LOSARTAN 25 mg Film-Coated Tablets

Зміст інструкції

1. Losartan Aurobindo 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets
   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. Package contents and other information
2. LOSARTAN ARROW LAB 100 mg, film-coated tablet

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

Generic medicine*

(*only for 50 mg and 100 mg dosages)

Read this leaflet carefully before taking this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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, causing relaxation of the blood vessels with a consequent lowering of blood pressure. Losartan slows the decrease in kidney function in patients with high blood pressure and type 2 diabetes.

• 2.

Losartan Aurobindo is used:

• to treat high blood pressure (hypertension) in adult, children and adolescent patients between the ages of 6 and 18.
• to protect the kidneys in hypertensive patients with type 2 diabetes with laboratory evidence of impaired renal function and proteinuria ≥ 0.5 g per day (a condition in which urine contains an abnormal 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 by therapy with an ACE inhibitor, you should not switch to therapy with losartan.
• in patients with high blood pressure and thickening of the left ventricle, 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 pregnant for more than three months (it is best to avoid Losartan Aurobindo even in the early stages of pregnancy - see section “Pregnancy”),
• if you have diabetes or impaired kidney function and are being treated with a medicine to lower blood pressure that contains aliskiren

Warnings and precautions
You must tell your doctor if you think you may be pregnant (or if you could become pregnant). Losartan Aurobindo is not recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than 3 months, as it may cause serious harm to the baby if 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 suffer from excessive vomiting or diarrhoea which has caused a large loss of fluids and/or salts from the body,
• if you are being treated with diuretics (medicines that increase the amount of water eliminated through the kidneys) or if you are on a salt-restricted diet which causes a large loss of fluid and salt from the body (see section 3 “Dosage in particular patient groups”),
• if you know you have a narrowing or blockage of the blood vessels that supply the kidneys or if you have recently had 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 concomitant life-threatening serious heart rhythm disturbances. Particular care is needed when you are receiving concomitant treatment with a beta-blocker,
• if you have problems with the heart valves or the heart muscle,
• if you suffer from coronary artery disease (caused by reduced blood flow in the blood vessels of the heart) or if you suffer from cerebrovascular disease (caused by reduced blood circulation in the brain),
• if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality of 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, etc.) particularly if you have kidney problems related to diabetes
• aliskiren.

Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood 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 more information, consult your doctor.
The use of Losartan Aurobindo is not recommended in children who suffer from kidney or liver problems, as limited data are available in these patient groups. The use of Losartan Aurobindo is not recommended in children under 6 years of age, as it has not been shown to work in this age group.

Other medicines and Losartan Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Be particularly careful if you are taking the following medicines while being treated with Losartan Aurobindo:

• other medicines to lower blood pressure because 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 that can increase potassium levels (e.g. potassium supplements, salt substitutes containing potassium or potassium-sparing diuretics such as some diuretics [amiloride, triamterene, spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs such as indometacin, including COX-2 inhibitors (medicines that reduce inflammation, and that can be used to relieve pain) because they can decrease the effect of losartan in lowering blood pressure.

If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of kidney function.
Medicines containing lithium must not be taken in combination with losartan without close medical supervision. Appropriate precautionary measures may be indicated (e.g. blood tests).
The doctor may need to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the information in section “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, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you may be pregnant (or could become pregnant).
Generally your doctor will advise you to stop taking Losartan Aurobindo before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Losartan Aurobindo. Losartan Aurobindo is not recommended in the early stages of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or intend to start breastfeeding. Losartan Aurobindo is not recommended for mothers who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
Studies have not been performed on the effects on the ability to drive and operate machines. It is unlikely that Losartan Aurobindo will affect your ability to drive and operate 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 should consult your doctor before driving or operating machines.

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

3. How to take Losartan Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The doctor will decide the appropriate dosage 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 time prescribed by your doctor, in order to keep your blood
pressure under control.
Adult patients with high blood pressure
Treatment usually starts with 50 mg of losartan (one tablet of Losartan Aurobindo 50 mg)
once a day. The maximum effect in reducing blood pressure is achieved 3-6 weeks after the start
of treatment. In some patients, the dosage may be subsequently increased to 100 mg of
losartan (two tablets of Losartan Aurobindo 50 mg) once a day. 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 Losartan Aurobindo is not recommended in children under 6 years of age, as it has not
proven to be effective in this age group.
Children from 6 to 18 years of age
The recommended starting dose in patients weighing between 20 and 50 kg is 0.7 of losartan per kg of body
weight administered once a day (up to 25 mg of Losartan Aurobindo). The doctor may
increase the dose if your blood pressure is not controlled.
There are other dosages of this medicine that may be more suitable for children; ask your
doctor or pharmacist.
Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg of losartan (one tablet of Losartan Aurobindo 50 mg) once a
day. The dose may be subsequently increased to 100 mg of losartan (2 tablets of
Losartan Aurobindo 50 mg or 1 tablet of Losartan Aurobindo 100 mg) once a day depending
on the blood pressure response.
Losartan tablets can be administered with other medicines that lower blood pressure (e.g. diuretics, calcium antagonists, alpha- or beta-blockers and centrally acting agents) as
well as insulin and other commonly used medicines that lower blood glucose levels
(e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Adult patients with heart failure
Treatment usually starts with 12.5 mg of losartan (half a tablet of Losartan Aurobindo 25 mg)
once a day. Generally, the dose can be increased on a weekly basis (e.g. 12.5 mg at
day during the first week, 25 mg a day during the second week, 50 mg a day
during the third week, 100 mg a day during the fourth week, 150 mg a day during the
fifth week) up to the maintenance dose determined by your doctor. A
maximum daily dose of 150 mg of losartan can be used (for example, 3 tablets of Losartan Aurobindo 50
mg or 1 tablet each of Losartan Aurobindo100 mg and Losartan Aurobindo 50 mg) once a
day.
In the treatment of heart failure, losartan is usually associated with a diuretic
(a medicine that increases the amount of fluid eliminated through the kidneys) and/or digitalis (a medicine that
helps to make the heart stronger and more efficient) and/or beta-blockers.

Dosage in special patient groups
The doctor may recommend a lower dosage, especially when starting treatment in
some patients such as those treated with high-dose diuretics, in patients with impaired liver function, or in patients over 75 years of age. The use of losartan is not recommended in patients with
severe impairment of liver function (see paragraph “Do not take Losartan Aurobindo”).

Administration
The tablets must 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 until
your doctor tells you to do otherwise.

If you take more Losartan Aurobindo than you should
If you accidentally take too many tablets, contact your doctor immediately. Symptoms of
overdose are low blood pressure, increased heart rate, possible decrease in
heart rate.

If you forget to take Losartan Aurobindo
If you accidentally forget to take your daily dose, take the next dose as usual.
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience the following side effect, stop taking losartan tablets and immediately inform your
doctor or go to the emergency room of the nearest hospital:
a severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat that can
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 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 fluid loss from the body into the blood vessels, e.g. in patients with severe heart failure or treated with high doses of diuretics)
• orthostatic effects related to dosage such as low blood pressure when getting up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• too much potassium in the blood (hyperkalemia),
• changes in kidney function including kidney failure,
• reduced number of red blood cells (anemia),
• increased blood urea, serum creatinine and serum potassium in patients with heart failure. Uncommon (may affect up to 1 in 100 people):
• sleepiness,
• headache,
• sleep disturbances,
• feeling of increased heart rate (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnea)
• abdominal pain,
• constipation,
• diarrhea,
• nausea
• vomiting,
• urticaria,
• itching,
• skin rash,
• localized swelling (edema),
• cough.

Rare (may affect up to 1 in 1,000):

• hypersensitivity
• angioedema
• inflammation of blood vessels (vasculitis including Henoch-Schönlein purpura),
• feeling of numbness or tingling (paresthesia),
• fainting (syncope),
• very fast and irregular heartbeat (atrial fibrillation),
• stroke,
• liver inflammation (hepatitis),
• elevated levels in the blood of alanine aminotransferase (ALT), usually reversible with discontinuation of treatment. Frequency not known (the frequency cannot be estimated based on available data):
• reduction in the number of platelets
• migraine,
• abnormal liver function,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark urine (tea-colored) (rhabdomyolysis),
• impotence
• inflammation of the pancreas (pancreatitis)
• low levels of sodium in the blood (hyponatremia),
• depression,
• general feeling of discomfort,
• sounds, ringing, buzzing 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 effects, including those not listed in this leaflet, please
tell your doctor or pharmacist or nurse. You can also report side effects
directly through 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, on the carton and on 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 any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Losartan Aurobindo contains

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

Description of the appearance of Losartan Aurobindo and package contents
Film-coated tablet.
Losartan Aurobindo 25 mg film-coated tablets:
White to almost white, oval-shaped, biconvex coated tablets imprinted with “5” and “7” on either side of the fracture line on one side and “J” with a fracture line 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-shaped, biconvex coated tablets imprinted with “E” on one side and “4” and “6” separated by a fracture line 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-shaped, biconvex coated tablets imprinted with “E” on one side and “47” on the other side.
Blister packs in PVC/PE/PVDC-aluminium:
Pack size: 28, 98 and 100 film-coated tablets
HDPE bottle with polypropylene closure:
Pack size: 30 and 1000 film-coated tablets.
Not all pack sizes may be marketed.

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
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, film-coated tablet

Germany: Losartan Aurobindo 50 mg/ 100 mg film-coated tablets
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, film-coated tablets
United Kingdom: Losartan potassium 25 mg/50 mg/ 100 mg film-coated tablets
Czech Republic: Losartan Aurobindo 50 mg/ 100 mg coated tablets
Spain: Losartan Aurobindo 25 mg/ 50 mg/ 100 mg film-coated tablets EFG
Sweden: Losartan Aurobindo 25 mg/ 50 mg/ 100 mg film-coated tablets