Thiaretic 25 mg Tablets

Thiaretic belongs to a group of medicines known as thiazide diuretics. Diuretics help the body to get rid of extra fluid by increasing the excretion of electrolytes and fluid from the body and are used in patients with high blood pressure. Because they get rid of fluid, diuretics are sometimes called ‘water tablets’.

Thiaretic is used in the treatment and management of:

• Swelling due to retained fluid (oedema) due to salt and water retention, or due to serious heart, liver or kidney problems
• Diabetes insipidus (a condition which causes abnormally large amounts of urine to be passed and increased thirst) where Thiaretic may be of value in managing this disease due to it having the opposite effect of retaining fluids in the body (antidiuretic effect) in these patients
• High blood pressure that has an unknown cause (essential hypertension), in combination with or without other specific medicines used to treat high blood pressure.

Do not take Thiaretic:

• if you are hypersensitive (allergic) to hydrochlorothiazide, other medicines containing sulfonamides or any of the other ingredients of Thiaretic (listed in section 6)
• if you have severe kidney problems
• if you have severe liver problems
• if you have Addison's disease when your adrenal glands, located just above your kidneys, does not produce enough steroid hormones – e.g. too little cortisol and, often, too little aldosterone)
• if you have too much calcium in your blood (hypercalcaemia)
• if you have previously had or currently have cancer of the skin and/or lip
• if you are in the second or third trimester of pregnancy
• if you are breastfeeding your baby
• if you are taking lithium, a medicine used to treat depression (see sections “Warnings and precautions” and “Other medicines and Thiaretic”)

Warnings and precautions

Take special care with Thiaretic:

• if you have severe liver problems the small changes caused by Thiaretic in the amount of different salts in your body (electrolytes) in your blood, may cause the loss of brain function which can include forgetfulness, confusion and breath with a sweet or musty odour and can progress to shaking of the hands or arms, disorientation and slurred speech and loss of consciousness (coma). If you experience these symptoms, stop taking Thiaretic and contact your doctor immediately
• if you have kidney problems, you may show elevated levels of urea and other nitrogen compounds in the blood (azotaemia) and produce abnormally small amounts of urine than what is usual for you (oliguria) and your kidneys’ ability to remove waste and balance fluids in your body become progressively worse. Your doctor might discontinue the use of Thiaretic
• if you suffer from very high levels of uric acid in your blood, Thiaretic may trigger a gout attack which is characterised by severe pain, redness and tenderness in your joints
• if you have high blood sugar, Thiaretic 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 are experiencing symptoms of a disturbances of the amount of different salts in your body (electrolyte imbalances) such as 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. If you are an elderly patient you may be more prone to 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 experience a sudden drop in blood pressure when standing up after sitting or lying down (orthostatic hypotension) which can make you feel lightheaded or dizzy when you stand, causing blurred eyesight, weakness and fainting
• if you experience symptoms of having too much calcium in your blood (hypercalcaemia) such as excessive thirst, frequent urination. upset stomach, nausea, vomiting, constipation. bone pain. muscle weakness, confusion, feeling very tired and having very fast heartbeats (palpitations) and other changes in the way your heart beats. You should contact your doctor if you develop these signs and symptoms that might indicate hypercalcemia
• if you develop a blood level that is below normal in potassium, an important body chemical (hypokalaemia). The problem can result in fatigue, muscle cramps and abnormal heart rhythms. You should contact your doctor
• if you develop symptoms of metabolic alkalosis, a condition where the pH of tissue is elevated beyond the normal range, such as confusion (this can progress to a state of state of near-unconsciousness or insensibility or complete unconsciousness), shaking of your hands, light-headedness, muscle twitching, nausea, vomiting, numbness or tingling in the face, hands, or feet and prolonged muscle spasms (tetany). You should contact your doctor
• if you develop symptoms of low sodium concentration in your blood (hyponatraemia) such as confusion, irritability, disorientation in mild cases to seizures (fits), brain swelling and coma in serious cases which can be life-threatening, you should contact your doctor
• if you experience symptoms related to low magnesium levels in your blood (hypomagnesaemia) such as shaking, muscle spasms, muscle cramps and/or numbness in your hands and feet, abnormal eye movements (nystagmus), fatigue and weakness, fits, confused thinking and a lack of awareness of your surroundings (delirium) and abnormal heart rhythms (dysrhythmia). You should contact your doctor if you experience any of these symptoms
• if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Thiaretic. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this
• if you had skin cancer or if you develop an unexpected skin lesion during treatment with Thiaretic. Treatment with Thiaretic, particularly long-term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect you skin from sun exposure and UV rays while taking Thiaretic
• if you suffer from systemic lupus erythematosus (SLE), a chronic condition in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels and can be life-threatening in severe cases (see also section 2). Thiaretic may activate or worsen this condition
• if you are taking blood pressure medicines (antihypertensives) used to bring your blood pressure down, as Thiaretic can make your blood pressure drop too low and cause you to experience confusion, dizziness, nausea, fainting (syncope), fatigue, neck or back pain, headache, blurred vision, heart palpitations, or feelings that your heart is skipping a beat, fluttering, or beating too hard or too fast
• if you suffer from high cholesterol and high triglyceride (types of fat in your blood) levels as Thiaretic may increase these levels
• if you have a history of allergy or asthma as Thiaretic may cause allergic reactions
• if you develop an inflammation of the organ lying behind the lower part of the stomach (pancreas) causing severe upper belly pain that may spread to your back or chest (it may feel worse after you eat), nausea and vomiting
• if you are taking lithium to treat a mental disorder, since the combination with Thiaretic may lead to toxic blood concentrations of lithium which can include feeling weak, having a worsening tremor, feeling unbalanced or uncoordinated, poor concentration, diarrhoea, severe nausea, vomiting, slurred speech and confusion
• if you had a surgery to stop excessive sweating called a sympathectomy as Thiaretic can then make your blood pressure drop too low
• if you are going to have an anti-doping test, Thiaretic could show a false positive result.

Do not share medicines prescribed for you with any other person. Always take Thiaretic exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Treatment should be started at the lowest dose needed to achieve the desired effect. Treatment should be suited to the individual patient.

The usual dose is:

Adults

In the treatment of swelling due to retained fluid (oedema) An initial daily dose of one tablet (25 mg) to four tablets (100 mg) is usually given, and later reduced to a smaller maintenance dose suitable to you when water retention in the body is controlled, often this can mean that you will be taking a lower dose on alternative days. An initial dose of up to eight tablets (200 mg) may be necessary in some patients, but larger doses have no additional effect.

In the treatment of high blood pressure (hypertension)

One tablet (25 mg) to four tablets (100 mg) daily in conjunction with a reduced dose of the hypotensive medicine.

Children

The correct dosage for your child will be determined by your doctor and is usually 2,5 mg per kg body mass daily in two divided doses (e.g., in the morning and in the evening). Your doctor will ensure that the dosage you or your child take is not higher than necessary to achieve the desired effect. Do not increase or decrease your/your child’s dose without prior consultation with your doctor. If you or your child take Thiaretic for a long time, it may cause lower levels of potassium in your blood (hypokalaemia) (see section 2). You/your child may need to take potassium supplements. Your doctor will tell you how long your treatment with Thiaretic will last. Do not stop treatment early because it may affect your condition.

If you have the impression that the effect of Thiaretic is too strong or too weak, tell your doctor or pharmacist.

Method of administration

Thiaretic tablets must be taken by mouth after food with a drink of water to minimise the possibility of disturbances of the digestive tract such as nausea.

If you take more Thiaretic than you should When more Thiaretic was taken than you should take, it can lead to a loss of body fluid (dehydration) and disturbances of the amount of different salts in your body (electrolyte imbalances) such as a dry mouth, thirst, weakness, dizziness, 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 (see sections 2 and 4). In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take a dose of Thiaretic It is important to take your tablets regularly at the same time each day in order for the desired effects of Thiaretic to be achieved. If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for the forgotten individual doses.

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

If any of the following happens, stop taking/giving Thiaretic 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, chest pain, red patches on the skin. This can be an allergic reaction to Thiaretic
• Severe and serious skin reactions which can include:
• Toxic epidermal necrolysis (Lyell's syndrome) and Steven-Johnson syndrome (SJS) – life-threatening diseases that begin with a fever and flu-like symptoms and then within a few days the skin begins to blister and peel, forming very painful raw areas, called erosions that resemble severe hot-water burns, usually starting on the face and chest before spreading to other parts of the body
• Systemic lupus erythematosus (SLE) is a condition in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels and can be life-threatening in severe cases (see also section 2)
• Inflammation of blood vessel walls, affecting small and medium blood vessels which interrupt your normal blood flow. It results in skin and muscle damage, including necrosis (necrotizing vasculitis). Necrosis is the death of tissues and organs. The affected blood vessels may be located in any part of your body. The effect of this condition depends on where the affected blood vessels are located and how much damage they cause. You might notice initial symptoms on your own without a medical test. These include chills, fatigue, fever, weight loss. As the disease progresses, symptoms can worsen and become more varied. You may have pain, skin discoloration, lesions, which are usually seen on the legs, ulcers on the skin or genitals, or in the mouth. In some cases, the condition may be limited to your skin. In other cases, you might develop kidney damage or bleeding in your lungs. If your brain is affected, you may have difficulty swallowing, speaking, or moving
• Severe shortness of breath in which you could be unable to breathe on your own without support from a ventilator (respiratory distress) due to the collection of fluid in the air sacs of the lungs which deprives organs of oxygen. This condition can be fatal, the risk increasing with age and severity of illness.

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

• Skin and lip cancer (skin cancer may be a sore that does not heal or comes back after healing, pale, white or yellow flat areas that look like scars, raised and scaly red patches, small, smooth and shiny lumps that are pearly white, pink or red, pink growths with raised edges and indents in the centre or growths that has small blood vessels on the surface) (see section 2)
• Changes in the blood cells (e.g., reduction in white and red blood cells), resulting in feeling weak, tired or listless, pale skin, and experiencing more frequent and recurrent infections such as fever or sore throat
• Harmful changes in the fat in your blood called cholesterol and triglycerides
• Prolonged or excessive bleeding which can include nosebleeds, bleeding gums, bruising due to low levels of platelets in your blood (thrombocytopenia) which in severe cases can cause dangerous internal bleeding
• Purple-coloured spots that are most recognizable on the skin, but may also appear on organs or mucous membranes, including the membranes on the inside of the mouth (purpura). These purple spots occurs when small blood vessels burst, causing blood to pool under the skin. This can create purple spots on the skin that range in size from small dots to large patches
• Allergic reactions such as skin rashes and asthma
• Low sodium concentration in your blood that can cause neurologic symptoms ranging from confusion, irritability, disorientation in mild cases to seizures (fits), brain swelling and coma in serious cases which can be life-threatening (hyponatraemia) (see section 2)
• Low levels of potassium in your blood (hypokalaemia), which can result in fatigue, muscle cramps and abnormal heart rhythms (see section 2)
• Confusion which can progress to a state of state of near-unconsciousness or insensibility or complete unconsciousness, shaking of your hands, dizziness, muscle twitching, nausea, vomiting, numbness or tingling in the face, hands, or feet and prolonged muscle spasms (tetany) – these are symptoms caused by a condition where the pH of tissue is elevated beyond the normal range (metabolic alkalosis) (see section 2)
• Excessive thirst, frequent urination. upset stomach, nausea, vomiting, constipation. bone pain. muscle weakness, confusion, feeling very tired and having very fast heartbeats (palpitations) and other changes in the way your heart beats which are symptoms of having too much calcium in your blood (hypercalcaemia) (see section 2)
• Shaking, muscle spasms, muscle cramps and/or numbness in your hands and feet, abnormal eye movements (nystagmus), fatigue and weakness, fits, confused thinking and a lack of awareness of your surroundings (delirium) and abnormal heart rhythms (dysrhythmia) which are symptoms related to low magnesium levels in your blood (hypomagnesaemia) (see section 2)
• Disturbances of the amount of different salts in your body (electrolyte imbalances), decrease in chloride in the blood, low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma and may occur in patients with severe heart problems who have swelling due to retained fluid, especially with large doses of Thiaretic in conjunction with restricted salt in the diet (see section 2)
• Fits (convulsions or seizures)
• Sudden blurry vision when looking at distant objects and difficulty seeing objects (acute myopia) or raised pressure in the eye with symptoms such as severe eye pain, blurred vision, tears, nausea, vomiting and headache (secondary acute angle-closure glaucoma) or 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)
• Improper beating of the heart, whether irregular, too fast or too slow (cardiac dysrhythmias)
• Inflammation of the lungs or difficulty in breathing
• Inflammation of the pancreas with severe upper stomach pain, often with nausea and vomiting (pancreatitis)
• Liver problems with symptoms such as nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine (jaundice)
• Kidney problems which can include pain and swelling in your flank, lower back, feet and ankles, problems with your urine, difficulty passing urine, passing more or less urine than usual, reduced excretion of calcium through your kidneys.

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

• Decreased appetite
• High blood sugar (hyperglycaemia) 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.

Less frequent side effects

• Restlessness
• Mental and physical sluggishness (lethargy), drowsiness
• Headache, dizziness
• Burning or prickling sensation (pins and needles) that is usually felt in the hands, arms, legs, or feet (paraesthesia)
• Yellow and/or blurred vision
• A fall in blood pressure on standing up which causes dizziness or fainting (postural hypotension)
• Stomach and intestine complaints and irritation, dry mouth, nausea, vomiting, constipation, diarrhoea
• A sore or ulcer that develops on the lining of the food pipe (oesophagus), stomach or small intestine (intestinal ulceration) with symptoms such as pain in the upper part of the stomach
• Rash, itchy, raised, red or skin-coloured welts or hives on the skin's surface (urticaria)
• Red, itchy patches on your skin when you have been outside (even on a cloudy day) due to skin’s overreaction to sunlight (photosensitivity reaction)
• Muscle pain and cramps, muscle spasm
• Loss of male sexual ability (impotence)
• Thirst, weakness and fever (high temperature).

Side effects occurring with frequency unknown

• Infection of salivary glands (sialadenitis)
• Depression, a mood disorder that causes a persistent feeling of sadness or worthlessness and loss of interest
• Difficulty to sleep
• Feeling unsteady or giddy (vertigo)
• Stomach and intestinal cramps
• Hair loss or baldness (alopecia).

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, 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. Alternately you can contact Gulf Drug Company (Pty) Ltd at +27 31 538 8700 or per [email protected]. By reporting side effects, you can help provide more information on the safety of Thiaretic.

Store all medicines out of reach of children.

• Store at or below 25 °C in a cool, dry place.
• Protect from light and moisture.
• Keep HDPE/PP containers tightly closed.
• Do not remove tablets from container/blister strips until required for use.
• Do not remove tablets from patient ready packs until required for use.
• Keep in the original packaging until required for use.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the container or label. Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).