Glucovance

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

metformin hydrochloride and glibenclamide

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common questions about Glucovance.

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

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Glucovance against the benefits expected for you.

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

Keep this leaflet with your medicine.

You may need to read it again.

What Glucovance is used for

Glucovance is used to control blood glucose levels (the amount of sugar in the blood) in adults with type II diabetes mellitus. This type of diabetes is also known as non-insulin dependent diabetes mellitus (NIDDM) or maturity onset diabetes.

Glucovance is used:

when diet, exercise and treatment with either metformin or a sulfonylurea medicine are not enough to control your blood glucose

in people whose blood sugar levels are already well controlled by the combination of metformin and a sulfonylurea medicine. Glucovance is to replace these two medicines.

Glucovance contains two active ingredients, metformin hydrochloride and glibenclamide.

Metformin belongs to a group of medicines called biguanides. Metformin lowers blood glucose by helping your body make better use of insulin.

Glibenclamide belongs to a group of medicines called sulfonylureas. Glibenclamide lowers blood glucose by increasing the amount of insulin produced by your pancreas.

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. Signs 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 quickly, 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 such as heart disease, blindness, poor blood circulation, gangrene or kidney damage.

Ask your doctor if you have any questions about why Glucovance has been prescribed for you.

Glucovance is available only with a doctor's prescription.

There is no evidence that Glucovance is addictive.

This medicine has been prescribed for you personally and you should not pass it onto others even if their symptoms are the same as yours.

Before you take Glucovance

When you must not take it

Do not take Glucovance if you are allergic to the following:

metformin hydrochloride (e.g. Diabex, Diaformin, Glucophage)

glibenclamide (e.g. Daonil, Glimel)

any other sulfonylurea medicine such as gliclazide (e.g. Diamicron, Glyade), glipizide (e.g. Minidiab, Melizide), glimepiride (e.g. Amaryl, Dimirel) or any other sulfonamides (e.g. Septrin)

any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.

Do not take Glucovance if you are currently taking miconazole (Daktarin), either orally or as a mouth gel.

Taking Glucovance with miconazole may cause an excessive drop in your blood glucose level.

Do not take Glucovance if you have the following conditions:

type I diabetes mellitus also known as insulin dependent diabetes

type II diabetes that is already well controlled by diet alone

serious complications with your diabetes or or any type of metabolic acidosis such as lactic acidosis, diabetic ketoacidosis (a symptom of uncontrolled diabetes, in which substances called ketone bodies accumulate in the blood - you may notice this as an unusual fruity odour on your breath)

severe liver disease

kidney failure or severe kidney disease

dehydration (for instance due to persistent or severe diarrhoea or recurrent vomiting), severe blood loss or shock

severe infection or gangrene

certain heart or blood vessel problems, including a recent heart attack or heart failure (when the heart fails to pump blood effectively)

severe breathing difficulties

blood clots in the lung (symptoms include coughing, shortness of breath, chest pain and a fast heart rate)

pancreatitis (symptoms include severe upper stomach pain, often with nausea and vomiting) if associated with severe infection or hypoxia (lack of oxygen)

alcohol dependence or binge drinking

porphyria, an inherited disorder

glucose and galactose malabsorption syndrome or lactase deficiency.

Do not take Glucovance if you need to have major surgery or an examination such as an X-ray or a scan involving the injection of contrast medicines that contain iodine into your bloodstream.

You must stop taking Glucovance for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment for this time. It is important that you follow your doctor's instructions precisely.

Do not take Glucovance if you are pregnant.

Insulin is more suitable for controlling blood glucose during pregnancy. Your doctor will replace Glucovance with insulin while you are pregnant.

Do not take Glucovance if you are breastfeeding.

Since it is not known whether Glucovance passes into breast milk, Glucovance is not recommended while you are breast-feeding.

Do not take Glucovance after the expiry date (EXP.) printed on the pack has passed.

If you take this medicine after the expiry date, it may not work as well.

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

Do not give Glucovance to children or adolescents.

The safety and effectiveness of Glucovance have not been established in children or adolescents.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to:

any other medicines

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

Tell your doctor if you have, or have had, any medical conditions, especially the following:

kidney problems

liver problems

hormone problems with the thyroid, pituitary or adrenal gland

heart or blood vessel problems including heart failure.

Your doctor may want to take special care if you have any of these conditions.

Tell your doctor if you:

drink alcohol

do not eat regular meals, are fasting or have changed your diet

do a lot of exercise

are ill or feeling unwell.

Alcohol, diet, exercise and your general health all strongly affect the control of your diabetes.

If you have not told your doctor about any of the above, tell him/her before you start taking Glucovance.

Taking other medicines

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

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

other medicines containing metformin or glibenclamide

other medicines used to treat diabetes

iodinated contrast agents (dyes)

medicines that contain alcohol, such as cough and cold syrups

diuretics, also called fluid tablets

certain antifungal medicines, such as miconazole (Daktarin Oral Gel) and fluconazole (Diflucan)

certain antibiotics including medicines used to treat tuberculosis

medicines used to treat high blood pressure and heart conditions (clonidine, reserpine, guanethidine, sympathicomimetics, beta-blockers, calcium channel blockers and ACE inhibitors)

disopyramide (Rhythmodan), a medicine used to treat an irregular heart beat

non-steroidal anti-inflammatory drugs (NSAIDS), medicines used to relieve pain, swelling and other symptoms of inflammation including arthritis, such as aspirin and phenylbutazone

desmopressin (Minirin), a medicine used to treat diabetes insipidus, a condition causing large amounts of urine to be produced

danazol (Danocrine, Azol), a medicine used to treat endometriosis

bosentan, a medicine used to treat pulmonary hypertension

phenytoin (Dilantin), a medicine used to treat epilepsy (fits or seizures)

medicines used to treat depression such as fluoxetine (e.g. Prozac, Lovan) and monoamine oxidase inhibitors (MAOIs)

medicines used to treat schizophrenia and mental illnesses, such as chlorpromazine (Largactil) and phenothiazines

corticosteroids, such as prednisone (Panafcort, Sone) and cortisone (Cortate)

medicine used to stimulate the adrenocortical hormones, such as tetracosactide (tetracosactrin)

anabolic steroids

oestrogens and progestagens in hormone replacement therapy and oral contraceptives

thyroid hormones, such as thyroxine (e.g. Oroxine, Eutrosig)

some medicines used for asthma

medicines used to treat for ulcers and reflux, such as cimetidine (e.g. Tagamet, Magicul) and ranitidine (e.g. Zantac, Rani 2)

medicines used to prevent or to treat blood clots such as warfarin (Coumadin, Marevan), heparin or sulphinpyrazone

medicines used to lower lipids, such as bezafibrate, clofibrate, gemfibrozil (Lopid) and nicotinic acid

pentoxifylline (oxpentifylline)injection, a medicine used to treat blood vessel problems

certain medicines used to treat cancer

certain medicines used to treat gout such as probenecid (Pro-cid)

acetazolamide (Diamox), a medicine used to treat glaucoma

certain weight reducing medicines

large doses of laxatives.

medicines that are substrates/ inhibitors of organic cation transporters - OCT 1 such as verapamil; OCT 2 such as dolutegravir, crizotinib, olaparib, daclatasvir or vandetanib

medicines that are inducers of OCT 1 such as rifampicin

medicines that may increase the risk of lactic acidosis when concomitantly used with metformin hydrochloride such as topiramate and other carbonic anhydrase inhibitors, such as zonisamide, acetazolamide or dicchlorphenamide.

These medicines may be affected by Glucovance or may affect how well it works. You may need different amounts of your medicines or you may need to take different medicines.

Your doctor can tell you what to do if you are taking any of these medicines.

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

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Glucovance.

How to take Glucovance

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist.

How much to take

The dose varies from person to person. Your doctor will decide the right dose for you.

People who do not respond to either metformin or a sulfonylurea medicine alone.

The usual starting dose is one Glucovance 500 mg/2.5 mg tablet once a day.

Replacing combined use of metformin and a sulfonylurea or glibenclamide medicine.

The usual starting dose is one to two tablets of Glucovance 500 mg/2.5 mg daily.

Elderly people

The dose depends on the renal function. The usual starting dose for elderly patients may be one Glucovance 250mg/1.25mg tablet daily.

Age 65 years and older has been identified as a risk factor for hypoglycaemia in patients treated with sulfonylureas. Hypoglycaemia can be difficult to recognize in the elderly. Starting and maintenance doses of glibenclamide must be carefully adjusted to reduce the risk of hypoglycaemia.

It is recommended that these patients are not titrated to the maximum dose of Glucovance to avoid the risk of hypoglycaemia.

Smaller doses may be prescribed by your doctor if you have kidney problems or generally poor health.

Your doctor may increase the dose slowly over one or two weeks, depending on your blood glucose levels and other tests.

The usual maximum recommended dose is one Glucovance 500mg/5mg tablet three times a day.

How to take it

Swallow the tablets with a glass of water.

When to take it

Take Glucovance immediately before your meal.

This will reduce the chances of you having an upset stomach or a hypoglycaemic episode.

Take your medicine at about the same time each day.

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

How long to take it for

Keep taking Glucovance for as long as your doctor tells you to.

Glucovance will help control diabetes but will not cure it. Most people will need to take Glucovance for long periods of time.

If you forget to take it

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 or have any questions, ask your doctor or pharmacist.

If you take too much (overdose)

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

You may need urgent medical attention.

If you take too much Glucovance, 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). If not treated quickly, these symptoms may progress to loss of co-ordination, slurred speech, confusion, fits or loss of consciousness.

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.

While you are taking Glucovance

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.

Hypoglycaemia

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.

Make sure that you have a full breakfast immediately after your first dose. If you usually have a light breakfast, hold off the first dose until lunch.

Due to the hypoglycaemic effect of Glucovance, it is recommended that you have a full meal immediately after a dose, to avoid a drop in your blood glucose level.

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.

The risk of hypoglycaemia is increased in the following situations:

irregular meals or changes to diet

intensive or prolonged exercise

after alcohol intake

taking more Glucovance than prescribed

taking certain other medicines

in patients with kidney or liver problems

in patients with hormone problems with the thyroid, pituitary or adrenal gland

in patients from 65 years of age. Hypoglycaemia may be more severe and more prolonged than in younger adults.

Discuss with your doctor whether Glucovance is the appropriate treatment for your diabetes if you often experience severe symptoms of low blood sugar or if you find it hard to recognise them.

Hyperglycaemia

If you notice the return of any symptoms of hyperglycaemia, contact your doctor immediately.

Your doctor may need to consider additional or other treatments for your diabetes.

The risk of hyperglycaemia is increased in the following situations:

taking less Glucovance than prescribed

taking certain other medicines

too little exercise

eating more carbohydrates than normal.

Tell your doctor if you:

become ill

become dehydrated (for instance due to persistent or severe diarrhoea or recurrent vomiting)

are injured

have a fever

have a serious infection such as influenza, respiratory tract infection or urinary tract infection

are having surgery with general anaesthesia (including dental surgery)

are having any X-ray or scan that requires the injection of contrast medicines that contain iodine into your bloodstream.

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 Glucovance with insulin.

Before starting any new medicine, tell your doctor or pharmacist that you are taking Glucovance.

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

If you become pregnant while taking Glucovance, tell your doctor.

Visit your doctor regularly for check ups.

Your doctor may want to perform blood tests to check your kidneys, liver, heart, and vitamin B12 levels while you are taking Glucovance. Make sure that you return to your doctor at least once a year (more often if you are elderly or if your kidney function is at the limit of normal).

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 from your doctor and dietician on diet, drinking alcohol and exercise.

If you drink alcohol while taking Glucovance, you may get flushing, headache, breathing difficulties, rapid heartbeat, stomach pains or feel sick and vomit.

Your doctor may suggest avoiding alcohol.

Things you must not do

Do not use any other medicines containing metformin or glibenclamide, in the form of either a single or a combination product, while you are being treated with Glucovance.

Taking additional metformin or glibenclamide-containing products may increase the risk of you getting unwanted side effects.

Do not skip meals while taking Glucovance.

You are more at risk of developing hypoglycaemia if you skip meals.

Do not stop taking Glucovance, or change the dose, without checking with your doctor.

Do not use Glucovance to treat any other conditions unless your doctor tells you to.

Do not give Glucovance 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 driving, be 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.

Protect your skin when you are in the sun, especially between 10 am and 3 pm. If outdoors, wear protective clothing and use a 15+ sunscreen. If your skin does appear to be burning, tell your doctor immediately.

Glucovance may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight may cause skin rash, itching, redness or severe sunburn.

If you become sick with a cold, fever or flu, it is very important to continue eating your normal meals. If you have trouble eating solid food, use sugar-sweetened drinks as a carbohydrate substitute or eat small amounts of bland food.

Your diabetes educator or dietician 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 Glucovance tablets 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 you are taking Glucovance.

Glucovance helps most people with type II 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 an elderly person over 65 years of age, report any side effects promptly to your doctor.

You may have an increased chance of getting side effects.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

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

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

signs of hypoglycaemia which may include weakness, trembling or shaking, sweating, light headedness, headache, dizziness, irritability and tearfulness

stomach upset including nausea (feeling sick), vomiting and indigestion

pressure on the stomach or feeling of fullness

diarrhoea

loss of appetite

taste disturbance

mild skin rash

transient visual disturbances due to a decrease of blood glucose levels

flushing, headache, breathing difficulties, rapid heart beat, stomach pains or feel sick and vomit if you drink alcohol while taking Glucovance.

The above list includes some of the milder side effects of Glucovance.

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

skin reactions including severe skin rash, itching or hives

symptoms of sunburn such as redness, itching or blistering, which may occur more quickly than normal

bleeding or bruising more easily than normal, reddish or purplish blotches under the skin

symptoms of liver disease such as yellowing of the eyes or skin (jaundice) and dark coloured urine

frequent signs of infection, such as fever, chills, sore throat or mouth ulcers.

The side effects listed above are serious and require urgent medical attention or hospitalization.

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 (BUILD UP OF 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 heartbeat.

LACTIC ACIDOSIS IS A VERY RARE BUT SERIOUS SIDE EFFECT REQUIRING URGENT MEDICAL ATTENTION OR HOSPITALISATION. ALTHOUGH RARE, IF LACTIC ACIDOSIS DOES OCCUR, IT CAN BE FATAL. THE RISK OF LACTIC ACIDOSIS IS HIGHER IN THE ELDERLY, THOSE WHOSE DIABETES IS POORLY CONTROLLED, THOSE WITH PROLONGED FASTING, THOSE WITH CERTAIN HEART CONDITIONS, THOSE WHO DRINK ALCOHOL AND THOSE WITH KIDNEY OR LIVER PROBLEMS.

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 severe, occurred suddenly or gets worse rapidly.

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

After taking Glucovance

Storage

Keep Glucovance 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 the pack until it is time to take them.

If you take the tablets out of the pack, they will not keep well.

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

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

Do not leave Glucovance in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

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