Cozaar  Tablets

COZAAR is an angiotensin II receptor antagonist which lowers blood pressure. COZAAR also provides kidney protection by delaying the worsening of kidney disease in type 2 diabetic patients with protein in their urine (proteinuria). Kidney disease can be measured by testing the urine for protein. Your doctor has prescribed COZAAR because you have a condition known as hypertension or high blood pressure, or because you have high blood pressure and type 2 diabetes with protein in the urine.

Do not take COZAAR if

• you are allergic to any of its ingredients (listed in Contents of the pack and other information)
• you have had angioedema (swelling of the face, lips, mouth, tongue or throat with or without difficulty in swallowing or breathing) while taking an ACE inhibitor or an angiotensin receptor blocker such as COZAAR
• you have hereditary or idiopathic angioedema
• 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
• you have severe kidney disease
• you have narrowing of the blood vessels to both kidneys, or to a single kidney
• you have aortic stenosis, a narrowing of the aortic valve opening between the left ventricle (large pumping chamber of the heart) and the aorta (the main artery leading away from the heart)
• you are taking diuretics (water pills) that cause your body to retain potassium such as spironolactone, triamterene and amiloride
• you have porphyria
• you take lithium therapy. Concomitant administration with COZAAR may lead to toxic blood concentrations of lithium.
• you have liver disease
• you are pregnant or breastfeeding (see Pregnancy and breastfeeding)
• if you have moderate to severe kidney disease and are prescribed a course of an antibiotic of the fluoroquinolone class for an infection. Ask your doctor what other medicines than COZAAR you should receive to control your blood pressure, or if you should receive a different antibiotic.
• if you have diabetes and are taking the medicine aliskiren to reduce blood pressure.

Warnings and precautions

Talk to your doctor or pharmacist before taking COZAAR if

• you have or have had any medical problems, and any allergies
• you have recently suffered from excessive vomiting or diarrhoea
• you have liver or kidney disease.

Tell your doctor if you are taking other medicines that may increase serum potassium (see Other medicines and COZAAR).

Do not share medicines prescribed for you with any other person. Always take COZAAR exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on the appropriate dose of COZAAR, depending on your condition and whether you are taking other medicines.

High blood pressure
The usual dose of COZAAR for most patients with high blood pressure is 50 mg taken per day to control blood pressure over the 24-hour period.

Type 2 diabetes with protein in the urine
The usual dose of COZAAR for most patients is 50 mg taken once a day. The dose may be increased to 100 mg taken once daily.

COZAAR can be taken with or without food. For convenience and to help you remember, try to take COZAAR at the same time each day. Your doctor will tell you how long your treatment with COZAAR will last. Do not stop treatment early. If you have the impression that the effect of COZAAR is too strong or too weak, tell your doctor or pharmacist.

If you take more COZAAR 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
Try to take COZAAR daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

If any of the following happens, stop taking COZAAR and tell your doctor immediately or go to the casualty department at your nearest hospital: If you develop an allergic reaction such as swelling of the face, lips and/or tongue which may cause difficulty in breathing or swallowing (angioedema). These are all very serious side effects. If you have them, you may have had a serious allergic reaction to COZAAR. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following: Intestinal angioedema (a swelling in the gut presenting with symptoms like abdominal pain, nausea, vomiting and diarrhoea), dizziness, fatigue, light-headedness, rash or hives, taste alteration, vomiting or increased sensitivity of the skin to sun.

Some patients, especially those with type 2 diabetes with protein in the urine, may also develop increased levels of potassium in their blood. If you have kidney disease and type 2 diabetes with protein in the urine, and/or are taking potassium supplements, potassium-sparing agents or salt substitutes containing potassium, talk to your doctor. Your doctor or pharmacist has a more complete list. Tell your doctor or pharmacist promptly about these or any other unusual symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects to the South African Health Products Regulatory Authority (SAHPRA) via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of COZAAR.

Store COZAAR in a dry place at or below 30 ºC. If the temperature rises above 30 ºC for an extended period of time, you may store COZAAR in the refrigerator. Keep the container tightly closed. Do not open the blister pack until you are ready to take the medicine. Store all medicines out of reach of children. Do not use this medicine after the month and year following EXP.: on the carton. Store in the original package in order to protect from oxygen. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).