GenRx Indapamide

GENRX INDAPAMIDE TABLETS

Contains the active ingredient, indapamide hemihydrate (pronounced ind-ap-a-mide)

Consumer Medicine Information

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about indapamide. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not understand in this leaflet,

if you are worried about taking your medicine, or

to obtain the most up-to-date information

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

The name of your medicine is GenRx Indapamide. It contains the active ingredient, indapamide hemihydrate.

It is used either alone or with other medicines to treat:

mild to moderate hypertension (high blood pressure).

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor’s prescription.

Indapamide, at a dose of 2.5 mg, is thought to lower blood pressure by relaxing some of the blood vessels in the body. The blood vessels can then carry the same volume of blood more easily. It is not fully understood how it exactly does this.

Indapamide can be used alone or in combination with other medicines to lower blood pressure.

Everyone has blood pressure.This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are.

You have high blood pressure (also known as hypertension) 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.

There are usually no symptoms of high blood pressure. The only way of knowing that you have it is to have your blood pressure checked on a regular basis.

There is no known evidence to show that this medicine is addictive.

There is not enough information to recommend the use of this medicine in children.

Do not take this medicine if:

You have or have had any of the following:

severe renal failure

severe liver disease or suffer from a condition called hepatic encephalopathy (liver problems which affect the brain and central nervous system)

a condition called anuria where there is a very low production of urine

very low potassium levels in your blood

You are taking any medications that could increase the risk of Torsades de pointes such as, chlorpromazine thioridazine, trifluoperazine, amisulpride, droperidol, haloperidol, pimozide. erythromycin IV, pentamidine, , moxifloxacin, diphemanil and methadone

It has passed the expiry date (EXP) printed on the pack.

The packaging is torn, shows signs of tampering or it does not look quite right.

You are hypersensitive to, or have had an allergic reaction to indapamide, other sulphonamide or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body, itching or hives on the skin.

If you think you are having an allergic reaction, contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

People who are in a coma should not be given this medicine.

Do not take this medicine if you are intolerant or allergic to lactose.

This medicine contains lactose.

Tell your doctor if:

1. You have allergies to:

any other medicines

any other substances, such as foods, preservatives or dyes.

2. You have or have had any medical conditions, especially the following:

liver problems

kidney problems

gout

diabetes

SLE (systemic lupus erythematosus)- a disease affecting the skin, joints and kidneys

low levels of potassium, sodium or chlorine, or high levels of uric acid. If you have a salt imbalance you may feel thirsty, weak, faint, drowsy, restless, sick, or have weak or cramped muscles, or have changes in your heart rate or rhythm. You may also have gout due to high uric acid levels.

3. You are currently pregnant or plan to become pregnant or. There is limited data on how indapamide may affect your developing baby if you take it during pregnancy, so taking it is not recommended. Your doctor will discuss with you the benefits and risks of taking this medicine whilst pregnant.

4. You are currently breastfeeding or you plan to breast-feed. Taking indapamide is not advisable, as it can cross into breast milk. Your doctor will discuss with you the benefits and risks of taking this medicine whilst breast-feeding.

5. You are planning to have surgery.

6. You are currently receiving or are planning to receive dental treatment.

7. You drink alcohol or you are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines must not be taken with indapamide because they may increase the risk of Torsades de pointes, these include:

certain medicines for treating psychoses: chlorpromazine, thioridazine, trifluoperazine, amisulpride, droperidol, haloperidol and pimozide

antiarrhythmic medicines such as disopyramide, amiodarone and sotalol

erythromycin, an antibiotic (when given via injection or infusion); pentamidine and moxifloxacin

diphemanil

strong pain killers (narcotics), including and methadone

Some medicines may also interact with indapamide. These include:

lithium, a medicine used to treat mood swings and some types of depression

medicines known as barbiturates, used as sedatives or for treating epilepsy

diuretic (fluid) tablets, for treating excess fluid and high blood pressure

other medicines used to treat high blood pressure, such as ACE inhibitors or Angiotensin II receptor blockers

medicines used to treat heart problems, such as digoxin, quinidine, disopyramide, amiodarone and sotalol

tetracosactide, used for diagnosing some illnesses

stimulant laxatives containing, for example, bisacodyl or senna

some anti-inflammatory drugs such as steroid medicines and non-steroidal anti-inflammatory medicines (including high-dose aspirin)

metformin tablets, used for treating diabetes

calcium supplements or medicines containing calcium

cyclosporine and tacrolimus, medicines taken by people who have had organ transplants or who have auto-immune disease or cancer

baclofen, a muscle relaxant

medicines containing iodine, which are used to diagnose certain medical conditions

allopurinol, medicine used to treat gout

corticosteroids, medicines used to reduce inflammation and suppress the immune system

medicines which can affect the amount of indapamide which is broken down by the liver enzymes CYP2C9 and CYP3A4, such as ritonavir, ketoconazole, rifampicin phenytoin, imipramine and carbamazepine.

Taking strong painkillers, barbiturates or blood pressure tablets or drinking alcohol whilst taking this medicine may cause your blood pressure to drop too much and you may feel faint or pass out.

You may also develop serious kidney problems if you take a combination of diuretic tablets, other medicines for blood pressure, and non-steroidal anti-inflammatory drugs.

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicine not listed above may also interact with indapamide.

Alcohol should also be avoided whilst taking indapamide.

Follow all directions given to you by your doctor or pharmacist carefully. Their instructions may be different to the information in this leaflet.

Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether or not you are taking any other medicines.

The usual dose is one tablet daily.

Swallow the tablet whole with a glass of water.

Take the tablet in the morning.

Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.

It does not matter if you take it before, with or after food.

Indapamide can help to control your blood pressure but cannot cure it, so you should keep taking your medicine for as long as your doctor tells you.

Make sure you have enough to last over weekends and holidays.

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses.

This may increase the chance of unwanted side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much indapamide.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much indapamide, you may have nausea, vomiting, weakness, reduced breathing, fainting, dizziness, stomach upsets and/or electrolyte (salt) imbalance (feeling thirsty, weak, drowsy, restless, sick, or have weak or cramped muscles, or changes in your heart rate or rhythm).

Tell your doctor that you are taking this medicine if:

you are about to be started on any new medicine

you become pregnant or plan to breastfeed

you are about to have any blood tests

you are going to have surgery.

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking indapamide.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.

Indapamide affects the levels of potassium, chloride and sodium in the blood. Your doctor may conduct blood tests to monitor levels of these salts before and during your treatment. This is especially important for patients, who are at high risk of developing electrolyte disturbances (such as elderly, patients who are taking many medicines or patients who are malnourished).

Make sure you drink plenty of water in hot weather and during exercise, especially if you are sweating a lot. Not drinking enough water could cause a sudden drop in blood pressure.

Also make sure you tell your doctor if you become sick and have severe or continuing vomiting or diarrhoea while taking indapamide.

The loss of additional water and certain salts such as potassium from the body may make you feel faint, lightheaded, weak or sick.

Indapamide may increase the sensitivity of your skin to sunlight.

If taking indapamide, protect your skin from the sun or artificial UV light. If you develop severe sunburn after being in the sun, tell your doctor, who may tell you to stop taking your medicine.

Do not:

Give this medicine to anyone else, even if their symptoms seem similar to yours

Take your medicine to treat any other condition unless your doctor or pharmacist tells you to

Stop taking your medicine, or change the dosage, without first checking with your doctor.

Be careful while driving or operating machinery until you know how indapamide affects you.

Indapamide may cause dizziness or drowsiness. Do not drive or operate machinery if indapamide affects you in this way.

If you drink alcohol or take strong pain killers, barbiturates or other medicines for blood pressure, dizziness or light-headedness may be worse.

Be careful getting up from a lying or sitting position. Get up slowly.Getting up too fast may cause a feeling of light-headedness, dizziness or fainting.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking indapamide or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor or pharmacist if you notice any of the following:

feeling tired or weak or as if you have less energy

nausea, vomiting, diarrhoea, constipation or stomach ache

dry mouth

muscle pain or cramps

headache

dizziness, giddiness or light-headedness, especially when getting up from a sitting or lying position

tinnitus (pain or ringing in the ears), problems with your eyesight

gout (painful red, swollen joints)

change in libido

sleepiness, problems sleeping

increased blood sugar levels

Tell your doctor as soon as possible if you notice any of the following.

These may be serious side effects. You may need medical attention. Most of these side effects are rare.

skin rash

itching

sunburn following only a small exposure to the sun

joint or back pain

weak legs

excessive urination or sweating

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

fast or irregular heartbeat

fainting or passing out

visual disturbances

symptoms of an imbalance of the electrolyte (salt) levels in the blood: dry mouth, thirst, weakness, fatigue, lethargy, drowsiness, restlessness, muscle pains or cramps, low blood pressure, low urine output, stomach upsets, nausea or irregular heart beat .This is more likely if you are vomiting a lot, are on a drip, have heart failure, poor kidney or liver function, or are on a salt restricted diet.

skin rash made up of purple spots, with occasional blisters – most often found on the front of the arms and legs, neck and around the ears, very rarely, accompanied by a fever. These are signs of something called Stevens Johnson Syndrome. This syndrome is very rare, but potentially very serious

Other side effects not listed above may occur in some patients.

If you think you are having an allergic reaction to indapamide, tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

cough, shortness of breath, wheezing or difficulty breathing.

swelling of the face, lips, tongue, or other parts of the body

rash, itching or hives on the skin

fainting

hayfever-like symptoms

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Do not store your 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 this medicine 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 or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

2.5 mg tablets:

White, round, biconvex, sugar coated tablets.

They are available in blister packs containing 90 tablets.

Each tablet contains 2.5 mg of indapamide hemihydrate as the active ingredient.

It also contains the following inactive ingredients:

lactose monohydrate

povidone

maize starch

magnesium stearate

Opaseal clear P-2-0300G (ethyl acetate, stearic acid, polyvinyl acetate phthalate, purified water, industrial methylated spirit 74 OP)

purified talc

calcium carbonate

acacia

titanium dioxide

sucrose

Opaglos 6000P off-white (shellac, industrial methylated spirit 74 OP, beeswax white, carnauba wax)

This medicine is gluten-free, tartrazine-free and free of other azo dyes.

GenRx Indapamide 2.5mg Tablets (blister pack):

AUST R 167027

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was prepared in September 2015