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Document: leaflet MAH GENERIC_PL 18110-0019 change

• leaflet MAH GENERIC_PL 18110-0019
• leaflet MAH GENERIC_PL 21880-0139

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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 yourcondition 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.

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

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.

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.

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 orto reduce blood pressure)

•    you have a reduced blood flowto the brain (cerebrovasculardisease)

•    you have received a kidney transplant

•    you sufferfrom 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"(forexampleenalapril, lisinopril, ramipriletc.), 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 othermedicines

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 (forthe 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 orwithoutfood.

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 doctorfor 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. Howto 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.

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.

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.

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.

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.

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 orhospitalisation.

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 waterfrom 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 longerfitforuse. Do not use this medicine afterthis 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 leafletwas prepared in May 2015

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