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COZAAR 100MG FILM-COATED TABLETS

Active substance(s): LOSARTAN POTASSIUM / LOSARTAN POTASSIUM / LOSARTAN POTASSIUM

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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 - Filmtabletten
Austria
Cosaar 50 mg - Filmtabletten
Austria
Cosaar 100 mg - Filmtabletten
Belgium
COZAAR 12,5 mg
Belgium
COZAAR 50 mg
Belgium
COZAAR 100 mg
Bulgaria
COZAAR 12,5 mg film-coated tablets
Bulgaria
COZAAR 50 mg film-coated tablets
Cyprus
COZAAR
Czech Republic
COZAAR 50 mg
Czech Republic
COZAAR 100 mg
Denmark
Cozaar
Finland
Cozaar 12,5 mg kalvopäällysteiset tabletit
Finland
Cozaar 50 mg kalvopäällysteiset tabletit
Finland
Cozaar 100 mg kalvopäällysteiset tabletit
France
COZAAR 50 mg scored coated tablets
France
COZAAR 100 mg film-coated tablets
Germany
LORZAAR PROTECT 100 mg Filmtabletten
Germany
LORZAAR PROTECT 50 mg Filmtabletten
Germany
LORZAAR START 12,5 mg Filmtabletten
Greece
COZAAR
Hungary
COZAAR
Iceland
COZAAR
Ireland
COZAAR 12.5mg film-coated tablets
Ireland
COZAAR 50 mg film-coated tablets
Ireland
COZAAR 100 mg film-coated tablets
Italy
LORTAAN 12,5 mg compresse rivestite con film
Italy
LORTAAN 50 mg compresse rivestite con film
Italy
LORTAAN 100 mg compresse rivestite con film
Luxembourg
COZAAR 12,5 mg
Luxembourg
COZAAR 50 mg
3849,8441,8442

Invented name
COZAAR 100 mg
COZAAR 12,5 mg film-coated tablets
COZAAR 50 mg film-coated tablets
COZAAR 100 mg film-coated tablets
COZAAR 12,5 mg
COZAAR 50 mg
COZAAR 100 mg
Cozaar
COZAAR
Cozaar
Cozaar 100 mg
Cozaar IC
COZAAR 12,5 mg comprimate filmate
COZAAR 50 mg comprimate filmate
Cozaar 12,5 mg filmsko obložene tablete
Cozaar 50 mg filmsko obložene tablete
Cozaar 100 mg filmsko obložene tablete
COZAAR 12,5 mg Inicio comprimidos
recubiertos con película
Spain
COZAAR 50 mg comprimidos recubiertos con
película
Spain
COZAAR 100 mg comprimidos recubiertos con
película
Sweden
COZAAR 12,5 mg filmdragerade tabletter
Sweden
COZAAR 50 mg filmdragerade tabletter
Sweden
COZAAR 100 mg filmdragerade tabletter
United Kingdom COZAAR 12,5 mg film-coated tablets
United Kingdom COZAAR 25 mg film-coated tablets
United Kingdom COZAAR 50 mg film-coated tablets
United Kingdom COZAAR 100 mg film-coated tablets
This leaflet was last revised in May 2017
PIL.CZR.17.UK.5020.Art 61(3)
© Merck Sharp & Dohme Limited 2017. All rights reserved.

Package leaflet: Information for the user

Member State
Luxembourg
Malta
Malta
Malta
Netherlands
Netherlands
Netherlands
Norway
Poland
Portugal
Portugal
Portugal
Romania
Romania
Slovenia
Slovenia
Slovenia
Spain

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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

For Position Only

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.

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
Do not take COZAAR:
• if you are allergic to losartan or to any of the other ingredients of
this medicine (listed in section 6),
• if you are more than 3 months pregnant (It is also better to avoid
COZAAR in early pregnancy - see Pregnancy),
• if your liver function is severely impaired,
• if you have diabetes or impaired kidney function and you are treated
with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking COZAAR.
You must tell your doctor if you think you are (or might become)
pregnant. COZAAR is not recommended in early pregnancy,
and must not be taken if you are more than 3 months pregnant,
as it may cause serious harm to your baby if used at that stage
(see pregnancy section).
It is important to tell your doctor before taking COZAAR:
• 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:
• an ACE-inhibitor (for example enalapril, lisinopril, ramipril),
in particular if you have diabetes-related kidney problems.
• 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 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.
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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.
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 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”).
Administration
The tablets should be swallowed whole 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:
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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 Website:
www.mhra.gov.uk/yellowcard
Malta: ADR Reporting Website:
www.medicinesauthority.gov.mt/adrportal
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) and indigo carmine (E132) aluminum lake.
The COZAAR 25 mg tablets also contain carnauba wax (E903) and
titanium dioxide (E171).
The COZAAR 50 mg tablets also contain carnauba wax (E903) and
titanium dioxide (E171).
The COZAAR 100 mg tablets also contain carnauba wax (E903) and
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 score line is not intended for
breaking the tablet.
COZAAR 100 mg is supplied as unscored film‑coated tablets
containing 100 mg of losartan potassium.
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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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