Patient leaflet - Lamzarin 60 mg prolonged-release tablets
1. What Lamzarin 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 to gliclazide or any of the other ingredients of Lamzarin Prolonged-release Tablets (listed in section 6), or to other medicine of the same group (sulphonylurea), 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 Lamzarin Prolonged-release Tablets’)
If you are breast-feeding (see section ‘Pregnancy and breast-feeding’)
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 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 heartbeat, 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 heartbeat 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, for instance glucose tablets, sugar cubes, sweet juice and 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 (for instance those acting on the central nervous system and beta blockers).
If you are in stress-situations (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 Lamzarin
Prolonged-release Tablets”) 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 of 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.
Cases of acute porphyria have been described with some other sulphonylurea drugs, in patients who have porphyria (inherited genetic disorders with accumulation in the body of porphyrins or porphyrin precursors).
Children
Lamzarin Prolonged-release Tablets are not recommended for use in children 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, GLP-1 receptor inhibitors or insulin)
- Antibiotics (sulphonamides or 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 (phenylbutazone, ibuprofen)
- Medicines containing alcohol
The blood glucose lowering effect of gliclazide 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)
- 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 hospital, tell the medical staff you are taking Lamzarin Prolonged-release Tablets.
Lamzarin Prolonged-release Tablets with food, drink and alcohol
Lamzarin Prolonged-release Tablet 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
Lamzarin Prolonged-release Tablets are not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You must not take Lamzarin Prolonged-release Tablets 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)
Lamzarin Prolonged-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 Lamzarin Prolonged-release Tablets
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 (weight reduction, change in lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses. Lamzarin 60 mg Prolonged-release Tablets- The recommended daily dose is half to two tablets (maximum 120 mg) in a single intake at breakfast time. Lamzarin 30 mg Prolonged-release Tablets- The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Lamzarin Prolonged-release Tablets are for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your tablets whole. Do not chew them. You must always eat a meal after taking your tablet(s). If a combination therapy of Lamzarin Prolonged-release Tablets 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.
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, for instance 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 “What you need to know before you take Lamzarin 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.
Blood disorders
Decrease in the number of cells in the blood (for instance platelets, red and white blood cells) which 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
- Blisters
- Angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat that may result in breathing difficulty). Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking Lamzarin Prolonged-release Tablets, seek urgent advice from doctor and tell him that you are taking this medicine
- Exceptionally, signs of severe hypersensitivity reactions (DRESS): initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature
Digestive disorders
- Stomach pain or discomfort
- Feeling or being sick
- Indigestion
- Diarrhoea
- Constipation
These effects are reduced when Lamzarin Prolonged-release Tablets is taken with a meal as 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.
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), and symptoms of liver impairment (for instance 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 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.
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 30 mg or 60 mg of gliclazide in a Prolonged-release formulation. The other ingredients are: lactose monohydrate, hypromellose and magnesium stearate.
See section 2 for further excipient information on lactose.
What Lamzarin Prolonged-release Tablets look like and the contents of the pack
Lamzarin 30 mg Prolonged-release Tablets are white, biconvex capsule shaped tablets engraved ‘GLI30’ on one side and plain on other side.
Lamzarin 60 mg Prolonged-release Tablets are white biconvex oval shaped tablets with a deep break line on both sides and engraved ‘GLI’ on one side of score and ‘60’ on other side of score on both the side. Blisters: 14, 28, 56 Prolonged-release Tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Key Pharmaceuticals Ltd.
18 Oxleasow Road,
Redditch, B98 0RE, UK