Cozaar 100mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Losartan potassium
Available from:
CST Pharma Ltd
ATC code:
C09CA01
INN (International Name):
Losartan potassium
Dosage:
100mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02050502; GTIN: 5055946804712

S0221-28-PL-PIL-05.07.2019

PACKAGE LEAFLET: INFORMATION FOR THE

USER

Cozaar® 100mg tablets

(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.

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:

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”.

if you are taking other medications that may increase

serum potassium (see section 2 “Other medicines

and 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.

Tell your doctor if you are taking potassium

supplements, potassium

containing salt substitutes,

potassium

sparing medicines such as certain diuretics

(amiloride, triamteren, spironolactone), or other

medicines that may increase serum potassium (e.g.,

heparin, trimethoprim

containing medicines), as the

combination with Cozaar is not advisable.

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,

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.

S0221-28-PL-PIL-05.07.2019

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,

100mg 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 on this leaflet. You can also report

side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA

Yellow Card in the Google Play or Apple App Store.

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 33902/0221

Leaflet revision Date: 05/07/2019

Cozaar® is a registered trade mark of Merck Sharp &

Dohme Corp.

Blind or partially sighted?

Is this leaflet hard to see or

read? Call 02082033203 to

obtain the leaflet in a

format suitable for you.

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

COZAAR 100 mg film-coated tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each COZAAR 100 mg tablet contains 100 mg of losartan potassium.

Each COZAAR 100 mg tablet contains 51.0 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Film-coated tablets

COZAAR 100 mg tablet

White, teardrop-shaped film-coated tablets marked 960 on one side and plain

on the other.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Treatment of essential hypertension in adults and in children and

adolescents 6 - 18 years of age.

Treatment of renal disease in adult patients with hypertension and type 2

diabetes mellitus with proteinuria

0.5 g/day as part of an

antihypertensive treatment (see sections 4.3, 4.4, 4.5, and 5.1).

Treatment of chronic heart failure in adult patients when treatment with

Angiotensin-converting enzyme (ACE) inhibitors is not considered

suitable due to incompatibility, especially cough, or contraindication.

Patients with heart failure who have been stabilised with an ACE inhibitor

should not be switched to losartan. The patients should have a left

ventricular ejection fraction

40% and should be clinically stable and on

an established treatment regimen for chronic heart failure.

Reduction in the risk of stroke in adult hypertensive patients with left

ventricular hypertrophy documented by ECG (see section 5.1 LIFE study,

Race).

4.2

Posology and method of administration

Posology

Hypertension

The usual starting and maintenance dose is 50 mg once daily for most patients. The

maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy.

Some patients may receive an additional benefit by increasing the dose to 100 mg

once daily (in the morning).

Losartan may be administered with other antihypertensive agents, especially with

diuretics (e.g. hydrochlorothiazide) (see sections 4.3, 4.4, 4.5, and 5.1).

Hypertensive type II diabetic patients with proteinuria

0.5 g/day

The usual starting dose is 50 mg once daily. The dose may be increased to 100 mg

once daily based on blood pressure response from one month onwards after initiation

of therapy. Losartan may be administered with other antihypertensive agents (e.g.

diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting

agents) (see sections 4.3, 4.4, 4.5, and 5.1) as well as with insulin and other

commonly used hypoglycaemic agents (e.g. sulfonylureas, glitazones and glucosidase

inhibitors).

Heart Failure

The usual initial dose of losartan in patients with heart failure is 12.5 mg once daily.

The dose should generally be titrated at weekly intervals (i.e. 12.5 mg daily, 25 mg

daily, 50 mg daily, 100 mg daily, up to a maximum dose of 150 mg once daily) as

tolerated by the patient.

Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy

documented by ECG

The usual starting dose is 50 mg of losartan once daily. A low dose of hydrochlorothiazide

should be added and/or the dose of losartan should be increased to 100 mg once daily based

on blood pressure response.

Special populations

Use in patients with intravascular volume depletion:

For patients with intravascular volume-depletion (e.g. those treated with high-dose diuretics),

a starting dose of 25 mg once daily should be considered (see section 4.4).

Use in patients with renal impairment and haemodialysis patients:

No initial dosage adjustment is necessary in patients with renal impairment and in

haemodialysis patients.

Use in patients with hepatic impairment:

A lower dose should be considered for patients with a history of hepatic impairment. There is

no therapeutic experience in patients with severe hepatic impairment. Therefore, losartan is

contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).

Paediatric population

6 months – less than 6 years

The safety and efficacy of children aged 6 months to less than 6 years has not been

established. Currently available data are described in sections 5.1 and 5.2 but no

recommendation on posology can be made.

6 years to 18 years

For patients who can swallow tablets, the recommended dose is 25 mg once daily in

patients >20 to <50 kg. (In exceptional cases the dose can be increased to a maximum

of 50 mg once daily). Dosage should be adjusted according to blood pressure

response.

In patients >50 kg, the usual dose is 50 mg once daily. In exceptional cases the dose

can be adjusted to a maximum of 100 mg once daily. Doses above 1.4 mg/kg (or in

excess of 100 mg) daily have not been studied in paediatric patients.

Losartan is not recommended for use in children under 6 years old, as limited data are

available in these patient groups.

It is not recommended in children with glomerular filtration rate < 30 ml/min/1.73 m

as no data are available (see also section 4.4).

Losartan is also not recommended in children with hepatic impairment (see also

section 4.4).

Use in Elderly

Although consideration should be given to initiating therapy with 25 mg in patients over

75 years of age, dosage adjustment is not usually necessary for the elderly.

Method of administration

Losartan tablets should be swallowed whole with a glass of water.

Losartan tablets may be administered with or without food.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in

sections 4.4 and 6.1.

and 3

trimester of pregnancy (see sections 4.4 and 4.6).

Severe hepatic impairment.

The concomitant use of losartan with aliskiren-containing products is

contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60

ml/min/1.73 m

) (see sections 4.5 and 5.1).

4.4

Special warnings and precautions for use

Hypersensitivity

Angioedema. Patients with a history of angioedema (swelling of the face, lips, throat,

and/or tongue) should be closely monitored (see section 4.8).

Hypotension and Electrolyte/Fluid Imbalance

Symptomatic hypotension, especially after the first dose and after increasing of the dose, may

occur in patients who are volume- and/or sodium-depleted by vigorous diuretic therapy,

dietary salt restriction, diarrhoea or vomiting. These conditions should be corrected prior to

administration of losartan, or a lower starting dose should be used (see section 4.2). This also

applies to children 6 to 18 years of age.

Electrolyte imbalances

Electrolyte imbalances are common in patients with renal impairment, with or without

diabetes, and should be addressed. In a clinical study conducted in type 2 diabetic patients

with nephropathy, the incidence of hyperkalaemia was higher in the group treated with

losartan as compared to the placebo group (see section 4.8). Therefore, the plasma

concentrations of potassium as well as creatinine clearance values should be closely

monitored, especially patients with heart failure and a creatinine clearance between 30-50

ml/min should be closely monitored.

The concomitant use of potassium-sparing diuretics, potassium supplements,

potassium-containing salt substitutes, or other drugs that may increase serum

potassium (e.g., trimethoprim-containing products) with losartan is not recommended

(see section 4.5).

Hepatic impairment

Based on pharmacokinetic data which demonstrate significantly increased plasma

concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients

with a history of hepatic impairment. There is no therapeutic experience with losartan in

patients with severe hepatic impairment. Therefore losartan must not be administered in

patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).

Losartan is not recommended in children with hepatic impairment (see section 4.2).

Renal impairment

As a consequence of inhibiting the renin-angiotensin system, changes in renal function

including renal failure have been reported (in particular, in patients whose renal function is

dependent on the renin- angiotensin-aldosterone system such as those with severe cardiac

insufficiency or pre-existing renal dysfunction). As with other medicinal products that affect

the renin-angiotensin-aldosterone system, increases in blood urea and serum creatinine have

also been reported in patients with bilateral renal artery stenosis or stenosis of the artery to a

solitary kidney; these changes in renal function may be reversible upon discontinuation of

therapy. Losartan should be used with caution in patients with bilateral renal artery stenosis or

stenosis of the artery to a solitary kidney.

Use in paediatric patients with renal impairment

Losartan is not recommended in children with glomerular filtration rate <

30 ml/min/1.73 m

as no data are available (see section 4.2).

Renal function should be regularly monitored during treatment with losartan as it may

deteriorate. This applies particularly when losartan is given in the presence of other

conditions (fever, dehydration) likely to impair renal function.

Concomitant use of losartan and ACE-inhibitors has shown to impair renal function.

Therefore, concomitant use is not recommended (see section 4.5).

Renal transplantation

There is no experience in patients with recent kidney transplantation.

Primary hyperaldosteronism

Patients with primary aldosteronism generally will not respond to antihypertensive medicinal

products acting through inhibition of the renin-angiotensin system. Therefore, the use of

losartan is not recommended.

Coronary heart disease and cerebrovascular disease

As with any antihypertensive agents, excessive blood pressure decrease in patients with

ischaemic cardiovascular and cerebrovascular disease could result in a myocardial infarction

or stroke.

Heart failure

In patients with heart failure, with or without renal impairment, there is - as with other

medicinal products acting on the renin-angiotensin system - a risk of severe arterial

hypotension, and (often acute) renal impairment.

There is no sufficient therapeutic experience with losartan in patients with heart failure and

concomitant severe renal impairment, in patients with severe heart failure (NYHA class IV)

as well as in patients with heart failure and symptomatic life-threatening cardiac arrhythmias.

Therefore, losartan should be used with caution in these patient groups. The combination of

losartan with a beta-blocker should be used with caution (see section 5.1).

Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy

As with other vasodilators, special caution is indicated in patients suffering from aortic or

mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Excipients

This medicinal product contains lactose. Patients with rare hereditary problems of galactose

intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take

this medicine.

Pregnancy

Losartan should not be initiated during pregnancy. Unless continued losartan therapy

is considered essential, patients planning pregnancy should be changed to alternative

anti-hypertensive treatments which have an established safety profile for use in

pregnancy. When pregnancy is diagnosed, treatment with losartan should be stopped

immediately, and, if appropriate, alternative therapy should be started (see

sections 4.3 and 4.6).

Other warnings and precautions

As observed for angiotensin converting enzyme inhibitors, losartan and the other angiotensin

antagonists are apparently less effective in lowering blood pressure in black people than in

non-blacks, possibly because of higher prevalence of low-renin states in the black

hypertensive population.

Dual blockade of the renin-angiotensin-aldosterone system (RAAS)

There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers

or aliskiren increases the risk of hypotension, hyperkalaemia, and decreased renal function

(including acute renal failure). Dual blockade of RAAS through the combined use of ACE-

inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see

sections 4.5 and 5.1).

If dual blockade therapy is considered absolutely necessary, this should only occur under

specialist supervision and subject to frequent close monitoring of renal function, electrolytes

and blood pressure.

ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in

patients with diabetic nephropathy.

4.5

Interaction with other medicinal products and other forms of interaction

Other antihypertensive agents may increase the hypotensive action of losartan.

Concomitant use with other substances which may induce hypotension as an adverse

reaction (like tricyclic antidepressants, antipsychotics, baclofen and amifostine) may

increase the risk of hypotension.

Losartan is predominantly metabolised by cytochrome P450 (CYP) 2C9 to the active

carboxy-acid metabolite. In a clinical trial it was found that fluconazole (inhibitor of

CYP2C9) decreases the exposure to the active metabolite by approximately 50%. It was

found that concomitant treatment of losartan with rifampicin (inducer of metabolism

enzymes) gave a 40% reduction in plasma concentration of the active metabolite. The clinical

relevance of this effect is unknown. No difference in exposure was found with concomitant

treatment with fluvastatin (weak inhibitor of CYP2C9).

As with other medicinal products that block angiotensin II or its effects, concomitant use of

other medicinal products which retain potassium (e.g. potassium-sparing diuretics: amiloride,

triamterene, spironolactone) or may increase potassium levels (e.g. heparin, trimethoprim-

containing products), potassium supplements or salt substitutes containing potassium may

lead to increases in serum potassium. Co-medication is not advisable.

Reversible increases in serum lithium concentrations and toxicity have been

reported during concomitant administration of lithium with ACE inhibitors. Very

rare cases have also been reported with angiotensin II receptor antagonists.

Co-administration of lithium and losartan should be undertaken with caution. If this

combination proves essential, serum lithium level monitoring is recommended

during concomitant use.

When angiotensin II antagonists are administered simultaneously with NSAIDs

(i.e. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses and

non-selective NSAIDs), attenuation of the antihypertensive effect may occur.

Concomitant use of angiotensin II antagonists or diuretics and NSAIDs may lead to

an increased risk of worsening of renal function, including possible acute renal

failure, and an increase in serum potassium, especially in patients with poor

pre-existing renal function. The combination should be administered with caution,

especially in the elderly. Patients should be adequately hydrated and consideration

should be given to monitoring renal function after initiation of concomitant

therapy, and periodically thereafter.

Clinical trial data have shown that dual blockade of the renin-angiotensin-aldosterone

system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor

blockers or aliskiren is associated with a higher frequency of adverse events such as

hypotension, hyperkalaemia, and decreased renal function (including acute renal

failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4, and

5.1).

4.6

Fertility, pregnancy and lactation

Pregnancy

The use of losartan is not recommended during the first trimester of pregnancy (see

section 4.4). The use of losartan is contraindicated during the 2

and 3

trimester of

pregnancy (see section 4.3 and 4.4).

Epidemiological evidence regarding the risk of teratogenicity following exposure to

ACE inhibitors during the first trimester of pregnancy has not been conclusive;

however a small increase in risk cannot be excluded. Whilst there is no controlled

epidemiological data on the risk with Angiotensin II Receptor Inhibitors (AIIRAs),

similar risks may exist for this class of medicinal products. Unless continued AIIRA

therapy is considered essential, patients planning pregnancy should be changed to

alternative anti-hypertensive treatments which have an established safety profile for

use in pregnancy. When pregnancy is diagnosed, treatment with losartan should be

stopped immediately and, if appropriate, alternative therapy should be started.

Exposure to AIIRA therapy during the second and third trimesters is known to induce

human foetotoxicity (decreased renal function, oligohydramnios, skull ossification

retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see also

section 5.3).

Should exposure to losartan have occurred from the second trimester of pregnancy,

ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken losartan should be closely observed for hypotension

(see also section 4.3 and 4.4).

Breastfeeding

Because no information is available regarding the use of losartan during breastfeeding,

losartan is not recommended and alternative treatments with better established safety profiles

during breastfeeding are preferable, especially while nursing a new-born or preterm infant.

4.7

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

However, when driving vehicles or operating machines it must be borne in mind that

dizziness or drowsiness may occasionally occur when taking antihypertensive therapy, in

particular during initiation of treatment or when the dose is increased.

4.8

Undesirable effects

Losartan has been evaluated in clinical studies as follows:

In a controlled clinical trial in > 3,000 adult patients 18 years of age and older

for essential hypertension

In a controlled clinical trial in 177 hypertensive paediatric patients 6 to 16

years of age

In a controlled clinical trial in > 9,000 hypertensive patients 55 to 80 years of

age with left ventricular hypertrophy (see LIFE Study, section 5.1)

In controlled clinical trials in > 7,700 adult patients with chronic heart failure

(see ELITE I, ELITE II, and HEAAL study, section 5.1)

In a controlled clinical trial in > 1,500 type 2 diabetic patients 31 years of age

and older with proteinuria (see RENAAL study, section 5.1).

In these clinical trials, the most common adverse event was dizziness.

The frequency of adverse reactions listed below is defined using the following convention:

very common (

1/10); common (

1/100, to < 1/10); uncommon (

1/1,000, to < 1/100); rare

1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the

available data).

Table 1. The frequency of adverse reactions identified from placebo-controlled

clinical studies and post marketing experience

Adverse reaction

Frequency of adverse reaction by indication

Other

Hypertension

Hypertensive

patients with

left-

ventricular

hypertrophy

Chronic

Heart

Failure

Hypertension

and type 2

diabetes with

renal disease

Post-marketing

experience

Blood and lymphatic system disorders

anaemia

common

frequency not

known

thrombocytopaenia

frequency not

known

Immune system disorders

hypersensitivity

reactions,

anaphylactic

reactions,

angioedema*, and

vasculitis**

rare

Psychiatric disorders

depression

frequency not

known

Nervous system disorders

dizziness

common

common

common

common

somnolence

uncommon

headache

uncommon

uncommon

sleep disorders

uncommon

paraesthesia

rare

migraine

frequency not

known

dysgeusia

frequency not

known

Adverse reaction

Frequency of adverse reaction by indication

Other

Hypertension

Hypertensive

patients with

left-

ventricular

hypertrophy

Chronic

Heart

Failure

Hypertension

and type 2

diabetes with

renal disease

Post-marketing

experience

Ear and labyrinth disorders

vertigo

common

common

tinnitus

frequency not

known

Cardiac disorders

palpitations

uncommon

angina pectoris

uncommon

syncope

rare

atrial fibrillation

rare

cerebrovascular

accident

rare

Vascular disorders

(orthostatic)

hypotension

(including dose-

related

orthostatic

effects)

uncommon

common

common

Respiratory, thoracic and mediastinal disorders

dyspnoea

uncommon

cough

uncommon

frequency not

known

Gastrointestinal disorders

abdominal pain

uncommon

obstipation

uncommon

diarrhoea

uncommon

frequency not

known

nausea

uncommon

vomiting

uncommon

Hepatobiliary disorders

pancreatitis

frequency not

known

hepatitis

rare

liver function

abnormalities

frequency not

known

Adverse reaction

Frequency of adverse reaction by indication

Other

Hypertension

Hypertensive

patients with

left-

ventricular

hypertrophy

Chronic

Heart

Failure

Hypertension

and type 2

diabetes with

renal disease

Post-marketing

experience

Skin and subcutaneous tissue disorders

urticaria

uncommon

frequency not

known

pruritus

uncommon

frequency not

known

rash

uncommon

uncommon

frequency not

known

photosensitivity

frequency not

known

Musculoskeletal and connective tissue disorders

myalgia

frequency not

known

arthralgia

frequency not

known

rhabdomyolysis

frequency not

known

Renal and urinary disorders

renal impairment

common

renal failure

common

Reproductive system and breast disorders

erectile

dysfunction /

impotence

frequency not

known

General disorders and administration site conditions

asthenia

uncommon

common

uncommon

common

fatigue

uncommon

common

uncommon

common

oedema

uncommon

malaise

frequency not

known

Investigations

hyperkalaemia

common

uncommon

common

increased alanine

aminotransferase

(ALT)

rare

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