APO-Glimepiride

What this medicine is used for

The name of your medicine is APO-Glimepiride. It contains the active ingredient glimepiride.

It is used to control blood glucose in patients with Type II diabetes mellitus.

This type of diabetes is also known as non-insulin-dependent diabetes mellitus (NIDDM) or maturity onset diabetes.

Glimepiride is used when diet and exercise are not enough to control your blood glucose.

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.

How it works

Glimepiride belongs to a group of medicines called sulphonylureas.

Glimepiride lowers high blood glucose by increasing the amount of insulin produced by your pancreas.

Glucose is used by the body as fuel, and all people have glucose circulating in their blood.

In diabetes, levels of blood glucose are higher than is needed. This is called hyperglycaemia.

A section at the end of this leaflet contains advice about recognising and treating hyperglycaemia.

It is very important to control high blood glucose whether or not you feel unwell. This really helps to avoid serious long-term health problems, which can involve the heart, eyes, circulation, and/or kidneys.

As with many medicines used for the treatment of diabetes, there is a possibility that blood glucose levels may become very low during treatment with glimepiride.

This is known as hypoglycaemia.

A section at the end of this leaflet contains advice about recognising and treating hypoglycaemia.

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

This medicine is available only with a doctor's prescription.

There is no evidence that this medicine is addictive.

Be careful driving or operating machinery until you know how glimepiride affects you.

If you have to be alert, e.g. 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. Your vision may also be temporarily affected.

Use in children

There is not enough information to recommend the use of this medicine in children.

Before you take this medicine

When you must not take it

Do not take this medicine if:

You have or have had any of the following conditions:

  • type 1 diabetes mellitus (insulin dependent diabetes mellitus, also known as IDDM, or juvenile or growth onset diabetes)
  • a history of ketoacidosis
  • unstable diabetes
  • diabetic ketoacidosis
  • diabetic coma or pre-coma
  • severe kidney disease or undergoing dialysis
  • severe liver disease.
  • You are pregnant.
Glimepiride may affect your developing baby if you take it during pregnancy. Your doctor will usually replace glimepiride with insulin while you are pregnant.
  • You are breastfeeding.
Glimepiride can pass into breast milk and may harm your baby.
  • You are hypersensitive to, or have had an allergic reaction to:
Glimepiride or other sulfonylureas
antibiotics called sulfonamides
thiazide diuretics (a type of "fluid" or "water" tablet)
lactose - these tablets contain lactose
any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1. You have allergies to:

  • any other medicines
  • lactose
  • any other substances, such as foods, preservatives or dyes.

2. You have or have had any medical conditions, especially the following:

  • liver problems
  • kidney problems
  • adrenal, thyroid or pituitary problems
  • a deficiency of the enzyme in your body called glucose-6-phosphate dehydrogenase (G6PD).

3. You have any medical condition, or do anything, that may increase the risk of hyperglycaemia - for example:

  • you are ill or feeling unwell (especially with fever or infection)
  • you are injured.
  • you are having surgery
  • you are taking less glimepiride than prescribed
  • you are doing less exercise than normal
  • you are eating more carbohydrate than normal.

4. You are taking a medicine called a beta-blocker.

Taking this may mask the symptoms of diabetes.

5. You have any medical condition, or do anything, that may increase the risk of hypoglycaemia - for example:

  • drinking alcoholic drinks.
  • not eating regular meals, including breakfast
  • doing more exercise than usual
  • eating less carbohydrate than normal.

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

6. You plan to become pregnant or breast-feed.

7. You are planning to have surgery or an anaesthetic.

8. You are currently receiving or are planning to receive dental treatment.

9. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with glimepiride. These include:

  • other medicines used to treat diabetes (tablets and insulin)
  • some medicines used to treat high blood pressure or heart conditions, e.g. beta-blockers, ACE inhibitors, calcium channel blockers, amiodarone, disopyramide, reserpine or guanethidine
  • some hormones used in hormone replacement therapy and oral contraceptives (oestrogens and progestogens)
  • monoamine oxidase inhibitors (MAOIs), used for treating depression, Parkinson's Disease or infections
  • some medicines used for mental illness (e.g. phenothiazines)
  • barbiturates, used for epilepsy and sedation during anaesthetics
  • phenytoin, used for epilepsy
  • medicines for treating high cholesterol / blood fats
  • some medicines used to treat arthritis, pain and inflammation (diclofenac, naproxen, ibuprofen , azapropazone, fenyramidol , oxyphenbutazone, phenylbutazone, salicylates)
  • antibiotics called sulfonamides, quinolones, sulfinpyrazone, tetracyclines, rifampicin, isoniazid, clarithromycin or chloramphenicol
  • miconazole, or fluconazole, used to treat fungal infections
  • some medicines used to prevent or treat blood clots (warfarin and similar medicines)
  • cimetidine, famotidine, nizatidine and ranitidine, used to treat acid reflux and stomach ulcers
  • medicines called corticosteroids (e.g. prednisolone, cortisone)
  • anabolic steroids, male sex hormones
  • thyroid hormones, used to treat thyroid problems
  • oxpentifylline used to prevent or treat blood vessel problems
  • clonidine, used for high blood pressure or migraine
  • diuretics, also known as fluid tablets (e.g. chlorothiazide)
  • diazoxide, used mainly for treating very high blood pressure
  • acetazolamide, used to treat glaucoma, epilepsy and oedema (swelling due to fluid)
  • some antidepressants
  • weight reduction medicines
  • tritoqualine, an antihistamine
  • trofosfamide, cyclophosphamide, ifosfamide, used for treating certain cancers
  • laxatives (long-term use)
  • probenecid, used for treating gout
  • clonidine, used for high blood pressure or migraine
  • glucagon, used to help balance blood sugar levels
  • medicines used in asthma medicines and cold remedies.

These medicines may be affected by glimepiride or may affect how well it works. This may result in levels of blood sugar which are too high or too low.

In addition, beta- blockers, clonidine, guanethidine or reserpine, may mask the warning symptoms of a hypoglycaemic attack.

Remember to keep checking your blood glucose levels.

You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking glimepiride.

Drinking alcohol can also affect your blood sugar levels and how well glimepiride works.

Other medicines not listed above may also interact with glimepiride.

How to take this medicine

Follow carefully all directions given to you by your doctor or diabetes educator. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor 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.

The usual starting dose for adults is one 1 mg tablet each day. Your doctor may increase this dose up to 4 mg a day, depending on your blood glucose levels.

How to take it

Swallow the tablets with a glass of water.

When to take it

Take glimepiride immediately before a meal.

If you only eat a light breakfast, you should delay taking the tablet until the first main meal of the day (e.g. lunch).

Take it at about the same time each day.

Taking these tablets immediately before food can help to minimise the risk of hypoglycaemia.

It will also help you remember when to take them.

It is important that you eat regular meals.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

Glimepiride will help control your Type 2 diabetes but will not cure it. Most people will need to take glimepiride for long periods of time.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

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.

Skipping a dose may result in hyperglycaemia. If you experience any symptoms of hyperglycaemia, contact your doctor immediately.

Do not take a double dose to make up for missed doses.

If you double a dose, this may cause low blood glucose.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

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 glimepiride, you may experience symptoms of hypoglycaemia (low blood glucose). See the end of this leaflet for a list of symptoms.

If not treated quickly, these symptoms may progress to loss of co-ordination, slurred speech, confusion, loss of consciousness and fitting.

At the first 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 this medicine

Things you must do

Take your tablets exactly as your doctor has prescribed.

Otherwise you may not get the full benefits from treatment.

Tell your doctor immediately if you become pregnant.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking glimepiride.

Tell all doctors, dentists, pharmacists and diabetes educators who are involved with your treatment that you are taking this medicine.

Make sure you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia (low blood glucose) and hyperglycaemia (high blood glucose) and know what to do.

Instructions at the end of this leaflet can help you with this.

Tell your doctor immediately if you notice the return of any symptoms of hyperglycaemia that you had before starting glimepiride, or if your blood sugar levels are high.

These may be signs that glimepiride is no longer working, even though you may have been taking it successfully for some time.

If you are elderly or are taking other medicines for diabetes (e.g. insulin or metformin), the risk of hypoglycaemia (low blood sugar) is increased.

The risk of hypoglycaemia is also increased in the following situations:

  • too much glimepiride
  • too much or unexpected exercise
  • delayed meal or snack
  • too little food.

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:

  • undiagnosed or uncontrolled diabetes
  • illness, infection or stress
  • too little glimepiride
  • taking certain other medicines
  • too little exercise
  • eating more carbohydrates than normal.

Tell your doctor if any of the following happen:

  • you become ill
  • you become dehydrated
  • you are excessively stressed
  • you are injured
  • you have a fever
  • you have a serious infection
  • you are having surgery.

Your blood glucose may become difficult to control at these times. Your doctor may decide to replace glimepiride with insulin.

Visit your doctor for regular blood tests and checks of your eyes, feet, kidneys, heart, circulation, blood, and blood pressure.

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:

  • Do not skip meals while taking glimepiride.
  • Give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Take your medicine to treat any other condition unless your doctor tells you to.
  • Stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

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

Glimepiride 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.

Be careful while driving or operating machinery until you know how glimepiride affects you.

If you have to be alert, e.g. 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. Your vision may also be temporarily affected.

However, glimepiride by itself is unlikely to affect how you drive or operate machinery.

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

  • Wear some form of identification showing you have diabetes
  • carry some form of sugar to treat hypoglycaemia (low blood glucose) 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
  • keep glimepiride tablets readily available.

If you become sick with a cold, fever or flu, it is very important to continue taking glimepiride, even if you feel unable to eat your normal meal.

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 use for sick days.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking glimepiride 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 if you notice any of the following.

This list includes the more common side effects. Mostly, these are mild:

  • nausea, vomiting, abdominal pain or discomfort, diarrhoea, or a feeling of fullness in the stomach
  • blurred or double vision.

Tell your doctor as soon as possible if you notice any of the following.

These may be serious side effects and you may need medical attention:

  • Hypoglycaemia or hyperglycaemia. A section at the end of this leaflet contains advice about recognising and treating hypoglycaemia or hyperglycaemia.
  • symptoms of sunburn such as redness, itching, swelling or blistering which may occur more quickly than normal after being in the sun
  • bleeding or bruising more easily than normal, or reddish or purplish blotches under the skin
  • signs of frequent or worrying infections, such as fever, severe chills, sore throat or mouth ulcers
  • signs of anaemia, such as tiredness, being short of breath and looking pale.

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 you may need urgent medical attention or hospitalisation. These side effects:

  • rash, sores, redness or itching of the skin, itchy hives-like rash or spots (this could mean that you are allergic to glimepiride)
  • yellowing of the skin or eyes, also called jaundice

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

Allergic reactions

If you think you are having an allergic reaction to glimepiride, 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:

  • cough, shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin
  • fainting
  • hay fever-like symptoms.

Storage and disposal

Storage

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.

Disposal

If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Glimepiride looks like

APO-Glimepiride 1 mg Tablets:

Pink, round, G1 on one side and the Arrow logo on the other.

APO-Glimepiride 2 mg Tablets:

Green, capsule-shaped, G2, scoreline, G2 on one side and Arrow logo, scoreline, Arrow logo on the other.

APO-Glimepiride 3 mg Tablets:

Yellow, capsule-shaped, G3, scoreline, G3 on one side and Arrow logo, scoreline, Arrow logo on the other.

APO-Glimepiride 4 mg Tablets:

Blue, capsule-shaped, G4, scoreline, G4 on one side and Arrow logo, scoreline, Arrow logo on the other.

Blister packs of 30 tablets.

Ingredients

Each tablet contains 1, 2, 3 or 4 mg of glimepiride as the active ingredient.

It also contains the following inactive ingredients:

  • lactose
  • microcrystalline cellulose
  • povidone
  • sodium starch glycollate
  • magnesium stearate
  • iron oxide red (1 mg tablets)(172)
  • iron oxide yellow (2 mg, 3 mg tablets)(172)
  • indigo carmine (2 mg, 4 mg tablets)(120).

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

APO-Glimepiride 1mg Tablets

AUST R 151570

APO-Glimepiride 2mg Tablets

AUST R 151571

APO-Glimepiride 3mg Tablets

AUST R 151572

APO-Glimepiride 4mg Tablets

AUST R 151573