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COZAAR 50 MG TABLETS

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• inflammation of the pancreas (pancreatitis),
• low levels of sodium in the blood (hyponatraemia),
• depression,

Manufactured by: Merck Sharp & Dohme Ltd, Shotton Lane,
Cramlington, Northumberland, NE23 3JU, UK.

• generally feeling unwell (malaise),

Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

®

Cozaar 50mg Tablets

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,

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

Package leaflet: Information for user

Side effects in children are similar to those seen in adults.
If you get any of the side effects, talk to your doctor, pharmacist,
or nurse. This includes any possible side effects not listed in this
leaflet.

5. How to store Cozaar
Keep your tablets out of the sight and reach of children.
Do not store your tablets above 30°C. Store in the original
package.
Do not put the tablets into another container, they might get mixed
up.
Do not remove the tablets from the blister pack until you are ready
to take the medicine.
Do not take the tablets past the expiry date, which is clearly
marked on the pack.
REMEMBER: This medicine is for you. Do not share it with anyone
else. It may not suit them. If you stop taking this medicine, return
any unused tablets to your pharmacist.
If your tablets become discoloured or show any signs of
deterioration, you should seek the advice of your pharmacist.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and further information
What Cozaar contains
The active ingredient in Cozaar Tablets is losartan.
Each tablet contains 50mg losartan potassium, equivalent to
losartan 45.8mg.
The other ingredients are: hyprolose, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinised maize starch, titanium dioxide (E171) and carnauba
wax.

What Cozaar looks like and contents of the pack
Cozaar is available as white, oval-shaped, film-coated tablet
marked '952' on one side and a break line on the reverse.
Cozaar is available in blister packs containing 28 tablets.

Cozaar® 50mg Tablets
PLPI No: 18799/0245

POM

Leaflet date: 16.11.2012
Cozaar is a registered trademark of Merck Sharp & Dohme group
of companies.

(losartan potassium)
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist,
or nurse.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any of the side effects, talk to your doctor, pharmacist,
or nurse. This includes any possible side effects not listed in this
leaflet.
The name of your medicine is Cozaar 50mg Tablets but will be
referred to as Cozaar throughout this leaflet. Please note that the
leaflet also contains information about other strengths Cozaar
12.5mg, 25mg and 100mg 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 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.
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).

Children and adolescents
Cozaar has been studied in children. For more information, talk
to your doctor. Cozaar is not recommended for use in children
suffering from kidney or liver problems, or children under 6 years
old, as limited data are available in these patient groups.

Other medicines and 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 indometacin,
including COX-2-inhibitors (medicines that reduce
inflammation, and can be used to help relieve pain) as they
may reduce the blood pressure lowering effect of losartan.
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 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

Dosage in special patient groups

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.

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 ").

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) 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 (6 to 18 years old)
The recommended starting dose in patients who weigh between
20 and 50 kg is 0.7 mg of losartan per kg of body weight
administered once a day (up to 25 mg of 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) once daily depending on your
blood pressure response.
Losartan tablets may be administered with other blood pressure
lowering medicines (e.g. diuretics, calcium channel blockers,
alpha- or beta-blockers, and centrally acting agents) as well as
with insulin and other commonly used medicines that decrease the
level of glucose in the blood (e.g. sulfonylureas, glitazones and
glucosidase inhibitors).
Adult Patients with Heart Failure
Treatment usually starts with 12.5 mg losartan (one tablet 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.

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.

Uncommon (may affect up to 1 in 100 people):
• somnolence,
• headache,
• sleep disorders,
• feeling of increased heart rate (palpitations),
• severe chest pain (angina pectoris),
• low blood pressure (especially after excessive loss of water
from the body within blood vessels e.g. in patients with severe
heart failure or under treatment with high dose diuretics),
• dose-related orthostatic effects such as lowering of blood
pressure appearing when rising from a lying or sitting position,
• shortness of breath (dyspnoea),

If you take more Cozaar than you should

• abdominal pain,

If you accidentally take too many tablets, contact your doctor
immediately. Symptoms of overdose are low blood pressure,
increased heartbeat, possibly decreased heartbeat.

• obstipation,

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.

• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localised swelling (oedema),

4. Possible side effects

• cough.

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

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

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

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

• angiooedema,

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

• numbness or tingling sensation (paraesthesia),

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.

• brain attack (stroke),

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

• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• inflammation of the liver (hepatitis),
• elevated blood alanine aminotransferase (ALT) levels, usually
resolved upon discontinuation of treatment.

• low blood pressure,

Not known (frequency cannot be estimated from the available
data):
• reduced number of thrombocytes,

• debility,

• migraine,

• fatigue,

• liver function abnormalities,

• too little sugar in the blood (hypoglycaemia),

• muscle and joint pain,

• too much potassium in the blood (hyperkalaemia),

• flu-like symptoms,

• changes in kidney function including kidney failure,

• back pain and urinary tract infection,

• reduced number of red blood cells (anaemia),

• increased sensitivity to the sun (photosensitivity),

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

• unexplained muscle pain with dark (tea-coloured) urine
(rhabdomyolysis),

• dizziness,

• impotence,

Not known (frequency cannot be estimated from the available
data):
• reduced number of thrombocytes,

6. Contents of the pack and further information

• migraine,

The active ingredient in Losartan Potassium Tablets is losartan.
Each tablet contains 50mg losartan potassium, equivalent to
losartan 45.8mg.

• 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),

Losartan Potassium 50mg Tablets

What Losartan Potassium contains

The other ingredients are: hyprolose, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinised maize starch, titanium dioxide (E171) and carnauba
wax.

What Losartan Potassium looks like and contents of the
pack
Losartan Potassium is available as white, oval-shaped, film-coated
tablet marked '952' on one side and a break line on the reverse.
Losartan Potassium is available in blister packs containing
28 tablets.

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

Manufactured by: Merck Sharp & Dohme Ltd, Shotton Lane,

Side effects in children are similar to those seen in adults.

Cramlington, Northumberland, NE23 3JU, UK.

If you get any of the side effects, talk to your doctor, pharmacist,
or nurse. This includes any possible side effects not listed in this
leaflet.

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,

5. How to store Losartan Potassium
Keep your tablets out of the sight and reach of children.
Do not store your tablets above 30°C. Store in the original
package.
Do not put the tablets into another container, they might get mixed
up.
Do not remove the tablets from the blister pack until you are ready
to take the medicine.
Do not take the tablets past the expiry date, which is clearly
marked on the pack.
REMEMBER: This medicine is for you. Do not share it with anyone
else. It may not suit them. If you stop taking this medicine, return
any unused tablets to your pharmacist.
If your tablets become discoloured or show any signs of
deterioration, you should seek the advice of your pharmacist.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

Package leaflet: Information for user

Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Losartan Potassium 50mg Tablets
PLPI No: 18799/0246

POM

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist,
or nurse.
• This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any of the side effects, talk to your doctor, pharmacist,
or nurse. This includes any possible side effects not listed in this
leaflet.
The name of your medicine is Losartan Potassium 50mg 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 12.5mg, 25mg and 100mg
Tablets.

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

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

Leaflet date: 16.11.2012

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 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.
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).

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, or children under 6 years old, as limited data are
available in these patient groups.

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.

• reduced number of red blood cells (anaemia),

3. How to take Losartan Potassium

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 ").

• headache,

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.

Other medicines and Losartan Potassium

Losartan Potassium contains lactose

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

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.

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 indometacin,
including COX-2-inhibitors (medicines that reduce
inflammation, and can be used to help relieve pain) as they
may reduce the blood pressure lowering effect of losartan.
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.

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) 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 (6 to 18 years old)
The recommended starting dose in patients who weigh between
20 and 50 kg is 0.7 mg of losartan per kg of body weight
administered once a day (up to 25 mg of Losartan 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) once
daily depending on your blood pressure response.
Losartan tablets may be administered with other blood pressure
lowering medicines (e.g. diuretics, calcium channel blockers,
alpha- or beta-blockers, and centrally acting agents) as well as
with insulin and other commonly used medicines that decrease the
level of glucose in the blood (e.g. sulfonylureas, glitazones and
glucosidase inhibitors).
Adult Patients with heart failure
Treatment usually starts with 12.5 mg losartan (one tablet
Losartan 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.

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.

• increase in blood urea, serum creatinine and serum potassium
in patients with heart failure.
Uncommon (may affect up to 1 in 100 people):
• somnolence,
• sleep disorders,
• feeling of increased heart rate (palpitations),
• severe chest pain (angina pectoris),
• low blood pressure (especially after excessive loss of water
from the body within blood vessels e.g. in patients with severe
heart failure or under treatment with high dose diuretics),
• dose-related orthostatic effects such as lowering of blood
pressure appearing when rising from a lying or sitting position,
• shortness of breath (dyspnoea),
• abdominal pain,
• obstipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),

If you forget to take Losartan Potassium

• itching (pruritus),

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.

• rash,

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,
• debility,
• fatigue,
• too little sugar in the blood (hypoglycaemia),
• too much potassium in the blood (hyperkalaemia),
• changes in kidney function including kidney failure,

• localised swelling (oedema),
• cough.
Rare (may affect up to 1 in 1,000 people):
• hypersensitivity,
• angiooedema,
• inflammation of blood vessels (vasculitis including
Henoch-Schonlein 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.

Expand Transcript

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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