General Information
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Natrilix. It 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 Natrilix against the benefits they expect it will have 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 Natrilix is used forNatrilix is used to treat high blood pressure (which is also called hypertension). 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 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, including stroke, heart disease and kidney failureThere 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. 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.Natrilix lowers blood pressure by relaxing some of the blood vessels in the body. It can be used alone or in combination with other medicines to lower blood pressure.Natrilix is available only with a doctor's prescription.Before you take NatrilixThere are some people who shouldn't take Natrilix. Please read the list below. If you think any of these situations apply to you or you have any questions, please consult your doctor.When you must not take Natrilix
Do not take Natrilix if:
1. you have an allergy to - Natrilix
related medicines such as sulfur antibiotics or some medicines used to treat diabetes
any of the ingredients listed at the end of this leaflet
2. you are pregnant or are trying to become pregnant
3. you are breastfeeding or plan to breast-feed
4. you have severe kidney failure
5. you have severe liver disease
6. the package is torn or shows sign of tampering
7. the expiry date (EXP) on the pack has passed.
Natrilix is not recommended for children.
Before you start to take it
Tell your doctor if you have or have had any medical conditions, especially the following:
liver problems
Systemic Lupus Erythematosus (SLE), a disease affecting the skin, joints and kidneys
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and Natrilix may interfere with each other. These include:
certain other fluid tablets or diuretic medicines,
other medicines used to treat high blood pressure,
lithium, a medicine used to treat mood swings and some types of depression.
These medicines may be affected by Natrilix, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. You doctor will advise you.How to take NatrilixThe usual dose of Natrilix is one tablet daily.Swallow your Natrilix tablet with a glass of water, preferably in the morning. It does not matter is you take Natrilix before or after food.If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
How long to take it
Natrilix helps control your blood pressure, but does not cure it. Continue taking the tablets for as long as your doctor tells you.If you take too much
Immediately telephone your doctor, or pharmacist or the Poisons Information Centre (telephone in Australia: 13 11 26; in New Zealand: 03 4747 000) if you think you or anyone else may have taken too much Natrilix. Do this even if there are no signs of discomfort or poisoning.
While you are taking Natrilix
Things you must not do
Do not give Natrilix to anyone else, even if they have the same condition as you.
Do not use Natrilix to treat other complaints unless your doctor tells you to.
Do not stop taking Natrilix, or change the dosage, without checking with your doctor.
Do not stop taking your tablets because you are feeling better, unless advised by your doctor.
Do not give Natrilix to children.
Things to be careful of
Be careful driving or operating machinery until you know how Natrilix affects you. Natrilix may cause dizziness or light-headedness in some people. Make sure you know how you react to Natrilix before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs, do not drive.
If you drink alcohol or take strong pain killers, dizziness or light-headedness may be worse.
Side effects
Natrilix helps most people with high blood pressure, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.With Natrilix, the side effects can include:
light-headedness
dizziness, headache
fatigue
muscle cramps
nausea or other gastrointestinal disturbances
skin rashes and other allergic reactions
These side effects, when they occur, are usually mild. Consult your doctor or pharmacist if you experience any of these or notice anything else that is making you fell unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them.
In some people, Natrilix may cause a reduction in the amount of potassium in the blood. Sometimes the doctor may take a blood test to make sure that the amount of potassium and some other substances in the blood known as 'electrolytes' are at the right level. In very rare instances, where this shortage of potassium becomes severe, people may experience some or all of the first four unwanted effects listed above at the same time. Should this occur, it is important that you contact your doctor immediately.
Tell your doctor immediately or go to accident and emergency at your nearest hospital if the any of signs below occur. It is called Stevens Johnson Syndrome and is very rare but potentially serious. The signs of Stevens Johnson syndrome consist of a 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. The mouth and eyelids can also be affected. Very rarely it may be associated with a fever.
After taking Natrilix
Storage
Keep your tablets in the pack until it is time to take them. Keep them in a cool dry place away from light where the temperature stays below 30ºC. Keep them where children cannot reach them.
Disposal
If your doctor tells you to stop taking Natrilix or the tablets have passed their expiry date, return any leftover tablets to your pharmacist for disposal.Product DescriptionNatrilix is registered on the Australian Register of Therapeutic Goods and its registration number is AUST R 10246.What it looks like
Natrilix tablets are white film coated tablets with a rounded top and bottom. Each box of Natrilix contains either 30 or 90 tablets in blister strips.Ingredients
Each tablet of Natrilix contains 2.5mg of indapamide hemihydrate as the active ingredient and a number of inactive ingredients.
The inactive ingredients include lactose, starch maize, magnesium stearate, talc, povidone, glycerol, white beeswax, sodium laurylsulphate, methylhydroxypropylcellulose, polyoxyethylene glycol 6000, titanium dioxide, purified water, ethyl alcohol.
Manufacturer
Natrilix is a product discovered and developed by Servier Research International and is distributed in Australia by:
Servier Laboratories (Aust.) Pty Ltd
8 Cato Street
Hawthorn Victoria, 3122
ABN 54 004 838 500
The New Zealand contact address for Servier Laboratories is:
2nd Floor, 29 Union Street
Auckland, New Zealand
This leaflet was last revised in September 2001.