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COZAAR 12.5 MG FILM COATED TABLETS

Active substance(s): LOSARTAN POTASSIUM

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XXXXXX/XX-X

6560

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
Losartan potassium

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist, or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor,
pharmacist, or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
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
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

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 indomethacin, including COX‑2‑inhibitors
(medicines that reduce inflammation, and can
be used to help relieve pain) as they may reduce
the blood pressure lowering effect of losartan.
Your doctor may need to change your dose and/or
to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also
information under the headings “Do not take
COZAAR” and “Warnings and precautions”)
If your kidney function is impaired, the concomitant
use of these medicines may lead to a worsening of
the kidney function.
Lithium containing medicines should not be taken in
combination with losartan without close supervision
by your doctor. Special precautionary measures
(e.g. blood tests) may be appropriate.
COZAAR with food and drink
COZAAR may be taken with or without food.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are
(or might become) pregnant. Your doctor will normally
advise you to stop taking Cozaar before you become
pregnant or as soon as you know you are pregnant
and will advise you to take another medicine instead
of Cozaar. Cozaar is not recommended in early
pregnancy, and must not be taken when more than
3 months pregnant, as it may cause serious harm to
your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to
start breast-feeding. Cozaar is not recommended for
mothers who are breast-feeding, and your doctor
may choose another treatment for you if you wish
to 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.

Do not take COZAAR:

3. How to 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.

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.

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).
• 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.

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
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 or one tablet of
COZAAR 100 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”).

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XXXXXX/XX-X

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.
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
COZAAR:
Common (may affect up to 1 in 10 people):
• dizziness,
• low blood pressure (especially after excessive
loss of water from the body within blood vessels
e.g. in patients with severe heart failure or under
treatment with high dose diuretics),
• dose‑related orthostatic effects such as lowering
of blood pressure appearing when rising from a
lying or sitting position,
• debility,
• fatigue,
• too little sugar in the blood (hypoglycaemia),
• too much potassium in the blood
(hyperkalaemia),
• changes in kidney function including kidney
failure,
• reduced number of red blood cells (anaemia),
• increase in blood urea, serum creatinine and
serum potassium in patients with heart failure.
Uncommon (may affect up to 1 in 100 people):
• somnolence,
• headache,
• sleep disorders,
• feeling of increased heart rate (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnoea),
• abdominal pain,
• obstipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localised swelling (oedema),
• cough.
Rare (may affect up to 1 in 1,000 people):
• hypersensitivity,
• angiooedema,
• inflammation of blood vessels (vasculitis including
Henoch‑Schönlein purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial
fibrillation),
• brain attack (stroke),
• inflammation of the liver (hepatitis),
• elevated blood alanine aminotransferase (ALT)
levels, usually resolved upon discontinuation of
treatment.
Not known (frequency cannot be estimated from the
available data):
• reduced number of thrombocytes,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu‑like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to the sun (photosensitivity),
• unexplained muscle pain with dark (tea-coloured)
urine (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low levels of sodium in the blood (hyponatraemia),
• depression,
• generally feeling unwell (malaise),
• ringing, buzzing, roaring, or clicking in the ears
(tinnitus),
• disturbed taste (dysgeusia).
Side effects in children are similar to those seen in
adults.
Reporting of side effects
If you get any side effects, talk to your doctor,
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 at:
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 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.
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 other 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).
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.
The COZAAR 12.5 mg tablets also contain
carnauba wax (E903), titanium dioxide (E171), indigo
carmine (E132) aluminum lake.
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.
COZAAR 25 mg, is supplied as unscored film‑coated
tablets containing 25 mg of losartan potassium.
COZAAR 50 mg 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.
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
100 mg Filmtabletten
Belgium
COZAAR 12.5 mg, 50 mg or 100 mg
Belgium
LOORTAN 12.50 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 scored coated or
100 mg film‑coated tablets
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
LORTAAN 12.5 mg, 50 mg or 100 mg
Italy
compresse rivestite con film
Italy
NEO‑LOTAN 12.5 mg, 50 mg or
100 mg compresse rivestite con
film
LOSAPREX 12.5 mg, 50 mg, or
Italy
100 mg compresse rivestite con film
Latvia
COZAAR 50 mg or 100 mg
film‑coated tablets
Lithuania
COZAAR
(Losartan)
Luxembourg
COZAAR 12.5mg, 50 mg or 100 mg
LOORTAN 12.5 mg, 50 mg or 100 mg
Luxembourg
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
COZAAR 12.5 mg, 50 mg, or 100 mg
Sweden
filmdragerade tabletter
United Kingdom COZAAR 12.5 mg, 25 mg, 50 mg or
100 mg film-coated tablets
Iceland
COZAAR
Norway
COZAAR
This leaflet was last revised in September 2014
PIL.CZR.14.UK.4118.WS-094.IB
© Merck Sharp & Dohme Limited 2014. All rights
reserved.

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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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