Zidaflo 12,5 mg/25 mg/50 mg Tablets

ZIDAFLO tablets contain the active substance hydrochlorothiazide. ZIDAFLO is a diuretic (medicine that increases urine output). Thiazide diuretics are usually used to treat high blood pressure. They are also used for to treat congestive heart failure, accumulation of fluid and edema.

Do not take ZIDAFLO

• if you are hypersensitive (allergic) to hydrochlorothiazide, other medicines containing sulphonamides or any of the other ingredients of ZIDAFLO (listed in section 6).
• if you have severe kidney problems.
• if you have severe liver problems.
• if suffer from Addison’s disease (when your adrenal glands, located just above your kidneys, produce too little cortisol and, often, too a little aldosterone).
• if you have too much calcium in your blood (hypercalcaemia).
• if you are in the second or third trimester of pregnancy.
• if you are breastfeeding your baby.
• if you have previously had or currently have cancer of the skin and/or lip.

Warnings and precautions

Take special care with ZIDAFLO:

• if you have liver problems.
• if you have high blood sugar. ZIDAFLO may cause increased blood sugar and aggravate or unmask diabetes mellitus (a disease that results in too much sugar in the blood with symptoms such as severe thirst, frequent urination, tiredness, weight loss and blurred vision). Your blood sugar concentrations should be monitored if you are taking any medicine to treat diabetes.
• if you suffer from high cholesterol and high triglyceride (a type of fat in your blood) levels, ZIDAFLO may increase these levels.
• if you have kidney problems.
• if you suffer from gout characterized by severe pain, redness and tenderness in joints, ZIDAFLO may cause an attack of this condition.
• if you are experiencing a dry mouth, thirst, weakness, tiredness, drowsiness, restlessness, confusion, fits, muscle pains, cramps or weakness, low blood pressure, passing a reduced amount of urine, a fast, irregular heartbeat, breathing problems or nausea and vomiting as these may be signs of disturbances of the amount of different salts in your body (electrolyte imbalances). You should be carefully observed for signs of fluid and electrolyte imbalance, especially if you are vomiting or receiving parenteral fluid (intravenous) therapy. If you are an elderly patient you may be more prone to electrolyte imbalances.
• if you have high calcium levels in your blood as ZIDAFLO may decrease excretion of calcium through the urine, which may cause increase calcium in the body.
• if you are going to have a test to measure the functioning of a gland situated in your neck behind your thyroid gland, called the parathyroid gland, ZIDAFLO should be discontinued before the test.
• if you have low magnesium levels in your blood as ZIDAFLO may increase the excretion of magnesium through the urine.
• if you are taking or have taken a medicine called corticotropin which may affect your heart and your heart medication.

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

Dose

For adults - For the treatment of oedema: An initial dose of 25 to 100 mg is usually given, and later reduced to a smaller maintenance dose, often given on alternative days. For adults – in the treatment of mild to moderate hypertension: 12,5 mg daily. For adults - As an adjunct in the treatment of hypertension: 25 – 100 mg daily in conjunction with a reduced dose of the hypotensive agent.

Method of administration

The tablet should be taken orally. If a single dose is indicated, it should preferably be taken in the morning to minimise the effect of increased frequency of urination.

If you take more ZIDAFLO than you should If you have taken more ZIDAFLO than you should, severe hypotension (drastic reduction in blood pressure), unconsciousness, nausea, drowsiness, thirst, muscle aches, difficulty in walking, cardiac dysrhythmias, reduced heart rate and kidney failure. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take ZIDAFLO The missed dose should be taken as soon as you remember. Skip the missed dose if it’s time for the next dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking ZIDAFLO Do not stop taking ZIDAFLO without consulting your doctor or pharmacist. If you have the impression that the effect of ZIDAFLO is too strong or too weak, tell your doctor or pharmacist.

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

If any of the following happens, stop taking ZIDAFLO 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,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens - Johnson Syndrome (SJS),
• fever, flu - like symptoms, a painful red rash (may include purplish spots) that spreads, and blisters follows where the top part of the skin dies and peels off known as toxic epidermal necrolysis (TEN).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ZIDAFLO. 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:

• abnormal, irregular heart rhythm, muscle weakness and twitching that could be caused by low blood levels of potassium
• seizures (fits)
• a sore or ulcer that develops on the lining of the food pipe (oesophagus), stomach or small intestine with symptoms such as upper abdominal pain
• yellow pigmentation of skin and eyes caused by liver or blood problems (jaundice)
• inflammation of the pancreas which causes severe pain in the abdomen and back
• serious decrease of blood cells which can cause weakness, bruising or make infections more likely excessive fluid accumulation in lungs
• kidney failure, swelling and inflammation in between the kidney tubules
• too few white blood cells known as neutropenia

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:
• electrolyte imbalances, decrease in chloride in the blood, low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma (may occur in patients with severe heart failure who have swelling due to retained fluid, especially with large doses of ZIDAFLO in conjunction with restricted salt in the diet)
• stomach and intestine complaints, dry mouth
• thirst, weakness
• mental and physical sluggishness, drowsiness
• restlessness
• muscle pain and cramps
• reduced urine production.
• Less frequent side effects:
• metabolic (physical and chemical processes necessary to maintain life) disturbances especially at high doses
• high blood sugar and the presence of glucose in the urine (glycosuria) in diabetic and other susceptible patients
• increased levels of uric acid in the blood that causes attacks of gout in some patients
• the urinary excretion of calcium is reduced
• deficiency of magnesium in the blood
• harmful changes in plasma lipids (fats)
• loss of appetite, stomach irritation, nausea, vomiting, constipation, diarrhoea
• headache, dizziness
• increased sensitivity of skin to sun
• numbness, tingling, pins and needles, cold, warmth, tingling pressure of the skin (paraesthesia)
• a fall in blood pressure on standing up which causes dizziness or fainting (postural hypotension)
• yellow vision
• inflammation of a salivary gland
• sense of spinning (vertigo)
• loss of male sexual ability.
• Side effects with frequency unknown:
• Skin and lip cancer (non - melanoma skin cancer)
• Decreased vision or pain in the eyes
• fever
• light - headedness
• feelings of sadness or worthlessness (depression), sleep disturbances
• muscle spasm
• kidney problems
• temporary blurred vision
• hair loss
• increases in blood levels of fat in your blood called cholesterol and triglycerides,
• an inflammation of blood vessel walls (inflammation of blood vessels, often with skin rash, inflamed blood vessels in the skin),
• small purple coloured spots caused by bleeding into the skin,
• decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle - closure glaucoma).

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 “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 ZIDAFLO.

Store all medicines out of reach of children

Store at or below 25 ºC.

Store in original packaging to protect it from light.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).