e.g. three Neo-lotan 50 mg tablets or one Neo-lotan 100 mg tablet and one Neo-lotan 50 mg tablet) once daily may be used.

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.

Dosing in specific patient groups
Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those receiving high-dose diuretic therapy, patients with impaired liver function, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Neo-lotan").

Administration
The tablets should be swallowed whole with a glass of water.
Try to take your daily dose at the same time each day. It is important to continue taking Neo-lotan unless your doctor tells you otherwise.

If you take more Neo-lotan 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 Neo-lotan
If you accidentally miss a daily dose, take the next tablet at the 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, 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 side effects, 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 patients but less than 1 in 1,000. It may require urgent medical treatment or hospitalization.

The following side effects have been reported with Neo-lotan:

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

• dizziness,
• low blood pressure (especially after excessive fluid loss from the blood vessels, 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,
• low blood sugar (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in kidney function including kidney failure,
• reduction in the number of red blood cells (anaemia),
• increased blood urea, 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,
• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea,
• 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), usually reversible upon discontinuation of treatment.

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

• reduction in platelet count,
• migraine,
• abnormalities in liver function,
• 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 (malaise),
• perception of sounds, ringing, buzzing, crackling noises in the ears (tinnitus),
• taste disturbances (dysgeusia).

Side effects in children are similar to those observed in adults.
Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website: http://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 Neo-lotan

Keep Neo-lotan out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the label of the bottle.
The expiry date refers to the last day of the month.

Blister packs:
Store Neo-lotan in the original packaging to protect it from light and moisture.
Do not open the blister packaging until it is time to take the tablet.

Bottles:
Store Neo-lotan in the original packaging to protect it from light.
Do not store above 25°C. Keep the bottle tightly closed to protect from moisture.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Neo-lotan Contains
The active substance is losartan potassium.
Each Neo-lotan 12.5 mg tablet contains 12.5 mg of losartan potassium.
Each Neo-lotan 50 mg tablet contains 50 mg of losartan potassium.
Each Neo-lotan 100 mg tablet contains 100 mg of losartan potassium.
The excipients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hypromellose (E463), and hydroxypropyl cellulose (E464).
Neo-lotan 12.5 mg, 50 mg, and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 4.24 mg (0.108 mEq), and 8.48 mg (0.216 mEq), respectively.
Neo-lotan 12.5 mg tablets also contain carnauba wax (E903), titanium dioxide (E171), and indigo carmine aluminium lake (E132).
Neo-lotan 50 mg tablets also contain carnauba wax (E903) and titanium dioxide (E171).
Neo-lotan 100 mg tablets also contain carnauba wax (E903) and titanium dioxide (E171).

Description of the Appearance of Neo-lotan and Pack Contents
Neo-lotan 12.5 mg is supplied as non-scored film-coated tablets containing 12.5 mg of losartan potassium.
Neo-lotan 50 mg is supplied as film-coated tablets containing 50 mg of losartan potassium.
The score line is not intended to divide the tablet into equal doses.
Neo-lotan 100 mg is supplied as non-scored film-coated tablets containing 100 mg of losartan potassium.
Neo-lotan is available in the following pack sizes:

• Neo-lotan 12.5 mg – Tablets are contained in PVC/PE/PVDC blisters with aluminium foil lids, in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets, and a single-dose pack of 28 tablets for hospital use. HDPE bottles containing 100 tablets.
• Neo-lotan 50 mg – Tablets are contained in PVC/PE/PVDC blisters with aluminium foil lids, in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets, and single-dose packs of 28, 56 and 98 tablets for hospital use. HDPE bottles containing 100 or 300 tablets.
• Neo-lotan 100 mg – PVC/PE/PVDC blisters with aluminium foil lids in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets, and single-dose packs of 28, 56 and 98 tablets for hospital use. HDPE bottles containing 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Neopharmed Gentili S.p.A.
Via S.G. Cottolengo, 15 – 20143 Milano
Manufacturers:
Vamfarma S.r.l.
Via Kennedy, 5 – 26833 Comazzo (Lodi)
Doppel Farmaceutici S.r.l.
Via Volturno, 48 – Quinto de' Stampi 20089 Rozzano (Milano)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

| Member State | Brand Name | |------------------|----------------| | Austria | Cosaar 12.5 mg – Filmtabletten | | Austria | Cosaar 50 mg – Filmtabletten | | Austria | Cosaar 100 mg – Filmtabletten | | Belgium | COZAAR 100 mg | | Belgium | COZAAR 50 mg | | Belgium | COZAAR 12.5 mg | | Bulgaria | COZAAR 12.5 mg film-coated tablets | | Bulgaria | COZAAR 50 mg film-coated tablets | | Cyprus | COZAAR | | Czech Republic | COZAAR 50 mg | | Czech Republic | COZAAR 100 mg | | Denmark | Cozaar | | Finland | Cozaar 12.5 mg kalvopäällysteiset tabletit | | Finland | Cozaar 50 mg kalvopäällysteiset tabletit | | Finland | Cozaar 100 mg kalvopäällysteiset tabletit | | France | COZAAR 100 mg film-coated tablets | | France | COZAAR 50 mg scored coated tablets | | Germany | LORZAAR PROTECT 100 mg Filmtabletten | | Germany | LORZAAR PROTECT 50 mg Filmtabletten | | Germany | LORZAAR START 12.5 mg Filmtabletten | | Greece | COZAAR | | Hungary | COZAAR | | Ireland | COZAAR 50 mg film-coated tablets | | Ireland | COZAAR 100 mg film-coated tablets | | Ireland | COZAAR 12.5 mg film-coated tablets | | Iceland | COZAAR | | Italy | LORTAAN 50 mg film-coated tablets | | Italy | LORTAAN 12.5 mg film-coated tablets | | Italy | LORTAAN 100 mg film-coated tablets | | Luxembourg | COZAAR 100 mg | | Luxembourg | COZAAR 50 mg | | Luxembourg | COZAAR 12.5 mg | | Malta | COZAAR 12.5 mg film-coated tablets | | Malta | COZAAR 50 mg film-coated tablets | | Malta | COZAAR 100 mg film-coated tablets | | Netherlands | COZAAR 12.5 mg | | Netherlands | COZAAR 50 mg | | Netherlands | COZAAR 100 mg | | Norway | Cozaar | | Poland | COZAAR | | Portugal | Cozaar | | Portugal | Cozaar 100 mg | | Portugal | Cozaar IC | | Romania | COZAAR, 12.5 mg comprimate filmate | | Romania | COZAAR, 50 mg comprimate filmate | | Slovenia | Cozaar 12.5 mg filmsko obložene tablete | | Slovenia | Cozaar 50 mg filmsko obložene tablete | | Slovenia | Cozaar 100 mg filmsko obložene tablete | | Spain | COZAAR 12.5 mg Inicio comprimidos recubiertos con película | | Spain | COZAAR 50 mg comprimidos recubiertos con película | | Spain | COZAAR 100 mg comprimidos recubiertos con película | | Sweden | COZAAR 12.5 mg filmdragerade tabletter | | Sweden | COZAAR 50 mg filmdragerade tabletter | | Sweden | COZAAR 100 mg filmdragerade tabletter | | United Kingdom | COZAAR 12.5 mg film-coated tablets | | United Kingdom | COZAAR 50 mg film-coated tablets | | United Kingdom | COZAAR 100 mg film-coated tablets |

Package leaflet: information for the user

NEO-LOTAN 2.5 mg/ml powder and solvent for oral suspension

Losartan potassium
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, pharmacist, or nurse.
• 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 may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What NEO-LOTAN is and what it is used for

Losartan (Neo-lotan) 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 blood vessels, causing the blood vessels to narrow. 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 kidney function in patients with high blood pressure and type 2 diabetes.
Neo-lotan is used

• to treat patients with 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 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 treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) is not considered adequate by the physician. If your heart failure has been stabilized by ACE-inhibitor therapy, you should not switch to losartan therapy;
• in patients with high blood pressure and thickening of the walls of the left ventricle, Neo-lotan has been shown to reduce the risk of stroke ("LIFE study indication").

2. What you need to know before taking NEO-LOTAN

Do not take NEO-LOTAN:

• if you are allergic to losartan or to any of the other excipients of this medicine (listed in section 6);
• if you are more than three months pregnant (it is also advisable to avoid using Neo-lotan during early pregnancy – see section Pregnancy);
• if you have severe impairment of liver function;
• 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, pharmacist, or nurse before taking Neo-lotan.
You must inform your doctor if you think you are (or might become) pregnant. Neo-lotan is not recommended
during the first trimester of 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 used during this period (see section Pregnancy).
Before taking Neo-lotan, 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 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 excreted by the kidneys) or are on a low-salt diet causing significant loss of body fluids and salts (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 kidney transplantation;
• if you have impaired liver function (see sections 2 "Do not take Neo-lotan" and 3 "Dosage in specific patient groups");
• if you have 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 cardiomyopathy;
• if you suffer from coronary heart disease (caused by reduced blood flow in the heart's blood vessels) 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 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 Neo-lotan”.
Contact your doctor if, after taking Neo-lotan, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Neo-lotan on your own.
Children and adolescents
Neo-lotan has been studied in children. For further information, consult your doctor. Neo-lotan is not recommended in children with kidney or liver problems, as available data in these patient groups are limited. Neo-lotan is not recommended for children under 6 years of age, as efficacy has not been demonstrated in this age group.
Other medicines and NEO-LOTAN
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 Neo-lotan treatment:

• 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 (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.

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
Neo-lotan” and “Warnings and precautions”).
If your kidney function is impaired, concomitant use of these medicines may lead to worsening of kidney function.
Lithium-containing medicines must not be taken in combination with losartan without close medical monitoring. Appropriate precautionary measures may be required (e.g. blood tests).
NEO-LOTAN with food and drink
Neo-lotan can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop treatment with Neo-lotan before you become pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Neo-lotan. Neo-lotan 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 used after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Neo-lotan is not recommended for nursing mothers, and your doctor may choose an alternative treatment if you wish to breast-feed. This is especially important if your baby is a newborn or premature infant.
Consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been conducted.
It is unlikely that Neo-lotan has any effect on the ability to drive and use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If dizziness or drowsiness occurs, you must consult your doctor before engaging in such activities.
NEO-LOTAN contains lactose and preservatives
Neo-lotan contains monohydrate lactose and sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Neo-lotan contains methylhydroxybenzoate and propylhydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to take NEO-LOTAN

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Your doctor will determine the appropriate dosage of NEO-LOTAN based on your condition and any other medicines you may be taking. It is important to continue taking NEO-LOTAN for the entire 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 (20 ml of NEO-LOTAN suspension) once daily. The maximum blood pressure-lowering effect is achieved 3–6 weeks after starting treatment. In some patients, the dose may subsequently be increased to 100 mg of losartan (40 ml of NEO-LOTAN suspension) 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
The use of Lortaan is not recommended in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Children aged between 6 and 18 years
In patients weighing between 20 and 50 kg, the recommended starting dose is 0.7 mg of losartan per kg of body weight once daily (up to a maximum of 25 mg or 10 ml of NEO-LOTAN suspension). 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 (20 ml of NEO-LOTAN suspension) once daily. The dose may subsequently be increased to 100 mg of losartan (40 ml of NEO-LOTAN suspension) once daily, depending on your blood pressure response to therapy.

Losartan 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 (5 ml of NEO-LOTAN suspension) once daily. The dose should generally be increased gradually on a weekly basis (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 established by the doctor is reached. A maximum dose of 150 mg of losartan (60 ml of NEO-LOTAN suspension) once daily may be used.

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 strengthen and improve heart function) and/or beta-blockers.

Dosing 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 hepatic impairment (see section "Do not take NEO-LOTAN").

How to measure and administer an oral suspension dose
NEO-LOTAN oral suspension must always be shaken well before use!

1. Shake the bottle well before use.

2. Push the syringe plunger fully down.
3. Insert the syringe into the adapter on the medicine bottle until a tight seal is achieved.
4. Turn the assembled system (syringe, adapter, and bottle) upside down.

5. Pull back the plunger to draw the medicine into the syringe.
6. Return the system to an upright position.
7. Remove the syringe and take the medicine.
8. Replace the screw cap on the bottle.

If you take more NEO-LOTAN than you should
If you accidentally take too much NEO-LOTAN oral suspension, contact your doctor immediately.
Symptoms of overdose include low blood pressure, increased heart rate, and possibly decreased heart rate.

If you forget to take NEO-LOTAN
If you accidentally miss a daily dose, take the next dose at your usual time. Do not take a double dose to make up for a missed dose. If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

The following side effects have been reported with NEO-LOTAN:

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 standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in kidney function including kidney failure,
• reduction in the number of red blood cells (anaemia),
• increased blood urea, 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,
• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea,
• 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), usually reversible upon discontinuation of treatment.

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

• reduction in the number of platelets,
• 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),
• general feeling of being unwell (malaise),
• perception of ringing, buzzing, roaring, or crackling sounds in the ears (tinnitus),
• taste disturbances (dysgeusia).

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

Reporting of side effects
If you experience any side effect, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at 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 NEO-LOTAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.
Store in the original container.
After reconstitution, the suspension liquid should be stored in the refrigerator (2°C – 8°C) for a maximum of 4 weeks.
Do not dispose of any medicine 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 NEO-LOTAN contains
The active substance is losartan potassium.
Each sachet contains 500 mg of losartan potassium powder. A doctor or healthcare professional/pharmacist mixes each sachet with 200 ml of solvent to create a suspension. One ml of suspension contains 2.5 mg of losartan potassium.
The other excipients are:
Powder
Microcrystalline cellulose (E460), lactose monohydrate, pregelatinized corn starch, magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464), and titanium dioxide (E171)
Solvent
Microcrystalline cellulose (E460), sodium carboxymethylcellulose, anhydrous citric acid, purified water, xanthan gum (E415), methylhydroxybenzoate (E218), monosodium phosphate monohydrate, potassium sorbate, calcium carrageenan trisodium phosphate, sweet orange flavor, glycerin, propylhydroxybenzoate (E216), anhydrous sodium citrate, sodium saccharin, sorbitol (E420), antifoaming emulsion (containing water, polydimethylsiloxane, C14-18, mono- and diglycerides, polyethylene glycol stearate and polyethylene glycol).

Description of the appearance of NEO-LOTAN and contents of the pack
NEO-LOTAN powder is white to off-white in color. After suspension in the solvent, NEO-LOTAN is a white to off-white liquid.
NEO-LOTAN powder and solvent for oral suspension is supplied in a kit containing:

• One aluminum sachet filled with powder equivalent to 500 mg of losartan potassium
• One 473 ml bottle of solvent
• One 240 ml bottle with child-resistant closure for mixing the suspension
• One 10 ml oral dosing syringe
• One bottle adapter

Marketing Authorization Holder and Manufacturer
Neopharmed Gentili S.p.A.
Via S.G. Cottolengo, 15 – 20143 Milan, Italy
Manufacturer
Merck Sharp & Dohme BV/MMD, Waarderweg 39, 2031 BN, 2003 PC Haarlem, the Netherlands

This medicinal product is authorized in the European Economic Area Member States under the following names:
COZAAR
Belgium/Luxembourg, Denmark, Finland, France, Ireland, Iceland, Norway, the Netherlands, Portugal, the United Kingdom, Slovenia.
LORZAAR
Germany
LORTAAN
NEO-LOTAN
LOSAPREX
Italy

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The following information is intended exclusively for physicians or healthcare professionals:
Preparation of oral losartan potassium suspension (for 200 ml of a 2.5 mg/ml suspension):
Add 200 ml of solvent to the 240 ml polyethylene terephthalate (PET) bottle provided. Before opening the sachet, gently tap the side of the sachet to facilitate transfer of the powder. Carefully add the entire contents of the sachet into the PET container bottle containing the solvent, tap the side of the sachet gently and invert as necessary. It is normal for a small amount of residual powder to remain adherent to the inner surface of the sachet. The sachet MUST NOT be rinsed. Place the cap on the bottle and shake well to facilitate dispersion. After reconstitution, losartan suspension is a white to off-white liquid. Remove the cap, place the bottle adapter onto the bottle, and close the bottle again. The suspension must be stored refrigerated at 2–8°C for up to a maximum of 4 weeks. Shake the suspension well before each use and return immediately to the refrigerator.
Discard any unused solvent remaining after preparation of the suspension.