Active ingredient
- gliclazide
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00093/0024.
Diamicron 80mg Tablets
Package Leaflet: Information for the patient
diamicron® 80 mg Tablets
gliclazide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
Diamicron 80 mg Tablets will be referred as to Diamicron 80 mg throughout.
1. What Diamicron 80 mg is and what it is used for
2. What you need to know before you take Diamicron 80 mg
3. How to take Diamicron 80 mg
4. Possible side effects
5. How to store Diamicron 80 mg
6. Contents of the pack and other information
1. What Diamicron 80 mg is and what it is used for
Diamicron 80 mg contains the active substance gliclazide, one of a group of medicines called sulfonylureas. It is an oral hypoglycaemic medicine (blood sugar lowering drug).
Diamicron 80 mg is used to keep blood sugar at the correct level in adults with non-insulin dependent diabetes when it is not controlled by diet, physical exercise and weight loss alone.
2. What you need to know before you take Diamicron 80 mg
Do not take Diamicron 80 mg
Children and adolescents
Diamicron 80 mg is not recommended for use in children.
If you have been told by your doctor that you have an intolerance to some sugars (for instance glucose, lactose, galactose), contact your doctor before taking this medicinal product.
Warnings and precautions
Follow your doctor's advice about diet and treatment. This is to reduce the chances of very low blood sugar (hypoglycaemia). Make sure your doctor knows:
Dietary advice
This medicine may cause episodes of low blood sugar (hypoglycaemia). This is more likely if:
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, for instance 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.
While taking Diamicron 80 mg you should:
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), 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).
Other medicines and Diamicron 80 mg
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:
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:
Diamicron 80 mg 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 Diamicron 80 mg.
Taking Diamicron 80 mg with food, drink and alcohol
Diamicron 80 mg can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes.
Pregnancy and breastfeeding
Diamicron 80 mg 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 while taking this medicine, inform your doctor so that he may prescribe a more suitable treatment for you.
You must not take Diamicron 80 mg while you are breastfeeding.
Driving and using machines
Provided your blood glucose levels are satisfactorily controlled on Diamicron 80 mg, your ability to drive or use machines should not be affected. However, if your blood glucose levels become too low, this could adversely affect your concentration, and therefore your ability to perform these tasks.
Ask your doctor whether you can drive a car if you:
3. How to take Diamicron 80 mg
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 recommended daily dose is from one half to four tablets. This depends on the response to treatment. When the total daily dose exceeds two tablets, it should be divided into two equal doses taken morning and evening.
Diamicron 80 mg is for oral use. Take your tablet(s) with a glass of water (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 Diamicron 80 mg 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 Diamicron 80 mg 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.
If you forget to take Diamicron 80 mg
It is important to take your medicine every day as regular treatment works better.
However, if you forget to take a dose of Diamicron 80 mg, 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 Diamicron 80 mg
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.
Low blood sugar (Hypoglycaemia)
The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs see Section 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.
Other side effects
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 (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, 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 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 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 Diamicron 80 mg
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 after Exp. The expiry date refers to the last day of that month. Store in the original package.
This medicinal product does not require any special storage conditions.
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 Diamicron 80 mg contains
The active substance is gliclazide. Each tablet contains 80 mg of gliclazide. The other ingredients are: lactose monohydrate, maize starch, pregelatinised maize starch, talc, magnesium stearate.
What Diamicron 80 mg looks like and contents of the pack
Diamicron 80 mg is a white, circular tablet with flat bevelled edges and cross scoring on one face and come in cartons of 28, 56, 60 and 112 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in 02/2020
Sefton House, Sefton Park, Bells Hill, Stoke Poges, Slough, SL2 4JS, UK
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