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LOSARTAN POTASSIUM 50MG TABLETS

Active substance: LOSARTAN POTASSIUM

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Cozaar® 50 mg tablets
Losartan Potassium 50 mg tablets

0097
14.03.15[16]

(losartan potassium)
PATIENT INFORMATION LEAFLET
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 available using any one of the above names but will be
referred to as Cozaar throughout the following leaflet.
Other strengths are also available.
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 are taking a
medicine called aliskiren to reduce blood pressure.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cozaar.
You must tell your doctor if you think you are (or might become) pregnant.
Cozaar is not recommended in early pregnancy, and must not be taken if
you are more than 3 months pregnant, as it may cause serious harm to
your baby if used at that stage (see pregnancy section)
It is important to tell your doctor before taking Cozaar:
- if you have had a history of angiooedema (swelling of the face, lips,
throat, and/or tongue) (see also section 4 ‘Possible side effects’),
- if you suffer from excessive vomiting or diarrhoea leading to an extreme
loss of fluid and/or salt in your body,
- if you receive diuretics (medicines that increase the amount of water that
you pass out through your kidneys) or are under dietary salt restriction
leading to an extreme loss of fluid and salt in your body (see section 3
‘Dosage in special patient groups’),
- if you are known to have narrowing or blockage of the blood vessels
leading to your kidneys or if you have received a kidney transplant
recently,
- if your liver function is impaired (see sections 2 "Do not take Cozaar" and
3 "Dosage in special patient groups"),
- if you suffer from heart failure with or without renal impairment or
concomitant severe life threatening cardiac arrhythmias. Special caution
is necessary when you are treated with a ß-blocker concomitantly,
- if you have problems with your heart valves or heart muscle,
- if you suffer from coronary heart disease (caused by a reduced blood flow
in the blood vessels of the heart) or from cerebrovascular disease
(caused by a reduced blood circulation in the brain),
- if you suffer from primary hyperaldosteronism (a syndrome associated
with increased secretion of the hormone aldosterone by the adrenal
gland, caused by an abnormality within the gland).
- if you are taking a medicine called aliskiren to reduce blood pressure.
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.

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 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.
The following is a translation of the days of the week shown on the blister
strip:
LUN - Monday
MAR - Tuesday
MIE - Wednesday
JUE - Thursday
VIE - Friday
SAB - Saturday
DOM - Sunday
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).

MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Merck Sharp & Dohme Ltd, Shotton Lane, Cramlington,
Northumberland, UK and is procured from the EU by the Product Licence
holder P.I.E. Pharma Ltd, 207 Kenton Road, Harrow, Middlesex HA3 0HD.
POM

PL 15361/0097

Leaflet revision and issue date (Ref) 14.03.15[16]
Cozaar is a trademark of E.I. du Pont de Nemours and Company.

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 Henöch-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. The
expiry date refers to the last day of that month.
Keep this medicine below 30oC in the original pack. Keep in a dry place.
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
What Cozaar contains
The active substance is losartan potassium.
Each Cozaar tablet contains 50mg of the active ingredient losartan
potassium.
Your medicine also contains the following: Lactose, hypromellose,
hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose,
pregelatinised maize starch and titanium dioxide (E171).
What Cozaar looks like and contents of the pack
Cozaar are white, oval tablets coded '952’ on one side with a breakline on
the reverse.
Cozaar is available in calendar blister packs of 28 tablets.

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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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