The name of your medicine is APO-Metformin XR 500. It contains the active ingredient metformin hydrochloride.
Metformin is used control blood glucose (sugar) in people with Type 2 diabetes mellitus, especially in those who are overweight. It is used when diet and exercise are not enough to control high levels of blood glucose.
Metformin XR 500 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 to 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 may include:
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.
Metformin belongs to a group of medicines called biguanides. It lowers high blood glucose levels by:
There is no evidence that this medicine is addictive.
This medicine should not be used in children since safety and effectiveness in this age group has not been established.
Do not take this medicine if:
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
2. You have or have had any medical conditions, especially the following:
3. You drink alcohol.
4. You are planning to have any operations or radiographic procedures
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interact with metformin. These include:
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking metformin.
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with metformin.
Follow carefully all directions given to you by your doctor or pharmacist. 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 you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
The usual starting dose is 1 tablet (500 mg) once daily with the evening meal. Your doctor may increase the dose slowly, depending on your blood glucose levels.
The maximum recommended dose is 2 grams once per day.
The elderly and people with kidney problems may need smaller doses.
Swallow the tablets whole with a glass of water.
Do not break, crush or chew the tablets.
If you break, crush or chew the tablets, they will not work as well. Metformin XR are modified release tablets. This means they have a special coating which allows the active ingredient, metformin, to be released slowly over time.
Take your medicine everyday with the evening meal.
Taking the tablets during or with your evening meal will reduce the chance of a stomach upset.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
Continue taking your medicine for as long as your doctor tells you.
Metformin will help control diabetes but will not cure it. Most people will need to take metformin for long periods of time.
When you start treatment with metformin, it can take up to some weeks for your blood glucose levels to be properly controlled.
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 you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much metformin, you may feel very tired, sick, vomit, have trouble breathing and have unusual muscle pain, stomach pain or diarrhoea. These may be early signs of a serious condition called lactic acidosis (build-up 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 metformin 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 a non-diet soft drink or taking glucose tablets.
Tell your doctor that you are taking this medicine if:
Your doctor will advise you when to stop taking metformin before you have these procedures and when to start again.
Your doctor may also do tests to make sure the medicine is working and to prevent side effects.
Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Metformin does not normally cause hypoglycaemia (low blood sugar), although you may experience it while taking other medicines for diabetes such as insulin, sulfonylureas or glitinides. Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia (low blood sugar) and know how to treat them.
Hypoglycaemia can occur suddenly. Initial signs may include:
If not treated promptly, these may progress to:
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:
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.
If you experience any of the signs of hyperglycaemia (high blood sugar), contact your doctor immediately.
The risk of hyperglycaemia is increased in the following situations:
Tell your doctor if any of the following happen:
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 metformin with insulin.
Visit your doctor regularly for check-ups.
Your doctor may want to check your kidneys, liver, heart and blood levels while you are taking metformin.
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 the advice of your doctor and dietician on diet, drinking alcohol and exercise.
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, metformin by itself is unlikely to affect how you drive or operate machinery.
After metformin is absorbed into your body, you may see the empty tablet shell in your faeces (bowel motions). This is normal and does not affect the way metformin works.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine 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 and they worry you.
This list includes the more common side effects:
These are generally mild side effects which disappear after the first few weeks. Taking metformin with meals can help reduce nausea and diarrhoea.
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.
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 and are usually very rare. You may need urgent medical attention or hospitalisation.
Symptoms of lactic acidosis (build-up of lactic acid in the blood):
LACTIC ACIDOSIS IS A VERY RARE BUT SERIOUS SIDE EFFECT REQUIRING URGENT MEDICAL ATTENTION OR HOSPITALISATION. ALTHOUGH RARE, IF IT DOES OCCUR, LACTIC ACIDOSIS CAN BE FATAL. THE RISK OF LACTIC ACIDOSIS IS HIGHER IN THE ELDERLY, OR PEOPLE WITH POORLY CONTROLLED DIABETES, PROLONGED FASTING, CERTAIN HEART CONDITIONS, SEVERE LIVER OR KIDNEY PROBLEMS OR PEOPLE WHO DRINK ALCOHOL.
Tell your doctor or pharmacist 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 severe, occurred suddenly or gets worse rapidly.
Other side effects not listed above may occur in some people.
Some side effects (e.g. reduced vitamin B12 level) can only be found when your doctor does tests from time to time to check your progress.
If you think you are having an allergic reaction to Metformin XR, do not take any more of this medicine and 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:
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.
Metformin XR 500 contain 500 mg metformin hydrochloride as modified release tablets: white to off-white capsule-shaped, unscored tablet; engraved "APO" on one side and "XR500" on the other side.
It is available in blister packs of 120 tablets.
It is available in bottles of 120 tablets.
Each modified release tablet contains 500 mg of metformin hydrochloride as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
APO-Metformin XR 500
Blister: AUST R 197402.
APO-Metformin XR 500
Bottles: AUST R 197407