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LOSARTAN POTASSIUM 12.5MG FILM-COATED TABLETS

Active substance(s): LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LOSARTAN
LOSARTAN
LOSARTAN
LOSARTAN

POTASSIUM
POTASSIUM
POTASSIUM
POTASSIUM

12.5 MG FILM-COATED TABLET
25 MG FILM-COATED TABLET
50 MG FILM-COATED TABLET
100 MG FILM-COATED TABLET

Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Losartan Potassium Tablets are and what they are used for
2. Before you use Losartan Potassium Tablets
3. How to take Losartan Potassium Tablets
4. Possible side effects
5. How to store Losartan Potassium Tablets
6. Further information

Patients with High Blood Pressure
The usual dose of Losartan Potassium Tablets for most patients is one 50 mg tablet once a day. The maximal reduction in blood pressure
should be reached 3-6 weeks after starting treatment. In some patients, the doctor may prescribe a higher dose (such as 100 mg). Follow your
doctor's instructions exactly. If you have the impression that the effect of Losartan Potassium Tablets is too strong or too weak, tell your doctor
or pharmacist.
Patients with High Blood Pressure and Type 2 diabetes
The usual starting dose of Losartan Potassium Tablets is 50 mg once daily. The dose may be increased to 100 mg once daily depending onyour
blood pressure response.
Losartan Potassium Tablets may be given with other medicines used to lower blood pressure, as well as insulin and other medicines which
decrease the level of glucose in the blood.
Patients with Heart Failure
Treatment usually starts with 12.5mg of losartan once a day. Generally, the dose is increased gradually (i.e. 12.5mg daily during the first week,
25mg daily during the second week and 50mg daily during the third week).
In the treatment of heart failure, losartan is usually given with a diuretic (medicine that increases the amount of water which you pass 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
In patients over 75 years of age, the doctor may prescribe a lower dose.
A lower dose may also be prescribed in patients given high doses of diuretics or in patients with liver disorders. The use of losartan should not
be given to patients with severe liver problems (see section 2, "Do not take Losartan Potassium Tablets if..").
Keep taking the medicine until your doctor tells you to stop. Do not stop taking the tablets just because you feel better. If you stop taking them
your condition may get worse.

1. What Losartan Potassium Tablets are and what they are used for
The name of your medicine is Losartan Potassium 12.5mg Film-Coated Tablets, Losartan Potassium 25mg Film-Coated Tablets, Losartan
Potassium 50mg Film-Coated Tablets or Losartan Potassium 100mg Film-Coated Tablets. They are prescribed for the treatment of high
blood pressure.

If you take more Losartan Potassium Tablets than you should
Contact your nearest hospital casualty department or your doctor immediately for advice if you have swallowed too many tablets or if you think
a child has swallowed any.

Losartan Potassium belongs to a group of medicines known as angiotensin-II antagonists.

Take this leaflet, and any tablets that you still have to show the doctor.
An overdose of this medicine may be dangerous; the symptoms of overdose are low blood pressure, increased heartbeat or possibly a
decreased heartbeat.

In patients with type 2 diabetes, where there has been damage to the kidneys (shown by the presence of protein in the urine), Losartan
Potassium (can provide kidney protection by blocking the harmful effects of angiotensin II (a chemical in the body which tightens blood
vessels causing blood pressure to increase) and slowing the worsening of kidney damage.
Losartan Potassium is also used to treat chronic heart failure if another medicine, called an ACE inhibitor, is not considered to be suitable by
your doctor. If your heart failure has been stabilised with an ACE inhibitor, you should not be switched to losartan potassium.

If you forget to take Losartan Potassium Tablets
Try to take Losartan Potassium Tablets daily as prescribed. However, if you miss a dose, just carry on with the next dose as normal. Do not take
an extra tablet to make up for a forgotten tablet.

Losartan potassium is also used to treat patients with high blood pressure and a thickening of the left ventricle of the heart, to reduce the risk
of a stroke.

4. Possible side effects
Like all medicines Losartan Potassium may cause side effects. They are generally mild and do not normally need treatment. Stop taking
Losartan Potassium and contact your doctor or pharmacist immediately if you develop any of these symptoms:
! an allergic reaction, causing swelling of the face, lips, throat which may cause difficulty in breathing or swallowing.

Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have
the same effect.
2. Before you use Losartan Potassium Tablets
Do not take Losartan Potassium Tablets if
! you are more than 3 months pregnant. (It is also better to avoid Losartan Potassium Tablets in early pregnancy - see pregnancy section.)
! you have a liver disorder
! if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
! you are allergic to losartan potassium or any of the other ingredients (see section 6 of this leaflet).
Tell your doctor if any of the above conditions apply to you, before you take Losartan Potassium Tablets.
Take Special Care (check with your doctor) with Losartan Potassium Tablets if
! you suffer from liver problems (see section 2 of this leaflet "Do not take Losartan Potassium Tablets if " and section 3 "Dosage in special
patient groups")
! you suffer from heart disease (caused by a reduced blood flow in the blood vessels of the heart), or problems with your heart valves or
heart muscle
! you suffer from heart failure; special caution is necessary if you are being treated with beta-blockers (medicines used to treat some heart
problems or to reduce blood pressure)
! you have a reduced blood flow to the brain (cerebrovascular disease)
! you have received a kidney transplant
! you suffer from excessive vomiting and/or diarrhoea leading to an extreme loss of fluid and/or salt from your body
! you are known to have narrowing or blockage of the blood vessels leading to your kidneys
! you know that you have high levels of potassium in your blood (hyperkalaemia) or you are on a low potassium diet.
! you have a history of angiooedema (swelling of the face, lips, throat, and/or tongue); see also section 4 of this leaflet ("Possible Side
Effects")
! you are taking diuretics (medicines used to increase the amount of water that you pass out through your kidneys) or if you are under a
special diet to reduce your salt intake (see section 3 of this leaflet; "Dosage in special patient groups")
! you have a disorder of the adrenal gland (a condition known as hyperaldosteronism caused by increase in secretion of the hormone
aldosterone by the adrenal gland) "
! you think you are (or might become) pregnant. Losartan Potassium Tablets are 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).
! you are taking any of the following medicines used to treat high blood pressure:
, an "ACE-inhibitor" (for example enalapril, lisinopril, ramipril etc.), in particular if you have diabetes-related kidney problems.
, aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular
intervals.
See also information under the heading "Do not take Losartan Potassium Tablets".
Taking other medicines
Tell your doctor if you are taking any of the following medicines:
! other medicines which can lower blood pressure (as they may additionally reduce your blood pressure), e.g. tricyclic antidepressants,
baclofen, amifostine, antipsychotics (for the treatment of mental disorders)
! lithium, a medicine used to treat certain mental disorders; if you are taking lithium as well as losartan, your doctor will need to supervise
you carefully and you may need regular blood tests
! non-steroidal anti-inflammatory painkillers (such as indometacin) and COX-2 inhibitors (such as celecoxib, etoricoxib or lumiracoxib) as
they may reduce the effect of losartan potassium tablets
! medicines which retain potassium or which may increase potassium levels, such as potassium supplements, potassium sparing
medicines (e.g. heparin or certain diuretics like amiloride, triamterene and spironolactone) or potassium-containing salt substitutes.
Your doctor may need to change your dose and/or take other precautions:
if you are taking an ACE-inhibitor or aliskiren (see also information under the headings "Do not take Losartan Potassium" and "Take
special care").

!

If your kidney function is reduced and you take any of the above medicines together with Losartan Potassium Tablets, it may make your
kidney problem worse.
You should also tell your doctor about all medicines that you are taking or plan to take. This includes any medicines obtained without a
prescription, herbal medicines or natural health products.
Taking Losartan Potassium Tablets with Food and Drink
Losartan Potassium Tablets 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 Tablets 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 Tablets. Losartan Potassium Tablets are 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 in the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan Potassium Tablets are 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 newborn, or
was born prematurely.
Use in children and adolescents:
Ask your doctor for information about the use of Losartan Potassium Tablets in children.
Driving and using machines
Losartan Potassium Tablets are unlikely to affect your ability to drive or use machines. However, Losartan Potassium Tablets may cause
dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before attempting such activities.
Important information about some of the ingredients of Losartan Potassium Tablets Tablets
If you have an allergy to any of the ingredients of Losartan Potassium Tablets (see "Further Information" below), contact your doctor before
taking this medicine.
3. How to take Losartan Potassium Tablets
You must take your tablets as instructed by your doctor who will decide on the appropriate dose depending on your condition and whether you
are taking other medicines. Losartan Potassium Tablets should be taken by mouth with a drink of water. You must keep taking Losartan
Potassium Tablets every day and exactly as your doctor has told you. It is important that you take Losartan Potassium Tablets for as long as
your doctor prescribes it, in order to keep your blood pressure controlled and/or protect your kidneys from worsening damage. You can take
the tablets with or without food. It is recommended that you take your tablets at the same time each day.

This is a serious but rare side effect, which affects more than 1 in 10,000 patients but fewer than 1 in1,000 patients. You may need urgent
medical attention or hospitalisation.
The side effects of medicines are classified as follows:
very common:
happening in more than 1 in 10 patients
common:
happening in 1 in 100 to 1 in 10 patients
uncommon:
happening in 1 in 1,000 to 1 in 100 patients
rare:
happening in 1 in 10,000 to 1 in 1,000 patients
very rare:
happening in less than 1 in 10,000 patients
not known:
(cannot be estimated from the available data)
The following side effects have been reported with Losartan Potassium:Common:
! spinning sensation
! feeling dizzy
! low blood pressure (due to excessive loss of water from the body)
! weakness or feeling very tired
! too little sugar in the blood (hypoglycaemia)
! too much potassium in the blood (hyperkalaemia)
! Your doctor will take regular blood samples to monitor the levels of potassium in your blood.
Uncommon:
! drowsiness
! shortness of breath
! headache
! abdominal pain
! severe constipation
! nausea (feeling sick), vomiting (being sick)
! sleep problems
! localised swelling (oedema)
! diarrhoea
! feeling of increased heart rate (palpitations)
! hives, itching or rash
! severe chest pain (angina)
! a rapid drop in blood pressure (symptoms of which may be feeling light-headed or dizzy, particularly when standing up).
Rare:
! inflammation of the blood vessels including inflammation of small veins, causing hard, purple blotches on the skin
! numbness or tingling sensation (paraesthesia)
! fainting
! irregular or rapid heartbeat
! stroke
! inflammation of the liver (hepatitis)
! elevated blood enzyme levels (can be reversible upon stopping treatment).
Frequency not known:
! anaemia - symptoms may be feeling tired or short of breath (a blood test will confirm this)
! a cough
! migraine
! muscle and joint pains
! liver problems (yellowing of the eyes and skin and flu-like symptoms)
! flu like symptoms
! back pain and urinary tract infection
! increase in blood urea, serum creatinine and serum potassium in patients with heart failure
! changes in kidney function including kidney failure (may be reversible upon stopping treatment)
! a reduction in the number of platelets in the blood. This may occasionally lead to abnormal (unexpected) bruising or bleeding.
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 Website 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 Losartan Potassium Tablets
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
On the label you will find the letters "EXP" followed by some numbers. These numbers are the date when the medicine is no longer fit for use.
Do not use this medicine after this date.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines which you no
longer require. These measures will help to protect the environment.
6. Further information
What Losartan Potassium Tablets contain
The active substance is losartan potassium. Each 12.5mg, 25mg, 50mg or 100mg film-coated tablet contains 12.5mg, 25 mg, 50mg or 100mg
of losartan potassium respectively.
The other ingredients are:
microcrystalline cellulose (E460), sodium stearyl fumarate, croscarmellose sodium, colloidal anhydrous silica, hypromellose (E464),
polyoxyethylene stearate, titanium dioxide (E171).
What Losartan Potassium Tablets look like and contents of the pack
Losartan Potassium 12.5mg Tablet is a white, round, biconvex, film-coated tablet.
Losartan Potassium 25 mg Tablet is a white, oblong, biconvex, non-scored film-coated tablet.
Losartan Potassium 50 mg Tablet is a white, oval, biconvex, scored film-coated tablet (the tablets can be divided into two equal halves).
Losartan Potassium 100 mg Tablet is a white, oblong, biconvex, non-scored film-coated tablet.
Losartan Potassium Tablets are available in packs containing 28 tablets in blister strips.
Marketing Authorisation Holder
Chanelle Medical UK Limited, The Lodge, Stanford Bridge Farm, Station Road, Pluckley, Ashford, Kent, TN27 0RU, United Kingdom
Manufacturer:
Sofarimex Industria Quimica e Farmaceutica Lda., Av. Industrias, Alto do Colaride Agualva 2735-213 Cacem Portugal
This leaflet was prepared in May 2015

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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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