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COZAAR 100MG TABLETS

Active substance(s): LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE
USER



Cozaar® 100mg tablets

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”).

(losartan potassium)
Your medicine is known as any of the above but
will be referred to as Cozaar throughout this
leaflet. Your medicine is available in other strengths.
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.

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
What is in this leaflet:
pregnancy, and must not be taken if you are more than
1. What Cozaar is and what it is used for
3 months pregnant, as it may cause serious harm to
2. What you need to know before you take Cozaar
your baby if used at that stage (see pregnancy section)
3. How to take Cozaar
It is important to tell your doctor before taking Cozaar:
4. Possible side effects
 if you have had a history of angiooedema (swelling
5. How to store Cozaar
of the face, lips, throat, and/or tongue) (see also
6. Contents of the pack and other information
section 4 ‘Possible side effects’),
 if you suffer from excessive vomiting or diarrhoea
1. What Cozaar is and what it is used for
leading to an extreme loss of fluid and/or salt in your
Losartan (Cozaar) belongs to a group of medicines
body,
known as angiotensin-II receptor antagonists.
 if you receive diuretics (medicines that increase the
Angiotensin-II is a substance produced in the body
amount of water that you pass out through your
which binds to receptors in blood vessels, causing
kidneys) or are under dietary salt restriction leading
them to tighten. This results in an increase in blood
to an extreme loss of fluid and salt in your body (see
pressure. Losartan prevents the binding of
section 3 ‘Dosage in special patient groups’),
angiotensin-II to these receptors, causing the blood
 if you are known to have narrowing or blockage of
vessels to relax which in turn lowers the blood
the blood vessels leading to your kidneys or if you
pressure. Losartan slows the decrease of kidney
have received a kidney transplant recently,
function in patients with high blood pressure and type
 if your liver function is impaired (see sections 2 "Do
2 diabetes.
not take Cozaar" and 3 "Dosage in special patient
groups"),
Cozaar is used
 if you suffer from heart failure with or without renal
 to treat patients with high blood pressure
impairment or concomitant severe life threatening
(hypertension) in adults and in children and
cardiac arrhythmias. Special caution is necessary
adolescents 6-18 years of age.
when you are treated with a ß-blocker
 to protect the kidney in hypertensive type 2 diabetic
concomitantly,
patients with laboratory evidence of impaired renal
 if you have problems with your heart valves or heart
function and proteinuria ≥ 0.5 g per day (a condition
muscle,
in which urine contains an abnormal amount of
 if you suffer from coronary heart disease (caused by
protein).
a reduced blood flow in the blood vessels of the
 to treat patients with chronic heart failure when
heart) or from cerebrovascular disease (caused by
therapy with specific medicines called angiotensina reduced blood circulation in the brain),
converting-enzyme inhibitors (ACE inhibitors,
 if you suffer from primary hyperaldosteronism (a
medicine used to lower high blood pressure) is not
syndrome associated with increased secretion of
considered suitable by your doctor. If your heart
the hormone aldosterone by the adrenal gland,
failure has been stabilised with an ACE inhibitor you
caused by an abnormality within the gland).
should not be switched to losartan.
S0221-28-PL-PIL-07.07.2015



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.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might
become) pregnant. Your doctor will normally advise
you to stop taking Cozaar before you become
pregnant or as soon as you know you are pregnant
and will advise you to take another medicine instead of
Cozaar. Cozaar is not recommended in early
pregnancy, and must not be taken when more than 3
months pregnant, as it may cause serious harm to
your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to
start breast-feeding. Cozaar is not recommended for
mothers who are breast-feeding, and your doctor may
choose another treatment for you if you wish to breastfeed. Especially if your baby is a newborn, or born
prematurely.
Ask your doctor or pharmacist for advice before taking
this medicine.

Driving and using machines
No studies on the effects on the ability to drive and use
machines have been performed.
Cozaar is unlikely to affect your ability to drive or use
machines. However, as with many other medicines
used to treat high blood pressure, losartan may cause
dizziness or drowsiness in some people. If you
experience dizziness or drowsiness, you should
consult your doctor before attempting such activities.

Cozaar contains lactose
Cozaar contains lactose monohydrate. If you have
been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this
medicine.

3. How to take Cozaar

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
Your doctor may need to change your dose and/or
pharmacist if you are not sure. Your doctor will decide
to take other precautions:
on the appropriate dose of Cozaar, depending on your
If you are taking an ACE-inhibitor or aliskiren (see also condition and whether you are taking other medicines.
information under the headings “Do not take Cozaar” It is important to continue taking Cozaar for as long as
and “Warnings and precautions”)
your doctor prescribes it in order to maintain smooth
control of your blood pressure.
If your kidney function is impaired, the concomitant
use of these medicines may lead to a worsening of the Adult patients with High Blood Pressure
kidney function.
Treatment usually starts with 50mg losartan (one
tablet Cozaar 50mg) once a day. The maximal blood
Lithium containing medicines should not be taken in
pressure lowering effect should be reached 3-6 weeks
combination with losartan without close supervision by after beginning treatment. In some patients the dose
your doctor. Special precautionary measures (e.g.
may later be increased to 100mg losartan (two tablets
blood tests) may be appropriate.
Cozaar 50mg or one tablet of Cozaar 100mg) once
daily. If you have the impression that the effect of
Cozaar with food and drink
losartan is too strong or too weak, please talk to your
Cozaar may be taken with or without food.
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 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



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.

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 Rare (may affect up to 1 in 1,000 people):
 hypersensitivity,
on the use of this medicine, ask your doctor,
 angiooedema,
pharmacist, or nurse.
 inflammation of blood vessels (vasculitis including
Henoch- Schönlein purpura),
4. Possible side effects
 numbness or tingling sensation (paraesthesia),
Like all medicines, this medicine can cause side
 fainting (syncope),
effects, although not everybody gets them.
 very rapid and irregular heartbeat (atrial fibrillation),
 brain attack (stroke),
If you experience the following, stop taking losartan
 inflammation of the liver (hepatitis),
tablets and tell your doctor immediately or go to the
 elevated blood alanine aminotransferase (ALT)
casualty department of your nearest hospital:
levels, usually resolved upon discontinuation of
treatment.
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,

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side
effects, you can help provide more information on the
safety of this medicine.

5. How to store Cozaar
Keep out of the sight and reach of children.
Do not use Cozaar after the expiry date which is stated
on the carton. The expiry date refers to the last day of
that month.
Keep them in the original package.
Protect from light and moisture.
Medicines should not be disposed of via wastewater or
household waste.
Ask your pharmacist how to dispose of medicines no
longer required.
These measures will help to protect the environment.

6. Contents of the pack and other
information
What Cozaar contains
The active substance is losartan potassium.
Each Cozaar tablet contains 100mg of losartan
potassium.
Your medicine also contains the following: hyprolose,
hypromellose (E464), lactose monohydrate,
magnesium stearate (E572), microcrystalline cellulose,
pregelatinised maize starch, titanium dioxide (E171)
and carnauba wax (E903).

What Cozaar looks like and contents of the
pack
PVC/PE/PVDC blister packages with aluminium foil
lidding in cartons containing 28 white pear shaped
tablets with 960 on one side and plain on the reverse.
Cozaar tablets are supplied in packs containing 28
tablets.

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

Procured from within the EU and repackaged:
Amimed Direct Ltd, Hendon, London, NW9 6AQ.

Product Licence Holder:
Sam Pharma Ltd, Unit 20, Garrick Industrial Estate,
Irving Way, Hendon, London, NW9 6AQ.
PL Number: 33902/0221

POM

Leaflet revision Date: 07/07/2015
Cozaar® is a registered trademark of E.I. du Pont de
Nemours and Company.
S0221-28-PL-PIL-07.07.2015

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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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