Kaliumlosartan Arrow 50 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”).

Do not take Kaliumlosartan Arrow

Page 1 of 9

• if you are allergic (hypersensitive) to losartan or 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 Arrow in early pregnancy – see pregnancy).

Warnings and precautions

Talk to your doctor or pharmacist before taking <Product name>

You must tell your doctor if you think you are (or might become) pregnant. <Product name> 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 <Product name> :

• 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.

Other medicines and <Product name>

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

Take particular care if you are taking the following medicines while under treatment with <Product name> :

Page 2 of 9

• 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, baclofen, 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 indometacin, including cox-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood 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.

<Product name> with food and drink

<Product name> may be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking <Product name> before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of <Product name> . <Product name> 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.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. <Product name> 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 newborn, or was born prematurely.

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

Driving and using machines

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.

Page 3 of 9

<Product name> contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on the appropriate dose of <Product name> , depending on your condition and whether you are taking other medicines. It is important to continue taking <Product name> 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 <Product name> 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 <Product name> 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 <Product name> ). The doctor may increase the dose if blood pressure is not controlled.

Adult Patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg losartan (one tablet <Product name> 50 mg) once a day. The dose may be increased to 100 mg (two tablets <Product name> 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).

Adult Patients with Heart Failure

Treatment usually starts with 12.5 mg losartan (one tablet <Product name> 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) up to the usual maintenance dose of 50 mg losartan (one tablet <Product name> 50 mg) once daily, according to your condition.

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

Page 4 of 9

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 <Product name> ").

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 <Product name> until your doctor tells you otherwise.

If you take more <Product name> 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 <Product name>

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, this medicine 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).

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:	may affect more than 1 in 10 people
Common.	may affect up to 1 in 10 people
Uncommon:	may affect up to 1 in 100 people
Rare:	may affect up to 1 in 1,000 people
Very rare:	may affect up to 1 in 10,000 people
Not known:	frequency can not be estimated from the available data

The following side effects have been reported with losartan:

Common:

• dizziness,

Page 5 of 9

• 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)
• reduced number of red blood cells (anaemia),
• changes in kidney function (may be reversible upon discontinuation of treatment) including kidney failure,
• increase in blood urea, serum creatinine and serum potassium in patients with heart failure,

Uncommon:

	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.

Rare:

• hypersensitivity
• angiooedema
• inflammation of blood vessels (vasculitis including Henoch-Schonlein 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.

Page 6 of 9

Not known:

• reduced number of thrombocytes,
• migraine,
• distortion of the sense of taste (dysgeusia),
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary track 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).

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

If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. HOW TO STORE

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 that month.

This medicinal product does not require any special storage conditions.

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

What <Product name> contains

• The active susbtance is losartan potassium.

Each <Product name> 12.5 mg Tablet contains 12.5 mg of losartan potassium equivalent to 11.44 mg of losartan.

Each <Product name> 25 mg Tablet contains 25 mg of losartan potassium equivalent to 22.9 mg of losartan.

Each <Product name> 50 mg Tablet contains 50 mg of losartan potassium equivalent to 45.8 mg of losartan.

Each <Product name> 100 mg Tablet contains 100 mg of losartan potassium equivalent to 91.6 mg of losartan.

Page 7 of 9

• 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 <Product name> looks like and contents of the pack

<Product name> 12.5 mg film-coated tablets are white, round, biconvex film-coated tablets with a diameter of 5.1 mm approximately.

<Product name> 25 mg film-coated tablets are white, round, biconvex film-coated tablets with a diameter of 5.1 mm approximately.

<Product name> 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.

<Product name> 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:

7, 10, 14, 20, 21, 28, 30, 56, 60, 90, 98 and 112 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorisation holder

Arrow Generics Limited

Whiddon Valley, Barnstaple,

Devon, EX32 8NS

United Kingdom

Manufacturer

Specifar S.A.

1, 28 Octovriou str. 123 51 Ag. Varvara Athene, Griekenland

Arrow Pharm (Malta) Ltd

HF 62, Hal Far Industrial Estate

Hal Far

Malta

Juta Pharma GmbH

Gutenburgstrasse 13

Page 8 of 9

24941 Flensburg

Duitsland

Medicofarma S.A

Ul. Kozieńcka 97

26-600 Radom

Polen

RVG 103128 Kaliumlosartan Arrow 12,5 mg, filmomhulde tabletten

RVG 103130 Kaliumlosartan Arrow 25 mg, filmomhulde tabletten

RVG 103131 Kaliumlosartan Arrow 50 mg, filmomhulde tabletten

RVG 103132 Kaliumlosartan Arrow 100 mg, filmomhulde tabletten

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

Denmark	Lostankal
Germany	Losar-Q 50, 100mg Filmtabletten
Netherlands	Kaliumlosartan Arrow 12.5, 25, 50, 100 mg
Norway	Lostankal 12.5, 25, 50, 100mg tabletter, filmdrasjerte
Poland	Losartan Arrow
Sweden	Lostankal, 12.5, 25, 50, 100mg filmdragerad tablet
UK	Losartan potassium 25, 50, 100mg Film-coated Tablets

Deze bijsluiter is voor het laatst goedgekeurd in september 2013.

Page 9 of 9