Indapamide hemihydrate tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about INSIG. It does not contain all the available information about this medicine. Reading this leaflet does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking INSIG against the expected benefits for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What INSIG is used for
The name of your medicine is INSIG. INSIG contains the active ingredient indapamide which belongs to a group of medicines called chlorosulfamoyl diuretics (a type of “fluid” or “water” tablet).
You have been prescribed INSIG for high blood pressure.
INSIG is available only with a doctor’s prescription.
There is no evidence that INSIG is addictive.
Why INSIG is used for high blood pressure
Everyone has blood pressure. This pressure helps to circulate blood all around the body. Your blood pressure may be different at different times of the day, depending on how busy or stressed you are.
You have high blood pressure (also known as hypertension) which is when your blood pressure stays higher than is needed, even when you are calm and relaxed.
If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually it can cause stroke, heart disease and kidney failure.
INSIG helps to lower your blood pressure.
Ask your doctor if you have any questions about why INSIG has been prescribed for you.
Before you take INSIG
There are some people who should not take INSIG. Please read the list below. If you think any of these situations apply to you, or you have any questions, please consult your doctor or pharmacist.
When you must not take INSIG
Do not take INSIG if:
- You are allergic to indapamide, or any of the other ingredients of INSIG listed at the end of this leaflet.
- You are allergic to sulfonamide (sulfa) antibiotics, or to thiazide diuretics (a type of “fluid” or “water” tablet.
- You are pregnant or trying to become pregnant.
- You are breastfeeding or plan to breast-feed.
- You have severe kidney disease.
- You have severe liver disease or suffer from a condition called hepatic encephalopathy (liver problems which affect the brain and central nervous system).
- You have low potassium levels in your blood.
- The packaging is torn or shows signs of tampering, or the tablets do not look quite right.
- The expiry date (EXP) on the pack has passed.
Before you start to take it
Tell your doctor straight away if:
- You have an intolerance to lactose monohydrate.
- You have or have had any other health problems, including:
– High or low levels of potassium, sodium, or other problems with salt balance.
– Increased sensitivity to sunlight (photosensitivity reactions).
– Systemic lupus erythematosus (a disease affecting the skin, joints and kidneys).
– Heart rhythm problems.
– Problems with your kidneys.
– If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye or an increase of pressure in your eye and can happen within hours to a week of taking INSIG. 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.
– You have muscle disorders including muscle pain, tenderness, weakness or cramps.
– A test to check how well your parathyroid gland is working.
– Athletes should be aware that this medicine contains an active ingredient, which may give a positive reaction in doping tests.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Taking INSIG may change the effect of some medicines, and some medicines may affect how well INSIG works. You may need different amounts of your medication or to take different medicines.
You should not take INSIG with lithium medications (used to treat mood swings and some types of depression) due to the risk of increased levels of lithium in the blood.
The medicines that may interact with INSIG including the following:
- Some steroid medicines.
- Diuretics (sometimes called “fluid” or “water” tablets, e.g. amiloride, spironolactone, triamterene).
- Medicines used for heart rhythm problems (e.g. disopyramide, amiodarone, sotalol, flecainide).
- Some medications used to treat high blood pressure (e.g. angiotensin converting enzyme (ACE) inhibitors), a fast or irregular heartbeat and other heart conditions.
- Medicines to treat mental illnesses such as some medicines for epilepsy, anxiety, schizophrenia and some antidepressants (e.g. tricyclic antidepressants, antipsychotic drugs, neuroleptics such as: droperidol, haloperidol, chlorpromazine, trifluoperazine, amisulpride, sulpiride, psychoanaleptics e.g. donepezil).
- Antiparasitic medicines used to treat certain types of malaria (e.g. chloroquine).
- Pentamidine (a medicine used to treat certain types of pneumonia).
- Antihistamines used to treat allergic reactions, such as hay fever.
- Medicines used to treat nausea and vomiting (e.g. ondansetron, domperidone).
- Medicines used to treat cancer (e.g. vandetanib, oxaliplatin).
- Anaesthetics (e.g. propofol, sevoflurane).
- Anagrelide (used to reduce elevated blood platelet counts).
- Non-steroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen) or high doses of aspirin.
- Calcium supplements.
- Stimulant laxatives.
- Baclofen (a medicine used to treat muscle stiffness occurring in diseases such as multiple sclerosis).
- Metformin (a medicine used to treat diabetes).
- Ciclosporin, tacrolimus (medicines used to treat certain problems with the immune system).
- Medicines used to treat fungal infections (e.g. Amphotericin B (amphotericin) by IV, fluconazole).
- Medicines used during scans to see the images of your body.
- Medicines used to treat gastro-intestinal problems (e.g. cisapride, papaverine).
- Medicines used to treat bacterial infections (e.g. Moxifloxacin, ciprofloxacin, clarithromycin, erythromycin by IV).
- Allopurinol (used to treat gout).
- Tetracosactide (tetracosactrin) (to treat Crohn’s disease).
- Methadone (used to treat addiction).
- Cilostazol (used to treat cramp-like pain in the legs when you walk).
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this INSIG.
For older people or children
- Elderly people can generally use INSIG safely. However, some older people have reduced kidney function, in which case additional care may be required.
- INSIG is not recommended for use in children.
How to take INSIG
Follow all directions given to you by your doctor and pharmacist carefully. If you do not understand the instructions on the label, ask your doctor or pharmacist for help.
Your doctor will select a dose when they prescribe INSIG for you. The usual dose is one tablet once daily.
Swallow your tablet with water, preferably in the morning. Do not crush or break them.
How long to take INSIG for
INSIG can help to control your blood pressure but cannot cure it.
INSIG treatment is usually for life, you should keep taking the tablets regularly unless advised otherwise by your doctor.
If you forget to take INSIG
If your next usual dose is less than 6 hours away, just leave out the dose that you missed. Take the next dose at the usual time and continue as normal.
If your next dose is more than 6 hours away, take the dose you have missed as soon as you realise. Then take the next dose at the usual time and continue as normal.
Do not try to make up for missed doses by taking more than one dose at a time.
If you take too much INSIG
Taking too much INSIG (an overdose) may cause low blood pressure (also known as hypotension). Other effects like sickness, cramps, sleepiness, confusion, kidney problems, salt and water disturbances are possible. You may require urgent medical attention.
If you think that you or anyone else may have taken too much INSIG then act immediately.
Telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at the nearest hospital. Do this even if there are no signs of discomfort or poisoning.
While you are taking INSIG
Things you must do
Take INSIG exactly as your doctor has prescribed. Otherwise you may not get the benefits from treatment.
Tell all doctors, dentists and pharmacists who are involved with your treatment that you are taking INSIG.
Make sure you drink enough water during exercise and hot weather especially if you sweat a lot. This will help you avoid any dizziness or light-headedness caused by a sudden drop in blood pressure.
Tell your doctor straight away if you have excessive vomiting or diarrhoea while taking INSIG as these may affect how INSIG is processed in your body, If you experience any of the following symptoms, you may be dehydrated because you are losing too much water:
- dry mouth or thirst
- tiredness or drowsiness
- muscle pain or cramps
- fast heartbeat
- passing less urine than normal.
Things you must not do
Do not give this medicine to anyone else, even if they have the same condition as you.
Do not use INSIG to treat any other complaints unless your doctor tells you to.
Do not stop taking INSIG or change the dose, without checking with your doctor.
Things to be careful of
Be careful when driving or operating machinery until you know how INSIG affects you.
You may feel light-headed or dizzy when you begin to take INSIG. This is because your blood pressure is falling. Symptoms are likely to be made worse if you drink alcohol or take strong pain killers.
If you have these symptoms when standing up or getting out of bed then getting up more slowly can help. This allows your body to get used to the change in position and blood pressure.
INSIG may cause your skin to become more sensitive to the sun. If this happens you should stop taking INSIG and contact your doctor.
If you have these symptoms and they do not get better in a short time then talk to your doctor.
If you do not feel well while you are taking INSIG then tell your doctor or pharmacist as soon as possible.
All medicines can have side effects. Most of the time they are not serious but sometimes they can be.
INSIG helps most people with high blood pressure, but it may sometimes have unwanted side effects. These can include:
- Feeling tired or as if you have less energy, difficulty sleeping.
- Feeling faint, light-headed, or dizzy.
- Feeling nervous or anxious.
- Feeling sick or having an upset stomach, having an uncomfortable feeling after eating, vomiting, constipation, diarrhoea or loss of appetite.
- Muscle weakness, pain, tenderness, back pain, joint pain, cramp or tingling or numbness of the hands or feet (and particularly if at the same time you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown (not known)).
- Skin rashes or other allergic reactions.
- Increased sensitivity to sunlight.
- An increased risk of becoming dehydrated (in elderly patients and in patients with heart failure).
- Low blood levels of potassium, magnesium or chlorine.
- Kidney disease.
- Inflammation of the pancreas.
- Hepatic encephalopathy (liver problems which affect the brain and central nervous system).
- Abnormal liver function.
- If you suffer from systemic lupus erythematosus (a type of collagen disease), this might get worse.
- Changes in blood cells, such as thrombocytopenia (a decrease in the number of platelets which causes easy bruising and nasal bleeding), leucopoenia (a decrease of white blood cells which may cause unexplained fever, soreness of the throat or other flu-like symptoms) and anaemia (a decrease in red blood cells).
- Low blood pressure, unusual heartbeat.
- High level of calcium in blood.
- Blurred or changed vision, short sightedness (myopia).
- Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye or acute angle-closure glaucoma).
- Dry mouth.
- Erectile dysfunction.
Most of these side effects are mild when they occur. Do not be alarmed by this list of possible side effects. You may not experience any of them. However, if you do, or if you notice anything else that is making you feel unwell, you should consult your doctor or pharmacist.
Changes may occur in your laboratory parameters (blood tests) and your doctor may need to give you blood tests to check your condition. The following changes in laboratory tests may occur low potassium in the blood, low sodium in the blood, low sodium in the blood (that may lead to dehydration and low blood pressure), increase in uric acid (a substance which may cause or worsen gout), increase in blood glucose levels in diabetic patients, increased levels of liver enzymes.
If any of the signs below occur then tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- Swelling of your lips, face, mouth, tongue or throat.
- Purple spots with occasional blisters on the front of your arms and legs and/or around your neck and ears. (A rare condition known as Stevens-Johnson Syndrome).
- Toxic epidermal necrolysis.
- A fast and irregular heartbeat.
- Severe blisters, skin rash, itching or other allergic reactions.
These side effects are extremely rare but can become serious.
Storage and Disposal
Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store this medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking INSIG, or the tablets have passed their expiry date, return any leftover tablets to your pharmacist for disposal.
What it looks like
INSIG 2.5 mg tablets are white, biconvex, sugar coated tablets.
INSIG tablets are presented in blister packs of 60 or 90 tablets.
AUST R 184244.
Each tablet of INSIG contains 2.5 mg of indapamide hemihydrate as the active ingredient.
This medicine also contains the following inactive ingredients:
- calcium carbonate
- lactose monohydrate
- magnesium stearate
- maize starch
- OPAGLOS tablet core sealant product OPAGLOS 6000P OFF-WHITE
- OPASEAL Pharmaceutical Enteric – Phthalavin (Pvap) Solution P-2-0300G Clear
- purified talc
- titanium dioxide.
This medicine contains lactose
This medicine is supplied in Australia by:
Arrow Pharma Pty Ltd
15-17 Chapel Street
This leaflet was prepared in November 2021.
Published by MIMS January 2022