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GB 726-9970-APIL

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan Potassium 25 mg film-coated tablets Losartan Potassium 50 mg film-coated tablets Losartan Potassium 100 mg film-coated tablets

Losartan potassium

The name of your medicine is Losartan Potassium 25, 50,100 mg film-coated tablets, which will be referred to as Losartan Potassium tablets throughout the rest of this document.

Read all of this leaflet carefully before you start taking 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 becomes severe, 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 take Losartan Potassium tablets

3.    How to take Losartan Potassium tablets

4.    Possible side effects

5.    How to store Losartan Potassium tablets

6.    Further information

1.    WHAT LOSARTAN POTASSIUM TABLETS ARE AND WHAT THEY ARE USED FOR

Losartan 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 (narrow). This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax (widen) 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 tablets are used:

•    to treat high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years old;

•    to protect the kidney in patients with high blood pressure and type 2 diabetes who have laboratory evidence of impaired renal function and proteinuria > 0.5 g per day (a condition in which urine contains an abnormal amount of protein).

This medicine may also be authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.

2.    BEFORE YOU TAKE LOSARTAN POTASSIUM TABLETS Do not take Losartan Potassium tablets if:

•    you are allergic (hypersensitive) to losartan or any of the other ingredients in the tablets (see Section 6 for a full list of ingredients);

•    you suffer from severe liver problems;

•    you are, think you may be or are planning to become pregnant (see also ‘Pregnancy and breastfeeding');

•    you are more than 3 months pregnant. It is also better to avoid taking Losartan Potassium tablets in early pregnancy (see also ‘Pregnancy and breast-feeding').

Take special care with Losartan Potassium tablets

It is important to tell your doctor before taking this medicine if you:

•    have had a history of angioedema (swelling of the face, lips, throat and/or tongue) (see also section 4 ‘Possible side effects');

•    have suffered from excessive vomiting (being sick) or diarrhoea leading to a loss of fluid and/or salt in your body;

•    are taking diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are on a low salt diet (see section 3 ‘Dosage in special patient groups');

•    have a narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant recently;

•    have problems with the way your liver works (see sections 2 ‘Do not take Losartan Potassium tablets' and 3 ‘Dosage in special patient groups');

•    suffer from heart failure, with or without kidney problems or accompanying severe life threatening cardiac arrhythmias (irregular heart rhythm). You will need to take special care when taking this medicine if you are also taking beta-blockers (used to treat high blood pressure and some heart problems);

•    have problems with your heart valves or heart muscle;

•    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);

•    suffer from primary hyperaldosteronism (a condition where your adrenal gland produces too much of the hormone aldosterone).

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.

Take particular care if you are taking the following medicines while under treatment with Losartan Potassium tablets:

•    other blood pressure lowering medicines, as they may reduce your blood pressure further. Blood pressure may also be lowered by one of the following drugs/class of drugs: tricyclic antidepressants, antipsychotics, baclofen (used in treatment of spasticity), amifostine (used in chemotherapy);

•    medicines which may raise the levels of potassium in your body (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamteren, spironolactone] or heparin);

•    non-steroidal anti-inflammatory drugs (that are used to relieve pain and inflammation) such as indomethacin and cox-2-inhibitors, as they may reduce the blood lowering effect of this medicine. If your kidneys do not work properly, using these medicines together may make the problem worse;

•    lithium containing medicines (used to treat mania) should not be taken in combination with these tablets without close supervision by your doctor. You may need to have regular blood tests to make sure that you are taking the right dose of lithium.

Taking Losartan Potassium tablets with food and drink

These tablets may be taken with or without food.

Pregnancy and breast-feeding Pregnancy

You must tell your doctor if you think you are (or may 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 suggest you take another medicine instead of Losartan Potassium tablets. These tablets are not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as they 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 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

This medicine can be used in children for to treat certain conditions. Please speak to your doctor for further information if your child has been prescribed these tablets.

Use in black patients

This medicine is less effective in lowering blood pressure in black patients and the dose may need to be adjusted in this group of patients.

Driving and using machines

These tablets are unlikely to affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, this medicine may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.

Important information about some of the ingredients of Losartan Potassium tablets

This medicine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

3. HOW TO TAKE LOSARTAN POTASSIUM TABLETS

Always take Losartan Potassium tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will decide on the appropriate dose, depending on your condition and whether you are taking other medicines. It is important to continue taking Losartan Potassium tablets for as long as your doctor prescribes them in order to maintain smooth control of your blood pressure.

Adult patients with high blood pressure

The usual starting dose is 50 mg losartan (one Losartan Potassium 50 mg tablet) 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 Losartan Potassium 50 mg tablets) once daily.

If you are concerned about the dose of medicine you have been prescribed, please talk to you 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 25 mg of losartan once a day. In patients who weigh more than 50 kg, the usual dose is 50 mg once daily. The doctor may increase the dose if blood pressure is not controlled. Doses above 100 mg daily have not been studied in children.

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 Losartan Potassium 50 mg tablet) once a day. The dose may later be increased to 100 mg losartan (two Losartan Potassium 50 mg tablets) once daily depending on your blood pressure response.

Losartan Potassium tablets 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).

Dosage in special patient groups

When starting treatment in certain patients, such as those taking high doses of diuretics, patients with liver problems, or those over the age of 75 years, the doctor may recommend a lower dose.

Losartan Potassium tablets are not recommended in patients with severe liver problems (see section ‘Do not take Losartan Potassium tablets').

If this medicine has been prescribed for a child or adolescent, the doctor will decide the appropriate dose for them to take.

How to take the tablets

The tablets should be swallowed with a glass of water. You should try to take your dose at about the same time each day. It is important that you continue to take Losartan Potassium tablets until your doctor tells you otherwise.

If you take more Losartan Potassium tablets than you should

If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately. Symptoms of overdose are related to a fall in blood pressure, such as dizziness or feeling faint and changes in heart rate, which may get faster or slower.

If you forget to take Losartan Potassium tablets

If you accidentally miss a dose, just take the next dose when it is due. Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Losartan Potassium tablets can cause side effects, although not everybody gets them.

If you experience the following, stop taking the 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 hospitalization.

The following side effects have been reported:

Common (may affect up to 1 in 10 people):

•    dizziness;

•    low blood pressure;

•    weakness (debility);

•    fatigue;

•    occasional low blood sugar levels (hypoglycaemia);

•    too much potassium in the blood (hyperkalemia);

•    changes in kidney function including kidney failure;

•    reduced numbers 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):

•    drowsiness (somnolence);

•    headache;

•    sleep disorders;

•    feeling of increased heart rate (palpitations);

•    severe chest pain (angina pectoris);

•    low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or those taking a high dose of diuretics);

•    dizziness upon standing due to a fall in blood pressure when rising from a lying or sitting position;

•    shortness of breath (dyspnoea);

•    abdominal pain;

•    severe constipation (obstipation);

•    diarrhoea;

•    nausea;

•    vomiting;

•    hives (urticaria);

•    itching (pruritus);

•    rash;

•    localised swelling (oedema);

•    cough.

Rare (may affect up to 1 in 1,000 people):

•    hypersensitivity;

•    angioedema;

•    inflammation of blood vessels (vasculitis including Henoch-Schoenlein purpura);

•    numbness or tingling sensation (paraesthesia);

•    fainting (syncope);

•    very rapid and irregular heartbeat (arterial fibrillation) and stroke;

•    inflammation of the liver (hepatitis);

•    elevated blood alanine aminotransferase (ALT) levels (a type of liver enzyme).This would be detected by a blood test and levels usually go back to normal once treatment is stopped.

Not known (cannot be estimated from the available data):

•    reduced number of thrombocytes (thrombocytopenia), common signs of which are unusual bruising or bleeding under the skin;

•    migraine;

•    problems with the way your liver works;

•    muscle and joint pain;

•    flu-like symptoms;

•    increase in blood urea;

•    increase in serum creatinine and serum potassium in patients with heart failure. This would be detected by a blood test;

•    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).

Side effects in children are similar to those seen in adults.

If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE LOSARTAN POTASSIUM TABLETS

Keep out of the reach and sight of children.

Do not use Losartan Potassium tablets after the expiry date which is stated on the blister and carton.

The expiry date refers to the last day of that month.

There are no special storage conditions for these tablets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Losartan Potassium tablets contain

-    The active substance is losartan potassium.

Each Losartan Potassium 25 mg tablet contains 25 mg of losartan potassium.

Each Losartan Potassium 50 mg tablet contains 50 mg of losartan potassium.

Each Losartan Potassium 100 mg tablet contains 100 mg of losartan potassium.

-    The other ingredients are:

Tablet core: Lactose monohydrate, microcrystalline cellulose (E460), pregelatinised starch and magnesium stearate (E572).

Tablet film-coating: Hypromellose (E464), titanium dioxide (E171) and hydroxypropylcellulose (E463).

What Losartan Potassium tablets look like and contents of the pack

Appearance of the tablets:

Losartan Potassium 25 mg tablets are white to off-white, oval shaped, film-coated tablets, debossed with “J” on one side and “25” on the other side.

Losartan Potassium 50 mg tablets are white to off-white, oval shaped, film-coated tablets, debossed with “J” on one side and “50” on the other side.

Losartan Potassium 100 mg tablets are white to off-white, capsule shaped, film-coated tablets, debossed with “J” on one side and “100” on the other side.

Pack sizes:

10, 28, 30, 50, 56, 90, 98 and 100 tablets in blisters of 10 or 14 tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Waymade Healthcare Plc trading as Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom

Manufacturer

PSI supply nv, Axxes Business Park, Guldensporenpark 22, Block C, 9820 Merelbeke, Belgium.

Waymade Healthcare Plc, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom

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