patient information leaflet cozaar

PATIENT INFORMATION LEAFLET

COZAAR®

(losartan potassium)

100 mg Film Coated Tablets

50 mg Film Coated Tablets

25 mg Film Coated Tablets

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR TABLETS, EVEN IF YOU HAVE JUST HAD A REPEAT PRESCRIPTION. SOME OF THE INFORMATION IN YOUR PREVIOUS LEAFLET MAY HAVE CHANGED.

Keep this leaflet. You may want to read it again.

WHAT IS IN YOUR TABLETS?

Active ingredients: The active ingredient in ‘Cozaar’ Tablets is losartan. ‘Cozaar’ Tablets are available in three strengths:

‘Cozaar’ 100 mg Tablet is available as a white, teardrop-shaped, film-coated tablet with ‘960’ marked on one side and plain on the other containing 91.6 mg of losartan present as 100 mg of losartan potassium.

‘Cozaar’ 50 mg Tablet is available as a white, oval-shaped, film-coated tablet marked ‘952’ on one side and scored on the other containing 45.8 mg of losartan, present as 50 mg of losartan potassium.

‘Cozaar’ 25 mg Tablet (previously called ‘Cozaar’ Half Strength Tablet 25 mg) is available as a white, oval-shaped, film-coated tablet marked ‘951’ on one side and plain on the other, containing 22.9 mg of losartan, present as 25 mg of losartan potassium.

Other ingredients: Hydroxypropylcellulose E463; hypromellose E464; lactose monohydrate; magnesium stearate E572; microcrystalline cellulose E460; pregelatinised starch; titanium dioxide E171 and carnauba wax.

Although ‘Cozaar’ Tablets contain a very small amount of potassium, they cannot replace potassium supplements. If your doctor has prescribed potassium supplements, continue to follow his or her advice.

‘Cozaar’ Tablets are supplied in packs containing 28 tablets.

HOW DO YOUR TABLETS WORK?

‘Cozaar’ belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a chemical occurring in the body, which tightens your blood vessels making it harder for the blood to pass through them and causing your blood pressure to increase. ‘Cozaar’ blocks this effect of angiotensin II, causing the blood vessels to relax, and so lowers your blood pressure. In patients with high blood pressure, who have developed thickening of the heart muscle, ‘Cozaar’ can help lower the risk of stroke. There are no data to support this effect in black patients.

In patients with type 2 diabetes, where there has been damage to the kidneys (shown by the presence of protein in the urine), ‘Cozaar’ can provide kidney protection by blocking the harmful effects of angiotensin II and slowing the worsening of kidney damage.

WHY DO YOU NEED TO TAKE THESE TABLETS?

Adults

Your doctor has prescribed ‘Cozaar’ because

1) you have hypertension (high blood pressure) or you have hypertension with thickening of the heart muscle (left ventricular hypertrophy)

and/or

2) you have type 2 diabetes with damage to your kidneys (shown by the presence of protein in your urine). In these patients ‘Cozaar’ has been shown to slow the worsening of kidney disease.

Children

There are limited data in children over 6 years old with high blood pressure (see “How should you take ‘Cozaar’?”). Your doctor will have decided if Cozaar is suitable for a particular child with high blood pressure.

See end of leaflet for further information on your condition.

ARE THERE PATIENTS WHO SHOULD NOT TAKE THESE TABLETS?

Yes, do not take the tablets if:

(1) you are or think you may be pregnant
(2) you are planning to become pregnant
(3) you are breast-feeding
(4) you are allergic to any of the ingredients.

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

In addition, ‘Cozaar’ is not recommended in newborn children or in children with liver disease or serious kidney problems. If this is the case, talk to your doctor before administering any tablets to your child.

WHAT ELSE SHOULD YOU KNOW BEFORE TAKING ‘COZAAR’?

The following information applies to both adults and children.

It is important to tell your doctor before taking ‘Cozaar’:

if you suffer from liver or kidney problems
if you have received a kidney transplant
if you have recently suffered from excessive vomiting and/or diarrhoea
if you have a condition called ‘aortic stenosis’ or ‘outflow obstruction’
if you are known to have narrowing or blockage of the blood vessels leading to your kidneys
if you know that you have high levels of potassium in your blood (hyperkalaemia) or you are on a low potassium diet.

CAN YOU TAKE ‘COZAAR’ WITH OTHER MEDICINES?

The following information applies to both adults and children.

‘Cozaar’ does not usually interact with food or most other medicines you may be taking. You should, however, tell your doctor if you are taking potassium supplements, potassium sparing agents, or potassium-containing salt substitutes. Your doctor will decide whether you should take these agents with ‘Cozaar’. In addition you should tell your doctor if you are taking any of the following medicines:

rifampicin used in the treatment of tuberculosis (TB)
fluconazole for the treatment of fungal infections such as thrush
lithium, a drug used to treat certain mental disorders
non-steroidal, anti-inflammatory painkillers (such as ibuprofen, naproxen or diclofenac), COX-2 inhibitors (such as celecoxib, etoricoxib or lumiracoxib) or more than 3 g of aspirin per day
high doses of water-losing tablets (diuretics).

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.

HOW SHOULD YOU TAKE ‘COZAAR’?

‘Cozaar’ should be taken by mouth. You must keep taking ‘Cozaar’ every day and exactly as your doctor has told you. It is important that you take ‘Cozaar’ 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 ‘Cozaar’ with or without food. It is recommended that you take your tablet at the same time each day.

Dose Instructions for Adults

Hypertension in Adults

The usual dose of ‘Cozaar’ for most adult patients is one 50 mg tablet once a day to control blood pressure over the 24-hour period. However, in certain patients such as those over 75 years of age or those with kidney or liver problems, the doctor may prescribe a lower dose of 25 mg once a day.

Alternatively, the doctor may prescribe a higher dose (i.e. 100 mg). Follow your doctor’s instructions exactly.

Hypertension with thickening of the heart muscle in adults

The usual dose of ‘Cozaar’ is 50 mg taken once a day. If necessary, your doctor may also prescribe a low dose of a diuretic and/or increase the daily dose of ‘Cozaar’ to 100 mg.

Type 2 diabetes with kidney disease (protein in the urine) in adults

The usual dose of ‘Cozaar’ is 50 mg once daily. The dose may be increased to 100 mg once daily based on your blood pressure response.

Dose Instructions for Children

Hypertension in Children aged 6 to 16 years old

For children who can swallow tablets, and who weigh between 20 and 50 kg, the recommended dose is 25 mg once daily. The dose can be increased to a maximum of 50 mg once daily.

For children who weigh 50 kg or over, the starting dose is 50 mg once daily. The dose can be increased to a maximum of 100 mg once daily.

The doctor will adjust the dosage according to the weight of the child and their blood pressure response.

WHAT IF YOU FORGET TO TAKE A TABLET OR TAKE TOO MANY?

The following information applies to both adults and children.

Try to take ‘Cozaar’ 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.

If you take too many tablets by mistake, contact your doctor immediately or attend the nearest hospital casualty department.

WHAT UNWANTED EFFECTS COULD ‘COZAAR’ HAVE?

The following information applies to both adults and children.

Any medicine may have unintended or undesirable effects, so-called side effects. They are generally mild and do not normally require treatment to be interrupted. Most patients do not have side effects from ‘Cozaar’; however, some patients may experience liver problems (signs of which may be yellowing of the eyes and skin and flu like symptoms), diarrhoea, muscle and joint pains, anaemia (symptoms may be tiredness or shortness of breath caused by the number of red blood cells or amount of haemoglobin in the blood being below normal) which is usually detected by a blood test, migraine, cough, hives, itchy rash and a rapid lowering in blood pressure (symptoms of which may be lightheadedness, or dizziness particularly when standing up). Rarely, patients have developed thrombocytopenia, which is a decrease in the number of platelets in the blood. The low platelet count may occasionally lead to abnormal (inexplicable) bruising or bleeding.

The most commonly reported side effects in patients with high blood pressure and thickening of the heart muscle were weakness/fatigue, dizziness and vertigo.

The most commonly reported side effects in type 2 diabetic patients with kidney disease (protein in the urine) were weakness/fatigue, dizziness, low blood pressure and high levels of potassium in the blood. Your doctor will take regular blood samples to monitor the levels of potassium in your blood as appropriate.

If you develop any of the effects detailed above, or if you have any other unusual symptoms or feelings, contact your doctor or pharmacist promptly.

Rarely, patients have reported developing an allergic reaction involving swelling of the face, lips, throat and/or tongue, which may cause difficulty in breathing or swallowing; and/or inflammation of blood vessels including inflammation of small veins, causing hard, purple blotches on the skin. If you develop any of these symptoms you should stop taking ‘Cozaar’ and contact your doctor immediately.

It will help if you make a note of what you experienced, when it started and how long it lasted.

HOW SHOULD YOUR TABLETS BE KEPT?

Keep your tablets out of the reach and sight of children.

Do not store your tablets above 30°C. Keep them in the original package.

Do not put the tablets into another container, they might get mixed up.

Do not remove the tablets from the blister pack until you are ready to take the medicine.

Do not take the tablets past the expiry date, which is clearly marked on the pack.

REMEMBER: This medicine is for you. Do not share it with anyone else. It may not suit them.

Information for patients with high blood pressure.

Blood pressure is the term given to the pressure produced by your heart pumping blood to all parts of your body. Your blood pressure is measured by two numbers, e.g. 120/80 mmHg. The top number measures the pressure while your heart beats and the bottom number measures the pressure in between heartbeats.

Normal blood pressure is part of good health. High blood pressure is caused when the blood vessels tighten and the measurement goes above the normal range for your age. There are usually no symptoms of high blood pressure and you will only know you have it if you have had your blood pressure measured.

Although you might feel quite well, if your high blood pressure is not treated, it can damage your heart and kidneys, and in some cases lead to strokes, heart attacks, heart and kidney failure, or blindness.

High blood pressure can be treated and controlled with medicines such as ‘Cozaar’.

In addition to prescribing drug(s) to reduce your blood pressure, your doctor may also recommend that you make some changes to your lifestyle to help your high blood pressure, such as losing weight, avoiding alcohol and smoking, and reducing the amount of salt in your diet. Your doctor may also encourage you to take more mild exercise.

Information for patients with type 2 diabetes and protein in their urine.

Insulin is a hormone produced by the body, necessary for sugar (glucose) to be used as energy. In patients with type 2 diabetes the body’s cells do not respond to the effects of insulin or too little insulin is produced. In either case, glucose (sugar) cannot enter the body’s cells. This causes a buildup of sugar in the blood, which is known as hyperglycaemia or high blood sugar.

Diabetes can damage many parts of the body, including the kidneys. When this happens, the kidneys start to leak protein into the urine. If the kidney damage progresses further, the kidneys lose their ability to remove waste products, such as creatinine and urea, from the blood. If this kidney failure is not stopped, dialysis or kidney transplantation may be required. In type 2 diabetic patients with kidney disease (protein in the urine), ‘Cozaar’ has been shown to slow the worsening of kidney disease and to reduce the need for dialysis or kidney transplantation.

Medicine: cozaar