Patient leaflet - Gliclazide Teva 30 mg modified-release tablets
What Gliclazide Teva is and what it is used for
Gliclazide Teva is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulfonylurea group). Gliclazide Teva is 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.
What you need to know before you take Gliclazide Teva
Do not take Gliclazide Teva:
if you are allergic to gliclazide, to other medicines of the same group
(sulfonylureas), to other related medicines (sulfonamides) or any of the other ingredients of this medicine (listed in section 6)
- 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 Gliclazide Teva’)
- if you are breast-feeding (see section ‘Pregnancy and breast-feeding’).
If you think any of the above situations applies to you, tell your doctor or pharmacist.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Gliclazide Teva
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 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, if you take St John’s Wort (Hypericum perforatum) preparations (see section ‘Other medicines and Gliclazide Teva 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.
Blood glucose disturbance (low blood sugar and high blood sugar) can occur when gliclazide is prescribed at the same time than medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you the importance of monitoring your blood glucose.
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 hemoglobin level and breakdown of red blood cells (hemolytic anemia) can occur. Contact your doctor before taking this medicinal product.
Cases of acute porphyria have been described with some other sulfonylurea drugs, in patients who have porphyria (inherited genetic disorders with accumulation in the body of porphyrins or porphyrin precursors).
Children and adolescents
Gliclazide Teva is not recommended for use in children due to a lack of data.
Other medicines and Gliclazide Teva
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use 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. sulfonamides, 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)
- painkillers or antirheumatics (ibuprofen, phenylbutazone)
- 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)
St John’s Wort -Hypericum
perforatum-preparations.
Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time than Gliclazide Teva, especially in elderly patients.
Gliclazide may increase the effects of medicines which reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking Gliclazide Teva.
Gliclazide Teva with food, drink and alcohol
Gliclazide Teva 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 and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 1
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What is in this leaflet
PACKAGE LEAFLET:
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Gliclazide Teva is not recommended for use during pregnancy.
You must not take Gliclazide Teva while you are breast-feeding.
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).
Gliclazide Teva contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Gliclazide Teva
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 starting dose is one tablet once daily. The usual dose can vary from one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment.
If a combination therapy of Gliclazide Teva 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.
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
Swallow your tablets whole with a glass of water whilst having your breakfast, preferably at the same time each day. Do not chew the tablets. You must always eat a meal after taking your tablet(s). It is important not to skip a meal when you are on Gliclazide Teva.
If you take more Gliclazide Teva 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 Gliclazide Teva
It is important to take your medicine every day as regular treatment works better. If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Gliclazide Teva
As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this medicine. 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms
Rare (may affect up to 1 in 1,000 people):
Skin reactions such as rash, redness, itching, hives, angioedema (rapid swelling of the tissue 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. If you develop this, stop taking Gliclazide Teva, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe
hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with high temperature.
Abnormal liver function tests, changes in your liver (which can cause yellow skin and eyes). If you get this, see your doctor immediately.
These effects generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Not known (frequency cannot be estimated from the available data):
- Severe hypoglycaemia (low blood sugar). For symptoms and signs of hypoglycaemia see section 2 ‘Warnings and precautions’. 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.
As for other sulfonylureas, 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 sulfonylureas, but may lead to
life-threatening liver failure in isolated cases.
Other possible side effects
Common (may affect up to 1 in 10 people):
- Hypoglycaemia (low blood sugar). For symptoms and signs see section 2 ‘Warnings and precautions’.
Uncommon (may affect up to 1 in 100 people):
Gastrointestinal disturbances including abdominal pain, nausea, vomiting, indigestion, diarrhoea, constipation. These effects are reduced when Gliclazide Teva is taken with a meal as recommended.
Rare (may affect up to 1 in 1,000 people):
- 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.
- 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. These effects generally disappear if the medicine is stopped.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Gliclazide Teva
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 blister, the tablet container and the carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Gliclazide Teva contains
- The active substance is gliclazide. Each modified-release tablet contains 30 mg gliclazide.
- The other ingredients are lactose monohydrate, hypromellose, calcium carbonate, colloidal anhydrous silica, magnesium stearate.
What Gliclazide Teva looks like and contents of the pack
The modified-release tablets are white, oval, biconvex tablets.
Gliclazide Teva is available in blisters in boxes of 10, 14, 20, 28, 30, 56, 60, 84, 90, 100, 120 or 180 tablets and in tablet containers of 90, 120 or 180 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom
Manufacturer
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland
This leaflet was last revised in June 2025.
PL 00289/2513
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