COZAAR 12.5MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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Patient Information Leaflet

Cozaar® 12.5mg 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 of the side effects, talk to your doctor, pharmacist, or
nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
Your medicine is also available in the following strengths 25mg, 50mg
and 100mg Tablets.
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

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 indometacin, including
COX-2-inhibitors (medicines that reduce inflammation, and can be
used to help relieve pain) as they may reduce the blood pressure
lowering effect of losartan.

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.

If your kidney function is impaired, the concomitant use of these
medicines may lead to a worsening of the kidney function.

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”).

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.

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 are taking a
medicine called aliskiren to reduce blood pressure.

Ask your doctor or pharmacist for advice before taking this medicine.

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 a medicine called aliskiren to reduce blood pressure.

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.

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 breastfeed. Especially if your baby is a newborn, or born prematurely.

Driving and using machines
No studies on the effects on the ability to drive and use machines have
been performed. Cozaar is unlikely to affect your ability to drive or use
machines. However, as with many other medicines used to treat high
blood pressure, losartan may cause dizziness or drowsiness in some
people.
If you experience dizziness or drowsiness, you should consult your
doctor before attempting such activities.
Cozaar contains lactose
Cozaar contains lactose monohydrate. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.
3. How to take Cozaar
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure. Your
doctor will decide on the appropriate dose of Cozaar, depending on your
condition and whether you are taking other medicines. It is important to
continue taking Cozaar for as long as your doctor prescribes it in order to
maintain smooth control of your blood pressure.
Adult patients with High Blood Pressure
Treatment usually starts with 50 mg losartan (one tablet Cozaar 50 mg)
once a day. The maximal blood pressure lowering effect should be
reached 3-6 weeks after beginning treatment. In some patients the dose
may later be increased to 100 mg losartan (two tablets Cozaar 50 mg)
once daily. If you have the impression that the effect of losartan is too
strong or too weak, please talk to your doctor or pharmacist.
Use in children and adolescents
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.

PP3/1232/V2

Adult patients with high blood pressure and Type 2 diabetes
Treatment usually starts with 50 mg losartan (one tablet Cozaar 50 mg)
once a day. The dose may later be increased to 100 mg losartan (two
tablets Cozaar 50 mg) once daily depending on your blood pressure
response.
Losartan tablets may be administered with other blood pressure lowering
medicines (e.g. diuretics, calcium channel blockers, alpha- or
beta-blockers, and centrally acting agents) as well as with insulin and
other commonly used medicines that decrease the level of glucose in the
blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Adult Patients with Heart Failure
Treatment usually starts with 12.5 mg losartan (one tablet Cozaar 12.5
mg) once a day. Generally, the dose should be increased weekly
step-by-step (i.e., 12.5 mg daily during the first week, 25 mg daily during
the second week, 50 mg daily during the third week, 100 mg daily during
the fourth week, 150 mg daily during the fifth week) up to the
maintenance dose as determined by your physician. A maximum dose of
150 mg losartan (for example, three tablets of COZAAR 50 mg or one
tablet each of Cozaar 100 mg and Cozaar 50 mg) once daily may be
used.
In the treatment of heart failure, losartan is usually combined with a
diuretic (medicine that increases the amount of water that you pass out
through your kidneys) and/or digitalis (medicine that helps to make the
heart stronger and more efficient) and/or a beta-blocker.
Dosage in special patient groups
The doctor may advise a lower dose, especially when starting treatment
in certain patients such as those treated with diuretics in high doses, in
patients with liver impairment, or in patients over the age of 75 years.
The use of losartan is not recommended in patients with severe hepatic
impairment (see section "Do not take Cozaar").
Administration
The tablets should be swallowed with a glass of water. You should try to
take your daily dose at about the same time each day. It is important that
you continue to take Cozaar until your doctor tells you otherwise.
If you take more Cozaar than you should
If you accidentally take too many tablets, contact your doctor
immediately. Symptoms of overdose are low blood pressure, increased
heartbeat, possibly decreased heartbeat.
If you forget to take Cozaar
If you accidentally miss a daily dose, just take the next dose as normal.
Do not take a double dose to make up for a forgotten tablet. If you have
any further questions on the use of this medicine, ask your doctor or
pharmacist or nurse.
4. Possible side effects
Like all medicines, Cozaar 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,
• angioedema,
• inflammation of blood vessels (vasculitis including Henoch-Schonlein
purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• brain attack (stroke),
• inflammation of the liver (hepatitis),
• elevated blood alanine aminotransferase (ALT) levels, usually
resolved upon discontinuation of treatment.
Not known (frequency cannot be estimated from the available data):
• reduced number of thrombocytes,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to the sun (photosensitivity),
• unexplained muscle pain with dark (tea-coloured) urine
(rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low levels of sodium in the blood (hyponatraemia),
• depression,
• generally feeling unwell (malaise),
• ringing, buzzing, roaring, or clicking in the ears (tinnitus),
• disturbed taste (dysgeusia).
Side effects in children are similar to those seen in adults.
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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. 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
label. The expiry date refers to the last day of that month.
Store 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.
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. Further Information
Cozaar 12.5mg tablets are blue, oval shaped film-coated tablets marked
11 on one side and plain on the other.
Each tablet contains 12.5mg of the active ingredient losartan potassium.
Also contains microcrystalline cellulose (E460), lactose monohydrate,
pregelatinized maize starch, magnesium stearate (E572), hyprolose
(E463), hypromellose (E464). Each Cozaar 12.5mg tablet contains
1.06mg (0.027 mEq) of potassium, carnauba wax (E903), titanium
dioxide (E171) and indigo carmine (E132) aluminium lake.
Cozaar Tablets are available in blister packs of 28 tablets.
Manufactured by: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN
Haarlem, The Netherlands. Procured from within the EU. Product
Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd,
Bolton BL6 4SA.
Cozaar 12.5mg film-coated Tablets

PL 20774/1232

POM

Cozaar is a registered trademark of E.I. du Pont de Nemours and
Company
th

Date of preparation 24 July 2014

PP3/1232/V2

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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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