Zartan Co Film-Coated Tablets

ZARTAN CO is a combination of losartan potassium which belongs to a class of medicines called angiotensin II receptor antagonists, and hydrochlorothiazide which is a diuretic (water tablet). ZARTAN CO keeps blood vessels from narrowing, thereby lowering blood pressure and improving blood flow. ZARTAN CO is used in the treatment of a condition called hypertension or high blood pressure.

Do not take ZARTAN CO:

• if you are hypersensitive (allergic) to losartan, hydrochlorothiazide, other sulphonamides (sulfa medicines) or to any of the ingredients of ZARTAN CO (see section 6)
• if you have a history of previous and/or current basal cell carcinoma and/or squamous cell carcinoma of the skin and lip
• if you are unable to pass or produce urine
• if you have a severe kidney disorder
• if you have a severe liver disorder
• if you have a history of angioedema (condition where severe swelling of the skin tissue occurs under the surface layer of the skin), be it either inherited, with unknown cause or as a result of taking medicines used to inhibit the angiotensin-converting enzyme or to block the angiotensin receptor (you must never again be given these medicines)
• if you have hereditary or idiopathic angioedema (swelling attacks happen regularly without an identifiable cause)
• if you have a condition which affects your blood vessels which decrease blood flow to your brain or your heart
• if your heart muscle does not pump blood as well as it should
• if you have narrowing or blockage of the blood vessels to both kidneys or to a single functioning kidney
• if you suffer from biliary obstruction (a problem with the drainage of the bile from the gall bladder)
• if you are taking fluoroquinolones (type of antibiotic) such as ciprofloxacin or levofloxacin with ZARTAN CO, contact your doctor to re-evaluate your treatment
• if 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)
• if you are taking medicines used to increase urine production which causes an increase of potassium levels in your blood (such as spironolactone, triamterene or amiloride)
• if you have a condition called porphyria
• if you have Addison's disease, characterised by low blood pressure, weight loss, weakness and bronze-like spots on the skin
• if you are receiving therapy with lithium (medicine to treat depression)
• if you have been told that you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment
• if you have diabetes and you are simultaneously using aliskiren (medication used for treatment of high blood pressure), see Other medicines with ZARTAN CO
• if you are pregnant or breastfeeding your baby (see Pregnancy, breastfeeding and fertility).
• Do not use in children as safety has not been established.

Do not share medicines prescribed for you with any other person. Always use ZARTAN CO exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. Take ZARTAN CO every day at the same time, exactly as your doctor has instructed. It is important to continue taking ZARTAN CO for as long as your doctor prescribes it in order to control your blood pressure. Adults: The usual starting and maintenance dose is ZARTAN CO 50/12,5 once daily. For patients who do not respond adequately, the dosage may be increased to two ZARTAN CO 50/12,5 tablets once daily or one ZARTAN CO 100/25 tablet once daily. It may take 3 weeks of using ZARTAN CO before your blood pressure is under control. ZARTAN CO may be taken with or without food. Children: Not applicable. Your doctor will tell you how long your treatment with ZARTAN CO will last. Do not stop treatment early because your high blood pressure may return. If you have the impression that the effect of ZARTAN CO is too strong or too weak, tell your doctor or pharmacist. If you take more ZARTAN CO 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. Symptoms of overdose may include: low blood pressure, abnormal or irregular heartbeat, electrolyte changes in your blood, dehydration. If you forget to take ZARTAN CO Take the missed dose as soon as possible. However, if it is almost time for your next dose, continue to take the next tablet at the usual time. Do not take a double dose to make up for forgotten individual doses. If you stop taking ZARTAN CO This medicine helps control high blood pressure. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke or kidney disease.

ZARTAN CO can have side effects. Not all side effects reported for ZARTAN CO are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using ZARTAN CO, please consult your healthcare provider for advice. If any of the following happens, stop using ZARTAN CO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting (syncope).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ZARTAN CO. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• heart attack (common symptoms are chest pain or discomfort, pressure or tightness in the chest that may spread to your arm, neck, jaw or back)
• increased or fast heart beat (tachycardia), irregular heartbeat, palpitations, chest pain (angina)
• low blood pressure or fainting when getting up from a lying or sitting position (orthostatic hypotension/dizziness), inflammation of blood vessels, often with skin rash
• weakness, fatigue, weight loss, headache (symptoms of a condition called vasculitis)
• kidney problems (passing less urine than is normal for you), abnormal kidney function including inflammation of the kidneys
• pancreatitis (inflammation of the pancreas with symptoms such as stomach pain, increased heart rate and fever)
• hepatitis (inflammation of the liver with symptoms such as nausea, mild fever, abdominal pain), abnormal liver function (clay coloured stool, dark urine, itching, loss of appetite, yellow eyes or skin)
• jaundice (yellow discolouration of the skin and eyes)
• high cholesterol
• electrolyte imbalances, including low blood levels of sodium (hyponatraemia) or low or high levels of potassium (hypokalaemia or hyperkalaemia respectively) in the blood which can cause tiredness, confusion, and fits (convulsion)
• eruption of lesions on the skin or mouth known as erythema multiforme that have a pink-red centre surrounded by a pale ring border and an outer pink-red ring. The lesions can sometimes be painful or itchy
• toxic epidermal necrolysis (TEN) - a life-threatening skin disorder characterised by a blistering and peeling of the skin
• skin and lip cancer (non-melanoma skin cancer), with abnormal growth of skin, bump or sores on the lips that persist for a long period of time
• a granulocytosis (a life-threatening condition that leads to severe infection) results when your body doesn’t make enough white blood cells (symptoms include fever, chills, increased heart rate and breathing, sudden drop in blood pressure, muscle weakness and fatigue, pain and/or ulcers in the mouth and throat and bleeding, inflamed gums).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• upper respiratory tract infections, cough, nasal congestion, sinus disorders, sore throat
• headaches, dizziness, light-headedness tension on the forehead, sides and on the back of the head, tenderness on scalp, neck and shoulder muscles
• abdominal pain, change in taste perception or complete loss of taste, nausea, diarrhoea, indigestion
• back pain, leg pain, muscle cramps, spasms, weakness or pain
• feeling weak and tired, general chest pain, swelling due to fluid retention
• decrease in blood sugar levels (hypoglycaemia) which could include symptoms such as thirst, increased urination, blurred vision, confusion, anxiety and shakiness
• problems sleeping.

Less frequent side effects:

• blood tests showing a decrease in the number of red blood cells, white blood cells, platelets or the amount of haemoglobin (anaemia), and changes in the results of your blood tests
• anorexia, excess amount of uric acid in the blood, gout, which can cause pain in the joints (hyperuricemia)
• mood and/or sleep disorders, confusion, feeling restless and depressed, memory loss, anxiety, panic attack, abnormal dreams, sleepiness
• migraine, weakness, nervousness, tingling sensation in hands, feet or lips (feeling of "pins and needles") which may result in lack of coordination and falling, heaviness in the legs, tremor
• blurred vision, worsening eyesight, conjunctivitis (pink eye), burning/stinging in the eye
• vertigo (loss of balance and dizziness), ringing or buzzing in the ears
• discomfort, pain, or scratchiness in the throat, inflammation of your voice box (larynx), shortness of breath, bronchitis, nose bleeds, runny or blocked nose, sneezing, fluid/mucous in the lungs
• hives, rash, inflammation of the skin, rash, redness of the skin, sensitivity to light, purple-colored spots and patches that occur on the skin
• arm pain, joint swelling and pain, knee pain, muscle and/or bone pain, shoulder pain, stiffness, hip pain, muscle weakness, arthritis, muscle injury
• excess urination during the night, urinary infection, sugar in the urine
• problems with sexual performance
• fever.

The following side effects have been reported but the frequency for them to occur is not known:

• changes in taste
• flatulence (gas), constipation, wind, stomach pain, stomach spasms, dry mouth, vomiting, dental pain
• flu-like symptoms, general sense of being unwell, often accompanied by fatigue, diffuse pain or lack of interest in activities
• inflammation of a salivary gland
• high blood sugar levels (hyperglycaemia)
• seeing things in yellow
• butterfly-shaped red, scaly rash across the cheeks and bridge of the nose.

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

Reporting of side effects If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/Publications/Index/8.

An email can be sent directly to the company, [email protected], to ensure safety of the product. By reporting side effects, you can help provide more information on the safety of ZARTAN CO.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light and moisture. Do not remove from the outer carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).