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LOSARTAN POTASSIUM 12.5MG FILM-COATED TABLETS

Active substance(s): LOSARTAN POTASSIUM / LOSARTAN POTASSIUM / LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cozaar® 12.5mg 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 side effects, talk to your doctor, pharmacist, or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
 The name of this medicine is Cozaar 12.5mg film-coated tablets, but
will be referred to as Cozaar throughout the remainder of this leaflet.
 Cozaar is also available in other strengths.
What is in this leaflet
1) What Cozaar is and what it is used for
2) What you need to know before you take Cozaar
3) How to take Cozaar
4) Possible side effects
5) How to store Cozaar
6) Contents of the pack and other information
1) WHAT COZAAR IS AND WHAT IT IS USED FOR
Losartan (Cozaar) 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.
Cozaar 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, Cozaar has been shown to decrease the risk of stroke (“LIFE
indication”).
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE COZAAR
Do not take Cozaar:
 if you are allergic to losartan or to any of the other ingredients of this
medicine (listed in section 6),
 if you are more than 3 months pregnant (It is also better to avoid
Cozaar in early pregnancy - see Pregnancy),
 if your liver function is severely impaired,
 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, pharmacist, or nurse before taking Cozaar.
You must tell your doctor if you think you are (or might become)
pregnant. Cozaar 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 Cozaar:
 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 Cozaar”
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).
 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
Cozaar”.

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, as limited data are available in these patient groups.
Cozaar is not recommended for use in children under 6 years old, as it
has not been shown to work in this age group.
Other medicines and Cozaar
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 Cozaar:
 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 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.
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 Cozaar” and “Warnings and precautions”)
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.
Cozaar with food and drink
Cozaar 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 Cozaar
before you become pregnant or as soon as you know you are pregnant
and will advise you to take another medicine instead of Cozaar. Cozaar
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.
Cozaar is not recommended for mothers who are breast-feeding, and
your doctor may choose another treatment for you if you wish to breastfeed. 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.
Cozaar 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.
Cozaar contains lactose
Cozaar 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 COZAAR
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 Cozaar, depending on your
condition and whether you are taking other medicines. It is important to
continue taking Cozaar 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 Cozaar 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 Cozaar 50 mg or
one tablet of Cozaar 100 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
Children below 6 years of age
Cozaar is not recommended for use in children under 6 years old, as it
has not been shown to work in this age group.
Children aged 6 - 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 Cozaar). 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 Cozaar 50 mg)
once a day. The dose may later be increased to 100 mg losartan (two
tablets Cozaar 50 mg or one tablet of Cozaar 100 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 betablockers, 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 Cozaar
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 Cozaar 50 mg or one
tablet each of Cozaar 100 mg and Cozaar 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 Cozaar”).
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 Cozaar until your doctor tells you otherwise.
If you take more Cozaar 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 Cozaar
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:
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth
or throat that may cause difficulty in swallowing or breathing).

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-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),
 disturbed taste (dysgeusia).
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 (see details below). By reporting side effects
you can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
5) HOW TO STORE COZAAR
Keep out of the sight and reach of children.
Do not use Cozaar after the expiry date which is stated on the carton or
the blister label. The expiry date refers to the last day of that month.
Store Cozaar 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.
If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION

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 Cozaar:
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 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),
 shortness of breath (dyspnoea),
 abdominal pain,
 obstipation,
 diarrhoea,
 nausea,
 vomiting,
 hives (urticaria),
 itching (pruritus),
 rash,
 localised swelling (oedema),
 cough.

What Cozaar contains
The active substance is losartan potassium.
Each film-coated tablet contains 12.5mg of losartan potassium.
The other ingredients are microcrystalline cellulose (E460), lactose
monohydrate, pregelatinized maize starch, magnesium stearate (E572),
hyprolose (E463), hypromellose (E464), carnauba wax (E903), titanium
dioxide (E171) and indigo carmine aluminium lake (E132).
Cozaar 12.5mg contains potassium in the following amount: 1.06mg
(0.027 mEq)
What Cozaar looks like and contents of the pack
Cozaar 12.5mg are blue, oval film-coated tablets marked 11 on one side
and plain on the other. Cozaar is available in blister packs containing 28
tablets.
Manufactured by
Merck Sharp & Dohme Ltd., Shotton Lane, Cramlington,
Northumberland, NE23 3JU, UK.
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem,
Netherlands.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, UK.
Repackaged by MPT Pharma Ltd

POM

PL: 33532/0740
Cozaar® is a registered trademark of Merck Sharp & Dohme Corp.
Leaflet dated 1st December 2016
Leaflet coded XXXXXXXXXXX

To request a copy of this leaflet in Braille, large print or
audio please call 01922 745645 and ask for the
Regulatory Department.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan potassium 12.5mg 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, 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 side effects, talk to your doctor, pharmacist, or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
 The name of this medicine is Losartan potassium 12.5mg film-coated
tablets, but will be referred to as Losartan potassium or Losartan
throughout the remainder of this leaflet.
 Losartan potassium is also available in other strengths.
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
3) How to take Losartan potassium
4) Possible side effects
5) How to store Losartan potassium
6) Contents of the pack and other information
1) WHAT LOSARTAN POTASSIUM IS AND WHAT IT IS USED
FOR

Children and adolescents
Losartan potassium has been studied in children. For more information,
talk to your doctor.
Losartan potassium is not recommended for use in children suffering
from kidney or liver problems, as limited data are available in these
patient groups. Losartan potassium is not recommended for use in
children under 6 years old, as it has not been shown to work in this age
group.
Other medicines and Losartan potassium
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,
 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 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.

Losartan potassium 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.

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” and “Warnings and
precautions”)

Losartan potassium 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 potassium has been shown to decrease the risk of
stroke (“LIFE indication”).

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.

2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN
POTASSIUM
Do not take Losartan potassium:
 if you are allergic to losartan or to any of the other ingredients of this
medicine (listed in section 6),
 if you are more than 3 months pregnant (It is also better to avoid
Losartan potassium in early pregnancy - see Pregnancy),
 if your liver function is severely impaired,
 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, pharmacist, or nurse before taking Losartan
potassium.
You must tell your doctor if you think you are (or might become)
pregnant. Losartan potassium 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 potassium:
 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
potassium” 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).
 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”.

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

Losartan potassium with food and drink
Losartan potassium 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
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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Losartan potassium is not recommended for mothers who are breastfeeding, 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 potassium 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 potassium contains lactose
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.
3) HOW TO TAKE LOSARTAN POTASSIUM
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 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.
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 increased to 100 mg losartan (two tablets
Losartan potassium 50 mg or one tablet of Losartan potassium 100 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
Children below 6 years of age
Losartan potassium is not recommended for use in children under 6
years old, as it has not been shown to work in this age group.

Children aged 6 - 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 potassium). 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
potassium 50 mg) once a day. The dose may later be increased to 100
mg losartan (two tablets Losartan potassium 50 mg or one tablet of
Losartan potassium 100 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 betablockers, 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
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.
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 potassium”).

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-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),
 disturbed taste (dysgeusia).
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 (see details below). By reporting side effects
you can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
5) HOW TO STORE LOSARTAN POTASSIUM

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 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 potassium
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:
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:
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 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),
 shortness of breath (dyspnoea),
 abdominal pain,
 obstipation,
 diarrhoea,
 nausea,
 vomiting,
 hives (urticaria),
 itching (pruritus),
 rash,
 localised swelling (oedema),
 cough.

Keep out of the sight and reach of children.
Do not use Losartan potassium after the expiry date which is stated on
the carton or the blister label. The expiry date refers to the last day of that
month.
Store Losartan potassium 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.
If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Losartan potassium contains
The active substance is losartan potassium.
Each film-coated tablet contains 12.5mg of losartan potassium.
The other ingredients are microcrystalline cellulose (E460), lactose
monohydrate, pregelatinized maize starch, magnesium stearate (E572),
hyprolose (E463), hypromellose (E464), carnauba wax (E903), titanium
dioxide (E171) and indigo carmine aluminium lake (E132).
Losartan potassium 12.5mg contains potassium in the following amount:
1.06mg (0.027 mEq)
What Losartan potassium looks like and contents of the pack
Losartan potassium 12.5mg are blue, oval film-coated tablets marked 11
on one side and plain on the other. Losartan potassium is available in
blister packs containing 28 tablets.
Manufactured by
Merck Sharp & Dohme Ltd., Shotton Lane, Cramlington,
Northumberland, NE23 3JU, UK.
Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem,
Netherlands.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, UK.
Repackaged by MPT Pharma Ltd

POM

PL: 33532/0740
Leaflet dated 1st December 2016
Leaflet coded XXXXXXXXXXX

To request a copy of this leaflet in Braille, large print or
audio please call 01922 745645 and ask for the
Regulatory Department.

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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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