Lortaan

PACKAGE LEAFLET

Package leaflet: information for the user

LORTAAN film-coated tablets

losartan potassium
Read this leaflet carefully before you start 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 their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What LORTAAN is and what it is used for

Losartan (LORTAAN) 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 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 a consequent reduction in blood pressure. Losartan slows the decline in renal function in patients with high blood pressure and type 2 diabetes.
LORTAAN 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 therapy 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, LORTAAN has been shown to reduce the risk of stroke (“LIFE study indication”).

2. What you need to know before taking LORTAAN

Do not take LORTAAN:

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if you are more than 3 months pregnant (it is also advisable to avoid taking LORTAAN 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 LORTAAN.
You must inform your doctor if you think you are (or might become) pregnant. LORTAAN is not
recommended during early 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 LORTAAN, 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 salt,
• if you are taking diuretics (medicines that increase the amount of fluid excreted by the kidneys) or are on a low-salt diet causing significant loss of body fluids and salt (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 LORTAAN” and 3 “Dosage in particular patient groups”),
• if you suffer from heart failure, with or without kidney impairment 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 heart’s blood vessels) 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, or 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 LORTAAN”.
• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and LORTAAN”).

Contact your doctor if, after taking LORTAAN, you experience abdominal pain, nausea, vomiting, or
diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking LORTAAN on your own.
Children and adolescents
LORTAAN has been studied in children. For further information, consult your doctor.
LORTAAN is not recommended in children with kidney or liver problems, as available data in this
patient group are limited. LORTAAN is not recommended in children under 6 years of age, as efficacy
has not been demonstrated in this age group.
Other medicines and LORTAAN
Tell 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 medicines such as certain diuretics (amiloride, triamterene, spironolactone), or other
medicines that may increase serum potassium (e.g., heparin, medicines containing trimethoprim), as
combination with LORTAAN is not recommended.
Pay special attention if you are taking any of the following medicines while on LORTAAN:

• 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: tricyclic antidepressants, antipsychotics, baclofen, amifostine,
• non-steroidal anti-inflammatory drugs (NSAIDs) 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 section “Do not take LORTAAN” 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 should not be taken in combination with losartan without close medical monitoring. Appropriate precautionary measures (e.g., blood tests) may be required.
LORTAAN with food and drink
LORTAAN can be taken with or without food.
Grapefruit juice should be avoided during treatment with LORTAAN.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking LORTAAN before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. LORTAAN is not recommended during early pregnancy, and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. LORTAAN 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 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 or operate machinery have been performed.
It is unlikely that LORTAAN will affect your ability to drive or 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 driving or operating machinery.
LORTAAN contains lactose
LORTAAN contains lactose. 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 LORTAAN

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

Adult patients with high blood pressure

Treatment is usually started at a dose of 50 mg of losartan (one LORTAAN 50 mg tablet) once daily. The maximum blood pressure-lowering effect is reached 3 to 6 weeks after starting treatment. In some patients, the dose may subsequently be increased to 100 mg of losartan (two LORTAAN 50 mg tablets or one LORTAAN 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

LORTAAN is not recommended for children under 6 years of age, as its effectiveness has not been demonstrated in this age group.

Use in 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 LORTAAN). Your doctor may increase the dose if blood pressure is not adequately controlled.

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

Adult patients with high blood pressure and type 2 diabetes

Treatment is usually started at a dose of 50 mg of losartan (one LORTAAN 50 mg tablet) once daily. The dose may subsequently be increased to 100 mg of losartan (two LORTAAN 50 mg tablets or one LORTAAN 100 mg tablet) once daily, depending on the blood pressure response to therapy.

Losartan may be administered together with other medicines that lower blood pressure (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 is usually started at a dose of 12.5 mg of losartan (one LORTAAN 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, and 150 mg daily during the fifth week) until the maintenance dose prescribed by the doctor is reached. A maximum dose of 150 mg of losartan (e.g. three LORTAAN 50 mg tablets, or one LORTAAN 100 mg tablet plus one LORTAAN 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 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 LORTAAN").

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 LORTAAN unless your doctor tells you otherwise.

If you take more LORTAAN 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, and possibly decreased heart rate.

If you forget to take LORTAAN

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 how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you experience any of the following adverse effects, stop taking losartan tablets 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 adverse 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 adverse effects have been reported with LORTAAN:

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 being treated with 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 glucose (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in renal function including renal 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 levels of alanine aminotransferase (ALT) in the blood, usually reversible upon discontinuation of treatment.

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

• reduction in platelet count,
• migraine,
• abnormal liver function,
• muscle and joint pain,
• influenza-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain associated 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 or popping noises in the ears (tinnitus),
• taste disturbances (dysgeusia).

Adverse effects in children are similar to those observed in adults.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. You may also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store LORTAAN

Keep this medicine 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 LORTAAN in the original packaging to protect the medicine from light and
moisture.
Do not open the blister pack until it is time to take the tablet.
Bottles:
Store LORTAAN in the original packaging to protect the medicine from light.
Do not store above 25°C. Keep the bottle tightly closed to protect the medicine from moisture.
Do not dispose of any medicine 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 LORTAAN Contains
The active substance is losartan potassium.
Each LORTAAN 12.5 mg tablet contains 12.5 mg of losartan potassium.
Each LORTAAN 50 mg tablet contains 50 mg of losartan potassium.
Each LORTAAN 100 mg tablet contains 100 mg of losartan potassium.
The excipients are microcrystalline cellulose (E460), monohydrate lactose (see section 2 "LORTAAN contains lactose"), pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464).
LORTAAN 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.
LORTAAN 12.5 mg tablets also contain carnauba wax (E903), titanium dioxide (E171) and indigo carmine aluminium lake (E132).
LORTAAN 50 mg tablets also contain carnauba wax (E903) and titanium dioxide (E171).
LORTAAN 100 mg tablets also contain carnauba wax (E903) and titanium dioxide (E171).

Description of the Appearance of LORTAAN and Contents of the Pack
LORTAAN 12.5 mg is supplied as film-coated tablets, not divisible, containing 12.5 mg of losartan potassium.
LORTAAN 50 mg is supplied as film-coated tablets containing 50 mg of losartan potassium. The score line is not intended to divide the tablet.
LORTAAN 100 mg is supplied as film-coated tablets, not divisible, containing 100 mg of losartan potassium.
LORTAAN is available in the following pack sizes:

• LORTAAN 12.5 mg – PVC/PE/PVDC blisters with aluminium foil lid 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.
• LORTAAN 50 mg – PVC/PE/PVDC blisters with aluminium foil lid 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.
• LORTAAN 100 mg – PVC/PE/PVDC blisters with aluminium foil lid 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
Marketing Authorization Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome, Italy

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN, Haarlem
The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

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

| Member State | Brand Name | |------------------|----------------| | Austria | Cosaar 12.5 mg – Film Tablets | | Austria | Cosaar 50 mg – Film Tablets | | Austria | Cosaar 100 mg – Film Tablets | | Belgium | COZAAR 12.5 mg | | Belgium | COZAAR 50 mg | | Belgium | COZAAR 100 mg | | Bulgaria | COZAAR 12.5 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 50 mg scored coated tablets | | France | COZAAR 100 mg film-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 12.5 mg film-coated tablets | | Ireland | COZAAR 50 mg film-coated tablets | | Ireland | COZAAR 100 mg film-coated tablets | | Iceland | COZAAR | | Italy | LORTAAN 12.5 mg film-coated tablets | | Italy | LORTAAN 50 mg film-coated tablets | | Italy | LORTAAN 100 mg film-coated tablets | | Luxembourg | COZAAR 12.5 mg | | Luxembourg | COZAAR 50 mg | | Luxembourg | COZAAR 100 mg | | Malta | COZAAR 12.5 mg film-coated tablets | | Malta | COZAAR 50 mg film-coated tablets | | Malta | COZAAR 100 mg film-coated tablets | | Norway | Cozaar | | Netherlands | COZAAR 12.5 mg | | Netherlands | COZAAR 50 mg | | Netherlands | COZAAR 100 mg | | Poland | COZAAR | | Portugal | Cozaar | | Portugal | Cozaar 100 mg | | Portugal | Cozaar IC | | 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 |