Diabetes Health

“Motivation is what gets you started. Habit is what keeps you going.”

- Jim Ryun

Type 2 Diabetes Mellitus

Sulphonylureas

DynaGlilazideRGB

SCHEDULING STATUS S3

PROPRIETARY NAME AND DOSAGE FORM
DY
NA GLICLAZIDE SR 30 mg tablets
(each modified release tablet contains 30 mg gliclazide).

Please read this patient information carefully before taking DYNA GLICLAZIDE SR 30 mg tablets.

  • Keep this information.  You may need to read it again.
  • If you have any further questions, please ask your doctor or your pharmacist.
  • DYNA GLICLAZIDE SR 30 mg has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

WHAT DYNA GLICLAZIDE SR 30 mg CONTAINS

Active ingredient: Gliclazide

Inactive ingredients: calcium carbonate, colloidal silica dioxide, hypromellose, lactose monohydrate and magnesium stearate.

WHAT DYNA GLICLAZIDE SR 30 mg IS USED FOR

The active ingredient, gliclazide, is a sulphonylurea antidiabetic agent. It is used to treat a certain type of diabetes mellitus called type 2 diabetes.

Following a diabetes diet plan and exercise will always be important to control your blood sugar level. Your doctor will only prescribe DYNA GLICLAZIDE SR 30 mg when your blood sugar level cannot be controlled with diet and exercise alone.

When you have type 2 diabetes, the amount of insulin your pancreas produces may not be enough or your body may not be using it properly and you may still need more.
DYNA GLICLAZIDE S30 mg works by causing your pancreas to release more insulin into the blood stream.

BEFORE YOU TAKE DYNA GLICLAZIDE SR 30 mg

Do not take DYNA GLICLAZIDE SR 30 mg:

  • If you are hypersensitive (allergic) to gliclazide or any of the other ingredients of DYNA GLICLAZIDE SR 30 mg.
  • If you are hypersensitive (allergic) to any other sulphonylurea or sulfonamides.
  • If you are pregnant or breast feeding your baby.
  • If you have a liver disease.
  • If you have severe kidney disease.
  • If you have type 1 diabetes mellitus (Type 1 diabetes patients cannot produce or release insulin from their pancreas).
  • If you have acid (acidosis) or ketones (diabetic ketoacidosis) in your blood.
  • If you have severe burns or injuries or had a major surgery.

DYNA GLICLAZIDE SR 30 mg is contraindicated in children.

Take special care with DYNA GLICLAZIDE SR 30 mg:

The presence of other medical problems may affect the use of these tablets. Make sure you tell your doctor if you have any other medical problems, especially:

  • If you have heart disease.
  • If you have an overactive or underactive thyroid not properly controlled.
  • If you have an underactive adrenal gland not properly controlled.
  • If you have an underactive pituitary gland not properly controlled. If you are undernourished or have a weakened physical condition.
  • In the initial weeks of treatment, the risk of low blood sugar may be increased and careful monitoring is necessary.  Symptoms of low blood sugar include aggression, apathy, behavioural changes that can mimic drunkenness, poor concentration, confusion, delirium, nightmares, sleepiness, sleep disorders, restlessness, depression, dizziness, seizures, blurred vision, slurred speech, excessive hunger, nausea, vomiting, shallow respiration, coma, slow heartbeat, anxiety, cold sweats, cool pale skin and shakiness. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly. You must also educate your family members about the symptoms of hypoglycaemia and how to treat them.

Symptoms of low blood sugar may develop quickly and may result from:

  • Delaying or missing a scheduled meal or snack, poor nutrition.
  • Exercising more than usual.
  • Drinking a significant amount of alcohol.
  • Taking certain medicines.
  • Impaired kidney or liver function.
  • Overdosage with DYNA GLICLAZIDE SR 30 mg.
  • Using too much insulin.
  • Sickness (especially vomiting and diarrhoea).
  • Elderly patients

Know what to do if symptoms of low blood sugar occur. Eating some form of quick-acting sugar when symptoms of low blood sugar first appear will usually prevent them from getting worse. Good sources of sugar include:

  • Glucose tablets or gel.
  • Fruit juice or nondiet soft drink (onehalf cup) and sugar sweetened tea.
  • Corn syrup or honey (1 tablespoon).
  • Sugar cubes or table sugar dissolved in water.

Do not use chocolate because its fat slows down the sugar entering your bloodstream.

Taking DYNA GLICLAZIDE SR 30 mg with food or drink:
Food does not affect the efficacy of the tablet.

Pregnancy and breast feeding:
You should not take this medicine if you are pregnant or breast feeding your baby (see BEFORE YOU TAKE DYNA GLICLAZIDE SR 30 mg). Please consult your doctor, pharmacist or other health care professional for advice.

Driving and using machinery:
You should be aware of the symptoms of hypoglycaemia (low blood sugar) which include dizziness, poor concentration, confusion, sleepiness and blurred vision (see alsoPOSSIBLE SIDE EFFECTS). You must be careful when driving or operating machinery.

Important information about some of the ingredients of DYNA GLICLAZIDE SR 30 mg: DYNA GLICLAZIDE SR 30 mg contains lactose and should not be taken if you have rare family problems with lactose, or a history of galactose intolerance, a condition called Lapp lactose deficiency or glucose-galactose malabsorption.

Using other medicines with DYNA GLICLAZIDE SR 30 mg:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of DYNA GLICLAZIDE SR 30 mg with these medicines may cause undesirable interactions. Tell your doctor or pharmacist if you are taking any other medicines, including any you have bought at your pharmacy, supermarket or health food shop. Please consult your doctor, pharmacist or other healthcare professional for advice.

The following medication may cause your blood sugar levels to fall even lower when taken together with DYNA GLICLAZIDE SR 30 mg:

  • Alcohol.
  • Allopurinol, probenecid, sulphinpyrazone (anti-gout medicine).
  • Anabolic steroids and androgens.
  • Anticoagulants (blood thinners).
  • Certain medications used to treat high blood pressure and heart disease such as ACE
  • inhibitors, antidysrhythmics (disopyramide), quinidine and quinine.
  • Betablockers may increase the chance that high or low blood sugar can occur. Also, they can hide the symptoms of low blood sugar.
  • Certain medications used to treat fungal and bacterial infections, such as miconazole, ketoconazole, ciprofloxacin, chloramphenicol, sulphonamides, quinolones and tetracyclines.
  • Certain antidepressants such as fluoxetine and monoamineoxidase inhibitors.
  • Certain medications used to treat pain and inflammation such as aspirin, phenylbutazone, azapropazone and oxyphenbutazone.
  • The appetite suppressant fenfluramine.
  • Ranitidine and cimetidine (medicines used to treat heartburn).
  • Insulin and other oral antidiabetic agents.

The following medicines may cause your blood sugar levels to rise when taken together with

DYNA GLICLAZIDE SR 30 mg:

  • Adrenaline, asthma medicines, cough and cold medicines.
  • Corticosteroids (cortisonelike medicines).
  • Calcium channel blocking agents, clonidine, diazoxide (cardiovascular medicines).
  • Lithium.
  • Thiazide diuretics.
  • Antiepileptic medication such as phenytoin.
  • Glucagon.
  • Female hormones oestrogen and progesterones.
  • Antibacterial medicines rifampicin and isoniazid.
  • Thyroid hormones.
  • Barbiturates.

HOW TO TAKE DYNA GLICLAZIDE SR 30 mg

Always take DYNA GLICLAZIDE SR 30 mg exactly as your doctor has instructed you. You should check with your doctor if you are unsure.

If you have the impression that the effect of DYNA GLICLAZIDE SR 30 mg is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will decide on the correct dose based on your metabolic response and blood sugar level. The tablet must be swallowed whole with half a glass of water and should be taken immediately before a substantial breakfast or the first main meal of the day. You should not miss a meal after you have taken the tablets. Take DYNA GLICLAZIDE SR 30 mg at the same time each day.

The initial dose is 30 mg (one tablet) once daily, taken with breakfast.

Dose adjustments:
If your fasting blood glucose levels have not decreased satisfactorily, your doctor may increase the dosage progressively to 60, 90 or 120 mg per day (2 to 4 tablets). Your doctor will instruct you

how to increase your dosage, but usually you should increase the number of tablets at an interval of at least one month between each increment.

Replacement of other oral sulphonylurea antidiabetic medicine with DYNA GLICLAZIDE SR 30 mg:

Your doctor may wish to replace your current oral sulphonylurea antidiabetic medicine with DYNA GLICLAZIDE SR 30 mg.

Your doctor will instruct you exactly how to make the replacement. The usual starting dose is 30 mg (one DYNA GLICLAZIDE SR 30 mg tablet) per day. If necessary, your doctor will increase the dosage by increments, according to your metabolic response.

If you take more DYNA GLICLAZIDE SR 30 mg than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

Too much of DYNA GLICLAZIDE SR 30 mg can cause low blood sugar (also called hypoglycaemia). Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include aggression, behavioural changes that can mimic drunkenness, poor concentration, confusion, delirium, nightmares, sleepiness, sleep disorders, restlessness, depression, dizziness, seizures, blurred vision, slurred speech, aphasia, excessive hunger, nausea, vomiting, shallow respiration, coma, slow heartbeat, anxiety, cold sweats, cool pale skin and shakiness (see also Take special care with DYNA GLICLAZIDE SR 30 mg).

Severe or persistent hypoglycaemia will need immediate treatment, followup by a medical doctor and may even require urgent hospital admission. If hypoglycaemia has persisted for a protracted period of time, neurological damage may not be reversible.

If you forget to take DYNA GLICLAZIDE SR 30 mg:
Do not take a double dose to make up for the forgotten individual doses. Continue to take the next tablet at the usual time.

If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

POSSIBLE SIDE EFFECTS

DYNA GLICLAZIDE SR 30 mg can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

Check with your doctor immediately if the following side effects occur:

  • Less frequent: Seizures, unconsciousness

Check with your doctor as soon as possible if the following side effects occur:

  • Frequent: Low blood sugar, including aggression, apathy, behavioural changes that can mimic drunkenness, poor concentration, confusion, delirium, nightmares, sleepiness, sleep
  • disorders, restlessness, depression, dizziness, seizures, blurred vision, slurred speech, aphasia, excessive hunger, nausea, vomiting, shallow respiration, coma, slow heartbeat, anxiety, cold sweats, cool pale skin and shakiness.
  • Less frequent: Peeling of skin, skin redness, itching or rash, chest pains, chills, coughing up blood, dark urine, fever, general feeling of illness, increased amounts of sputum, increased sweating, lightcoloured stools, pale skin, sensitivity to the sun, shortness of breath, sore throat, thinning of the skin, unusual bleeding or bruising, unusual tiredness or weakness, yellow eyes or skin.

The following side effects do not need medical attention and may go away during treatment:

  • Frequent: Changes in sense of taste, constipation, diarrhoea, dizziness, increased amount of urine or more frequent urination, heartburn, passing of gas, fullness or discomfort, vomiting.
  • Less frequent: Difficulty in focusing the eyes, increased sensitivity of skin to sun.

STORING AND DISPOSING OF DYNA GLICLAZIDE SR 30 mg

  • Store at or below 25 °C in a dry place.
  • Keep the tablets in the original packaging until required for use.
  • KEEP ALL MEDICINES OUT OF REACH OF CHILDREN
  • Do not use the tablets after the expiry date printed on the container and blister.
  • Return all unused medicine to your pharmacist
  • Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets)

PRESENTATION OF DYNA GLICLAZIDE SR 30 mg

DYNA GLICLAZIDE SR 30 mg tablets are available in pack sizes of 90, 120 or 180 tablets. The tablets are packed in white plastic containers with tamperevident screw closures or in Aluminium/PVC blister packs.

IDENTIFICATION OF DYNA GLICLAZIDE SR 30 mg

White to almost white, oval, slightly biconvex tablets.

REGISTRATION NUMBER

42/21.2/0249

NAME AND ADDRESS OF REGISTRATION HOLDER

Pharma Dynamics (Pty) Ltd.
F02
Grapevine House
Steenberg
Office Park
WESTLAKE
7945

DATE OF PUBLICATION

November 2011
Version: PD9012A

Back to Top