Dynacaz 30 mg Modified-Release Tablets

DYNACAZ MR contains gliclazide and belongs to a group of medicines called sulphonylurea antidiabetic medicine. It is used to treat a certain type of diabetes mellitus called type 2 diabetes in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.

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. DYNACAZ MR works by causing your pancreas to release more insulin into the blood stream.

Do not take DYNACAZ MR:

• if you are hypersensitive (allergic) to gliclazide, sulphonylureas (medicine for diabetes), sulphonamides (a type of antibiotic), or to any of the ingredients of DYNACAZ MR (see section 6)
• if you have type 1 diabetes mellitus (type 1 diabetes patients cannot produce or release insulin from their pancreas)
• if you have ketone bodies and sugar in your urine (this may mean you have diabetic keto-acidosis), a diabetic pre-coma or coma
• if you have acid (acidosis) or ketones (diabetic ketoacidosis - a life-threatening problem that occurs when the body cannot use sugar (glucose) as a fuel source because there is no insulin or not enough insulin in your blood)
• if you have severe burns or injuries, a severe infection or had a major surgery
• if you have a liver disease
• if you have a kidney disease
• if you are taking a medicine to treat fungal infections called miconazole (see Other medicines with DYNACAZ MR)
• if you are a child, as the safety of DYNACAZ MR has not been studied in children
• if you are pregnant or breastfeeding your baby.

Warnings and precautions

Take special care with DYNACAZ MR

Before taking DYNACAZ MR you should talk to your doctor. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight.

During DYNACAZ MR treatment regular monitoring of your blood, (and possibly urine), sugar level and also your glycated haemoglobin (HbA1c) is necessary.

In the initial weeks of treatment, the risk of low blood sugar may increase, and careful monitoring is necessary. Prolonged or serious episodes of hypoglycaemia (low blood sugar), even if controlled by sugar intake, require immediate medical treatment or even hospitalisation.

Low blood sugar (hypoglycaemia) may occur:

• if you are a patient, especially elderly or unable to cooperate
• if you do not eat meals at regular intervals or skip meals altogether
• if you are fasting
• if you are malnourished
• if you change your diet
• if you increase your physical activity and carbohydrate intake does not match this increase
• if you drink a significant amount of alcohol, especially when skipping meals
• if you have any severe abnormal condition of the blood vessels (arteries and veins), including severe heart disease
• if you are taking or have recently stopped taking high doses of corticosteroids (used for pain and inflammation)
• if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex)
• if your kidney function or liver function is severely decreased
• if you take other medicines or natural remedies at the same time
• if you have taken an overdose of DYNACAZ MR.

Do not share medicines prescribed for you with any other person. Always use DYNACAZ MR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how long your treatment with DYNACAZ MR will last. Do not stop treatment early because high blood sugar symptoms will return. If you have the impression that the effect of DYNACAZ MR is too strong or too weak, tell 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, do not chew them, with half a glass of water and should be taken immediately before a substantial breakfast or the first main meal of the day (and preferably at the same time each day). You should not miss a meal after you have taken the tablets. DYNACAZ MR 90 mg tablets may be subdivided into parts to ensure that medicine is taken as directed by your doctor.

Adults: The recommended daily dose is one to four tablets of the 30 mg or two of the 60 mg tablets (maximum 120 mg) i.e. 30 to 120 mg taken as a single daily dose, taken with breakfast.

If a combination therapy of DYNACAZ MR with metformin, an alpha glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin is initiated, your doctor will determine the proper dose of each medicine individually for you.

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 of 30 mg). Your doctor will instruct you on 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. The daily dose should not exceed 120 mg.

Children: The safety and efficacy of DYNACAZ MR in children and adolescents have not been established and should therefore not be used in children.

DYNACAZ MR can have side effects. Not all side effects reported for DYNACAZ MR are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking DYNACAZ MR, please consult your healthcare provider for advice.

If any of the following happens, stop using DYNACAZ MR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DYNACAZ MR. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Stevens-Johnson syndrome or other serious skin disorder (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters)
• low blood sugar levels — hypoglycaemia (see Take special care with DYNACAZ MR for the list of symptoms)
• liver failure (signs include yellow discolouration of the skin and eyes (jaundice) and pain in the upper right abdomen)
• kidney problems (passing more urine than is normal for you or more frequently).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• headache, dizziness, drowsiness
• constipation, diarrhoea, stomach pain or discomfort, stomach spasms, decreased or increased appetite, heartburn, bloating, flatulence (gas), weight gain, nausea, vomiting, changes in sense of taste (metallic taste).

Less frequent side effects:

• decrease in the number of cells in the blood, resulting in abnormal blood test results including anaemia
• low sodium levels in the blood, anorexia
• blurred vision, worsening eyesight
• abnormal liver function (clay coloured stool, dark urine, itching, loss of appetite, yellow eyes or skin).

The following side effects have been reported but the frequency for them to occur is not known:

• hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, blistering or peeling of the skin, thinning of the skin, pale skin, unusual bruising.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children.

Store at or below 30 °C in a dry place. Protect from light.

Keep blisters in carton until required for use.

Do not use after the expiry date stated on the carton.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).