Diaglyaran 60mg Modified-Release Tablets
Package leaflet: Information for the user
Diaglyaran 60 mg modified-release tablets
Gliclazide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Diaglyaran modified-release tablets are and what they are used for
2. What you need to know before you take Diaglyaran modified-release tablets
3. How to take Diaglyaran modified-release tablets
4. Possible side effects
5. How to store Diaglyaran modified-release tablets
6. Contents of the pack and other information
1. What Diaglyaran modified-release tablets are and what they are used for
Diaglyaran modified-release tablets are medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group).
Diaglyaran modified-release tablets are used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.
2. What you need to know before you take Diaglyaran modified-release tablets
Do not take Diaglyaran modified-release tablets:
- if you are allergic to this medicine or any of the other ingredients of Diaglyaran modified-release tablets (listed in section 6), or to other medicines of the same group (sulphonylureas), or to other related medicines (hypoglycaemic sulphonamides);
- if you have insulin-dependent diabetes (type 1);
- 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 severe kidney or liver disease;
- if you are taking medicines to treat fungal infections (miconazole, see Section “Other medicines and Diaglyaran modified-release tablets”);
- if you are breastfeeding (see Section “Pregnancy, breastfeeding and fertility”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Diaglyaran modified-release tablets.
You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, you observe the dietary regimen, have physical exercise and, where necessary, reduce weight.
During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary.
In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.
Low blood sugar (hypoglycaemia) may occur:
- if you take meals irregularly 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 alcohol, especially in combination with skipped meals,
- if you take other medicines or natural remedies at the same time,
- if you take too high doses of gliclazide,
- 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 have low blood sugar you may have the following symptoms:
headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor
concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness, and helplessness.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heart beat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self control, your breathing may be shallow and your heart beat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, e.g. glucose tablets, sugar cubes, sweet juice, sweetened tea.
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes).
Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (e.g. those acting on the central nervous system and beta blockers).
If you are in stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor or in special stress situations). These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
If these symptoms occur, you must contact your doctor or pharmacist.
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. Contact your doctor before taking this medicinal product.
Children and adolescents
Diaglyaran modified-release tablets are not recommended for use in children due to a lack of data.
Other medicines and Diaglyaran modified-release tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken:
- other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
- antibiotics (e.g. sulphonamides, clarithromycin),
- medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril,or enalapril),
- medicines to treat fungal infections (miconazole, fluconazole),
- medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
- medicines to treat depression (monoamine oxidase inhibitors),
- painkiller or antirheumatics (phenylbutazone, ibuprofen),
- medicines containing alcohol.
The blood glucose lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:
- medicines to treat disorders of the central nervous system (chlorpromazine),
- medicines reducing inflammation (corticosteroids),
- medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline),
- medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol).
Diaglyaran modified-release tablets may increase the effects of medicines which reduce blood clotting (e.g. warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking Diaglyaran modified-release tablets.
Diaglyaran modified-release tablets with food, drink and alcohol
Diaglyaran modified-release tablets can be taken with food and non-alcoholic drinks.
Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby while taking this medicine, inform your doctor so that he may prescribe a more suitable treatment for you.
Pregnancy
Diaglyaran modified-release tablets are not recommended for use during pregnancy.
Breast-feeding
You must not take Diaglyaran modified-release tablets while you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (e.g. when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
- have frequent episodes of low blood sugar (hypoglycaemia),
- have few or no warning signals of low blood sugar (hypoglycaemia).
Diaglyaran modified-release tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Diaglyaran modified-release tablets Dose
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dose is determined by the doctor, depending on your blood and possibly urine sugar levels.
Change in external factors (e.g. weight reduction, change in life style, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended dose is half to two tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment.
If a combination therapy of Diaglyaran modified-release tablets with metformin, another antidiabetic medicines (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.
If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
Routes and method of administration
Oral use.
Swallow your half tablet or whole tablet(s) in one piece. Do not chew or crush.
The tablet can be divided into equal doses.
Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day).
You must always eat a meal after taking your tablet(s).
If you take more Diaglyaran modified-release tablets than you should
If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia) described in Section 2.
The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, e.g. a child, has taken the product unintentionally. Unconscious patients must not be given food or drink.
It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Diaglyaran modified-release tablets
It is important to take your medicine every day as regular treatment works better.
However, if you forget to take a dose of Diaglyaran modified-release tablets take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Diaglyaran modified-release tablets
As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effect is low blood sugar (hvpoglvcacmia). For symptoms and signs see Section “Warnings and precautions” in “Section 2 What you need to know before you take”.
If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.
Blood disorders
Decrease in the number of cells in the blood has been reported (e.g. platelets, red and white blood cells). This may cause:
- Paleness
- Prolonged bleeding
- Bruising
- Sore throat
- Fever
These symptoms usually vanish when the treatment is discontinued.
Liver disorders
There have been isolated reports of abnormal liver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders
Skin reactions have been reported such as:
- Rash
- Redness
- Itching
- Hives
- Angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty).The rash may progress to widespread blistering or peeling of the skin. If you get any of these symptoms, you should seek immediate medical attention.
Digestive disorders
- Stomach pain
- Feeling or being sick
- Indigestion
- Diarrhoea
- Constipation.
These effects are reduced when Diaglyaran modified-release tablet is taken with a meal as recommended, See Section 3 “How to take Diaglyaran modified-release tablets”.
Eye disorders
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.
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 sulphonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Diaglyaran modified-release tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister strip. The expiry date refers to the last day of that month.
Discard any tablets remaining in the bottle after 100 days from opening.
Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Diaglyaran modified-release tablets contain
The active substance is gliclazide.
Each modified-release tablet contains 60 mg gliclazide.
The other ingredients are:
Maize Starch, Pregelatinised; Lactose Monohydrate; Sodium Citrate (E331); Hypromellose (E464); Magnesium Stearate
What Diaglyaran modified-release tablets look like and contents of the pack
White to off white oval-shaped tablets, scored on both sides, engraved with ‘Z’ and ‘I’ on one side and plain on the other side, with dimensions 15.0 x 7.0 mm.
OPA/AL/PVC/Al blister packs of 30, 60 or 90 modified-release tablets
PVC/PE/PvDC/Al blister packs of 30, 60 or 90 modified-release tablets
HDPE bottle containing 100 modified-release tablets.
The bottle is made of HDPE, containing absorbent cotton, with child resistant closure and induction seal liner.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ranbaxy (UK) Limited Building 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE United Kingdom
Manufacturer:
Ranbaxy Ireland Ltd Spafield, Cork Rd,
Cashel, Co. Tipperary,
Ireland
Basics GmbH Hemmelrather Weg 201 Leverkusen 51377 Germany
Terapia SA Str. Fabricii nr. 124 Cluj Napoca 400 632 Romania
This leaflet was last revised in 11/15