Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Dimirel.

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 you taking Dimirel 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 Dimirel is used for

Dimirel is used to control blood glucose in patients with type 2 diabetes mellitus.

Dimirel is used when healthy eating and increased physical activity are not enough to control your blood glucose.

Dimirel can be used alone, or together with insulin or other medicines for treating diabetes.

How it works

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

Dimirel belongs to a group of medicines called sulfonylureas.

If your blood glucose in 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
• lightheadedness, 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

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

There is no evidence that Dimirel is addictive.

Before you take Dimirel

When you must not take it

Do not take Dimirel if:

• you have an allergy to:
  - Dimirel
  - sulfonylureas
  - related medicines such as sulfur antibiotics or thiazide diuretics
  - any of the ingredients listed at the end of this leaflet
  Symptoms of an allergic reaction to Dimirel may include skin rash, itchiness, shortness of breath, or difficulty breathing.
  If you are not sure you have an allergy to Dimirel, check with your doctor.
• you have previously had a reaction to glimepiride or any other sulfonylurea or sulfonamide
• 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
  If you are not sure if you have any of the above, ask your doctor.
• you are pregnant or intend becoming pregnant
  Insulin is more suitable for controlling blood glucose during pregnancy. Your doctor will replace Dimirel with insulin.
• you are breastfeeding or plan to breastfeed
  Dimirel passes into breast milk and therefore there is the possibility that the breastfed baby may be affected.
• the packaging is torn or shows signs of tampering (or the tablets do not look quite right)
• the expiry date printed on the pack has passed
  If you take this medicine after the expiry date has passed, it may not work as well.

Do not give Dimirel to children. There is not enough experience with the use of Dimirel in children.

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

Before you start to take it

Tell your doctor if:

• you have any allergies to any other medicines or any other substances such as foods, preservatives or dyes
• you are breastfeeding or plan to breastfeed
  Dimirel passes into breast milk and therefore there is the possibility that the breastfed baby may be affected.
• you have or have had any of the following medical conditions
  - kidney problems
  - liver problems
  - a history of diabetic coma
  - adrenal, pituitary or thyroid problems
  - heart failure
  - glucose-6-phosphate dehydrogenase (G6PD) deficiency
• 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.
• you are taking any other anti-diabetic treatment

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Dimirel.

Taking other medicines

Tell your doctor, pharmacist or diabetes educator if you are taking any other medicines, including any that you buy 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 Dimirel. 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 Dimirel.

These include:

• alcohol
• some antibiotics, such as rifampicin
• some blood pressure, cholesterol and heart medications
• some medicines used to treat reflux and stomach ulcers
• thyroid medication
• some medicines used to treat epilepsy
• corticosteroids, glucagon, adrenaline and other hormonal therapies
• oral contraceptives
• some asthma medicines, preparations for coughs and colds, and weight reduction medicines
• some fluid and glaucoma medications
• large doses of laxatives
• some psychiatric and sedating medications

Dimirel 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

You may need different amounts of your medicine or you may need to take different medicines. Your doctor, pharmacist or diabetes educator can tell you what to do if you are taking any of these medicines. They also have a complete list of medicines to be careful with or avoid while taking Dimirel.

Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.

How to take Dimirel

Follow all directions given to you by your doctor, pharmacist or diabetes educator 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 glass of water.

When to take it

You must make sure that you take Dimirel just before or with a meal.

Dimirel tablets are usually taken once a day, immediately before breakfast. 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 Dimirel.

How long to take it

Continue to take Dimirel for as long as your doctor recommends. Make sure you keep enough Dimirel to last over weekends and holidays.

Dimirel will help control your diabetes but will not cure it. Therefore, you may have to take it for a long time.

If you forget to take it

If it is almost time for 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).

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

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 take too much (overdose)

Immediately telephone your doctor or pharmacist or the Poisons Information Centre (13 11 26 in Australia; 0800 POISON or 0800 764 766 in New Zealand), or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Dimirel.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Dimirel, 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 Dimirel

Things you must do

If you become pregnant while you are taking Dimirel, stop taking it and tell your doctor immediately.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Dimirel.

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

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking Dimirel.

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 in Australia; 0800 POISON or 0800 764 766 in New Zealand) 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 Dimirel
• 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.

The risk of hyperglycaemia is increased in the following situations:

• undiagnosed or uncontrolled diabetes
• illness, infection or stress
• too little Dimirel
• certain other medicines
• too little exercise
• sudden immobilisation, e.g. after an accident
• eating more carbohydrate than normal

If you become ill or experience extra stress, injury, fever, infection or need surgery, tell your doctor. Your blood glucose may become difficult to control at these times. Your doctor may decide to change your treatment and use insulin instead of Dimirel.

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 Dimirel, 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 Dimirel.

These may include lethargy or tiredness, headache, thirst, passing large amounts of urine and blurred vision.

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

Things you must not do

Do not give Dimirel to anyone else, even if they have the same condition as you.

Do not skip meals while taking Dimirel.

Things to be careful of

Protect your skin when you are in the sun, especially between 10am and 3pm.

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

Make sure you know how you react to Dimirel 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 Dimirel readily available

If you become sick with a cold, fever or flu, it is very important to continue taking Dimirel, 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 Dimirel.

Dimirel 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 treatment if you get some of the side effects.

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

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.

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.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Dimirel

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.

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

Do not store Dimirel or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days or on window sills. 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 using Dimirel or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Dimirel 1 mg tablets: pink oblong, scored tablets with "NMK" and the Hoechst logo on both sides.

Dimirel 2 mg tablets: green oblong, scored tablets with "NMM" and the Hoechst logo on both sides.

Dimirel 3 mg tablets: pale yellow oblong, scored tablets with "NMN" and the Hoechst logo on both sides.

Dimirel 4 mg tablets: light blue oblong, scored tablets with "NMO" and the Hoechst logo on both sides.

The tablets are packed in blister packs of 30 tablets.

Ingredients

Active Ingredients:

• glimepiride

Inactive Ingredients:

• lactose monohydrate
• magnesium stearate
• microcrystalline cellulose
• povidone
• sodium starch glycollate

In order to distinguish between the different tablet strengths, each strength contains different colourings. These are:

• Dimirel 1 mg tablets - iron oxide red
• Dimirel 2 mg tablets - iron oxide yellow and indigo carmine lake
• Dimirel 3mg tablets - iron oxide yellow
• Dimirel 4 mg tablets - indigo carmine lake

Manufacturer

Dimirel is supplied in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113

This leaflet was prepared in August 2016

Australian Registration Numbers:
Dimirel 1 mg: AUST R 94474
Dimirel 2 mg: AUST R 94476
Dimirel 3 mg: AUST R 94477
Dimirel 4 mg: AUST R 94478

® Registered Trademark

dimirel-ccdsv14-cmiv10-aug16

Published by MIMS February 2017

1 Name of Medicine

Glimepiride.

2 Qualitative and Quantitative Composition

Dimirel tablets contain 1 mg, 2 mg, 3 mg or 4 mg of glimepiride, and the excipient lactose monohydrate.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablet, uncoated.

1 mg.

2 mg.

3 mg.

4 mg.

4 Clinical Particulars

4.1 Therapeutic Indications

Dimirel is indicated as an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with noninsulin dependent (type 2) diabetes mellitus.

4.2 Dose and Method of Administration

In the management of type 2 diabetes mellitus, administration of an oral antidiabetic agent is not a substitute for appropriate dietary control.
In initiating treatment for type 2 diabetes mellitus, diet should be emphasised as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycaemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible.
If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea should be considered. Use of Dimirel must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient, thus requiring only short-term administration of Dimirel. During maintenance programs, Dimirel should be discontinued and insulin therapy initiated if satisfactory lowering of blood glucose is no longer achieved. Judgments should be based on regular clinical and laboratory evaluations.
The dosage of Dimirel must be the lowest which is sufficient to achieve the desired metabolic control. Dosage must be based on regular blood and urine glucose determinations, and must be carefully individualised to obtain optimum therapeutic effect. Periodic measurement of glycosylated haemoglobin is also recommended to monitor the patient's response to treatment. If appropriate glimepiride dosage regimens are not followed, hypoglycaemia may be precipitated.
Measures for dealing with errors in dosage such as forgetting to take a dose, skipping a meal or inability to take a dose at the prescribed time should be discussed with the patient at the time of initiating therapy. A missed dose must never be corrected by subsequently taking a larger dose.
Short-term administration of Dimirel may be sufficient during periods of transient loss of metabolic control in patients usually well controlled on diet.
Food does not alter the bioavailability or other pharmacokinetic parameters of glimepiride.

Initial dose and dose titration.

Secondary dosage adjustment.

Changeover from other antidiabetic agents to Dimirel.

Renal impairment.

Hepatic impairment.

4.3 Contraindications

Hypersensitivity to glimepiride, other sulfonylureas, other sulfonamides or any excipient.
Severe impairment of renal function (ClCr < 30 mL/min).
Dialysis patients.
Severe hepatic dysfunction.
Pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).
Lactation (see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation).
Dimirel is not suitable for the treatment of insulin dependent (type 1) diabetes mellitus (e.g. for the treatment of patients with a history of ketoacidosis), nor for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic precoma or coma.
In patients with severe impairment of hepatic function, changeover to insulin is indicated to achieve optimal metabolic control.

4.4 Special Warnings and Precautions for Use

Patients receiving glimepiride should be monitored with regular clinical and laboratory evaluations, including blood and urine glucose determinations, to determine the minimum effective dosage and to detect primary failure (inadequate lowering of blood glucose concentration at the maximum recommended dosage) or secondary failure (loss of control of blood glucose concentration following an initial period of effectiveness) to the drug. Glycosylated haemoglobin measurements may also be useful for monitoring the patient's response to glimepiride therapy.
Some improvement in glucose tolerance may take place after a few weeks of treatment with glimepiride. The clinical status should be checked within the first 4 to 8 weeks and at regular intervals thereafter to ascertain whether it is possible to reduce the dose.
The treatment of diabetes requires regular checks. Alertness and reactions may be impaired due to hypo- or hyperglycaemia, especially when beginning or after altering treatment or when Dimirel is not taken regularly. This may, for example, affect the ability to drive or to operate machinery.
In cases of unusual stress (e.g. trauma, emergency or elective surgery, febrile infection), blood glucose regulation may deteriorate and a temporary change to insulin may become necessary to maintain good metabolic control.
Dimirel tablets must not be used beyond the expiry date marked on the pack and must be stored out of the reach of children.

Hypoglycaemic reactions.

Haemolytic anaemia.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Glimepiride is metabolised by cytochrome P450 2C9 (CYP2C9). This should be taken into account when glimepiride is coadministered with inducers, inhibitors or substrates of CYP2C9 (e.g. rifampicin, fluconazole, amiodarone, tolbutamide, diclofenac, ibuprofen, naproxen).
Based on experience with glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of glimepiride include ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, clarithromycin, clofibrate, coumarin derivatives, cyclophosphamide monohydrate, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO inhibitors, miconazole, pentoxifylline (oxpentifylline) (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of glimepiride include acetazolamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives (protracted use), nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestogens, rifampicin, adrenaline (epinephrine) and other sympathomimetic agents, thyroid hormones.
H₂-receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood glucose lowering effect.
Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
Acute and chronic alcohol intake may either potentiate or attenuate the activity of Dimirel in an unpredictable fashion.
The effect of coumarin derivatives may be potentiated or weakened.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Alertness and reactions may be impaired due to hypo- or hyperglycaemia, especially when beginning or after altering treatment or when glimepiride is not taken regularly. This may affect the ability to drive or to operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Dimirel is generally well tolerated. Clinical experience has shown that adverse reactions serious enough to compel discontinuation of therapy are uncommon, even during long-term treatment.

Hypoglycaemia.

Visual reactions.

Gastrointestinal reactions.

Haematologic reactions.

Dermatologic reactions.

Hepatic reactions.

Electrolyte disturbance.

Other.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

Signs and symptoms.

Management.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Sulfonylurea anti diabetic agent, ATC code: A10BB12.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

The pharmacokinetics of glimepiride are similar in males and females and also in young and elderly (> 65 years) patients. Intraindividual variability is low.

Absorption.

Distribution.

Metabolism.

Excretion.

Renal impairment.

Hepatic impairment.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, sodium starch glycollate, povidone, microcrystalline cellulose, magnesium stearate, iron oxide red (1 mg tablet), iron oxide yellow (2 mg tablet), iron oxide yellow (3 mg tablet), and indigo carmine (2 mg and 4 mg tablets).

6.2 Incompatibilities

Incompatibilities were either not accessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

All strengths of Dimirel are available in blister packs of 10, 30*, 50 and 100 tablets.
* Marketed pack.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Dimirel tablets contain glimepiride which is a member of the sulfonylurea group of oral antidiabetic agents.
Glimepiride is a white odourless, crystalline powder, practically insoluble in methanol and water, slightly soluble in ethanol and sparingly soluble in methylene chloride.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes