COZAAR 12.5 MG FILM COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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377442A01
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Package leaflet: Information for user

Cozaar® 12.5 mg film‑coated
tablets
Cozaar® 25 mg film‑coated
tablets
Cozaar® 50 mg film‑coated
tablets
Cozaar® 100 mg film‑coated
tablets

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Technical Info

Profile

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.
What is in this leaflet
1. What COZAAR is and what it is used for
2. What you need to know before you take
COZAAR
3. How to take COZAAR
4. Possible side effects
5. How to store COZAAR
6. Contents of the pack and other information

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Profile: BG148x520_260
Profile Revision:
7
Profile Revision Date: 050708
Dimensions (mm):
148 x 520mm

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
COZAAR contains lactose monohydrate. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicine.
3. How to take COZAAR
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor
or pharmacist if you are not sure. Your doctor
will decide on the appropriate dose of COZAAR,
depending on your condition and whether you are
taking other medicines. It is important to continue
taking COZAAR for as long as your doctor prescribes
it in order to maintain smooth control of your blood
pressure.
Adult patients with High Blood Pressure
Treatment usually starts with 50 mg losartan (one
tablet COZAAR 50 mg) once a day. The maximal
blood pressure lowering effect should be reached
3‑6 weeks after beginning treatment. In some
patients the dose may later be increased to 100 mg
losartan (two tablets COZAAR 50 mg) 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 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.
Dosage in special patient groups
The doctor may advise a lower dose, especially
when starting treatment in certain patients such
as those treated with diuretics in high doses, in
patients with liver impairment, or in patients over
the age of 75 years. The use of losartan is not
recommended in patients with severe hepatic
impairment (see section “Do not take COZAAR”).
Administration
The tablets should be swallowed with a glass of water.
You should try to take your daily dose at about the
same time each day. It is important that you continue
to take COZAAR until your doctor tells you otherwise.
If you take more COZAAR than you should
If you accidentally take too many tablets, contact
your doctor immediately. Symptoms of overdose are
low blood pressure, increased heartbeat, possibly
decreased heartbeat.
If you forget to take COZAAR
If you accidentally miss a daily dose, just take the
next dose as normal. Do not take a double dose
to make up for a forgotten tablet. If you have any
further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.

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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).

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377442A01
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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.

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The following side effects have been reported with
COZAAR:

Technical Info

Profile

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 Henöch‑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.
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.
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 this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the carton or the bottle label. The expiry
date refers to the last day of that month.
Blisters
Store COZAAR in the original package in order to
protect from light and moisture. Do not open the
blister pack until you are ready to take the medicine.
Bottles
Store COZAAR in the original container in order to
protect from light. Do not store above 25°C. Keep
the bottle tightly closed in order to protect from
moisture.

COZAAR is supplied in the following pack sizes:
COZAAR 12.5 mg ‑ PVC/PE/PVDC blister packages
with aluminum foil lidding in packs of 7, 14, 21, 28,
50, 98, 210 or 500 tablets and a unit-dose package
of 28 tablets for hospital use. HDPE bottles of
100 tablets.
COZAAR 25 mg - PVC/PE/PVDC blister packages
with aluminum foil lidding in packs of 7 or
28 tablets.
COZAAR 50 mg - PVC/PE/PVDC blister packages
with aluminum foil lidding in packs of 7, 10, 14,
20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets and
unit-dose packages of 28, 56 and 98 tablets for
hospital use. HDPE bottles of 100 or 300 tablets.
COZAAR 100 mg - PVC/PE/PVDC blister packages with
aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30,
50, 56, 84, 90, 98 or 280 tablets and unit-dose packages
of 28, 56 and 98 tablets for hospital use. HDPE bottles of
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Merck Sharp & Dohme Limited, Hertford Road,
Hoddesdon, Hertfordshire, EN11 9BU, UK
Manufacturer:
12.5 mg: Merck Sharp & Dohme BV/MMD,
Waarderweg 39, 2031 BN, Haarlem, Netherlands.
25 mg, 50 mg and 100 mg: Merck Manufacturing
Division, Merck Sharp & Dohme Limited, Shotton
Lane, Cramlington, Northumberland, NE23 3JU, UK.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Member State

Invented name

Austria

COSAAR 12,5 mg, 50 mg or
100mg Filmtabletten

Belgium

COZAAR 12.5 mg, 50 mg or
100 mg

Belgium

LOORTAN 12.5 mg, 50 mg or
100 mg

Bulgaria

COZAAR

Cyprus

COZAAR

Czech Republic

COZAAR 12.5 mg, 50 mg or
100 mg film-coated tablets

Denmark

Cozaar

Estonia

COZAAR, COZAAR 12,5 mg

Finland

COZAAR 12.5 mg, 50 mg or
100 mg

France

COZAAR 12.5 mg film-coated
tablets, 50 mg scored coated tablets
 mg film‑coated

Germany

CARDOPAL START 12.5 mg
Filmtabletten

Germany

LORZAAR 50 mg or 100 mg
Filmtabletten

Germany

LORZAAR PROTECT 50 mg or
100 mg Filmtabletten

Germany

LORZAAR START 12,5 mg
Filmtabletten

Germany

PINZAAR 50 mg or 100 mg
Filmtabletten

Germany

LORZAAR VARIPHARMSTART
12,5 mg Filmtabletten

Greece

COZAAR

Hungary

COZAAR

Ireland

COZAAR 12.5 mg, 50  mg or
100 mg Film‑coated Tablets

Italy

LORTAAN 12.5 mg, 50 mg
or 100 mg compresse rivestite
con film

Italy

NEO‑LOTAN 12.5 mg, 50 mg
or 100 mg compresse rivestite
con film

Italy

LOSAPREX 12.5 mg, 50  mg, or
100 mg compresse rivestite
con film

Latvia

COZAAR 12.5 mg, 50 mg or
100 mg film‑coated tablets

Lithuania

COZAAR
(Losartan)

Luxembourg

COZAAR 12.5mg, 50 mg or
100 mg

Luxembourg

LOORTAN 12.5 mg, 50 mg or
100 mg

Malta

COZAAR 12.5 mg, 50mg or
100 mg film-coated tablets

Netherlands

COZAAR 50 or 100

Poland

COZAAR

Portugal

COZAAR, COZAAR 100 mg,
COZAAR IC

Portugal

LORTAAN , LORTAAN 100 mg,
LORTAAN IC

Romania

COZAAR, comprimate filmate,
12.5 mg or 50 mg

Slovakia

COZAAR 12.5 mg, 50 mg or
100mg

Slovenia

COZAAR 12,5 , 50 mg or
100 mg filmsko obložene
tablete

Spain

COZAAR 12,5 mg Inicio,
COZAAR 50  or 100 mg

Sweden

COZAAR 12,5 mg, 50 mg,
or 100 mg filmdragerade
tabletter

COZAAR 12.5 mg, 25 mg, 50 mg and 100 mg
contain potassium in the following amounts:
1.06 mg (0.027 mEq), 2.12 mg (0.054 mEq), 4.24 mg
(0.108 mEq) and 8.48 mg (0.216 mEq) respectively.

United Kingdom

COZAAR 12.5 mg, 25 mg,
50 mg or 100 mg FILM-COATED
TABLETS

Iceland

COZAAR

The COZAAR 12.5 mg tablets also contain
carnauba wax (E903), titanium dioxide (E171),
indigo carmine (E132) aluminum lake.

Norway

COZAAR

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 substance is losartan potassium.
Each COZAAR 12.5 mg tablet contains 12.5 mg of
losartan potassium.
Each COZAAR 25 mg tablet contains 25 mg of
losartan potassium.
Each COZAAR 50 mg tablet contains 50 mg of
losartan potassium.
Each COZAAR 100 mg tablet contains 100 mg of
losartan potassium.
The other ingredients are microcrystalline cellulose
(E460), lactose monohydrate, pregelatinized maize
starch, magnesium stearate (E572), hyprolose
(E463), hypromellose (E464).

The COZAAR 25 mg tablets also contain Carnauba
wax (E903), Titanium dioxide (E171).
The COZAAR 50 mg tablets also contain Carnauba
wax (E903), Titanium dioxide (E171).
The COZAAR 100 mg tablets also contain Carnauba
wax (E903), Titanium dioxide (E171).
What COZAAR looks like and contents of the pack
COZAAR 12.5 mg is supplied as unscored
film‑coated tablets containing 12.5 mg of losartan
potassium.

Profile: BG148x520_260
Profile Revision:
7
Profile Revision Date: 050708
Dimensions (mm):
148 x 520mm

COZAAR 25 mg, is supplied as unscored film‑coated
tablets containing 25 mg of losartan potassium.
COZAAR 50mg is supplied as scored film‑coated
tablets containing 50 mg of losartan potassium. The
tablet can be divided into equal halves.
COZAAR 100 mg is supplied as unscored film‑coated
tablets containing 100 mg of losartan potassium.

This leaflet was last revised December 2012
PIL.CZR.12.UK.3689_WS 033
Merck Sharp & Dohme Limited.
Hertford Road, Hoddesdon, Hertfordshire,
EN11 9BU, UK.

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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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