Cozaar

What Cozaar is and what it is used for

Cozaar Comp is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure. Cozaar Comp is indicated for the treatment of essential hypertension (high blood pressure).

How to take Cozaar

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on the appropriate dose of Cozaar Comp depending on your condition and whether you are taking other medicines. 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. High Blood Pressure The usual dose of Cozaar Comp for most patients with high blood pressure is 1 tablet of Cozaar Comp 50 mg/12.5 mg per day to control blood pressure over the 24-hour period. This can be increased to 2 tablets once daily of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or changed to 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets (a stronger strength) per day. The maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets. Administration The tablets should be swallowed whole with a glass of water. If you take more Cozaar Comp than you should In case of an overdose, contact your doctor immediately so that medical attention may be given promptly. Overdose can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration. 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.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience the following, stop taking Cozaar Comp 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 hospitalisation.

The following side effects have been reported:

Common (may affect up to 1 in 10 people):
• cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder;
• diarrhoea, abdominal pain, nausea, indigestion;
• muscle pain or cramps, leg pain, back pain;
• insomnia, headache, dizziness;
• weakness, tiredness, chest pain;
• increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels;
• changes in kidney function including kidney failure;
• too low sugar in the blood (hypoglycaemia).

Uncommon (may affect up to 1 in 100 people):
• anaemia, red or brownish spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, reduction in white blood cells, clotting problems, reduced number of platelets;
• loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal blood electrolyte levels;
• anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, sleepiness, memory impairment;
• pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting;
• blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in yellow;
• ringing, buzzing, roaring or clicking in the ears, vertigo;
• low blood pressure, which may be associated with changes in posture (feeling light-headed or weak when you stand up, angina (chest pain), abnormal heartbeat, cerebrovascular accident (TIA, “mini-stroke”), heart attack, palpitations;
• inflammation of blood vessels, which is often associated with a skin rash or bruising;
• sore throat, breathlessness, bronchitis, pneumonia, water on the lungs (which causes difficulty breathing), nosebleed, runny nose, congestion;
• constipation, obstipation, wind, stomach upsets,stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache;
• jaundice (yellowing of the eyes and skin), inflammation of the pancreas;
• hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss;
• pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness;
• frequent urination including at night, abnormal kidney function including inflammation of the kidneys, urinary tract infection, sugar in the urine;
• decreased sexual appetite, impotence;
• swelling of the face, localised swelling (oedema), fever.

Rare (may affect up to 1 in 1,000 people):
• hepatitis (inflammation of the liver), abnormal liver function tests.

Not known (frequency cannot be estimated from the available data):
• flu-like symptoms;
• unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis);
• low levels of sodium in the blood (hyponatraemia);
• generally feeling unwell (malaise);
• disturbed taste (dysgeusia).

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: [email protected] Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

How to Store Cozaar

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the container. The expiry date refers to the last day of that month. Blisters Store Cozaar Comp in the original package in order to protect from light and moisture. Do not store the package above 30°C. Bottle Store in the original container in order to protect from light. Keep the bottle tightly closed in order to protect from moisture. Do not store the bottle above 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.