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COZAAR 50MG FILM COATED TABLETS

Active substance(s): LOSARTAN POTASSIUM

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S1627 LEAFLET Cozaar 20150928

PACKAGE LEAFLET: INFORMATION FOR THE USER
COZAAR 50mg TABLETS
(losartan potassium)



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:

Your medicine is known as Cozaar 50mg Tablets but will be
referred to as Cozaar throughout the following leaflet.
Please note that information regarding other strengths 12.5mg,
25mg and 100mg of Cozaar Tablets may also be present in the
below leaflet.
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.

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

What is in this leaflet
1. What Cozaar is and what it is used for

Tell your doctor or pharmacist if you are taking, have recently taken,
or might take any other medicines.

2. What you need to know before you take Cozaar

Take particular care if you are taking the following medicines while
under treatment with Cozaar:

3. How to take 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.

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:

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 breastfeeding. Cozaar 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.
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



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,



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.

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’),

3. HOW TO TAKE COZAAR



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),

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

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

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.



hypersensitivity,



angiooedema,



Other form(s) of this medicine may be more suitable for children;
ask your doctor or pharmacist.

inflammation of blood vessels (vasculitis including
Henoch‑Schönlein purpura),



numbness or tingling sensation (paraesthesia),

Adult patients with high blood pressure and Type 2 diabetes



fainting (syncope),

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.



very rapid and irregular heartbeat (atrial fibrillation),



brain attack (stroke),



inflammation of the liver (hepatitis),

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).



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

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.

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 Website:
www.mhra.gov.uk/yellowcard
Malta: ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3, Rue D’Argens,
GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt,

If you forget to take Cozaar

e-mail: postlicensing.medicinesauthority@gov.mt

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.

5. HOW TO STORE COZAAR

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.



Keep out of the sight and reach of children.



Store in the original package. Protect from light. Protect from
moisture.



Do not use after the expiry date which is stated on the carton
and blister strip. The expiry date refers to the last day of that
month.



Do not open the blister pack until you are ready to take the
drug.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

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),

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cozaar contains


Each film-coated tablet contains 50mg of losartan potassium as
the active ingredient.



The other ingredients are microcrystalline cellulose (E460),
lactose monohydrate, maize starch pregelatinized, magnesium
stearate (E572), hydroxypropyl cellulose (E436), hypromellose
(E464), carnauba wax (E903) and titanium oxide (E171).



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),

What Cozaar looks like and contents of the pack



too much potassium in the blood (hyperkalaemia),



changes in kidney function including kidney failure,



reduced number of red blood cells (anaemia),

Cozaar Tablets are white, oval film-coated tablets marked 952 on
one side and scored on the other. The tablet can be divided into
equal halves.



increase in blood urea, serum creatinine and serum potassium
in patients with heart failure.

Cozaar Tablets are available in calendar blister packs of 28 tablets.
Product Licence holder

Uncommon (may affect up to 1 in 100 people):

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



somnolence,



headache,



sleep disorders,

Manufacturer



feeling of increased heart rate (palpitations),



severe chest pain (angina pectoris),

This product is manufactured by Merck Sharp & Dohme B. V.
Waarderweg 39, BN Haarlem 2031, The Netherlands



shortness of breath (dyspnoea),



abdominal pain,



obstipation,



diarrhoea,

Leaflet revision date: 28 September 2015



nausea,



vomiting,

Cozaar is a registered trade mark of EI du Pont de Nemours &
Company, Wilmington, Delaware, USA.



hives (urticaria),



itching (pruritus),



rash,



localised swelling (oedema),



cough.

POM

PL 19488/1627

S1627 LEAFLET Cozaar 20150928

S1627 LEAFLET Losartan 20150928

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN POTASSIUM 50mg TABLETS
(losartan potassium)



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:

Your medicine is known as Losartan Potassium 50mg Tablets but
will be referred to as Losartan Potassium Tablet throughout the
following leaflet.
Please note that information regarding other strengths 12.5mg,
25mg and 100mg of Losartan Potassium Tablets may also be
present in the below leaflet.
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.

What is in this leaflet
1. What Losartan Potassium Tablet is and what it is used for
2. What you need to know before you take Losartan Potassium
Tablet
3. How to take Losartan Potassium Tablet
4. Possible side effects

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 Tablet".
Children and adolescents
Losartan Potassium Tablet has been studied in children. For more
information, talk to your doctor.
Losartan Potassium Tablet is not recommended for use in children
suffering from kidney or liver problems, as limited data are available
in these patient groups. Losartan Potassium Tablet 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 Tablet
Tell your doctor or pharmacist if you are taking, have recently taken,
or might take any other medicines.

5. How to store Losartan Potassium Tablet

Take particular care if you are taking the following medicines while
under treatment with Losartan Potassium Tablet:

6. Contents of the pack and other information



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.

1. WHAT LOSARTAN POTASSIUM TABLET IS AND WHAT IT
IS USED FOR
Losartan (Losartan Potassium Tablet) 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 Tablet 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 Tablet has been shown to
decrease the risk of stroke (“LIFE indication”).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LOSARTAN POTASSIUM TABLET
Do not take Losartan Potassium Tablet:


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 Tablet 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 Tablet.
You must tell your doctor if you think you are (or might become)
pregnant. Losartan Potassium Tablet 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
Tablet:


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 Tablet" 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,

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 Tablet" 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 Tablet with food and drink
Losartan Potassium Tablet 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 Tablet 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 Tablet. Losartan
Potassium Tablet 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 breastfeeding. Losartan Potassium Tablet 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 Tablet 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 Tablet contains lactose
Losartan Potassium Tablet 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 TABLET
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 Tablet, depending on your condition and whether you
are taking other medicines. It is important to continue taking
Losartan Potassium Tablet 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 Tablet 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 Tablet 50 mg or one
tablet of Losartan Potassium Tablet 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.



nausea,



vomiting,

Use in children and adolescents



hives (urticaria),



itching (pruritus),



rash,



localised swelling (oedema),

Children aged 6 - 18 years old



cough.

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 Tablet). The doctor
may increase the dose if blood pressure is not controlled.

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

Children below 6 years of age
Losartan Potassium Tablet is not recommended for use in children
under 6 years old, as it has not been shown to work in this age
group.



hypersensitivity,



angiooedema,

Other form(s) of this medicine may be more suitable for children;
ask your doctor or pharmacist.



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

Adult patients with high blood pressure and Type 2 diabetes



numbness or tingling sensation (paraesthesia),

Treatment usually starts with 50 mg losartan (one tablet Losartan
Potassium Tablet 50 mg) once a day. The dose may later be
increased to 100 mg losartan (two tablets Losartan Potassium
Tablet 50 mg or one tablet of Losartan Potassium Tablet 100 mg)
once daily depending on your blood pressure response.



fainting (syncope),



very rapid and irregular heartbeat (atrial fibrillation),



brain attack (stroke),



inflammation of the liver (hepatitis),

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).



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,

Adult patients with Heart Failure



liver function abnormalities,

Treatment usually starts with 12.5 mg losartan (one tablet Losartan
Potassium Tablet 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 Tablet 50 mg or one tablet
each of Losartan Potassium Tablet 100 mg and Losartan
Potassium Tablet 50 mg) once daily may be used.



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),

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.



low levels of sodium in the blood (hyponatraemia),



depression,



generally feeling unwell (malaise),

Dosage in special patient groups



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

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 Tablet”).



disturbed taste (dysgeusia).

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 Tablet until
your doctor tells you otherwise.
If you take more Losartan Potassium Tablet 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 Tablet
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.

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 Website:
www.mhra.gov.uk/yellowcard
Malta: ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3, Rue D’Argens,
GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt,
e-mail: postlicensing.medicinesauthority@gov.mt
5. HOW TO STORE LOSARTAN POTASSIUM TABLET


Keep out of the sight and reach of children.



Store in the original package. Protect from light. Protect from
moisture.


Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Do not use after the expiry date which is stated on the carton
and blister strip. The expiry date refers to the last day of that
month.



If you experience the following, stop taking losartan tablets and tell
your doctor immediately or go to the casualty department of your
nearest hospital:

Do not open the blister pack until you are ready to take the
drug.



A severe allergic reaction (rash, itching, swelling of the face, lips,
mouth or throat that may cause difficulty in swallowing or
breathing).

If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

4. POSSIBLE SIDE EFFECTS

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 Tablet:

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Common (may affect up to 1 in 10 people):



Each film-coated tablet contains 50mg of losartan potassium as
the active ingredient.



The other ingredients are microcrystalline cellulose (E460),
lactose monohydrate, maize starch pregelatinized, magnesium
stearate (E572), hydroxypropyl cellulose (E436), hypromellose
(E464), carnauba wax (E903) and titanium oxide (E171).

What Losartan Potassium Tablet contains



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),

Losartan Potassium Tablet Tablets are available in calendar blister
packs of 28 tablets.



increase in blood urea, serum creatinine and serum potassium
in patients with heart failure.

Product Licence holder

Uncommon (may affect up to 1 in 100 people):

What Losartan Potassium Tablet looks like and contents of the
pack
Losartan Potassium Tablet Tablets are white, oval film-coated
tablets marked 952 on one side and scored on the other. The tablet
can be divided into equal halves.

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.



somnolence,



headache,



sleep disorders,



feeling of increased heart rate (palpitations),



severe chest pain (angina pectoris),



shortness of breath (dyspnoea),



abdominal pain,

POM



obstipation,

Leaflet revision date: 28 September 2015



diarrhoea,

Manufacturer
This product is manufactured by Merck Sharp & Dohme B. V.
Waarderweg 39, BN Haarlem 2031, The Netherlands
PL 19488/1627
S1627 LEAFLET Losartan 20150928

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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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