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TEVA UK Ref: 231-30-87369-ZC LEA LOSARTAN A/S TAB TUK Version: 2    23 November 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

Losartan Potassium 25 mg, 50 mg and 100 mg Film-Coated Tablets

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 further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:

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

2.    What you need to know before you take Losartan Potassium Film-Coated Tablets

3.    How to take Losartan Potassium Film-Coated Tablets

4.    Possible side effects

5.    How to store Losartan Potassium Film-Coated Tablets

6.    Contents of the pack and other information

What Losartan Potassium 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, 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 andType 2 diabetes.

Losartan Potassium is used:

•    to treat patients with high blood pressure (hypertension)

•    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)

•    in patients with high blood pressure and a thickening of the left ventricle. Losartan Potassium has been shown to decrease the risk of stroke (“LIFE indication")

©What you need to know before you take Losartan Potassium Film-Coated Tablets

Do not take Losartan Potassium Film-coated Tablets if:

• you are allergic to losartan or any of the other ingredients of this medicine (listed in section 6),

• your liver function is severly impaired

• you are more than 3 months pregnant. (It is also better to avoid Losartan Potassium Film-Coated Tablets in early pregnancy - see section 2: Pregnancy and breast-feeding).

• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions

• Talk to your doctor or pharmacist before taking Losartan tablets.

• You must tell your doctor if you think you are (or might become) pregnant. LosartanTablet are 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 this stage (see section 2: Pregnancy and breast-feeding).

Take special care with Losartan Potassium Film-Coated Tablets

It is important to tell your doctor before taking Losartan Potassium Film-Coated Tablets:

• if you have had a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see 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 potassium Film-coated Tablets" 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 0- blocker concomitantly

• if you have problems with your heart valves or heart muscle • if you suffer from coronary heart disease (caused by 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)

• if you are taking any of the following medicines used to treat high blood pressure:

- an ACE-inhibitor (for example enalapril,lisinopril, ramipril), in particular if you have diabetes-related kidney problems.

- 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 information under the heading 'Do not take Losartan potassium Film-coated Tablets '.

Children and adolescents

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

Other medicines and Losartan Potassium Film-Coated Tablets

•    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 Losartan Potassium:

•    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

•    your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings 'Do not take Losartan potassium Film-coated Tablets ' and 'Warnings and precautions')

•    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, triamterene, 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 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.

Losartan Potassium Film-Coated Tablets with food and drink

Losartan Potassium can be taken with or without food.

Pregnancy and breast-feeding

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

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Losartan Potassium Film-CoatedTablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan Potassium Film-Coated Tablets. Losartan Potassium Film-Coated Tablets are not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as they may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell you doctor if you are breast-feeding or about to start breast-feeding. Losartan Potassium Film-Coated Tablets are 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.

Driving and using machines

No studies of the effects on the ability to drive and use machines have been performed.

Losartan Potassium is unlikely to directly 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. Losartan Potassium Film-Coated Tablets contain lactose monohydrate:

Losartan Potassium 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.

a How to take Losartan Potassium Film-Coated Tablets

Your doctor will decide on the appropriate dose of Losartan Potassium, depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan Potassium for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Patients with high blood pressure

Treatment usually starts with 50 mg losartan (one tablet Losartan Potassium 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 Losartan Potassium 50 mg) once daily.

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

Patients with high blood pressure and Type 2 diabetes Treatment usually starts with 50 mg losartan (one tablet Losartan Potassium 50 mg) once a day. The dose may later be increased to 100 mg losartan (two tablets Losartan Potassium 50 mg) once daily depending on your blood pressure response.

Losartan tablets 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).

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

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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 2: "Do not take <Losartan potassium Film-coatedTablets>").

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

The recommended starting dose in patients who weigh between 20 and 50 kg is 25 mg of Losartan Potassium Film-Coated Tablets once a day. In patients who weigh more than 50 kg, the usual dose is 50 mg Losartan Potassium Film-Coated Tablets once daily. The doctor may increase the dose if blood pressure is not controlled.Losartan Potassium Film-Coated Tablets are not recommended for use in children under 6 years old.

Losartan Potassium Film-Coated Tablets are also not recommended in children with severe renal or hepatic impairment.

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 Losartan Potassium until your doctor tells you otherwise.

If you take more Losartan Potassium Film-Coated Tablets than you should

If you accidentially take too many tablets, or a child swallows some, contact your doctor immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat.

If you forget to take Losartan Potassium Film-Coated Tablets If you accidentially 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.

If you have any further questions on 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 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 following side effects have been reported with Losartan Potassium 25, 50 and 100 mg Film-Coated Tablets:

Common:

•    dizziness

•    vertigo

•    low blood pressure

•    debility

•    fatigue

•    too little 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:

•    somnolence,

•    headache,

•    sleep disorders,

•    feeling of increased heart rate (palpitations),

•    severe chest pain (angina pectoris),

•    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,

•    shortness of breath (dyspnoea),

•    cough,

•    abdominal pain,

•    obstipation,

•    diarrhoea,

•    nausea(feeling sick),

•    vomiting (being sick),

•    hives (urticaria),

•    itching (pruritus),

•    rash,

•    localised swelling (oedema).

Rare:

•    inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),

•    numbness or tingling sensation (paraesthesia),

•    fainting (syncope),

•    very rapid and irregular heartbeat (artrial fibrillation) brain attack (stroke),

•    inflammation of the liver (hepatitis),

•    elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment.

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

•    reduced number of thrombocytes,

•    migraine,

•    changes in the sense of taste

•    ringing, buzzing, roaring, or clicking in the ears (tinnitus)

•    depression,

•    generally feeling unwell (malaise),

•    liver function abnormalities,

•    muscle and joint pain,

•    unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),

•    increased sensitivity to the sun (photosensitivity),

•    impotence,

•    inflammation of the pancreas (pancreatitis),

•    low levels of sodium in the blood (hyponatraemia),

•    flu-like symptoms,

•    back pain

•    urinary tract infection.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

How to store Losartan Potassium Film-Coated Tablets

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 any 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.

^6 Contents of the pack and other information

What Losartan Potassium contains:

•    Each Film-Coated tablet contains 25 mg, 50 mg or 100 mg of the active substance, losartan Potassium.

•    The other ingredients are as follows:

Tablet core: lactose monohydrate, microcrystalline cellulose (E 460a), pregelatinised starch, magnesium stearate (E 572) Film-coat: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E 171), macrogol, talc.

What Losartan Potassium looks like and contents of the pack:

Losartan Potassium 25 mg Film-Coated Tablets are white, oval, slightly arched film-Coated tablets, debossed "2"' scoreline and "5" on one side, scoreline on the other. Available in pack sizes of: 1, 14, 20, 28, 30, 56, 60, 90, 98 and 100. Hospital packs of 50 (50 x 1). and

HDPE bottles with polypropylene tamper-evident screw cap with desiccant insert: 30, 100 and 250 Film-coated tablets.

Losartan Potassium 50 mg Film-Coated Tablets are white, oval, slightly arched film-Coated tablets, debossed "50" on one side, scoreline on the other. Available in pack sizes of: 1, 14, 20, 28, 30, 56, 60, 90, 98, 100,105 and 120. Hospital packs of 50 (50 x 1) & 280 (10 x 28 tablets). and

HDPE bottles with polypropylene tamper-evident screw cap with desiccant insert: 30, 100 and 250 Film-coated tablets.

Losartan Potassium 100 mg Film-Coated Tablets are white, oval, slightly arched film-Coated tablets, debossed "100" on one side, scoreline "on the other. Available in pack sizes of: 1, 14, 20, 28, 30,

56, 60, 90, 98, 100, 105, and 120. Hospital packs of 50 (50 x 1) & 280

(10 x 28 tablets).

and

HDPE bottles with polypropylene tamper-evident screw cap with desiccant insert: 30, 100 and 250 Film-coated tablets.

The tablets are packed in white opaque PVC/PVdC/Al blisters or in white opaque PVC/PE/PVdC/Al blisters or in OPA/Alu/PVC/Al blisters. and

HDPE bottles with polypropylene tamper-evident screw cap with desiccant insert.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer TEVA UK Limited, Eastbourne, BN22 9AG This leaflet was last revised in November 2015.

PL 00289/0963 PL 00289/0964 PL 00289/0965

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