Consumer medicine information

METFORMIN RANBAXY 1000

Metformin 1000 mg Tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about METFORMIN RANBAXY 1000.

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

All medicines have risks and benefits. Your doctor has weighed the risks of your taking METFORMIN RANBAXY 1000 against the benefits it is expected to have for you.

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

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

What METFORMIN RANBAXY 1000 is used for

METFORMIN RANBAXY 1000 is one of the group of medicines called oral hypoglycaemics, which work by reducing the level of sugar in the blood in people with diabetes mellitus, and by helping your body to make better use of the insulin produced by your pancreas.

Diabetes Mellitus is a condition in which the blood glucose levels are not adequately controlled.

If your blood glucose is not properly controlled, you may experience hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose).

Hypoglycaemia
Hypoglycaemia (low blood glucose) can occur suddenly. Initial signs 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 may progress to:

  • Loss of co-ordination
  • Slurred speech
  • Confusion
  • Fits or loss of consciousness

Hyperglycaemia
Hyperglycaemia (high blood glucose) usually occurs more slowly than hypoglycaemia. Signs of hyperglycaemia may include:

  • Lethargy or tiredness
  • Headache
  • Thirst
  • Passing large amounts of urine
  • Blurred vision

Long-term hyperglycaemia can lead to serious problems with your heart, eyes, kidneys or blood circulation.

There are two types of diabetes:

  • Type 1 which is called insulin-dependent diabetes or juvenile-onset diabetes, when insulin alone is not enough to control blood glucose levels.
  • Type 2 which is called non-insulin-dependent diabetes mellitus (NIDDM) or maturity-onset diabetes.

People with type 2 diabetes are not able to make enough insulin or respond normally to the insulin their bodies make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputation and blindness.

Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level. High blood sugar can he lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin injections.

METFORMIN RANBAXY 1000 tablets are used for the treatment of type 2 diabetes which usually only occurs in adults.

METFORMIN RANBAXY 1000 is especially useful in people with high blood glucose (hyperglycaemia) who are overweight and in whom diet and exercise alone are not enough to lower their blood glucose levels.

METFORMIN RANBAXY 1000 can be used alone or in combination with other medicines for treating diabetes. METFORMIN RANBAXY 1000 can also be used in patients with type 1 diabetes mellitus where insulin alone is not enough to control blood glucose levels.

METFORMIN RANBAXY 1000 is not recommended for use in children, except for those with insulin-resistant diabetes who are being treated in hospital.

Before you take METFORMIN RANBAXY 1000

When you must not take it

Do not take METFORMIN RANBAXY 1000 if you answer YES to any of the following questions.

  • Are you allergic to any of the ingredients in this medicine?
  • Do you have type 1 diabetes mellitus that is well controlled by insulin alone?
  • Do you have type 2 diabetes that is already well controlled by diet alone?
  • Are you suffering from diabetic ketoacidosis (a symptom of uncontrolled diabetes, in which substances called ketone bodies build up in the blood – you may notice this as an unusual fruity odour on your breath, difficulty in breathing, confusion and frequent urination)
  • Are you allergic to any other medicines, foods, dyes or preservatives?
  • Do you drink alcohol excessively or suffer from alcohol dependence? Alcohol can affect the control of your diabetes. Drinking excessive amounts of alcohol while you are being treated with METFORMIN RANBAXY 1000 may also lead to serious side effects. Your doctor may suggest you stop drinking or reduce the amount of alcohol you drink.
  • Do you have any problem with your liver or kidneys?
  • Do you have a heart disorder such as heart failure or have you suffered a heart attack recently?
  • Are you, or could you be, pregnant? lnsulin is more suitable for controlling blood glucose during pregnancy. Your doctor will replace METFORMIN RANBAXY 1000 with insulin while you are pregnant.
  • Are you breast-feeding? METFORMIN RANBAXY 1000 is not recommended while you are breast-feeding. Your doctor will discuss with you the other options of treatment.
  • Are you likely to have surgery or a scan involving the use of X-rays, including dental surgery within the next few days? Some types of X-ray procedures require an injection of iodinated contrast (dye). Using this type of dye while you are taking METFORMIN RANBAXY 1000 may cause severe kidney problems and increase the risk of a serious condition called lactic acidosis. Your doctor will tell you when to temporarily stop taking the tablets before the X-ray and when it is safe to restart them.
  • Do you have any problems with your circulation causing, for example, frequent cramp in your calves or leg ulcers that do not heal?
  • Do you have a fever or are you ill in any other way?
  • Are you on a special diet?
  • Are you suffering from an excessive loss of body water?
  • Do you have breathing problems?
  • Do you suffer from the symptoms of blood clots in the lungs? (symptoms include coughing, shortness of breath, chest pain and a fast heart rate)
  • Are you suffering from severe blood loss or shock?
  • Are you suffering from gangrene?
  • Are you suffering from inflammation of the pancreas? (Symptoms include severe stomach pain often with nausea and vomiting.)

If you are not sure whether you should start taking METFORMIN RANBAXY 1000, talk to your doctor or pharmacist.

Patients who are already on insulin should only be started on a course of treatment with METFORMIN RANBAXY 1000 tablets in hospital.

METFORMIN RANBAXY 1000 tablets should not be taken by children, except for those with insulin-resistant diabetes who are being treated in hospital.

Do not take METFORMIN RANBAXY 1000 tablets after the expiry date printed on the pack has passed. If you take it after the expiry date has passed, it may not work as well.

Do not take METFORMIN RANBAXY 1000 if the foil seal is broken or the pack shows signs of tampering.

Taking other medicines

Tell you doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food store. Some medicines and METFORMIN RANBAXY 1000 may interfere with each other. This is particularly important in the case of:

  • other antidiabetic drugs (e.g. insulin, guar gum), sulphonylureas such as gliclazide (eg Diarnicron Glyade), glipizide (eg Minidiab, Melizide), glimepiride (eg Amaryl, Dimirel), repaglinide (Novonorm)
  • anti-inflammatory pain killers such as salicylates or pyrazolones
  • medicines used to treat high blood pressure and some heart conditions (beta blockers, calcium channel blockers and ACE inhibitors eg. metoprolol ( Betaloc, Minax), nifedipine (Adalat, Adefin), enalapril (Renitec), Lisinopril (Zestril).
  • cimetidine (Tagamet Magicul) a medicine used to treat reflux and ulcers
  • corticosteroids such as prednisone (Panafcort, Sone) and Cortisone (Cortate)
  • tablets that thin the blood (anticoagulants such as warfarin. Coumarin, Marevan)
  • fluid tablets (thiazide diuretics such as Moduretic, Aprinox, Arnizide)
  • thyroid preparations such as thyroxine (Oroxine)
  • Contrast media given as injections when you undergo examination using X-rays; for example Ultravist. One ingredient called “propylene glycol” may cause allergic reactions.

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 to avoid while taking METFORMIN RANBAXY 1000.

How to take METFORMIN RANBAXY 1000

Follow all directions given to you by your doctor or pharmacist carefully. These may differ from the information contained in this leaflet.

How much to take

The dose varies from patient to patient. The usual starting dose is one 500 mg tablet once or twice a day with breakfast and the evening meal. Your doctor may increase or decrease the dose depending on your blood glucose levels. The maximum recommended dose is 1000 mg three times a day. Elderly patients may need smaller doses.

If your child has diabetes which is resistant to insulin and is being treated in hospital, your child’s doctor will decide the dose.

How to take it

The tablets should be swallowed whole with a glass of water during or after meals. This will lessen the chance of a stomach upset.

How long to take it

METFORMIN RANBAXY 1000 will help control diabetes but will not cure it. Most people need to take metformin tablets for long periods of time. Do not stop until your doctor tells you to, even if you feel better.

If you forget to take it

If you miss a dose, take it as soon as you remember (with food) unless it is nearly time for the next dose. If it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for the one missed.

If you take too much

If you take too much METFORMIN RANBAXY 1000, immediately telephone your doctor or the Poisons Information Centre (telephone 131126) for advice, or go to Accident & Emergency 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 RANBAXY 1000, you may feel sleepy, 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 RANBAXY 1000 together with other medicines for diabetes or with alcohol.

While taking METFORMIN RANBAXY 1000

Things you must do

Make sure that you, your friends, family and work colleagues can recognise the symptoms of

hypoglycaemia and hyperglycaemia and know how to treat them.

If you plan to have surgery, (including dental surgery) or anaesthesia, inform your doctor, dentist or anaesthetist that you are taking METFORMIN RANBAXY 1000 tablets.

If you do experience any signs of hypoglycaemia (low blood glucose), raise your blood glucose quickly by taking one of the following:

  • 5-7 jelly beans
  • 3 teaspoons of sugar or honey
  • Half a can of non-diet soft drink
  • 2-3 concentrated glucose tablets

Unless you are within 10-15 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. METFORMIN RANBAXY 1000 does not normally cause hypoglycaemia, although you may experience it while taking other medicines for diabetes such as insulin or sulphonylureas.

If you experience any of the signs of hyperglycaemia (high blood glucose), contact your doctor immediately.

The risk of hyperglycaemia is increased in the following situations:

  • Uncontrolled diabetes
  • Illness, infection or stress
  • Taking less METFORMIN RANBAXY 1000 than prescribed
  • Taking certain other medicines
  • Too little exercise
  • Eating more carbohydrates than usual

Tell your doctor immediately if you become pregnant while taking METFORMIN RANBAXY 1000.

Tell your doctor if you:

  • become ill
  • become dehydrated
  • are injured
  • have a fever
  • have a serious infection
  • are having surgery (including dental surgery)
  • are having X-ray procedures that require injection of contrast agents

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 RANBAXY 1000 with insulin.

Before starting any new medicines, tell your doctor or pharmacist that you are taking METFORMIN RANBAXY 1000.

Visit your doctor regularly for check-ups. Your doctor may want to check your kidneys, liver, heart, blood and vitamin B12 levels while you are taking METFORMIN RANBAXY 1000.

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.

When you start treatment with METFORMIN RANBAXY 1000, it can take up to three weeks for your blood glucose levels to be properly controlled.

Prolonged treatment with METFORMIN RANBAXY 1000 can deplete reserves of vitamin B12 and this may causeanaemia. Regular blood tests for kidney function and Vitamin Bl2 should therefore be carried out.

Carefully follow the advice of your doctor and dietician on diet, drinking alcohol and exercise.

Things you must not do

  • Do not skip meals while taking METFORMIN RANBAXY 1000.
  • Do not stop taking METFORMIN RANBAXY 1000 or change the dose without checking with your doctor.
  • Do not give METFORMIN RANBAXY 1000 to anyone else even if they have the same condition as you.
  • Do not use METFORMIN RANBAXY 1000 to treat any other condition unless your doctor tells you to.

Things to be careful of

METFORMIN RANBAXY 1000 tablets on their own should not affect your ability to drive, but if you are also taking other medicines which lower blood sugar, then it is possible that their combined effects could make you feel faint, dizzy, weak or jittery.

If this happens you should not drive or operate any machinery until you have recovered.

If you are 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.

If you become sick with cold, fever or flu, it is very important to continue eating your normal meals.

Your diabetes educator can give you a list of foods to eat on sick days.

When you are travelling, it is a good idea to:

  • Wear some form of identification (e.g. bracelet) showing you have diabetes.
  • Carry some form of sugar to treat hypoglycaemia if it occurs, for example. sugar sachets or jelly beans.
  • Carry emergency food rations in case of a delay, for example, dried fruit, biscuits or muesli bars.
  • Bring enough METFORMIN RANBAXY 1000 with you, so you don’t miss any doses.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking METFORMIN RANBAXY 1000. Like other medicines, metformin may cause some unwanted side effects. It is usually well tolerated, but sometimes they can cause stomach upsets such as feeling sick (nausea), vomiting, diarrhoea, loss of appetite or a metallic taste. If such side effects do occur, they often get better after the first few weeks. Taking METFORMIN RANBAXY 1000 with meals can help reduce nausea and diarrhoea. Rarely, skin reactions may occur. If you notice a red skin rash ask your doctor for advice about continuing with the tablets.

If you are over 65 years of age, you may have an increased chance of getting side effects.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • Stomach or abdominal pain, nausea, vomiting
  • You also develop muscle pains, feel weak, tired or generally unwell, have breathing problems, confusion or drowsiness, dizziness or light-headedness, shivering, feeling extremely cold, slow heart beat. These symptoms may indicate the uncommon but serious condition of lactic acidosis. Lactic acidosis is a very rare but serious side effect requiring urgent medical treatment in hospital. The risk of lactic acidosis is higher in some people, including the elderly, those taking doses greater than 2000 mg a day, those drinking excessive amounts of alcohol and people with kidney problems.

If you think you have any other side effects from taking this medicine, please tell your doctor or pharmacist.

After using it

Storage

Store the tablets in their original blister pack in a cool dry place where the temperature is below 25°C.

Do not store METFORMIN RANBAXY 1000 tablets or any other medicine in the bathroom or near a sink. Do not leave METFORMIN RANBAXY 1000 tablets in the car or on window sills. Heat and dampness can destroy some medicines.

Keep METFORMIN RANBAXY 1000 where children cannot reach it, preferably in a locked cupboard or medicine cabinet 1.5 metres above the ground.

Disposal

If your doctor tells you to stop taking METFORMIN RANBAXY 1000, or your medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What METFORMIN RANBAXY 1000 looks like

White, capsule-shaped film-coated tablets, with a breakline on one side, in blister packs of 90 tablets.

Ingredients

Active ingredient:
Each film-coated tablet contains 1000 mg of the active ingredient metformin.

Inactive ingredients:
Sodium starch glycollate, maize starch, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), propylene glycol, macrogol 6000 and purified talc.

METFORMIN RANBAXY 1000 is gluten-free.

Australian Registration Number

AUST R 170439

Sponsor

Meditab Specialities Pty Ltd
Suite 4, Pacific Chambers
3460 Pacific Highway
SPRINGWOOD QLD 4127

This leaflet was prepared in Jun 2010

Published by MIMS July 2011