Adco Zetomax Co Tablets

ADCO ZETOMAX CO is used to treat high blood pressure in patients using the same medicines as contained in ADCO ZETOMAX CO individually and in the same amounts.

ADCO ZETOMAX CO contains two medicines namely lisinopril dihydrate and hydrochlorothiazide. Lisinopril dihydrate is known as an angiotensin converting enzyme (ACE) inhibitor and hydrochlorothiazide as a diuretic (water tablet).

Both these medicines help to control high blood pressure in different ways.

Do not take ADCO ZETOMAX CO:

• if you are hypersensitive (allergic) to lisinopril dihydrate or hydrochlorothiazide or any of the other ingredients of ADCO ZETOMAX CO (listed in section 6).
• if your kidneys fail to produce urine (anuria).
• if you have a history of swelling under the skin (angioedema) relating to previous treatment with an ACE-inhibitor or medicines known as angiotensin receptor blockers (ARBs). These patients must never use these medicines again.
• if you have a disorder that results in regular outbreaks of severe swelling (hereditary angioedema) or swelling that occurs for no reason at all (idiopathic angioedema).
• if you are hypersensitive (allergic) to other sulphonamide-derived medicines (medicines similar to hydrochlorothiazide).
• if you are pregnant or breastfeeding your baby.
• if you have a heart condition known as aortic stenosis (narrowing of the valve in the large blood vessel that branches of to the heart; also known as the aorta) or hypertrophic obstructive cardiomyopathy (increase in the thickness of the heart muscle).
• if you have severe kidney problems.
• if you have severe liver problems.
• if you have moderate to severe kidney problems or if you are old and you are also taking a fluoroquinolone antibiotic together with an ACE-inhibitor or ARB.
• if you suffer from a severe kidney disorder where the blood vessels of both kidneys are narrowed (bilateral renal artery stenosis) or if you only have one kidney left of which the blood vessels are narrowed (unilateral renal artery stenosis).
• if you are also taking water tablets (diuretics) such as spironolactone, triamterene or amiloride.
• if you have a rare hereditary blood disorder known as porphyria.
• if you are currently taking lithium (a medicine used to treat depression or mood disorders). Taking lithium with ADCO ZETOMAX CO may lead to toxic blood concentrations of lithium.
• if you are being treated with a blood pressure lowering medicine called aliskiren.
• if you have previously had or currently have cancer of the skin and/or lip.

Warnings and precautions

Take special care with ADCO ZETOMAX CO:

• if you are pregnant or trying to fall pregnant. You should use a different medicine to control your high blood pressure.
• if you are also taking any of the following medicines to treat your high blood pressure: an ARB (for example valsartan, telmisartan) or aliskiren. When these medicines are used together, it may increase the risk for you to have very low blood pressure and can increase the amount of potassium in your blood. It can also decrease your kidney function.
• if you have low blood pressure (hypotension), which is likely to occur if you are dehydrated (excessive loss of body water) or have a salt deficiency due to diuretic therapy (water tablets), low-salt diet, dialysis, diarrhoea or vomiting.
• if you have heart problems that is caused by narrowed heart arteries (ischaemic heart disease). A lowered blood pressure in these patients may lead to a heart attack.
• if you have a condition that affects the blood flow and the blood vessels in the brain (cerebrovascular disease). A lowered blood pressure in these patients may lead to a stroke.
• if you experience any of the following: dry mouth, thirst, weakness, a lack of energy, drowsiness, muscle pain, cramps or weakness, low blood pressure, less urine production, increased heart rate, nausea and vomiting. You may be experiencing an electrolyte imbalance which is caused by the hydrochlorothiazide contained in ADCO ZETOMAX CO.
• if you have reduced kidney function, diabetes (high blood sugar) or if you are also using medicines such as potassium-sparing diuretics (water tablets), potassium supplements, potassium-containing salt substitutes, heparin or co-trimoxazole. The levels of potassium in your blood may increase if one or more of the above is applicable to you while taking ADCO ZETOMAX CO.
• if you are currently using a diuretic (water tablet). The diuretic therapy must first be stopped and only after 2 to 3 days may you start to use ADCO ZETOMAX CO.
• if you have had a kidney transplant. You should not use ADCO ZETOMAX CO since no information is available on these kinds of patients.
• if you are undergoing dialysis for kidney failure. ADCO ZETOMAX CO should not be used in this instance as it may cause an allergic reaction.
• if you have liver disease.
• if you are going to have major surgery or during anaesthesia.
• if you have diabetes (high blood sugar). Your doctor may change the dose of your medicine used to control your blood sugar.
• if you have been told that you have high levels of calcium.
• if you have been told that you have high levels of triglycerides (type of fat that circulates in blood) or cholesterol in your blood.
• if you have or have ever had gout.
• if you experience swelling of the face, arms and legs, lips, tongue and/or throat (angioedema). The use of ADCO ZETOMAX CO should be stopped immediately if this happens to you.
• if you are also taking a type of medicine known as mTOR inhibitors (sirolimus, everolimus, temsirolimus). You may experience swelling of the airways or tongue which might make it difficult for you to breathe.
• if you have or have had asthma.
• if you have or have had a condition known as systemic lupus erythematosus (a condition affecting the skin, joints and kidneys).
• if you are of black origin as ADCO ZETOMAX CO may be less effective and you also may have a higher risk of developing angioedema (swelling of the face, arms and legs, lips, tongue and/or throat).
• if you are having or are going to have treatment to lower the effects of an allergy such as insect stings (desensitisation treatment). Taking ADCO ZETOMAX CO while you are having this treatment may cause a severe allergic reaction.
• if you have collagen vascular disease (your body’s immune system attacks its own skin, tissues and organs), are on immunosuppressant therapy, or are using allopurinol or procainamide (or a combination of the above).
• if you have a persistent cough. This may be because of the lisinopril contained in ADCO ZETOMAX CO.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking ADCO ZETOMAX CO.
• if you are also taking a type of antibiotic known as fluoroquinolones (ciprofloxacin, moxifloxacin, levofloxacin). Your doctor should assess your kidney function before you use these antibiotics with ADCO ZETOMAX CO.
• if you need to take an anti-doping test as the hydrochlorothiazide in ADCO ZETOMAX CO may produce a positive analytic test.

Children

Safety and efficacy in children have not been established.

Other medicines and ADCO ZETOMAX CO

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) If you are taking any of the following medicines with ADCO ZETOMAX CO, tell your doctor, pharmacist or health care professional:

• Other medicines for your high blood pressure such as an ARB (for example valsartan, telmisartan) and/or aliskiren.
• Medicines known as mTOR inhibitors (everolimus, sirolimus, temsirolimus), neutral endopeptidase (NEP) inhibitors (racecadotril) or plasminogen activators.

Do not share medicines prescribed for you with any other person. Always take ADCO ZETOMAX CO exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is one tablet daily of either ADCO ZETOMAX CO 10/12,5 or ADCO ZETOMAX CO 20/12,5 (depending on which strength was prescribed to you by your doctor).

If your blood pressure does not lower after 2 to 4 weeks with one tablet daily of either ADCO ZETOMAX CO 10/12,5 or ADCO ZETOMAX CO 20/12,5 then your doctor might increase your dose to either one of the following:

• ADCO ZETOMAX CO 10/12,5: a maximum of two tablets, administered once a day.
• ADCO ZETOMAX CO 20/12,5: a maximum of two tablets, administered once a day.
• ADCO ZETOMAX CO 20/25: a maximum of one tablet a day.

Your first dose of ADCO ZETOMAX CO may cause a greater fall in blood pressure than later doses. This is also more likely to occur in patients that are dehydrated as a result of prior diuretic (water tablets) therapy. If possible, only start you’re your ADCO ZETOMAX CO 2 to 3 days after you have stopped using your water tablets. If this is not possible, please speak to your doctor so that the correct decision can be made on how to treat your high blood pressure.

ADCO ZETOMAX CO should not be used as initial therapy in any patient with kidney problems. ADCO ZETOMAX CO is not recommended for the use in children. Your doctor will tell you how long your treatment with ADCO ZETOMAX CO will last. Do not stop treatment early. If you have the impression that the effect of ADCO ZETOMAX CO is too strong or too weak, tell your doctor or pharmacist.

If you take more ADCO ZETOMAX CO than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. You may experience the following symptoms if you take more ADCO ZETOMAX CO than you should:

• Low blood pressure.
• Circulatory shock (confusion, sweating and rapid breathing).
• Electrolyte disturbances which can lead to you having the following: dry mouth, thirst, weakness, a lack of energy, drowsiness, muscle pain, cramps or weakness, low blood pressure, less urine production, increased heart rate, nausea and vomiting.
• Kidney failure.
• Rapid breathing.
• Increased or decreased heartbeat or feelings of having a fluttering or pounding heart.
• Dizziness.
• Anxiety.
• Cough.
• Increased urine production.
• Depression of consciousness (including coma).
• Convulsions.
• Weakened or impaired muscle movement.
• Irregular heartbeat.

Treatment of overdose is symptomatic and supportive. The recommended treatment of overdose is intravenous infusion of normal saline solution. If you get very low blood pressure, you should be placed on your back. If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered. If ingestion is recent, take measures aimed at eliminating lisinopril (e.g. induce vomiting, administration of absorbents and sodium sulphate).

Therapy with ADCO ZETOMAX CO should be discontinued and the patient should be kept under very close supervision. Lisinopril may be removed from the general circulation by haemodialysis (your blood is diverted into an external machine, where it is filtered before being returned to the body). Pacemaker therapy is indicated for therapy-resistant bradycardia (slow heartbeat). Vital signs, serum electrolytes and creatinine concentrations should be monitored frequently. Atropine administration may also help for your slow heartbeat.

If you forget to take ADCO ZETOMAX CO

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking ADCO ZETOMAX CO

Do not stop taking ADCO ZETOMAX CO, even if you are feeling better.

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

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

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

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

Tell your doctor if you notice any of the following:

Fixed dose combination (lisinopril and hydrochlorothiazide):

• headache, dry mouth
• dry cough
• muscle cramps

• swelling of the face, hands and feet, lips, tongue and throat
• gout
• burning or prickling sensation that is usually felt in the hands, arms, legs, or feet, but can also occur in other parts of the body, dizziness and feeling constant tiredness or weakness, abnormal physical weakness or lack of energy
• feelings of having a fast-beating, fluttering or pounding heart, chest discomfort
• low blood pressure including a form of low blood pressure that happens when standing after sitting or lying down
• diarrhoea, nausea and vomiting
• rash and skin that becomes very sensitive to sunlight or other forms of ultraviolet light and may burn easily
• inability in a man to achieve an erection or orgasm

Lisinopril component of ADCO ZETOMAX CO:

• dizziness, headache, fainting or passing out
• a form of low blood pressure that happens when standing after sitting or lying down
• cough
• diarrhoea and vomiting
• kidney dysfunction

• decreases in a protein (haemoglobin) in your red blood cells that carries oxygen to your body's organs and tissues and transports carbon dioxide from your organs and tissues back to your lungs
• decreased ratio of the volume of red blood cells to the total volume of blood
• bone marrow depression
• lacking of enough healthy red blood cells to carry adequate oxygen to your body's tissues
• decrease of the number of platelets in your blood
• decrease in disease-fighting cells in your blood
• decreased number of neutrophils, a type of white blood cell
• agranulocytosis (a life-threatening blood disorder)
• the destruction of red blood cells is faster than they can be made
• swelling of the lymph nodes
• autoimmune disease (when the body's natural defence system can't tell the difference between your own cells and foreign cells, causing the body to mistakenly attack normal cells)
• Syndrome of inappropriate antidiuretic hormone secretion: a condition in which high levels of a hormone causes the body to retain water
• low blood sugar level
• mood alterations, depressive symptoms, mental confusion
• burning or prickling sensation that is usually felt in the hands, arms, legs, or feet, but can also occur in other parts of the body, the sensation that you, or the environment around you, is moving or spinning, taste, sleep or smell disturbances
• heart attack, stroke, low blood pressure in high-risk patients, feelings of having a fast-beating, fluttering or pounding heart, fast heart rate
• Raynaud's syndrome (causes smaller arteries that supply blood flow to the skin to narrow in response to cold or stress)
• runny nose, tightening of the muscles that line your airways in your lungs, inflammation of the passages in the nose, diseases or infections of the lung
• nausea, abdominal pain and indigestion, dry mouth, inflammation of the pancreas, swelling of the intestines
• elevated liver enzymes and bilirubin, inflammation of the liver, jaundice (a liver condition in which the skin, whites of the eyes and mucous membranes turn yellow), liver failure
• rash, itching, swelling of the face, hands and feet, lips, tongue and throat, hives, hair loss, a disease that causes a rash with itchy, scaly patches, most commonly on the knees, elbows, trunk and scalp (psoriasis), excessive sweating, a disease that causes blistering of the skin and the inside of the mouth, nose, throat, eyes, and genitals (pemphigus), a life-threatening skin disorder characterized by a blistering and peeling of the skin (toxic epidermal necrolysis), a rare, serious disorder of the skin and mucous membranes (Stevens-Johnson Syndrome), a skin reaction that can be triggered by an infection or some medicines (erythema multiforme), a symptom complex (cutaneous pseudolymphoma) has been reported which may include one or more of the following: fever, inflammation of the blood vessels, muscle aches and pain, stiffness of the joints or swelling and tenderness of the joints, positive antinuclear antibodies, elevated red blood cell sedimentation rate, high levels of white blood cells, rash, skin that becomes very sensitive to sunlight or other forms of ultraviolet light and may burn easily or other skin manifestations may occur
• abnormally high levels of waste products in the blood, acute kidney failure, low or no urine production
• inability in a man to achieve an erection or orgasm, swelling of the breasts in men and become larger than normal
• abnormal physical weakness or lack of energy, feeling of constant tiredness or weakness, which generally diminished when the dosages are reduced
• increases in blood urea, increases in serum creatinine, increased potassium levels in your blood, decreased sodium levels in your blood

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

• anaphylaxis (skin rash, nausea, vomiting, difficulty in breathing, drop in blood pressure)
• hear, see, smell, taste or feel things that appear to be real but only exist in your mind
• become markedly red in the face and often other areas of the skin

Hydrochlorothiazide component of ADCO ZETOMAX CO:

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

• salivary gland infection
• non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
• decrease in disease-fighting cells in your blood
• decreased number of neutrophils, a type of white blood cell
• agranulocytosis (a life-threatening blood disorder)
• decrease of the number of platelets in your blood
• aplastic anaemia (a condition that occurs when your body stops producing enough new blood cells)
• the destruction of red blood cells is faster than they can be made
• bone marrow depression
• anorexia (eating disorder), the level of sugar in your blood is too high, excess sugar in the urine, too much uric acid in your blood, electrolyte imbalance (including decreased levels of sodium, potassium, chloride and magnesium in your blood, increases in cholesterol and triglycerides, gout
• restlessness, depression, sleep disturbance
• loss of appetite, burning or prickling sensation that is usually felt in the hands, arms, legs, or feet, but can also occur in other parts of the body, light-headedness
• colour vision deficiency in which there is a predominance of blue in vision due to a yellowing of the optical media of the eye, blurred vision, acute myopia (a common vision condition in which near objects appear clear, but objects farther away look blurry), acute angle-closure glaucoma (a sudden onset of severe unilateral eye pain or a headache associated with blurred vision, rainbow-colored halos around bright lights, nausea, and vomiting)
• the sensation that you, or the environment around you, is moving or spinning
• a form of low blood pressure that happens when standing after sitting or lying down
• necrotising angiitis (vasculitis, cutaneous vasculitis) – a group of disorders that involve inflammation of the blood vessel walls
• respiratory distress, including inflammation and swelling of the lung tissue
• gastric irritation, diarrhoea, constipation, inflammation of the pancreas
• jaundice (a liver condition in which the skin, whites of the eyes and mucous membranes turn yellow), excess sugar in the urine
• skin that becomes very sensitive to sunlight or other forms of ultraviolet light and may burn easily, rash, an inflammatory disease (or the reactivation of this disease) caused when the immune system attacks its own tissues and can affect the joints, skin, kidneys, blood cells, brain, heart and lungs (systemic lupus erythematosus), hives, anaphylaxis (skin rash, nausea, vomiting, difficulty in breathing, drop in blood pressure), life-threatening skin disorder characterized by a blistering and peeling of the skin (toxic epidermal necrolysis)
• muscle spasm, muscle weakness
• kidney dysfunction, a kidney disorder in which the spaces between the kidney tubules become swollen (interstitial nephritis)
• fever, weakness

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. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ADCO ZETOMAX CO.

Store all medicines out of reach of children.

Store at or below 25 °C.

Store tablets in a cool, dry place.

Store in the original packaging.

Do not remove the blister from the carton until required for use.