LOSARTAN POTASSIUM 50 MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Losartan potassium 12.5 mg
film-coated tablets

Losartan potassium 25 mg
film-coated tablets

Losartan potassium 50 mg
film-coated tablets

Losartan potassium 100 mg
film-coated tablets
Losartan potassium

Read all this information carefully before you start taking this
medicine.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious or if you note any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Losartan potassium is and what it is used for
2. Before you take Losartan potassium
3. How to take Losartan potassium
4. Possible side effects
5. How to store Losartan potassium
6. Further information

1. 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

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
Losartan potassium is used
potassium” and 3 ‘Dosage in special patient groups’),
• to treat patients with high blood pressure (hypertension) in adults and in
• if you suffer from heart failure with or without renal impairment or concomitant
children and adolescents 6-18 years of age.
severe life threatening cardiac arrhythmias. Special caution is necessary when
• 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 you are treated with a ß-blocker concomitantly,
• if you have problems with your heart valves or heart muscle,
in which urine contains an abnormal amount of protein).
• if you suffer from coronary heart disease (caused by a reduced blood flow in the
• to treat patients with chronic heart failure when therapy with specific
blood vessels of the heart) or from cerebrovascular disease (caused by a reduced
medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors,
blood circulation in the brain),
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 • if you suffer from primary hyperaldosteronism (a syndrome associated with
increased secretion of the hormone aldosterone by the adrenal gland, caused by
not be switched to losartan.
an abnormality within the gland).
• in patients with high blood pressure and a thickening of the left ventricle,
Taking other medicines
losartan has been shown to decrease the risk of stroke (“LIFE indication”).
Please tell your doctor or pharmacist if you are taking or have recently taken any
2. BEFORE YOU TAKE LOSARTAN POTASSIUM
other medicines, including medicines obtained without a prescription or herbal
medicines and natural products.
Do not take Losartan potassium
• if you are allergic (hypersensitive) to losartan or to any of its other ingredients; Take particular care if you are taking the following medicines while under
treatment with Losartan potassium:
• if your liver function is severely impaired;
• other blood pressure lowering medicines as they may additionally reduce your
• if you are more than 3 months pregnant. (It is also better to avoid Losartan
blood pressure. Blood pressure may also be lowered by one of the following
potassium in early pregnancy – see pregnancy section.).
drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofen,
Take special care with Losartan potassium
amifostine,
You must tell your doctor if you think that you are (or might become) pregnant.
• medicines which retain potassium or may increase potassium levels (e.g.
Losartan potassium is not recommended in early pregnancy, and must not be
potassium supplements, potassium-containing salt substitutes or potassiumtaken if you are more than 3 months pregnant, as it may cause serious harm to
sparing medicines such as certain diuretics [amiloride, triamterene,
your baby if used at that stage (see pregnancy section).
spironolactone] or heparin),
• non-steroidal anti-inflammatory drugs such as indomethacin, including
It is important to tell your doctor before taking Losartan potassium:
• if you have had a history of angiooedema (swelling of the face, lips, throat, and/ 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.
or tongue) (see also section 4 ‘Possible side effects’),
• if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of If your kidney function is impaired, the concomitant use of these medicines may
lead to a worsening of the kidney function.
fluid and/or salt in your body,
• if you receive diuretics (medicines that increase the amount of water that you
Lithium containing medicines should not be taken in combination with losartan
pass out through your kidneys) or are under dietary salt restriction leading to an without close supervision by your doctor. Special precautionary measures (e.g.
extreme loss of fluid and salt in your body (see section 3 ‘Dosage in special
blood tests) may be appropriate.
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.

Taking Losartan potassium with food and drink
Losartan potassium may be taken with or without food.

3. How to take Losartan potassium

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.

Always take Losartan potassium exactly as your doctor has instructed you. 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.

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 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. Losartan potassium 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.

Losartan potassium containing medicinal products are available in the following
strengths: 12.5 mg, 25 mg, 50 mg and 100 mg.

Adult 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
Breastfeeding
increased to 100 mg losartan (two tablets Losartan potassium 50 mg) once daily.
Tell your doctor if you are breast-feeding or about to start breast-feeding.
If you have the impression that the effect of losartan is too strong or too weak,
Losartan potassium is not recommended for mothers who are breast-feeding,
and your doctor may choose another treatment for you if you wish to breast-feed, please talk to your doctor or pharmacist.
especially if your baby is newborn, or was born prematurely.
Use in children and adolescents (6 to 18 years old)
The recommended starting dose in patients who weigh between 20 and 50 kg is
Use in children and adolescents
Losartan has been studied in children. For more information, talk to your doctor. 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg of
Losartan potassium). The doctor may increase the dose if blood pressure is not
Driving and using machines
controlled.
No studies on the effects on the ability to drive and use machines have been
Adult patients with high blood pressure and type 2 diabetes
performed.
Treatment usually starts with 50 mg losartan (one tablet Losartan potassium
Losartan potassium is unlikely to affect your ability to drive or use machines.
50 mg) once a day. The dose may later be increased to 100 mg losartan (two
However, as with many other medicines used to treat high blood pressure,
tablets Losartan potassium 50 mg) once daily depending on your blood pressure
losartan may cause dizziness or drowsiness in some people. If you experience
response.
dizziness or drowsiness, you should consult your doctor before attempting such
Losartan tablets may be administered with other blood pressure lowering
activities.
medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and
Important information about some of the ingredients of Losartan
centrally acting agents) as well as with insulin and other commonly used
potassium
medicines that decrease the level of glucose in the blood (e.g. sulfonylureas,
This product contains lactose. If you have been told by your doctor that you have glitazones and glucosidase inhibitors).
intolerance to some sugars, contact your doctor before taking this medicinal
Adult patients with heart failure
product.
Treatment usually starts with 12.5 mg losartan (one tablet Losartan potassium
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 (for example, three tablets of
Losartan potassium 50 mg or one tablet each of Losartan potassium 100 mg and
Losartan potassium 50 mg) once daily may be used.

high dose diuretics),
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat
• dose-related orthostatic effects such as lowering of blood pressure appearing
that may cause difficulty in swallowing or breathing).
when rising from a lying or sitting position,
This is a serious but rare side effect, which affects more than 1 out of 10,000
• shortness of breath (dyspnoea),
patients but fewer than 1 out of 1,000 patients. You may need urgent medical
• abdominal pain,
attention or hospitalisation.
• obstipation,
In the treatment of heart failure, losartan is usually combined with a diuretic
The side effects of medicines are classified as follows:
• asthenia,
(medicine that increases the amount of water that you pass out through your
• fatigue,
Very common affects more than 1 user in 10
kidneys) and/or digitalis (medicine that helps to make the heart stronger and
• diarrhoea,
more efficient) and/or a beta-blocker.
Common
affects 1 to 10 users in 100
• nausea,
Dosage in special patient groups
• vomiting,
Uncommon
affects 1 to 10 users in 1,000
The doctor may advise a lower dose, especially when starting treatment in certain
• hives (urticaria),
Rare
affects 1 to 10 users in 10,000
patients such as those treated with diuretics in high doses, in patients with liver
• itching (pruritus),
Very rare
affects less than 1 user in 10,000
impairment, or in patients over the age of 75 years. The use of losartan is not
• rash,
recommended in patients with severe hepatic impairment (see section “Do not
• localised swelling (oedema),
Not known
frequency cannot be estimated from the available data
take Losartan potassium”).
• cough.
The following side effects have been reported with losartan:
Administration
Rare:
The tablets should be swallowed with a glass of water. You should try to take your Common:
• hypersensitivity,
daily dose at about the same time each day. It is important that you continue to • dizziness,
• angiooedema,
• vertigo
take Losartan potassium until your doctor tells you otherwise.
• inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
• low blood pressure,
• numbness or tingling sensation (paraesthesia),
If you take more Losartan potassium than you should
• debility,
• fainting (syncope),
If you accidentally take too many tablets, or a child swallows some, contact your
• fatigue,
• very rapid and irregular heartbeat (atrial fibrillation),
doctor immediately. Symptoms of overdose are low blood pressure, increased
• too little sugar in the blood (hypoglycaemia),
• brain attack (stroke),
heartbeat, possibly decreased heartbeat.
• too much potassium in the blood (hyperkalaemia),
• inflammation of the liver (hepatitis),
If you forget to take Losartan potassium
• changes in kidney function including kidney failure,
• elevated blood alanine aminotransferase (ALT) levels, usually resolved upon
If you accidentally miss a daily dose, just take the next dose as normal. Do not
• reduced number of red blood cells (anaemia),
discontinuation of treatment.
take a double dose to make up for a forgotten tablet.
• increase in blood urea, serum creatinine and serum potassium in patients with
Not known:
heart failure.
If you have any further questions on the use of this product, ask your doctor or
• reduced number of thrombocytes,
pharmacist.
Uncommon:
• migraine,
• somnolence,
• liver function abnormalities,
• headache,
4. POSSIBLE SIDE EFFECTS
• muscle and joint pain,
• sleep disorders,
• flu-like symptoms,
Like all medicines, Losartan potassium can cause side effects, although not
• feeling of increased heart rate (palpitations),
• back pain and urinary tract infection,
everybody gets them.
• severe chest pain (angina pectoris),
• increased sensitivity to the sun (photosensitivity),
If you experience the following, stop taking losartan tablets and tell your doctor • low blood pressure (especially after excessive loss of water from the body within • unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
blood vessels e.g. in patients with severe heart failure or under treatment with • impotence,
immediately or go to the casualty department of your nearest hospital:

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

What Losartan potassium looks like and contents of the pack
Losartan potassium 12.5 mg: Oval, convex, yellow, film-coated tablet.
Losartan potassium 25 mg: Oval, convex, yellow, film-coated, one-side-scored
tablet. The tablet can be divided into equal halves.
Losartan potassium 50 mg: Round, convex, white film-coated, one-side-scored
tablet with bevelled edges. The score line is not intended for breaking the tablet.
Losartan potassium 100 mg: Oval, convex, white film-coated tablet.

Losartan potassium 12.5 mg/25 mg/50 mg/100 mg
PVC/PVDC blister of transparent foil, with aluminium foil used for covering; box.
Pack sizes:
5. How to store Losartan potassium
Losartan potassium 12.5 mg: 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98,
100 film-coated tablets,
Keep out of the reach and sight of children.
Do not use Losartan potassium after the expiry date which is stated on the carton Losartan potassium 25 mg: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100
film-coated tablets,
after EXP. The expiry date refers to the last day of that month.
Losartan potassium 50 mg: 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100
This medicinal product does not require any special storage conditions.
film-coated tablets,
Losartan potassium 100 mg: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100
Medicines should not be disposed of via waste water or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These measures film-coated tablets.
will help to protect the environment.
Losartan potassium 50 mg
Polyethylene (HDPE) tablet container with polypropylene closure. Polyethylene
6. FURTHER INFORMATION

dessicator filled with silica gel.
Pack size:
What Losartan potassium contains
250 film-coated tablets.
• The active substance is losartan potassium. Each film-coated tablet contains
12.5 mg, 25 mg, 50 mg or 100 mg losartan potassium, equivalent to 11.4 mg, Not all the pack sizes may be marketed.
22.9 mg, 45.8 mg and 91.5 mg losartan respectively.
Marketing authorisation holder
• The other ingredients of Losartan potassium 12.5 mg/25 mg are: maize starch, KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
pregelatinised maize starch, microcrystalline cellulose, colloidal anhydrous
Manufacturer
silica, magnesium stearate, cellactose (powdered cellulose and lactose
1. KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
monohydrate) in the tablet core and hypromellose, talc, propylene glycol,
2. TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
titanium dioxide (E171) and quinoline yellow (E104) in the film coating.
• The other ingredients of Losartan potassium 50 mg/100 mg are: maize starch, Distributed by:
pregelatinised maize starch, microcrystalline cellulose, colloidal anhydrous
Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon Thames, Surrey.
silica, magnesium stearate, cellactose (powdered cellulose and lactose
TW9 2QE.
monohydrate) in the tablet core and hypromellose, talc, propylene glycol and
titanium dioxide (E171) in the film coating.
This leaflet was last revised in June 2014.
P0273

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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