Kaliumlosartan Alet 12,5 mg, filmomhulde tabletten

Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Losartan is used

• to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6 – 18 years of age
• to protect the kidney in hypertensive type 2 diabetic patients 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 inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor. If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan.
• in patients with high blood pressure and a thickening of the left ventricle, losartan has been shown to decrease the risk of stroke (“LIFE indication”).

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2. What you need to know before you take Do not take Kaliumlosartan Alet

• if you are allergic (hypersensitive) to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if your liver function is severely impaired,
• if you are more than 3 months pregnant. (It is also better to avoid Kaliumlosartan Alet in early pregnancy – see pregnancy).

Warnings and precautions

You must tell your doctor if you think you are (or might become) pregnant. Kaliumlosartan Alet is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

It is important to tell your doctor before taking Kaliumlosartan Alet:

• if you have had a history of angiooedema (swelling of the face, lips, throat, and/or tongue)(see also section 4 ‘Possible side effects’),
• if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body,
• if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body (see section 3 ‘Dosage in special patient groups’),
• if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently,
• if your liver function is impaired (see sections 2 "Do not take Losartan" and 3 ‘Dosage in special patient groups’),
• if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias. Special caution is necessary when you are treated with a ß-blocker concomitantly,
• if you have problems with your heart valves or heart muscle,
• if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a 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 within the gland).

Children and adolescents

Losartan has been studied in children. For more information, talk to your doctor.

Losartan is not recommended for use in children suffering from kidney or liver problems, or children under 6 years old, as limited data are available in these patient groups.

Other medicines and Kaliumlosartan Alet:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines

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Take particular care if you are taking the following medicines while under treatment with Kaliumlosartan Alet:

• other blood pressure-lowering medicines as they may additionally reduce your blood pressure. Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofene, amifostine,
• medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamteren, spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs such as indomethacin, including cox-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood pressure lowering effect of losartan.

If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.

Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate.

Kaliumlosartan Alet with food and drink

Kaliumlosartan Alet may be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will normally advise you to stop taking Kaliumlosartan Alet before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kaliumlosartan Alet. Kaliumlosartan Alet is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding.Kaliumlosartan Alet is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn, or born prematurely.

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

Use in children and adolescents

Losartan has been studied in children. For more information, talk to your doctor.

Driving and using machines

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No studies on the effects on the ability to drive and use machines have been performed. Losartan is unlikely to affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.

Kaliumlosartan Alet contains lactose monohydrate

This product contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this -medicine.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

. Your doctor will decide on the appropriate dose of Kaliumlosartan Alet, depending on your condition and whether you are taking other medicines. It is important to continue taking Kaliumlosartan Alet for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

Adult Patients with High Blood Pressure

Treatment usually starts with 50 mg losartan (one tablet Kaliumlosartan Alet 50 mg) once a day. The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may later be increased to 100 mg losartan (two tablets Kaliumlosartan Alet 50 mg) once daily.

If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.

Use in children and adolescents (6 to 18 years old)

The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg of Kaliumlosartan Alet). The doctor may increase the dose if blood pressure is not controlled.

Other form(s) of this medicine 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 losartan (one tablet Kaliumlosartan Alet 50 mg) once a day. The dose may later be increased to 100 mg losartan (two tablets Kaliumlosartan Alet 50 mg) once daily depending on your blood pressure response.

Losartan may be administered with other blood pressure lowering medicines (e.g.diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as

well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).

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Adult patients with Heart Failure

Treatment usually starts with 12.5 mg losartan (one tablet Kaliumlosartan Alet 12.5 mg) once a day.

Generally, the dose should be increased weekly step-by-step (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 as determined by your physician. A maximum dose of 150 mg losartan (three tablets of Kaliumlosartan Alet 50 mg) once daily may be used.

In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and/or a beta-blocker.

Dosage in special patient groups

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years. The use of losartan is not recommended in patients with severe hepatic impairment (see section "Do not take Kaliumlosartan Alet").

Administration

The tablets should be swallowed with a glass of water. You should try to take your daily dose at about the same time each day. It is important that you continue to take Kaliumlosartan Alet until your doctor tells you otherwise.

If you take more Kaliumlosartan Alet than you should

If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.

If you forget to take Kaliumlosartan Alet

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten tablet

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Kaliumlosartan Alet can cause side effects, although not everybody gets them.

If you experience the following, stop taking losartan tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).

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This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than 1 out of 1,000 patients. You may need urgent medical attention or hospitalisation.

The side effects of medicines are classified as follows:

Very common:affects more than 1 user in 10

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000

Rare: affects 1 to 10 users in 10,000

Very rare: affects less than 1 user in 10,000

Not known: frequency cannot be estimated from the available data

The following side effects have been reported with losartan:

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

• dizziness,
• low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics),
• dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,
• debility,
• fatigue,
• too less sugar in the blood (hypoglycaemia),
• too much potassium in the blood (hyperkalaemia),
• changes in kidney function including kidney failure,
• reduced number of red blood cells (anaemia),
• increase in blood urea, serum creatinine and serum potassium in patients with heart failure.

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

• somnolence,
• headache,
• sleep disorders,
• feeling of increased heart rate (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnoea),
• abdominal pain,
• obstipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localised swelling (oedema),
• cough.

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

• hypersensitivity
• angiooedema
• inflammation of blood vessels (vasculitis including Henoch-Schönlein purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• brain attack (stroke),
• inflammation of the liver (hepatitis),
• elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.

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

• reduced number of thrombocytes,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to the sun (photosensitivity),
• unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low levels of sodium in the blood (hyponatraemia),
• depression,
• generally feeling unwell (malaise),
• ringing, buzzing, roaring, or clicking in the ears (tinnitus)
• disturbed taste (dysgeusia).

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine

Keep this medicine out of the reach and sight of children.

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Do not use Kaliumlosartan Alet after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Kaliumlosartan Alet contains

• The active susbtance is losartan potassium.

Each Kaliumlosartan Alet 12.5 mg Tablet contains 12.5 mg of losartan potassium equivalent to 11.44 mg of losartan.

Each Kaliumlosartan Alet 50 mg Tablet contains 50 mg of losartan potassium equivalent to 45.8 mg of losartan.

Each Kaliumlosartan Alet 100 mg Tablet contains 100 mg of losartan potassium equivalent to 91.6 mg of losartan.

• The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinised maize starch [botanical origin (maize)], sodium starch glycolate Type A, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose 6cP (E464), titanium dioxide (E171).

What Kaliumlosartan Alet looks like and contents of the pack

Kaliumlosartan Alet 12.5 mg film-coated tablets are white, round, biconvex film-coated tablets with a diameter of 5.1 mm approximately.

Kaliumlosartan Alet 50 mg film-coated tablets are white, round, biconvex film-coated tablets with a diameter of 7.6 mm approximately, bearing a breakline on one side. The tablet can be divided into equal halves.

Kaliumlosartan Alet 100 mg film-coated tablets are white, round, biconvex film-coated tablets with a diameter of 9.1 mm approximately, bearing a breakline on one side. The tablet can be divided into equal halves.

The tablets are provided in PVC/PE/PVDC/Aluminium blisters.

Pack sizes:

NL/H/1563/01/MR: 21 film-coated tablets

NL/H/1563/02-03/MR: 28 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorisation holder

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Alet Pharmaceuticals S.A.

Aidiniou 26, 124 61, Chaidari

Athene, Griekenland

In het register ingeschreven onder:

Kaliumlosartan Alet 12,5 mg, filmomhulde tabletten: RVG 102830

Kaliumlosartan Alet 50 mg, filmomhulde tabletten: RVG 102840

Kaliumlosartan Alet 100 mg, filmomhulde tabletten: RVG 102846

Manufacturer

Specifar S.A.

1, 28 Octovriou str. 123 51 Ag. Varvara Athens, Greece

This medicinal product is authorised in the Member States of the EEA under the following names:

Netherlands	Kaliumlosartan Alet
Italy	Losartan Pensa

Deze bijsluiter is voor het laatst goedgekeurd in augustus 2013.

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