Patient leaflet - LAMZARIN 30 MG PROLONGED-RELEASE TABLETS
1. What Gliclazide Prolonged-release
Tablets are and what they are used for Lamzarin Prolonged-release Tablets is a medicine that reduces blood sugar levels (oral anti- diabetic medicine belonging to the sulphonylurea group). Lamzarin Prolonged-release Tablets 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.
2. what you need to know before you take lamzarin prolonged-release tablets
Do not take Lamzarin Prolonged-release Tablets if you:
- are allergic (hypersensitive) to Gliclazide or to any of the other ingredients (see section 6 for list of ingredients), or to other medicine of the same group (sulphonylurea) or to other related medicine (hypoglycemic sulphonamide)
- have insulin-dependent diabetes (type 1)
- have ketone bodies and sugar in your urine (this may mean you have diabetic keto-acidosis), a diabetic pre-coma or coma
- have severe kidney or liver disease
- are taking medicines to treat fungal infections (miconazole, see section ‘Other medicines and Gliclazide’)
- are breastfeeding (see Section ‘Pregnancy and breastfeeding’).
Warnings and precautions
Talk to your doctor or pharmacist before taking Lamzarin Prolonged-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 Lamzarin Prolonged-release Tablet treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. It may also be useful to monitor your own blood sugar levels, although only following instruction from your doctor.
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 Lamzarin Tablets
- 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 heartbeat, high blood pressure, suddenstrong 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 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 Lamzarin Prolonged-release Tablets 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.
Blood glucose disturbance (low blood sugar and high blood sugar) can occur when gliclazide Prolonged release tablets 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 haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Children and adolescents
Lamzarin Prolonged-release Tablets are not recommended for use in children and adolescents due to a lack of data.
Other medicines and Lamzarin Prolonged-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 anti- diabetics or insulin)
- Antibiotics (e.g. sulphonamides or clarithromycin)
- Medicines to treat high blood pressure or heart failure (beta blockers, ACE inhibitors such as captopril or enalpril)
- Medicines to treat fungal infections (e.g. miconazole, fluconazole- see section ‘Do not take Lamzarin Prolonged-release Tablets’)
- Medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists)
- Medicines to treat depression (monamine oxidase inhibitors)
- Painkillers or antirheumatics (phenylbutazone, ibuprofen)
- Medicines containing alcohol
The blood glucose lowering effect of Gliclazide Prolonged-release Tablets may be weakened and raised blood sugar may occur when one of the following medicines is taken:
- Medicines to treat disorders of the central nervous system (chlorpromazine)
- Medicines reducing inflammation (corticosteroids or tetracosactrin)
- 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 medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time than Lamzarin Prolonged-release Tablets, especially in elderly patients.
Lamzarin Prolonged-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 to into hospital tell the medical staff you are taking Lamzarin Prolonged-release Tablets.
Lamzarin Prolonged-release Tablet with food, drink and alcohol
Lamzarin Prolonged-release Tablet can be taken
« with food and non-alcoholic drinks. Drinking g alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner. Pregnancy
Lamzarin Prolonged-release tablet is not recommended for use during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
You must not take Lamzarin Prolonged-release Tablets while you are breastfeeding.
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 (hypoglycemia)
- have few or no warning signals of low blood sugar (hypoglycaemia).
Lamzarin Prolonged-release Tablets 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.
3. how to take lamzain prolonged-release tablets
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.
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 such as rash, redness, itching, hives and 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. 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 a high temperature.
Blood disorders
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.
Digestive disorders
Stomach pain or discomfort, nausea, vomiting, indigestion, diarrhoea and constipation. These effects are reduced when Lamzarin Prolonged-release Tablets is taken with a meal as
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 Lamzarin Prolonged-release Tablet doses.
For 30mg Tablets: The usual dose is one to four tablets (maximum 120mg) in a single intake at breakfast time. This depends on the response to treatment.
If a combination therapy of Gliclazide 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.
Methods and routes of administration
Oral use. For 30mg Tablets: Swallow your whole tablet(s) in one piece.
Do not chew or crush. 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 Lamzarin Prolonged-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 (hypoglycemia) 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 Lamzarin Prolonged-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 Lamzarin Prolonged-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 Lamzarin Prolonged-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 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 (hypoglycaemia). For symptoms and signs see ‘Warnings and precautions’ in section 2. recommended, see section 3 ‘How to take Lamzarin Prolonged-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.
The following adverse events have been observed with other sulphonylureas: Severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels; reduction in blood sodium (hyponatraemia); and 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:
United Kingdom:
The Yellow Card Scheme Website: Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website:
E-mail:
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store lamzarin prolonged-release tablets
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the tablet carton and blister strip after ‘EXP’. The expiry date refers to the last day of that month.
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.
6. contents of the pack and other information
What Lamzarin Prolonged-release Tablets contain:
The active substance is Gliclazide.
One tablet contains 30mg of gliclazide in a Prolonged-release formulation. The other ingredients are: lactose monohydrate, hypromellose and magnesium stearate.
What Lamzarin Prolonged-release Tablets looks like and the contents of the pack:
Lamzarin 30mg Prolonged-release Tablets are white, biconvex capsule shaped tablets engraved ‘GLI30’ on one side and plain on other side Blisters: 14, 28, 56 Prolonged-release Tablets. Not all pack size may be marketed.
Marketing Authorisation Holder and Manufacturer:
Key Pharmaceuticals Ltd.
Galen House, 83 High Street Somersham, Cambridgeshire PE28 3JB UK
This leaflet was last revised in Sep 2018.