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COZAAR 12.5MG FILM-COATED TABLETS

Active substance(s): 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 your medicine is Cozaar 12.5mg filmcoated tablets but will be referred to as Cozaar
throughout this leaflet. Please note that the leaflet also
contains information about other strengths Cozaar
25mg, 50mg and 100mg film-coated tablets.

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

What Cozaar is and what it is used for
What you need to know before you take Cozaar
How to take Cozaar
Possible side effects
How to store Cozaar
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
3. 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
β-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:
o an ACE-inhibitor (for example enalapril,
lisinopril, ramipril), in particular if you have
diabetes-related kidney problems.
o 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 potassiumsparing 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
3.
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 50mg losartan (one tablet
Cozaar 50mg) 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 100mg losartan (two tablets
Cozaar 50mg or one tablet of Cozaar 100mg) 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 50kg is 0.7mg of losartan per kg of
body weight administered once a day (up to 25mg 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 50mg losartan (one tablet
Cozaar 50mg) once a day. The dose may later be
increased to 100mg losartan (two tablets Cozaar 50mg
or one tablet of Cozaar 100mg ) 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 12.5mg losartan (one
tablet Cozaar 12.5mg) once a day. Generally, the dose
should be increased weekly step-by-step (i.e., 12.5mg
daily during the first week, 25mg daily during the
second week, 50mg daily during the third week, 100mg
daily during the fourth week, 150mg daily during the
fifth week) up to the maintenance dose as determined
by your physician. A maximum dose of 150mg losartan
(for example, three tablets of Cozaar 50mg or one
tablet each of Cozaar 100mg and Cozaar 50mg) 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 betablocker.

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 whole 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
5. 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
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.

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 or
pharmacist. 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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Cozaar
Keep
6. out of the sight and reach of children.
Store in the original package in order to protect from
light and moisture.
Do not remove the tablets from the blister pack until
you are ready to take them.
Do not take the tablets after the expiry date which is
stated on the carton and blister labels after 'Exp'. The
expiry date refers to the last day of that month.
If the tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. This measure will help
to protect the environment.

6. Contents of the pack and other information
What Cozaar contains
The active ingredient in Cozaar is losartan potassium.
Each tablet contains 12.5mg losartan potassium.
The other ingredients are microcrystalline cellulose
(E460), lactose monohydrate, pregelatinized maize
starch, magnesium stearate (E572), hydroxypropyl
cellulose (E463), hypromellose (E464).
Cozaar 12.5mg contains potassium in the following
amount: 1.06mg (0.027 mEq).
Also contains carnauba wax (E903),titanium dioxide
(E171) and indigo carmine aluminium lake (E132).

What Cozaar looks like and contents of the pack
Cozaar is blue, oval film-coated tablets marked 11 on
one side and plain on the other.
Cozaar is available in blister of PVC/PE/PVDC with
aluminium foil in packs of 28 tablets.

Manufactured by: Merck Sharp & Dohme B.V.,
Waarderweg 39, 2031 BN Haarlem, The Netherlands.
OR
Merck Sharp & Dohme Ltd., Shotton Lane,
Cramlington, Northumberland NE23 3JU, UK.

Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU,
UK.

Cozaar® 12.5mg film-coated tablets;
PL 18799/3021

POM

Leaflet date: 26.02.2018
Cozaar is a registered trademark of Merck Sharp &
Dohme group of companies.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

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 your medicine is Losartan potassium
12.5mg film-coated tablets but will be referred to as
Losartan potassium throughout this leaflet. Please note
that the leaflet also contains information about other
strengths Losartan potassium 25mg, 50mg and 100mg
film-coated tablets.

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
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.
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’).

2. What you need to know before you take
Losartan potassium
Do
3. 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
β-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:
o an ACE-inhibitor (for example enalapril,
lisinopril, ramipril), in particular if you have
diabetes-related kidney problems.
o 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'.

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 potassiumsparing 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 Losartan
potassium’ 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.

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 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 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
3.
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 50mg losartan (one tablet
Losartan potassium 50mg) 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 100mg losartan (two

tablets Losartan potassium 50mg or one tablet of
Losartan potassium 100mg) 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 50kg is 0.7mg of losartan per kg of
body weight administered once a day (up to 25mg 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 50mg losartan (one tablet
Losartan potassium 50mg) once a day. The dose may
later be increased to 100mg losartan (two tablets
Losartan potassium 50mg or one tablet of Losartan
potassium 100mg ) 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 12.5mg losartan (one
tablet Losartan potassium 12.5mg) once a day.
Generally, the dose should be increased weekly stepby-step (i.e., 12.5mg daily during the first week, 25mg
daily during the second week, 50mg daily during the
third week, 100mg daily during the fourth week, 150mg
daily during the fifth week) up to the maintenance dose
as determined by your physician. A maximum dose of
150mg losartan (for example, three tablets of Losartan
potassium 50mg or one tablet each of Losartan
potassium 100mg and Losartan potassium 50mg) 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 betablocker.

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’).

Administration
The tablets should be swallowed whole 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
5. 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.
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 or
pharmacist. 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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Losartan potassium
Keep
6. out of the sight and reach of children.
Store in the original package in order to protect from
light and moisture. Do not remove the tablets from the
blister pack until you are ready to take them.
Do not take the tablets after the expiry date which is
stated on the carton and blister labels after 'Exp'. The
expiry date refers to the last day of that month.
If the tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. This measure will help
to protect the environment.

6. Contents of the pack and other information
What Losartan potassium contains
The active ingredient in Losartan potassium is losartan
potassium. Each tablet contains 12.5mg losartan
potassium. The other ingredients are microcrystalline
cellulose (E460), lactose monohydrate, pregelatinized
maize starch, magnesium stearate (E572),
hydroxypropyl cellulose (E463), hypromellose (E464).
Losartan potassium 12.5mg contains potassium in the
following amount: 1.06mg (0.027 mEq). Also contains
carnauba wax (E903),titanium dioxide (E171) and
indigo carmine aluminium lake (E132).

What Losartan potassium looks like and
contents of the pack
Losartan potassium is blue, oval film-coated tablet
marked '11' on one side and plain on the other.
The tablets are available in blister of PVC/PE/PVDC
with aluminium foil in packs of 28 tablets.
Manufactured by: Merck Sharp & Dohme B.V.,
Waarderweg 39, 2031 BN Haarlem, The Netherlands.
OR
Merck Sharp & Dohme Ltd., Shotton Lane,
Cramlington, Northumberland NE23 3JU, UK.

Procured from within the EU and repackaged by
the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU,
UK.

Losartan potassium 12.5mg film-coated tablets;
PL 18799/3021
Leaflet date: 26.02.2018

POM

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