Cozaar 50mg tablets

Main information

  • Trade name:
  • Cozaar 50mg tablets
  • Dosage:
  • 50mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cozaar 50mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02050502; GTIN: 5013945183511

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 0025/0515; PL 0025/0336; PL 0025/0324; PL 0025/0416
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the 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

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

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.

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:

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 or search for MHRA

Yellow Card in the Google Play or Apple App Store

Malta:

ADR Reporting at: 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.

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 - 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

Luxembourg

COZAAR 100 mg

Malta

COZAAR 12,5 mg film-coated tablets

Malta

COZAAR 50 mg film-coated tablets

Malta

COZAAR 100 mg film-coated tablets

Netherlands

COZAAR 12,5 mg

Netherlands

COZAAR 50 mg

Netherlands

COZAAR 100 mg

Norway

Cozaar

Poland

COZAAR

Portugal

Cozaar

Portugal

Cozaar 100 mg

Portugal

Cozaar IC

Romania

COZAAR 12,5 mg comprimate filmate

Romania

COZAAR 50 mg comprimate filmate

Slovenia

Cozaar 12,5 mg filmsko obložene tablete

Member State

Invented name

Slovenia

Cozaar 50 mg filmsko obložene tablete

Slovenia

Cozaar 100 mg filmsko obložene tablete

Spain

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 December 2017

PIL.CZR.17.UK.6185.IB-040

© Merck Sharp & Dohme Limited 2018. All rights reserved.