Glimepiride APOTEX
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
GLIMEPIRIDE APOTEX
Glimepiride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about this medicine.
It does not contain all the available information. It does not take the place of talking to your doctor.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What this medicine is used for
The name of your medicine is Glimepiride APOTEX. It contains the active ingredient glimepiride.
Glimepiride belongs to a group of medicines called sulfonylureas.
Glimepiride is used to control blood glucose in patients with type 2 diabetes mellitus.
Glimepiride is used when healthy eating and increased physical activity are not enough to control your blood glucose.
Glimepiride can be used alone, or together with insulin or other medicines for treating diabetes.
How it works
Glimepiride lowers high blood glucose by increasing the amount of insulin produced by your pancreas.
If your blood glucose is not controlled properly, you may experience hypoglycaemia (low blood glucose – a “hypo”) or hyperglycaemia (high blood glucose).
Low blood glucose can occur suddenly. Signs may include:
weakness, trembling or shaking
sweating
light-headedness, dizziness, headache or lack of concentration
tearfulness or crying
irritability
hunger
numbness around the lips and tongue
If not treated promptly, these may progress to:
loss of co-ordination
slurred speech
confusion
loss of consciousness or seizures
Hypoglycaemia can be very dangerous so make sure that you and your family can recognize its symptoms and know how to react.
High blood glucose usually occurs more slowly than low blood glucose.
Signs of high blood glucose may include:
lethargy or tiredness
headache
thirst
passing large amounts of urine
blurred vision
High blood glucose can lead to serious problems with your heart, eyes, circulation or kidneys.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is only available with a doctor’s prescription.
Before you take this medicine
When you must not take it
Do not take this medicine if you have an allergy to:
glimepiride
sulfonylureas
related medicines such as sulfur antibiotics or thiazide diuretics
any of the ingredients listed at the end of this leaflet
Some of the 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 this medicine if you have or have had any of the following conditions:
type 1 diabetes mellitus
unstable diabetes
diabetic acidosis
diabetic coma or pre-coma
severe kidney disease or if you require dialysis
severe liver failure
Do not take this medicine if you are pregnant or intend on becoming pregnant.
Insulin is more suitable for controlling blood glucose during pregnancy. Your doctor will replace glimepiride with insulin.
Do not breastfeed or plan to breastfeed if you are taking this medicine.
Glimepiride passes into breast milk and there is the possibility that your baby may be affected.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Do not give this medicine to children.
Safety and effectiveness in children has not been established.
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 any allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
kidney or liver problems
a history of diabetic coma
adrenal, pituitary or thyroid problems
heart failure
glucose-6-phosphate dehydrogenase (G6PD) deficiency
Tell your doctor if
you are taking any other anti-diabetic treatment
you drink alcohol in any amount
you do not eat regular meals
you do a lot of exercise, or you do heavy exercise or work
you 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 them before you start taking this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may lead to low blood glucose (hypoglycaemia) by increasing the blood glucose-lowering effect of glimepiride. These include:
alcohol
other medicines used to treat diabetes
anabolic steroids
some antibiotics
some antidepressants
some medicines used to treat reflux and stomach ulcers
some anti-inflammatory agents, such as ibuprofen and naproxen
some medicines used to treat arthritis and gout
some blood pressure lowering medicines, such as beta-blockers and ACE inhibitors
some medicines used to treat blood clots, blood vessel problems and irregular heart rhythms
some cholesterol-lowering and weight reduction medicines
some cancer and organ transplant treatments
Some medicines may lead to loss of control of your diabetes by weakening the blood glucose-lowering effect of glimepiride. These include:
alcohol
some antibiotics, such as rifampicin
some blood pressure, cholesterol and heart medications
some medicines used to treat reflux and stomach ulcers
corticosteroids, glucagon, adrenaline and other hormonal therapies
oral contraceptives
some asthma medicines, preparations for coughs and colds, and weight reduction medicines
some diuretic (fluid) and glaucoma medications
large doses of laxatives
some psychiatric and sedating medications
some medicines used to treat epilepsy, such as phenytoin
thyroid medications
Glimepiride may change the effects of other medicines. These include:
coumarin derivatives, which are used to prevent blood clots
Some medicines may hide the symptoms of low blood glucose (hypoglycaemia).
These include:
alcohol
certain heart medications, such as beta-blockers
If you are taking some of the above medicines, you may need different amounts of your medicine or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how many tablets to take each day. Your doctor may increase or decrease the dose, depending on your blood glucose levels.
How to take it
Swallow the tablets whole with a full glass of water.
When to take it
Take your medicine at about the same time each day, just before or with a meal.
If you eat only a light breakfast, you should delay taking the tablet until after the first main meal of the day (e.g. lunch).
Do not skip meals while taking glimepiride.
How long to take it
Continue taking glimepiride for as long as your doctor tells you.
Glimepiride will help control your diabetes but will not cure it. Therefore, you may have to take it for a long time.
Make sure you keep enough medicine to last over weekends and holidays.
If you forget to take it
If it is almost time to take your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Missed doses can cause high blood glucose (hyperglycaemia).
Do not take a double dose to make up for the dose that you missed.
If you double a dose, this may cause low blood glucose (hypoglycaemia).
If you are not sure what to do, talk to your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
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 your nearest hospital, if you think that you or anyone else may have taken too much glimepiride.
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 the symptoms of low blood glucose (hypoglycaemia).
At the first signs of hypoglycaemia, raise your blood glucose quickly by taking one of the following:
5-7 jelly beans
3 teaspoons of sugar or honey
1/2 can of a sugar-containing soft drink
2-3 concentrated glucose tablets
Unless you are within 10 to 15 minutes of your next meal, follow up with extra carbohydrates, e.g. plain biscuits, fruit or milk, when over the initial symptoms.
Taking this extra carbohydrate will prevent a second drop in your blood glucose level.
If not treated quickly, these symptoms may progress to loss of co-ordination, slurred speech, confusion, loss of consciousness and seizures.
While you are using this medicine
Things you must do
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking glimepiride.
Tell all doctors, dentists and pharmacists who are treating you that you are taking glimepiride.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking glimepiride.
If you become pregnant while taking glimepiride, tell your doctor immediately.
Make sure all friends, relatives, workmates or carers know that you have diabetes. Make sure they can recognise the symptoms of hypoglycaemia and know how to treat them. Provide them with the telephone number for your doctor, the Poisons Information Centre (13 11 26) and Emergency Services.
Always carry some sugary food or drink with you.
If you experience any of the symptoms of low blood glucose (hypoglycaemia), immediately eat some sugary food or have a drink, e.g. lollies, biscuits or fruit juice.
Diet and low calorie soft drinks do NOT contain sugar and are unsuitable to take for hypoglycaemia.
If you are elderly or are taking other medicines for diabetes, the risk of hypoglycaemia 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 high blood glucose (hyperglycaemia), contact your doctor immediately.
undiagnosed or uncontrolled diabetes
illness, infection or stress
too little glimepiride
certain other medicines
too little exercise
sudden immobilisation, e.g. after an accident
eating more carbohydrate than normal
Tell your doctor if you become ill or experience extra stress, injury, fever, infection or need surgery. Your blood glucose may become difficult to control at these times.
Your doctor may decide to change your treatment and use insulin instead of glimepiride.
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.
Visit your doctor for regular checks of your eyes, feet, kidneys, heart, circulation, blood and blood pressure.
Carefully follow your doctor’s and/or dietician’s advice on diet, drinking alcohol and exercise.
If you drink alcohol while taking glimepiride, you may get flushing, headache, breathing difficulties, rapid heart beat, stomach pains or feel sick and vomit.
Tell your doctor immediately if you notice the return of any symptoms you had before starting glimepiride.
These may include lethargy or tiredness, headache, thirst, passing large amounts of urine and blurred vision. These may be signs that glimepiride is no longer working, even though you may have been taking it successfully for some time.
Things you must not do
Do not take this medicine to treat any other complaints unless your doctor tells you to.
Do not give glimepiride to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Do not skip meals while taking glimepiride.
Things to be careful of
Protect your skin when you are in the sun, especially between 10am and 3pm.
Glimepiride may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, redness, or a severe sunburn.
If outdoors, wear protective clothing and use a 15+ sunscreen. If your skin does appear to be burning, tell your doctor immediately.
If you must be alert, such as when driving, be especially careful not to let your blood glucose levels fall too low.
Low blood glucose levels may low your reaction time and affect your ability to drive or operate machinery. Drinking alcohol can make this worse. However, glimepiride by itself is unlikely to affect how you drive or operate machinery.
Make sure you know how you react to glimepiride before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs, do not drive.
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 if it occurs, e.g. sugar sachets or jelly beans
carry emergency food rations in case of a delay, e.g. 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 foods, 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 food to use for sick days.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking glimepiride.
Glimepiride helps most people with diabetes, but it may have unwanted side effects in a few people
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention 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.
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 or pharmacist 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, lack of concentration, tearfulness or crying, irritability, hunger and numbness around the lips and fingers
eye problems, including blurred or double vision
stomach upset including nausea (feeling sick) and vomiting
diarrhoea, abdominal pain or a feeling of fullness in the stomach
The above list includes the more common side effects of your medicine.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
rash, sores, redness or itching of the skin, itchy hives-like rash or spots
symptoms of sunburn such as redness, itching, swelling or blistering which may occur more quickly than normal
bleeding or bruising more easily than normal, or reddish or purplish blotches under the skin
yellowing of the skin or eyes, also called jaundice
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.
The above list includes serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some people.
Storage and Presentation
Storage
Keep your tablets in the pack until time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool, dry place where the temperature stays below 25°C.
Do not store this 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 it 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 glimepiride or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
Glimepiride APOTEX 1 mg:
Pink round flat uncoated tablets with breakline on one side and plain on the other side of the tablet.
AUST R 281224
Glimepiride APOTEX 2 mg:
Light pink oval shaped uncoated tablets with score line on one side and plain on the other side of the tablet. AUST R 281225
Glimepiride APOTEX 3 mg:
Pale yellow oval shaped uncoated tablets with breakline on one side and plain on the other side of the tablet. AUST R 281226
Glimepiride APOTEX 4 mg:
White coloured oval shaped uncoated tablets with scoreline on one side and plain on the other side of the tablet. AUST R 281227
The tablets are packed in blister packs of 10 tablets (1mg, 2mg) and 30 tablets (all strengths).
Ingredients
This medicine contains glimepiride as the active ingredient.
This medicine also contains:
lactose
sodium starch glycollate
povidone
magnesium stearate
In order to distinguish between the different tablet strengths, each strength contains different colourings. These are:
iron oxide red (1 mg)
iron oxide yellow and indigo carmine aluminium lake (2 mg)
iron oxide yellow (3 mg)
indigo carmine aluminium lake (4 mg)
Sponsor
This medicine is sponsored in Australia by:
Accord Healthcare Pty Ltd
Level 24, 570 Bourke Street
Melbourne 3000
Distributor
This medicine is distributed in Australia by:
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
This leaflet was prepared in August 2018.
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