COZAAR 12.5 MG FILM COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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407661A02

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Technical Info

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Member State
Austria
Belgium
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Germany
Germany
Germany
Germany
Germany
Greece
Hungary
3849, 8441, 8442

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Profile Revision:
Profile Revision Date:
Dimensions (mm):

170 x 210 x 4
G
161008
170 x 210

COZAAR 12.5 mg, 50 mg or 100 mg Film‑coated Tablets
LORTAAN 12.5 mg, 50 mg or 100 mg compresse rivestite
con film
NEO‑LOTAN 12.5 mg, 50 mg or 100 mg compresse rivestite con
Italy
film
Italy
LOSAPREX 12.5 mg, 50  mg, or 100 mg compresse rivestite
con film
Latvia
COZAAR 12.5 mg, 50 mg or 100 mg film‑coated tablets
Lithuania
COZAAR(Losartan)
Luxembourg
COZAAR 12.5mg, 50 mg or 100 mg
Luxembourg
LOORTAN 12.5 mg, 50 mg or 100 mg
Malta
COZAAR 12.5 mg, 50 mg or 100 mg film-coated tablets
Netherlands
COZAAR 50 or 100
Poland
COZAAR
COZAAR, COZAAR 100 mg, COZAAR IC
Portugal
Portugal
LORTAAN, LORTAAN 100 mg, LORTAAN IC
COZAAR, comprimate filmate, 12.5 mg or 50 mg
Romania
Slovakia
COZAAR 12.5 mg, 50 mg or 100mg
Slovenia
COZAAR 12.5 , 50 mg or 100 mg filmsko obložene tablete
Spain
COZAAR 12.5 mg Inicio, COZAAR 50  or 100 mg
Sweden
COZAAR 12.5 mg, 50 mg, or 100 mg filmdragerade tabletter
United Kingdom COZAAR 12.5 mg, 25 mg, 50 mg or 100 mg film-coated tablets
Iceland
COZAAR
Norway
COZAAR
This leaflet was last revised December 2013
PIL.CZR.13.UK.4007.WS-048
Merck Sharp & Dohme Limited.
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.

Package leaflet: Information for user

Ireland
Italy

Invented name
COSAAR 12.5 mg, 50 mg or 100 mg Filmtabletten
COZAAR 12.5 mg, 50 mg or 100 mg
LOORTAN 12.50 mg, 50 mg or 100 mg
COZAAR
COZAAR
COZAAR 12.5 mg, 50 mg or 100 mg film-coated tablets
Cozaar
COZAAR, COZAAR 12.5 mg
COZAAR 12.5 mg, 50 mg or 100 mg
COZAAR 12.5 mg film-coated tablets, 50 scored coated or
100 mg film‑coated tablets
CARDOPAL START 12.5 mg Filmtabletten
LORZAAR 50 mg or 100 mg Filmtabletten
LORZAAR PROTECT 50 mg or 100 mg Filmtabletten
LORZAAR START 12.5 mg Filmtabletten
PINZAAR 50 mg or 100 mg Filmtabletten
LORZAAR VARIPHARMSTART 12.5 mg Filmtabletten
COZAAR
COZAAR
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Cozaar® 12.5 mg film‑coated tablets
Cozaar® 25 mg film‑coated tablets
Cozaar® 50 mg film‑coated tablets
Cozaar® 100 mg film‑coated tablets

For Position Only

COZAAR 25 mg, is supplied as unscored film‑coated tablets containing 25 mg
of losartan potassium.
COZAAR 50mg is supplied as scored film‑coated tablets containing 50 mg of
losartan potassium. The tablet can be divided into equal halves.
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:

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.
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,
baclofene, 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.
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407661A02

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Technical Info

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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.
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.
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Profile:
Profile Revision:
Profile Revision Date:
Dimensions (mm):

170 x 210 x 4
G
161008
170 x 210

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 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 (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
Malta: ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3, Rue D’Argens,
GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt,
e-mail: postlicensing.medicinesauthority@gov.mt
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 25OC. 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 further 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), indigo carmine (E132) aluminum lake.
The COZAAR 25 mg tablets also contain Carnauba wax (E903), Titanium
dioxide (E171).
The COZAAR 50 mg tablets also contain Carnauba wax (E903), Titanium
dioxide (E171).
The COZAAR 100 mg tablets also contain Carnauba wax (E903), 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.
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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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