LOSARTAN POTASSIUM 50MG TABLETS

Active substance: LOSARTAN POTASSIUM

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Cozaar 50mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464/0478 E

DATE OF PROOF:

18/02/14

DATE:

PROOF HISTORY:
v.1 - waymade - 18/02/14

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

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.

5. How to store Cozaar
Cozaar 50mg tablets should be stored in a dry place below 30°C. in the original packaging.
Do not remove the tablets from the blister strip until you are ready to take your medicine.
Do not use after the expiry date printed on the carton or blister strip. The expiry date refers to the last
day of that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who
will tell you what to do.
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 further information
Your medicine is called Cozaar 50mg tablets. Each white oval film-coated tablet contains 50 mg of the
active ingredient, losartan potassium and is marked '952' on one side with a breakline on the reverse.
Cozaar 50 mg tablets also contain the following inactive ingredients:
hydroxypropylmethylcellulose, microcrystalline cellulose, magnesium stearate, lactose, hydroxypropyl
cellulose, carnauba wax, titanium dioxide (E171) and pregelatinised maize starch.

COZAAR®

50 mg TABLETS
(losartan potassium)
Patient Information Leaflet

This product is known as the above name but will be referred to as Cozaar throughout this leaflet.
Other strengths (12.5 mg, 25 mg and 100 mg) are also available.
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 angiotensinconverting-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

Cozaar 50 mg tablets are available as calendar blister packs of 28 tablets.
POM

PL No: 6464/0478

This product is manufactured by Merck Sharp & Dohme Ltd., Cramlington, Northumberland, England
and is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 14.2.2014
Cozaar is a registered trademark of Merk Sharp & Dohme Corp.

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.

Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Cozaar 50mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0478 E

DATE OF PROOF:

18/02/14

DATE:

PROOF HISTORY:
v.1 - waymade - 18/02/14

DATE:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 3

Pg 2

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, or children under 6 years old, as limited data are
available in these patient groups.
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 (6 to 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 100mg) 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.
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.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Losartan 50mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

6464/0478 E

DATE OF PROOF:

18/02/14

DATE:

PROOF HISTORY:
v.1 - waymade - 18/02/14

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

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.

5. How to store Losartan Potassium
Losartan Potassium 50 mg tablets should be stored in a dry place below 30°C. in the original packaging. Do
not remove the tablets from the blister strip until you are ready to take your medicine.
Do not use after the expiry date printed on the carton or blister strip. The expiry date refers to the last day of
that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal.
Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will
tell you what to do.
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 further information
Your medicine is called Losartan Potassium 50 mg tablets. Each white oval film-coated tablet contains 50 mg
of the active ingredient, losartan potassium and is marked '952' on one side with a breakline on the reverse.
Losartan Potassium 50 mg tablets also contain the following inactive ingredients:
hydroxypropylmethylcellulose, microcrystalline cellulose, magnesium stearate, lactose, hydroxypropyl
cellulose, carnauba wax, titanium dioxide (E171) and pregelatinised maize starch.
Losartan Potassium 50 mg tablets are available as calendar blister packs of 28 tablets.
POM

PL No: 6464/0478

This product is manufactured by Merck Sharp & Dohme Ltd., Cramlington, Northumberland, England and is
procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 14.2.2014

LOSARTAN POTASSIUM 50 mg TABLETS
Patient Information Leaflet
This product is known as the above name but will be referred to as Losartan Potassium throughout this leaflet.
Other strengths (12.5 mg, 25 mg and 100 mg) are also available.
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 Losartan Potassium is and what it is used for
2. What you need to know before you take Losartan Potassium
3. How to take Losartan Potassium
4. Possible side effects
5. How to store Losartan Potassium
6. Contents of the pack and other information

1.What Losartan Potassium is and what it is used for
Losartan (Losartan Potassium) 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.
Losartan Potassium 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 calledan giotensinconverting-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. Losartan Potassium has
been shown to decrease the risk of stroke (“LIFE indication”).

2. What you need to know before you take Losartan Potassium
Do not take Losartan Potassium
• 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 Losartan Potassium 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 Losartan Potassium.
You must tell your doctor if you think you are (or might become) pregnant. Losartan Potassium 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 Losartan Potassium:











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 Losartan" 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 β-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.

Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Losartan 50mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0478 E

DATE OF PROOF:

18/02/14

DATE:

PROOF HISTORY:
v.1 - waymade - 18/02/14

DATE:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED SEPTEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 2

Children and adolescents
Losartan Potassium has been studied in children. For more information, talk to your doctor. Losartan
Potassium is not recommended for use in children suffering from kidney or liver problems, or children under 6
years old, as limited data are available in these patient groups.
Other medicines and Losartan Potassium
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 Losartan Potassium:




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.
Losartan Potassium with food and drink
Losartan Potassium 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 Losartan Potassium before you become pregnant or as soon as you know
you are pregnant and will advise you to take another medicine instead of Losartan Potassium.
Losartan Potassium 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. Losartan Potassium
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.
Losartan Potassium 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.
Losartan Potassium contains lactose
Losartan Potassium 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 Losartan Potassium
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 Losartan Potassium,
depending on your condition and whether you are taking other medicines. It is important to continue taking
Losartan Potassium 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 Losartan Potassium 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 Losartan Potassium 50 mg or one tablet of
Losartan Potassium 100 mg) once daily. If you have the impression that the effect of losartan is too strong or
too weak, pleas etalk to your doctor or pharmacist.
Use in children and adolescents (6 to 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 Losartan Potassium). 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 Losartan Potassium 50 mg) once a day. The dose
may later be increased to 100 mg losartan (two tablets Losartan Potassium 50 mg or one tablet of Losartan
Potassium 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).

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Adult Patients with Heart Failure
Treatment usually starts with 12.5 mg losartan (one tablet Losartan Potassium 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 Losartan Potassium 50 mg or one tablet
each of Losartan Potassium 100 mg and Losartan Potassium 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
Losartan Potassium").
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 Losartan Potassium until your doctor tells you
otherwise.
If you take more Losartan Potassium 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 Losartan Potassium
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 Losartan Potassium:
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.

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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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