Losartan Aurobindo

Package leaflet: Information for the user

Losartan Aurobindo 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine*
(*for 50 mg and 100 mg strengths only)
Please read all of 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 pass it on to other people, even if their symptoms are the same as yours, as 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 Losartan Aurobindo is and what it is used for
2. What you need to know before taking Losartan Aurobindo
3. How to take Losartan Aurobindo
4. Possible side effects
5. How to store Losartan Aurobindo
6. Contents of the pack and other information

1. What Losartan Aurobindo is and what it is used for

Losartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan 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 Aurobindo is used:

• to treat high blood pressure (hypertension) in adult patients, children and adolescents aged 6 to 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes who have laboratory evidence of impaired kidney function and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormally high amount of protein).
• to treat patients with chronic heart failure when 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 stabilised with ACE inhibitor therapy, you should not switch to losartan treatment.
• in patients with high blood pressure and left ventricular hypertrophy, Losartan Aurobindo has been shown to reduce the risk of stroke (“LIFE indication”).

2. What you need to know before taking Losartan Aurobindo

Do not take Losartan Aurobindo

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if you have severely impaired liver function,
• if you are more than three months pregnant (Losartan Aurobindo should also be avoided during early 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
You must inform your doctor if you think you may be pregnant (or if you might become pregnant). Losartan Aurobindo 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 when used at this stage of pregnancy (see section on “Pregnancy”).
Before taking Losartan Aurobindo, 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 fluid excreted by the kidneys) or are on a low-salt diet, which may cause significant fluid and salt loss (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 Aurobindo” 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 being treated with 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 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 glandular abnormalities),
• if you are taking any of the following medicines used to treat high blood pressure:
• an “ACE inhibitor” (e.g., enalapril, lisinopril, ramipril, etc.), 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 in section “Do not take Losartan Aurobindo”.
Children and adolescents
Losartan Aurobindo has been studied in children. For further information, consult your doctor.
The use of Losartan Aurobindo is not recommended in children with kidney or liver problems, as data in these patient groups are limited. The use of Losartan Aurobindo is not recommended in children under 6 years of age, as it has not been shown to be effective in this age group.
Other medicines and Losartan Aurobindo
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 being treated with Losartan Aurobindo:

• other medicines to lower blood pressure, as they may further reduce your blood pressure. Blood pressure may also be lowered by 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.

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 may be required (e.g., blood tests).
Your doctor may need to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also information in sections “Do not take Losartan Aurobindo” and “Warnings and precautions”).
Losartan Aurobindo with food, drinks and alcohol
Losartan Aurobindo can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or might become pregnant).
Generally, your doctor will advise you to stop taking Losartan Aurobindo before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine to Losartan Aurobindo. Losartan Aurobindo is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your unborn baby if used beyond the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or plan to breast-feed. Losartan Aurobindo 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 premature.
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 Aurobindo affects the ability to drive and 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, consult your doctor before engaging in such activities.
Losartan Aurobindo 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 Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Your doctor will decide the appropriate dose of Losartan Aurobindo based on your condition and any other medicines you may be taking. It is important to continue taking Losartan Aurobindo for the entire duration prescribed by your doctor in order to keep your blood pressure under control.

Adult patients with high blood pressure

Treatment is usually started at a dose of 50 mg losartan (one tablet of Losartan Aurobindo 50 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 losartan (two tablets of Losartan Aurobindo 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

Children under 6 years of age

Losartan Aurobindo is not recommended for children under 6 years of age, as it has not been shown to be effective 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 Losartan Aurobindo). Your doctor may increase the dose if your blood pressure is not adequately controlled.

Other dosage strengths 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 with 50 mg of losartan (one tablet of Losartan Aurobindo 50 mg) once daily. The dose may later be increased to 100 mg of losartan (two tablets of Losartan Aurobindo 50 mg or one tablet of Losartan Aurobindo 100 mg) once daily, depending on your blood pressure response.

Losartan tablets can be taken 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 with 12.5 mg of losartan (half a tablet of Losartan Aurobindo 25 mg) once daily. The dose is generally 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 daily dose of 150 mg of losartan may be used (e.g., three tablets of Losartan Aurobindo 50 mg, or one tablet each of Losartan Aurobindo 100 mg and Losartan Aurobindo 50 mg) once daily.

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.

Dosage in special patient groups

Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those taking high-dose diuretics, patients with impaired liver function, or patients over 75 years of age. The use of losartan is not recommended in patients with severe impairment of liver function (see section "Do not take Losartan Aurobindo").

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 Aurobindo unless your doctor tells you otherwise.

If you take more Losartan Aurobindo 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 Aurobindo

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effect, stop taking losartan tablets and contact your doctor immediately 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 in swallowing or breathing).
This is a serious but rare side effect, affecting more than 1 in 10,000 people but less than 1 in 1,000. It may require urgent medical treatment or hospitalization.

The following side effects have been reported with Losartan Aurobindo:

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 receiving high doses of diuretics),
• dose-related orthostatic effects such as low blood pressure 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,
• reduced number of red blood cells (anaemia),
• increased blood urea, serum creatinine and serum potassium in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disorders,
• sensation of increased heart rate (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), 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,
• influenza-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the blood (hyponatraemia),
• depression,
• general feeling of malaise,
• noises, buzzing, ringing 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, pharmacist or nurse. 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 Aurobindo

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 label, the carton and the
blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Aurobindo contains

• The active substance is potassium losartan.
  Each Losartan Aurobindo 25 mg tablet contains 25 mg of potassium losartan, equivalent to 22.9 mg of losartan.
  Each Losartan Aurobindo 50 mg tablet contains 50 mg of potassium losartan, equivalent to 48.8 mg of losartan.
  Each Losartan Aurobindo 100 mg tablet contains 100 mg of potassium losartan, equivalent to 91.7 mg of losartan.
• The other components are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, pregelatinized starch (corn starch), low-substituted hydroxypropylcellulose, magnesium stearate.
  Coating: hydroxypropylcellulose, hypromellose and titanium dioxide (E171).

Description of the appearance of Losartan Aurobindo and contents of the pack
Film-coated tablet.
Losartan Aurobindo 25 mg film-coated tablets:
White to almost white, oval, biconvex film-coated tablets, marked with “5” and “7” on either side of the breakline on one side and “J” with a breakline on the other side. The tablet can be divided into two equal doses.
Losartan Aurobindo 50 mg film-coated tablets:
White to almost white, oval, biconvex film-coated tablets, marked with “E” on one side and “4” and “6” separated by a breakline on the other side. The tablet can be divided into two equal doses.
Losartan Aurobindo 100 mg film-coated tablets:
White to almost white, oval, biconvex film-coated tablets, marked with “E” on one side and “47” on the other side.

Packs in PVC/PE/PVDC-aluminum blisters:
Pack size: 28, 98 and 100 film-coated tablets
HDPE bottle with polypropylene cap:
Pack size: 30 and 1000 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Bulgaria: Лосартан калий Ауробиндо 50 mg Филмирани таблетки
Cyprus: Losartan Aurobindo 50 mg επικαλυμμένα με λεπτό υμένιο δισκία
Denmark: Losartan “Aurobindo”
France: LOSARTAN ARROW LAB 50 mg, comprimé pelliculé sécable
LOSARTAN ARROW LAB 100 mg, comprimé pelliculé
Germany: Losartan Aurobindo 50 mg/ 100 mg Filmtabletten
Italy: Losartan Aurobindo
Ireland: Losartan potassium Milpharm 50 mg/ 100 mg film-coated tablets
Malta: Losartan potassium 50 mg/ 100 mg film-coated tablets
Netherlands: Losartankalium Aurobindo 25 mg/ 50 mg/ 100 mg, filmomhulde tabletten
United Kingdom: Losartan potassium 25 mg/50 mg/ 100 mg film-coated tablets
Czech Republic: Losartan Aurobindo 50 mg/ 100 mg potahované tablety
Spain: Losartan Aurobindo 25 mg/ 50 mg/ 100 mg comprimidos recubiertos con película EFG
Sweden: Losartan Aurobindo 25 mg/ 50 mg/ 100 mg filmdragerade tabletter