Metex XR 500mg Tablets 120

Metex XR
contains the active ingredient metformin hydrochloride
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Consumer Medicine Information

What is in this leaflet
This leaflet answers some common questions about METEX XR.

It does not contain all of the available information. It does not take the place of talking to your doctor, pharmacist or diabetes educator.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking METEX XR against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor, pharmacist or diabetes educator.

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

What METEX XR is used for
METEX XR is used to control blood glucose in patients with Type 2 diabetes mellitus, especially in those who are overweight. It is used when diet and exercise are not enough to control your blood glucose levels.

METEX XR can be used alone, or in combination with other medicines for treating diabetes.

Type 2 diabetes mellitus is also called non-insulin dependent diabetes mellitus (NIDDM) or maturity onset diabetes.

Insulin is a hormone that enables body tissues to take up glucose from the blood and use it for energy or fat storage for future use.

People with type 2 diabetes are unable to make enough insulin or their body does not respond properly to the insulin it does make. This causes a build up of glucose in the blood (hyperglycaemia), which can lead to serious medical problems.

Long term hyperglycaemia can lead to heart disease, blindness, kidney damage, poor blood circulation and gangrene.

Signs of hyperglycaemia include:

tiredness or lack of energy
headache
thirst
passing large amounts of urine
blurred vision.
METEX XR is available only with a doctor's prescription.

There is no evidence that METEX XR is addictive.

How METEX XR works
METEX XR belongs to a group of medicines called biguanides. It lowers high blood glucose levels by:

improving your body’s sensitivity to insulin and restoring the way it normally uses glucose
reducing the amount of glucose your liver makes
delaying the amount of glucose your intestine absorbs.
Ask your doctor if you have any questions about why METEX XR has been prescribed for you.

Before you take METEX XR
When you must not take it
Do not take METEX XR if you are allergic to:

medicines containing metformin or any other biguanide
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 or other parts of the body; rash, itching or hives on the skin.

Do not take METEX XR if you have any of the following medical conditions:

type 1 diabetes mellitus that is well controlled by insulin alone
type 2 diabetes that is already controlled by diet alone
diabetic ketoacidosis
kidney disease
severe liver disease
certain heart or blood vessel problems, including a recent heart attack or severe heart failure
excessive alcohol intake, binge drinking, alcohol dependence
dehydration, severe blood loss, shock
severe infection
certain heart or blood circulation problems, including a recent heart attack or heart failure
gangrene
blood clots in the lungs, severe breathing difficulties
inflammation of the pancreas.
If you are not sure whether you should start taking METEX XR, ask your doctor.

Do not take METEX XR if you are pregnant or plan to become pregnant. Insulin is more suitable for controlling blood glucose during pregnancy. Your doctor will replace METEX XR with insulin while you are pregnant.

Do not take METEX XR if you are breastfeeding. Your doctor will discuss the options available to you.

Do not take METEX XR if the expiry date (Exp.) printed on the pack has passed.

Do not take METEX XR if the packaging shows signs of tampering or the tablets do not look quite right.

Before you start to take it
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Before starting METEX XR your doctor will ask you to have a blood test to check your kidney function.

Tell your doctor if you drink alcohol in any amount. Alcohol can affect the control of your diabetes. Drinking excessive amounts of alcohol while you are being treated with METEX XR may also lead to serious side effects. Discuss this with your doctor.

Your doctor may suggest that you stop drinking or reduce the amount of alcohol you drink.

If you have not told your doctor about any of the above, tell them before you start taking METEX XR.

Taking other medicines
Tell your doctor if you are taking any other medicines, including those you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by METEX XR or may affect how well it works. These include:

other medicines used to treat diabetes
medicines used to treat high blood pressure and some heart conditions
medicines used to prevent blood clots such as warfarin
diuretics, also called fluid tablets
thyroid preparations such as thyroxine
corticosteroids such as prednisone, cortisone
medicines that contain alcohol, such as cough and cold syrups
medicines used to treat asthma such as salbutamol and terbutaline
NSAIDs, medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis such as aspirin, diclofenac, ibuprofen, meloxicam, naproxen and piroxicam
medicines used to treat ulcers and reflux, such as cimetidine.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. They also have more information on medicines to be careful with or avoid while taking METEX XR.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

How to take METEX XR
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

How much to take
The dose varies from patient to patient. Your doctor will decide the right dose for you.

The usual starting dose for adults is 500 mg (one tablet) with the evening meal. Your doctor may increase the dose, depending on your blood glucose levels.

The maximum recommended dose is 2 g (4 tablets) once a day.

The elderly and people with kidney problems may need smaller doses.

How to take METEX XR
Swallow the tablets with a glass of water.

Do not break, crush or chew the tablets. If you break, chew or crush the tablets, they will not work as well.

Take METEX XR with your evening meal. This will lessen the chance of a stomach upset. Taking it at the same time each day will also have the best effect.

How long to take METEX XR for
Keep taking METEX XR for as long as your doctor recommends. METEX XR will help control diabetes but will not cure it. Most people will need to take METEX XR for long periods of time.

When you first start treatment with METEX XR it may take some weeks before your blood glucose levels are properly controlled.

If you forget to take METEX XR
Do not take a double dose to make up for the dose you missed.

Take the next dose at the usual time.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much METEX XR (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much METEX XR. Do this even if there are no signs of discomfort or poisoning.

If you take too much METEX XR, you may feel sick, vomit, have trouble breathing and have unusual muscle pain, stomach pain or diarrhoea. These may be early symptoms of a serious condition called lactic acidosis (high level of lactic acid in the blood).

You may also experience symptoms of hypoglycaemia (low blood glucose). This usually only happens if you take too much METEX XR together with other medicines for diabetes or with alcohol.

If you do experience any signs of hypoglycaemia, raise your blood glucose quickly by eating jelly beans, sugar or honey, drinking non- diet soft drink or taking glucose tablets.

While you are taking METEX XR
Things you must do
Before starting any new medicine, tell your doctor or pharmacist that you are taking METEX XR.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking METEX XR.

If you become pregnant while taking METEX XR, tell your doctor.

Tell your doctor if you plan to have surgery that requires general anaesthesia. You doctor will tell you when to temporarily stop METEX XR and when to restart them.

Tell your doctor if you plan to have any X-ray procedures that require an injection of iodinated contrast (dye). Using this type of contrast while you are taking METEX XR can cause serious kidney problems and increase the risk of lactic acidosis.

Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia (low blood sugar) and hyperglycaemia (high blood sugar), and know how to treat them.

Hypoglycaemia

METEX XR does not normally cause hypoglycaemia although you may experience if you are also taking other medicines for diabetes such as insulin or sulfonylureas.

Hypoglycaemia can occur suddenly. Symptoms may include:

weakness, trembling or shaking
sweating
light- headedness, dizziness, headache or lack of concentration
irritability, tearfulness or crying
hunger
numbness around the lips and tongue.
If not treated promptly, these symptoms may progress to:

loss of co- ordination
slurred speech
confusion
fits or loss of consciousness.
If you experience any of the symptoms of hypoglycaemia, you need to raise your blood glucose immediately. You can do this by doing one of the following:

eating 5 to 7 jelly beans
eating 3 teaspoons of sugar or honey
drinking half a can of non-diet soft drink
taking 2 to 3 concentrated glucose tablets.
Unless you are within 10 to 15 minutes of your next meal or snack, follow up with extra carbohydrates such as plain biscuits, fruit or milk. Taking this extra carbohydrate will prevent a second drop in your blood glucose level.

Hyperglycaemia
If you experience any of the symptoms of hyperglycaemia (high blood sugar), contact your doctor immediately.

The risk of hyperglycaemia is increased in the following situations:

uncontrolled diabetes
illness, infection or stress
taking less METEX XR than prescribed
taking certain other medicines
too little exercise
eating more carbohydrates than normal.
Tell your doctor if you:

become ill
become dehydrated
are injured
have a fever
become pregnant
have a serious infection
having surgery (including dental surgery)
having X-ray procedures that require injection of iodinated contrast agents (dye).
Your blood glucose may become difficult to control at these times. You may also be more at risk of developing a serious condition called lactic acidosis. At these times, your doctor may replace METEX XR with insulin.

Visit your doctor regularly for check ups. Your doctor may want to check your kidneys, liver, heart and blood while you are taking METEX XR.

Make sure you check your blood glucose levels regularly. This is the best way to tell if your diabetes is being controlled properly. Your doctor or diabetes educator will show you how and when to do this.

Carefully follow your doctor's and dietician’s advice on diet, drinking alcohol and exercise.

Things you must not do
Do not skip meals while taking METEX XR.

Do not stop taking METEX XR or change the dose without checking with your doctor.

Do not give METEX XR to anyone else, even if they have the same condition as you.

Things to be careful of
If you have to be alert, for example when driving, be especially careful not to let your blood glucose levels fall too low. Low blood glucose levels may slow your reaction time and affect your ability to drive or operate machinery. Drinking alcohol can make this worse. However, METEX XR by itself is unlikely to affect how you drive or operate machinery.

If you become sick with a cold, fever or flu, it is very important to continue eating your normal meals. Your diabetes educator or dietician can give you a list of foods to eat on sick days.

Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking METEX XR. METEX XR helps most people with diabetes but it may have unwanted side effects in some 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.

If you are over 65 years of age, you may have an increased chance of getting side effects. Report any side effects to your doctor promptly.

Ask your doctor or pharmacist to answer any questions you may have.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor if you notice any of the following and they worry you:

stomach upset such as feeling sick (nausea), vomiting
diarrhoea
stomach pain
skin rash, itching, hives
taste disturbance, loss of appetite.
These are generally mild side effects which usually occur during the first few weeks. Taking METEX XR with meals can help reduce nausea and diarrhoea. Skin rash is rare and should go away in a few days.

TELL YOUR DOCTOR IMMEDIATELY OR GO TO ACCIDENT AND EMERGENCY AT THE NEAREST HOSPITAL IF YOU NOTICE ANY OF THE FOLLOWING SYMPTOMS OF LACTIC ACIDOSIS (HIGH LACTIC ACID IN THE BLOOD):

nausea, vomiting, stomach pain
trouble breathing
feeling weak, tired or generally unwell
unusual muscle pain
sleepiness
dizziness or light- headedness
shivering, feeling extremely cold
slow heart beat.
LACTIC ACIDOSIS IS A VERY RARE, BUT SERIOUS SIDE EFFECT OF METEX XR THAT REQUIRES URGENT MEDICAL ATTENTION OR HOSPITALISATION. IF LACTIC ACIDOSIS DOES OCCUR, IT CAN BE FATAL.

The risk of lactic acidosis is higher in some patients including:

the elderly
those drinking excessive amounts of alcohol
those whose kidneys or liver are not working properly
those whose diabetes is poorly controlled
those with certain heart conditions
those with prolonged fasting.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice anything that is making you feel unwell. It is very important that you speak to your doctor immediately if a side effect is sever, occurred suddenly or gets rapidly worse.

After taking METEX XR
Storage
Keep METEX XR 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.

Keep your tablets in a cool dry place where the temperature stays below 25 deg C.

Do not store METEX XR or any other medicine in the bathroom or near a sink.

Do not leave METEX XR in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal
If your doctor tells you to stop taking METEX XR, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description
What it looks like
METEX XR is a white capsule shaped tablet, marked XR5 on one side and ‘>’ on the other.

Blister packs contain 90 tablets.

Bottles contain 90 tablets or 300 tablets.

Ingredients
The active ingredient in METEX XR is metformin hydrochloride. Each tablet contains 500 mg of metformin hydrochloride.

The tablets also contain:

carmellose sodium
hypromellose
colloidal anhydrous silica
microcrystalline cellulose
magnesium stearate.
The tablets do not contain lactose, gluten, sucrose, tartrazine or any other azo dyes.

Supplier
Sigma Pharmaceuticals (Australia) Pty Ltd
(A.C.N. 004 118 594)
96 Merrindale Dve
Croydon Victoria 3136
Australia
Telephone: 03 - 9839 2800 03 - 9839 2800

Australian registration number
AUST R 143465

Date of preparation:
June 2007.

Published by MIMS/myDr March 2009

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