PHARMACOR GLICLAZIDE MR TABLETS

PHARMACOR GLICLAZIDE MR TABLETS

Active ingredient(s): gliclazide

---

Consumer Medicine Information (CMI)

This leaflet answers some common questions about PHARMACOR GLICLAZIDE MR.

It does not contain all the available information. Reading this leaflet 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 PHARMACOR GLICLAZIDE MR against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

Where to find information in this leaflet:

1. Why am I using PHARMACOR GLICLAZIDE MR?
2. What should I know before I use PHARMACOR GLICLAZIDE MR?
3. What if I am taking other medicines?
4. How do I use PHARMACOR GLICLAZIDE MR?
5. What should I know while using PHARMACOR GLICLAZIDE MR?
6. Are there any side effects?
7. Product details

1. Why am I using PHARMACOR GLICLAZIDE?

The name of your medicine is PHARMACOR GLICLAZIDE MR.

PHARMACOR GLICLAZIDE MR contains the active ingredient ‘gliclazide’.

Gliclazide belongs to a group of medicines called sulphonylureas.

PHARMACOR GLICLAZIDE MR is used to control blood glucose (sugar) in patients with Type II diabetes mellitus. This type of diabetes is also known as non-insulin-dependent diabetes (NIDDM), or maturity-onset diabetes).

Why PHARMACOR GLICLAZIDE MR is used for Type II diabetes mellitus

PHARMACOR GLICLAZIDE MR is used when diet and exercise are not enough to control your blood glucose.

PHARMACOR GLICLAZIDE MR can be used alone or together with insulin or other medicines for treating diabetes.

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, which is also known as hyperglycaemia.

If your blood glucose is not properly controlled, you may experience hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose). High blood glucose can lead to serious problems with our heart, circulation and/or kidneys.

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 kidney.

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

PHARMACOR GLICLAZIDE MR is used when diet and exercise are not enough to control your blood glucose properly. It lowers blood glucose by increasing the amount of insulin (a hormone that controls blood glucose levels) produced by your pancreas.

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 PHARMACOR GLICLAZIDE MR. This is known as hypoglycaemia.

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

PHARMACOR GLICLAZIDE MR is available only with a doctor’s prescription.

PHARMACOR GLICLAZIDE MR is not addictive

Ask your doctor if you have any questions about why PHARMACOR GLICLAZIDE MR has been prescribed for you.

2. What should I know before I use PHARMACOR GLICLAZIDE?

There are some people who should not take PHARMACOR GLICLAZIDE MR.

Please read the lists below.

If you think any of these situations apply to you, or you have any questions, please consult your doctor, pharmacist, or diabetes educator.

Do not take PHARMACOR GLICLAZIDE MR if

• you are allergic to: gliclazide, or any of the other ingredients listed at the end of this leaflet.
• you have had an allergic reaction to any other sulphonylureas, or related medicines such as sulfaantibiotics or to thiazide diuretics (a type of “fluid” or “water” tablet).

Symptoms of an allergic reaction to PHARMACOR GLICLAZIDE MR or to these medicines may include skin rash, itchiness or hives, shortness of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint pain. If you are not sure if you have an allergy to PHARMACOR GLICLAZIDE MR, check with your doctor.

• are pregnant or trying to become pregnant.

PHARMACOR GLICLAZIDE MR may affect your developing baby if you take it during pregnancy. Insulin is more suitable for controlling blood glucose during pregnancy. Your doctor will usually replace PHARMACOR GLICLAZIDE MR with insulin while you are pregnant.

• are breastfeeding or plan to breast-feed. PHARMACOR GLICLAZIDE MR is not recommended while you are breastfeeding. It is not known whether PHARMACOR GLICLAZIDE MR passes into breast milk.
• you have Type 1 diabetes mellitus (also known as insulindependent diabetes (IDDM), or juvenile-onset diabetes).
• you have unstable diabetes
• you have diabetic ketoacidosis (a problem which affects the acidity of your blood and can lead to coma – which is mainly associated with Type 1 diabetes).
• you have severe kidney disease
• you have severe liver disease
• you are taking an antibiotic medicine containing the active ingredient miconazole
• the expiry date (EXP) printed on the pack.

If you take it after the expiry date has passed, it may not work as well.

• the packaging is torn or shows signs of tampering.

If it is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking PHARMACOR GLICLAZIDE MR, talk to your doctor.

For children

Do not give PHARMACOR GLICLAZIDE MR to a child.

There is no experience with the use of PHARMACOR GLICLAZIDE MR in children.

For older people

Elderly people can generally use PHARMACOR GLICLAZIDE MR safely.

There are no special instructions for older people taking PHARMACOR GLICLAZIDE MR.

Tell your doctor straight away if:

• you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

• you are allergic to any of the ingredients listed at the end of this leaflet; to any other medicines; or to any other substances, such as foods, preservatives or dyes
• you have an intolerance to some sugars as PHARMACOR GLICLAZIDE MR contains lactose
• If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur.
• you have had any of the following medical conditions:
  – kidney disease
  – liver disease
  – a history of diabetic coma.
  – adrenal, pituitary or thyroid problems
  – heart failure
• 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 PHARMACOR GLICLAZIDE MR than prescribed you are taking less exercise than normal
  – you are eating more carbohydrate than normal.
  – drinking alcoholic drinks.
  – not eating regular meals.
  – taking more exercise than usual.

If you have not told your doctor, pharmacist or diabetes educator about any of the above, tell them before you start taking PHARMACOR GLICLAZIDE MR.

3. What if I am taking other medicines?

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

Taking PHARMACOR GLICLAZIDE MR may change the effect of some medicines, and some medicines may affect how well PHARMACOR GLICLAZIDE MR works. You may need different amounts of your medication or to take different medicines.

Some medicines may lead to low blood glucose (hypoglycaemia) by increasing the blood-glucose-lowering effect of PHARMACOR GLICLAZIDE MR.

These include:

• some medicines used to treat fungal or yeast infections (miconazole which is contraindicated)
• alcohol
• other medicines used to treat diabetes (such as biguanides and insulin)
• some medicines used to treat high blood pressure and other heart conditions (including angiotensin receptor blocker, beta-blockers)
• some medicines used to treat depression and other mental illness (MAOIs)
• some antibiotics (chloramphenicol; tetracyclines; long-acting sulphonamides)
• some medicines used to treat acid reflux and stomach ulcers

Some medicines may lead to high blood glucose levels (hyperglycaemia) by weakening the blood glucose-lowering effect of PHARMACOR GLICLAZIDE MR.

These include:

• alcohol
• some medicines for epilepsy (danazol)
• some medicines used to treat depression and other mental illness (chlorpromazine)
• St John’s Wort (Hypericum perforatum) preparations used to treat depression
• some hormones used in hormone replacement therapy and oral contraceptives (oestrogen, progesterone)
• some medicines for asthma (salbutamol, intravenous terbutaline).
• barbiturates, medicines used for sedation
• glucocorticoids

Some medicines may lead to unstable blood glucose (low blood sugar and high blood sugar) when taken at the same time as PHARMACOR GLICLAZIDE MR, especially in elderly patients.

These include:

• A class of antibiotics called fluoroquinolones.

PHARMACOR GLICLAZIDE MR may change the effects of some other medicines.

These include:

• some medicines used to prevent blood clots (warfarin)

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 more complete list of medicines to be careful with or avoid while taking PHARMACOR GLICLAZIDE MR.

4. How do I use PHARMACOR GLICLAZIDE?

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

• some cholesterol-lowering
• medicines [clofibrate]
• some medicines used to treat arthritis, pain and inflammation (including high dose aspirin, ibuprofen, phenylbutazone)

Your doctor will tell you how many tablets to take each day. They may increase or decrease the dose, depending on your blood glucose levels.

When to take it

Swallow the tablets with a glass of water. PHARMACOR GLICLAZIDE MR tablets can be broken in half. However they should not be crushed or chewed.

Crushing or chewing the tablets may change the effectiveness of the tablet.

It is important to take your PHARMACOR GLICLAZIDE MR at the same time each day – usually with breakfast. Taking PHARMACOR GLICLAZIDE MR with food can help to minimise the risk of hypoglycaemia.

Do not skip meals while taking PHARMACOR GLICLAZIDE MR.

How long to take it

Continue taking PHARMACOR GLICLAZIDE MR for as long as your doctor recommends. Make sure you keep enough PHARMACOR GLICLAZIDE MR to last over weekends and holidays.

PHARMACOR GLICLAZIDE MR 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 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 you remember (with food), then go back to taking your tablets 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 you have missed.

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

If you take too much (overdose)

Immediately telephone your doctor, Diabetes Australia or Poisons Information Centre (telephone in Australia: 13 11 26) for advice if you think that you or anyone else may have taken too much PHARMACOR GLICLAZIDE MR.
Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much PHARMACOR GLICLAZIDE MR together with other medicines for diabetes or alcohol, you may experience symptoms of low blood glucose (hypoglycaemia).

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 following the instructions at the end of this leaflet.

If you experience any of these symptoms, immediately get medical help.

5. What should I know while using PHARMACOR GLICLAZIDE?

If you become pregnant while you are taking PHARMACOR GLICLAZIDE MR, tell your doctor.

Tell all doctors, dentists, pharmacists and diabetes educators who are involved with your treatment that you are taking PHARMACOR GLICLAZIDE MR.

If you are about to start taking any new medicines, tell you doctor and pharmacist that you are taking PHARMACOR GLICLAZIDE MR.

Take PHARMACOR GLICLAZIDE MR exactly as your doctor has prescribed. Otherwise you may not get the full benefits from treatment.

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.

Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and hyperglycaemia and know how to treat them.

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

Visit your doctor regularly so that they can check on your progress.

Carefully follow your doctor’s and dietician’s advice on diet, drinking alcohol and exercise.

Tell your doctor immediately if you notice the return of any symptoms of hyperglycaemia that you had before starting PHARMACOR GLICLAZIDE MR.

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

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

Things you must not do

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

Do not use PHARMACOR GLICLAZIDE MR to treat other complaints unless your doctor tells you to.

Do not stop taking PHARMACOR GLICLAZIDE MR, or change the dosage, without checking with your doctor.

Do not skip meals while taking PHARMACOR GLICLAZIDE MR.

Things to be careful of

If you drink alcohol while taking PHARMACOR GLICLAZIDE MR, you may get flushing, headache, breathing difficulties, rapid heart beat, stomach pains or feel sick and vomit.

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

Sulphonylureas (the group of medicines that PHARMACOR GLICLAZIDE MR belongs to) 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 30+ sunscreen.

If your skin does appear to be burning, tell your doctor immediately.

Be careful driving or operating machinery until you know how PHARMACOR GLICLAZIDE MR affects you.

Also, be especially careful not to let your blood glucose levels fall too low.

PHARMACOR GLICLAZIDE MR may cause dizziness and drowsiness in some people. Low blood glucose levels may also slow your reaction time and affect your ability to drive or operate machinery. A section at the end of this leaflet contains advice about recognising and treating hypoglycaemia.

Drinking alcohol can make this worse. If either of these occurs, do not drive, operate machinery or do anything else that could be dangerous.

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, 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 PHARMACOR GLICLAZIDE MR readily available

If you become sick with a cold, fever or flu, it is very important to continue taking PHARMACOR GLICLAZIDE MR, even if you fell 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.

Keep your tablets in the pack until it is time to take them.

PHARMACOR GLICLAZIDE MR will not keep as well outside its blister packaging.

Store below 25°C.

Do not store medicines in the bathroom or near a sink. Do not leave them in a car or on a windowsill.

Heat and dampness can destroy some medicines.

Keep PHARMACOR GLICLAZIDE MR tablets where children cannot reach them.

A locked cupboard at least one-anda-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking PHARMACOR GLICLAZIDE MR, or the tablets have passed their expiry date, return any leftover tablets to your pharmacist for disposal

6. Are there any side effects?

If you do not feel well while you are taking PHARMACOR GLICLAZIDE MR then tell your doctor, pharmacist, or diabetes educator as soon as possible.

All medicines can have side effects. Most of the time they are not serious but sometimes they can be.

PHARMACOR GLICLAZIDE MR helps most people with Type 2 diabetes, but it may sometimes have unwanted side effects. These can include:

• HYPOGLYCAEMIA and HYPERGLYCAEMIA. A section at the end of this leaflet contains advice about recognising and treating HYPOGLYCAEMIA and HYPERGLYCAEMIA.
• runny or blocked nose, sneezing, facial pressure or pain, bronchitis, sore throat and discomfort when swallowing, upper respiratory infection, coughing
• back pain, arthralgia, arthrosis,
• high blood pressure,chest pain
• headache, unusual weakness
• viral infection, urinary tract Infection
• dizziness stomach upset with symptoms like feeling sick, stomach pain, vomiting, diarrhoea or constipation
• decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued
• increase of some hepatic enzymes levels, and exceptionally a liver disease
• your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels

Other side effects are usually mild when they occur. Do not be alarmed by this list of possible side effects.

You may not experience any of them.

However if you do – or if you notice anything else that is making you feel unwell – you should consult your doctor or pharmacist. Other uncommon side effects have been reported and you may wish to discuss this issue with your doctor, pharmacist, or diabetes educator.

If any of the signs below occur then tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital:

• Skin rash, redness itching and/ or hives, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. The rash may progress to widespread blistering or peeling of the skin and may be the first sign of rare life threatening conditions (e.g. Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and severe hypersensitivity reactions (DRESS).
  Exceptionally, DRESS have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.

As for other sulphonylureas, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (e.g. jaundice) which in most cases disappeared after withdrawal of the sulfonylurea,but may lead to life-threatening liver failure in isolated cases.

7. Product details

What it looks like

PHARMACOR GLICLAZIDE MR 30 mg are White to off-white, round tablets, engraved with “G3” on one face and plain on the other face.

PHARMACOR GLICLAZIDE MR 60 mg are white to off white, oblong shaped tablets, scored with a break bar on both sides, engraved with “G L” on one face and plain on the other face.

PHARMACOR GLICLAZIDE MR 30 mg come in a Alu-Alu, Alu-Alu Desiccant blister pack of 10,20,30, 60 &100 tablets and HDPE bottle of 60 & 100 tablets.

PHARMACOR GLICLAZIDE MR 60 mg come in a PVC/PVDC, Alu-Alu, Alu-Alu Desiccant blister pack of 10,20,30,60 &100 tablets and HDPE bottle of 60 & 100 tablets.

Ingredients

PHARMACOR GLICLAZIDE MR
Active ingredient:

PHARMACOR GLICLAZIDE MR
30 mg Modified Release tablets contain 30 mg of Gliclazide.

PHARMACOR GLICLAZIDE MR
60 mg Modified Release tablets contain 60 mg of Gliclazide.

The inactive ingredients in PHARMACOR GLICLAZIDE MR tablets include

• Lactose Monohydrate
• Mannitol
• Sodium Acetate
• Hypromellose
• Silicon Dioxide
• Magnesium Stearate

The tablets are gluten free

Sponsor

PHARMACOR GLICLAZIDE MR is supplied in Australia by:

Pharmacor Pty Ltd.
Suite 803, Tower A, The Zenith,
821 Pacific Highway,
Chatswood NSW 2067
www.pharmacor.com.au

Australian Register Number:

PHARMACOR GLICLAZIDE MR
30 mg: 316920, 316934

PHARMACOR GLICLAZIDE MR
60 mg: 316923, 316929

Recognising and treating HYPOGLYCAEMIA (very LOW blood sugar levels)

Hypoglycaemia may occur during PHARMACOR GLICLAZIDE MR treatment.

The first signs of hypoglycaemia are usually weakness, rembling or shaking, sweating, light headedness, dizziness, headache or lack of concentration, irritability, tearfulness, hunger, and/ or numbness around the lips and tongue.

At the first signs of hypoglycaemia take some sugar to raise your blood sugar level quickly.

Do this by eating 5 to 7 jelly beans, 3 teaspoons of sugar or honey, drinking half a can of non-diet soft drink,taking 2-3 glucose tablets or a tube of glucose gel.

Then take some extra carbohydrates –

such as plain biscuits, fruit or milk -unless you are within 10-15 minutes of your next meal. Taking this extra carbohydrate will help to prevent a second drop in your blood glucose level.

If not treated quickly, hypoglycaemia symptoms may progress to loss of co-ordination, slurred speech, confusion, fits or loss of consciousness.

If hypoglycaemia symptoms do not get better straight away after taking sugar then go to the Accident and Emergency department at your nearest hospital – if necessary by calling an ambulance.

Contact your doctor or diabetes educator for advice if you are concerned about hypoglycaemia.

Recognising and treating HYPERGLYCAEMIA (HIGH blood sugar levels)

Some people may feel fine when their glucose levels are high. Others notice symptoms of hyperglycaemia like tiredness, lack of energy, thirst, passing large amounts of urine, headache, and/or blurred vision.

If you notice symptoms of hyperglycaemia, or your blood sugar levels are high, tell your doctor immediately. You may need adjustments of the dose or type of medicines you are taking.

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.

If you experience any of the signs of hyperglycaemia (high blood glucose) contact your doctor or diabetes educator for advice immediately.

Further information

You can obtain more information from your doctor, pharmacist or the MS Society in your State, or by telephoning the MS Alliance on 1800 852 289 in Australia.

Date of preparation

This leaflet was prepared in 12/2022