Cozaar ® Comp Tablets

COZAAR COMP is a combination of angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Losartan and hydrochlorothiazide work together to lower high blood pressure. Your doctor has prescribed COZAAR COMP because you have a condition known as hypertension or high blood pressure.

Do not take COZAAR COMP:

• if you are hypersensitive (allergic) to any of its ingredients (see WHAT COZAAR COMP CONTAINS).
• if you have previously been treated with a medication in the same group of medicines as COZAAR COMP (angiotensin receptor antagonists) or with a medication in the group of medicines known as ACE inhibitors and have had allergic reactions with swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing.
• if you have or have had angioedema (swelling of the face, lips, mouth, tongue or throat with or without difficulty in swallowing or breathing) while taking COZAAR COMP or a similar medicine.
• if you have hypertrophic obstructive cardiomyopathy, a heart disorder in which the walls of the ventricles (lower heart chambers) thicken (hypertrophy) and become stiff and the thickened muscle blocks the flow of blood out of the heart.
• if you have severe kidney disease.
• if you have narrowing of the blood vessels to both kidneys or to a single kidney.
• if you have aortic valve stenosis, a narrowing of the aortic valve.
• if you are taking diuretics (water pills) that cause your body to retain potassium such as spironolactone, triamterene and amiloride.
• if you have porphyria.
• Thiazide water tablets in (fixed dose) combination with COZAAR COMP should not be given to patients with Addison's disease. This therapy should also not be used in patients with severe kidney disease or patients not passing urine, and in patients who show allergy to other sulphonamide-derived medicines (ask your doctor if you are not sure what sulphonamide-derived medicines are).
• Lithium therapy (a medicine used to treat a certain kind of depression): Concomitant administration with COZAAR COMP may lead to toxic blood concentrations of lithium.
• if you are pregnant or breastfeeding (see Pregnancy and Breastfeeding).
• if you have liver disease.
• if you are taking a medicine called aliskiren to reduce blood pressure.

Take special care with COZAAR COMP

• If you have or have had medical problems, any allergies, or if you have recently suffered from excessive vomiting or diarrhoea.
• If you have liver or kidney problems, gout, diabetes, lupus erythematosus or if you are being treated with diuretics (water tablets). In these cases, your doctor may need to adjust the dose of your medication.
• If you are taking other medicines that may increase serum potassium (see Taking other medicines with COZAAR COMP).
• Before surgery and anaesthesia (even at the dentist’s office), tell the doctor or dentist that you are taking COZAAR COMP, as there may be a sudden fall in blood pressure associated with the anaesthesia.

Use in children

There is no experience with the use of COZAAR COMP in children. Therefore, COZAAR COMP should not be given to children.

Taking COZAAR COMP with food and drink

COZAAR COMP can be taken with or without food. For convenience and to help you remember, try to take COZAAR COMP at the same time each day.

Take COZAAR COMP every day, exactly as your doctor has instructed. It is important to continue taking COZAAR COMP for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

The usual dose of COZAAR COMP for most patients is one tablet of COZAAR COMP per day. Do not share medicines prescribed for you with any other person.

If you take more COZAAR COMP than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison control centre.

If you forget to take COZAAR COMP

Try to take COZAAR COMP daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule.

COZAAR COMP can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking COZAAR COMP, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking COZAAR COMP and tell your doctor immediately or go to the casualty department at your nearest hospital:

• allergic reaction involving swelling of the face, lips, throat and/or tongue
• rash
• hives.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to COZAAR COMP. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• nausea
• vomiting
• cramping
• diarrhoea
• constipation
• headache
• weakness
• fatigue
• dizziness
• taste disturbances
• dizziness or light headedness due to a sudden drop in blood pressure when standing up quickly
• transient blurred vision
• increased sensitivity of the skin to the sun.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Do not use this medicine after the month and year following EXP.: on the container. Return all unused medicine to your pharmacist. Store COZAAR COMP at or below 30 °C.

Keep blister in carton until required for use. Protect from moisture. Store all medicines out of reach of children. Do not dispose of unused medicine in drains or the sewerage system (e.g. toilets).