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LOSARTAN 50 MG FILM-COATED TABLETS

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Package leaflet: Information for the user
Losartan® 12.5 mg film-coated tablets
Losartan® 25 mg film-coated tablets
Losartan® 50 mg film-coated tablets
Losartan® 100 mg film-coated tablets
Losartan potassium
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, pharmacist or nurse.
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 of the side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Losartan is and what it is used for
What you need to know before you take Losartan
How to take Losartan
Possible side effects
How to store Losartan
Contents of the pack and other information

1.

What COZAAR 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 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”).

2.

What you need to know before you take LOSARTAN

Do not take Losartan


if you are allergic to losartan or to any of the other ingredients of this medicine (listed in
section 6),
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if you are more than 3 months pregnant. (It is also better to avoid Losartan in early pregnancysee "Pregnancy".),
if your liver function is severely impaired.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking COZAAR.
You must tell your doctor if you think you are (or might become) pregnant. Losartan 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 Losartan:










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
COZAAR has been studied in children. For more information, talk to your doctor. COZAAR 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 LOSARTAN
Tell your doctor or pharmacist if you are taking or have recently taken, or might take any other
medicines.
Take particular care if you are taking the following medicines while under treatment with Losartan:




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, 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.

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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 with food and drink
Losartan 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 Losartan before you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine instead of Losartan. Losartan 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. Losartan 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 this 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.
Losartan contains lactose
Losartan 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.

3.

How to take LOSARTAN

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 Losartan,
depending on your condition and whether you are taking other medicines. It is important to continue
taking Losartan 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 Losartan 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 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.

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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 Losartan). 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 Losartan 50 mg) once a day. The dose may
later be increased to 100 mg losartan (two tablets Losartan 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 losartan 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 50 mg
or one tablet each of losartan 100 mg and losartan 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 Losartan").
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 until your doctor tells you
otherwise.
If you take more Losartan 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 Losartan
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 medicine, ask your
doctor, pharmacist or nurse.

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:
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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:
The following side effects have been reported with Losartan:
Common (may affect up to 1 in 10 people):

dizziness,

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 (may affect up to 1 in 100 people):

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),

abdominal pain,

obstipation,

diarrhoea,

nausea,

vomiting,

hives (urticaria),

itching (pruritus),

rash,

localised swelling (oedema),

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

hypersensitivity

angiooedema

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

numbness or tingling sensation (paraesthesia),

fainting (syncope),

very rapid and irregular heartbeat (atrial fibrillation)

brain attack (stroke),

inflammation of the liver (hepatitis),
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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-coloured) 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 of the side effects, talk toy your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.

5.

How to store LOSARTAN

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 or the bottle label. The
expiry date refers to the last day of that month.
Blisters
Store Losartan in the original package in order to protect from light and moisture. Do not open the
blister pack until you are ready to take the medicine.
Bottles
Store Losartan in the original container in order to protect from light. Do not store above 25OC. Keep
the bottle tightly closed in order to protect from moisture.
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 contains
The active substance is losartan potassium.
Each Losartan 12.5 mg tablet contains 12.5 mg of losartan potassium.
Each Losartan 25 mg tablet contains 25 mg of losartan potassium. Each Losartan 50 mg tablet contains
50 mg of losartan potassium.
Each Losartan 100 mg tablet contains 100 mg of losartan potassium.
The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize
starch, magnesium stearate (E572), hyprolose (E463), hypromellose (E464).
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Losartan 12.5 mg, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg
(0.027 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq) respectively.
The Losartan 12.5 mg tablets also contain
carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.
The Losartan 25 mg tablets also contain Carnauba wax (E903), Titanium dioxide (E171).
The Losartan 50 mg tablets also contain Carnauba wax (E903), Titanium dioxide (E171).
The Losartan 100 mg tablets also contain Carnauba wax (E903), Titanium dioxide (E171).
What Losartan looks like and contents of the pack
Losartan 12.5 mg is supplied as unscored film-coated tablets containing 12.5 mg of losartan
potassium.
Losartan 25 mg is supplied as unscored film-coated tablets containing 25 mg of losartan potassium.
Losartan 50mg is supplied as scored film-coated tablets containing 50 mg of losartan potassium. The
tablets can be divided into equal halves.
Losartan 100 mg is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.
Losartan is supplied in the following pack sizes:





Losartan 12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7,
14, 21, 28, 50, 98, 210 or 500 tablets. HDPE bottles of 100 tablets.
Losartan 25 mg – PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7 or
28 tablets
Losartan 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10,
14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets. HDPE bottles of 100 or 300 tablets.
Losartan 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7,
10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets. HDPE bottles of 100 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon,
Hertfordshire, EN11 9BU, UK
Manufacturer:
12.5 mg: Merck Sharp & Dohme BV/MMD, Waarderweg 39, 2031 BN, Haarlem, Netherlands.
50mg and 100mg: Merck Manufacturing Division, Merck Sharp & Dohme Limited, Shotton
Lane, Cramlington, Northumberland, NE23 3JU, UK.
This medicinal product is authorised in the Member States of the EEA under the following
names:
Member State

Invented name

Austria
Belgium

LOSARTAN MSD
LOSARTAN MSD
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France
Germany
Italy
Luxemburg
Spain
Portugal
Netherlands
UK

LOSARTAN ZENTIVA
ENTRIZEN 12.5mg 50 mg 100 mg
ENTRIZEN 12.5mg 50 mg 100 mg
LOSARTAN MSD
ENTRIZEN 12.5mg 50 mg 100 mg
LOSARTAN FROSST
ENTRIZEN 12.5mg 50 mg 100 mg
LOSARTAN

This leaflet was last approved 04/2012
LOSARTAN PIL.CZR - LOR.12.UK.xxxx_WS 021
LOGO MSD
Merck Sharp & Dohme Limited.
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.

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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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