Gliclazide 80mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Gliclazide 80mg Tablets
Gliclazide
Read all of this leaflet carefully before you start
to take this medicine.
- Keep this leaflet. You may need to read it again while you are receiving your treatment.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Gliclazide 80mg Tablets are and what they are used for
2. Before you take Gliclazide 80mg Tablets
3. How to take Gliclazide 80mg Tablets
4. Possible side effects
5. How to store Gliclazide 80mg Tablets
6. Further information
1. What Gliclazide 80mg Tablets are and what they are used for
The name of your medicine is Gliclazide 80mg Tablets. These tablets belong to a group of medicines called sulphonylureas.
Gliclazide 80mg Tablets are used to lower blood sugar levels and are used in the treatment of late-onset diabetes (type II diabetes mellitus) in patients whose blood sugar is not controlled by diet alone and who are not suitable for insulin injections.
2. Before you take Gliclazide 80mg Tablets
You should not take Gliclazide 80mg Tablets if you:
• are allergic (hypersensitive) to gliclazide, other sulphonylureas or any of the other ingredients in Gliclazide 80mg Tablets (see section 6, Further information)
• suffer from early onset or type I diabetes (requiring insulin)
• suffer from severe liver or kidney disease
• are suffering from ketoacidosis (caused by excessively high blood sugars in diabetics)
• are suffering from a severe infection
• are suffering from stress
• are suffering from any condition likely to make controlling your blood sugar difficult
• are due to undergo surgery
• are pregnant
• have reduced consciousness or coma resulting from your diabetes
• are suffering from porphyria (a disease of blood proteins affecting the skin, gut and nervous system).
This medicine can cause low blood sugar (hypoglycaemia). Symptoms of low blood sugar include sweating, hunger, increased heart rate, reduced consciousness, coma or seizures. Patients should use caution, particularly in the following situations:
Low blood sugar (Hypoglycaemia) may occur:
• in patients whose diabetes is controlled by diet alone
• if you take too high doses of Gliclazide 80mg Tablets
• if you are malnourished
• if you take meals irregularly or skip meals altogether
• if you increase your physical activity and carbohydrate intake does not match this increase
• if you are elderly or unwell
• if your kidney function or liver function is decreased
• if you suffer from particular hormone-induced disorders (functional disorders of the thyroid, pituitary or adrenal glands)
• if you drink alcohol, especially in combination with skipped meals.
Low blood sugar may occur if you are in stress situations (e.g. accidents, surgical operations, fever etc.). During such times you should inform your doctor you are taking Gliclazide 80mg Tablets, as your doctor may adjust your dose of medicine or may temporarily switch you to insulin therapy.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by Gliclazide 80mg Tablets:
• medicines used to reduce pain and inflammation (e.g. aspirin, other non-steroidal anti-inflammatory drugs, azapropazone and phenylbutazone)
• medicines used to treat bacterial infections (e.g. isoniazid, rifamycins, chloramphenicol, co-trimoxazole, sulphonamides and tetracyclines)
• medicines used to treat depression (e.g. monoamine oxidase inhibitors [MAOIs])
• medicines used to treat fungal infections (e.g. miconazole, fluconazole)
• medicines used to treat gout (e.g. allopurinol, sulfinpyrazone and probenecid)
• medicines used to treat high blood pressure (e.g. diazoxide, captopril, enalapril and beta-blockers)
• medicines used to treat and prevent malaria (e.g. quinine and quinidine)
• medicines used to thin the blood and prevent clotting (e.g. warfarin and disopyramide)
• medicines used to treat psychosis and other mental illness (e.g. chlorpromazine)
• medicines used to treat stomach ulcers (e.g. cimetidine and ranitidine)
• medicines used in the treatment of cancer (e.g. crisantaspase)
• medicines used to treat water retention and heart failure (e.g. loop and thiazide diuretics)
• medicines used to reduce cholesterol (e.g. clofibrate)
• lithium (used to treat manic depression/bipolar disorder)
• hormone treatments and contraceptives
(e.g. testosterone, oestrogens, progesterones, oral contraceptives, anabolic steroids, corticosteroids and ocreotides)
• thyroid hormone (used to treat an underactive thyroid gland).
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Pregnancy and breast-feeding
You should not take this medicine if you are pregnant or breast-feeding.
Driving and using machinery
If your blood sugar is not well controlled then this can affect your vision and/or concentration. If you are affected in any way do not drive or operate machinery.
Important information about some of the ingredients in Gliclazide 80mg Tablets
This medicine 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 Gliclazide 80mg Tablets
Always take Gliclazide 80mg Tablets as your doctor has told you. Your doctor will decide the right dose for you this will be on the pharmacist's label.
Adults and the elderly
• the usual starting dose is 40 to 80 mg (% to 1 tablet)
• this dose will be adjusted by your doctor according to your response to treatment
• total daily dose may vary from 40 to 320mg
• if you are taking a larger dose it may be taken as two doses with the main meals of the day.
Children
• Gliclazide tablets like any other medicine belonging to its class, is not recommended in children for the treatment of juvenile onset diabetes mellitus.
Patients with Kidney and/or Liver Disease
• the starting dose is 40mg (% tablet) and is increased until blood sugar control is achieved.
If you take more Gliclazide 80mg Tablets than you should
If you (or anybody else, including a child) take more Gliclazide 80mg Tablets than you should, contact your nearest hospital casualty department or your doctor immediately. Always take the container and this leaflet with you. Signs that could indicate you have taken too many tablets are symptoms of low blood sugar which include sweating, hunger, increased heart rate, reduced consciousness, coma or seizures.
If you forget to take Gliclazide 80mg Tablets
If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed
4. Possible side effects
Like all medicines, Gliclazide 80mg Tablets can cause side effects, although not everybody gets them.
As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, seek medical help immediately:
• rash, itching and/or difficulty breathing.
Side effects that have been reported with Gliclazide 80mg Tablets are:
• feeling and being sick (nausea/vomiting)
• indigestion
• heartburn
• diarrhoea
• constipation
• metallic taste in mouth
• stomach pains
• increased appetite
• loss of appetite
• weight gain
• liver failure
• liver problems
• jaundice (yellowing of skin and whites of eyes)
• rash
• itching
• skin inflammation
• skin blistering
• fever
• sensitivity to light
• changes in blood cells
• hepatitis
• Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals)
• low blood sugar (symptoms include sweating, hunger, increased heart rate, reduced consciousness, coma or seizures)
• water retention
• problems with blood salt levels.
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 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 Gliclazide 80mg Tablets
Keep out of the reach and sight of children.
• Gliclazide 80mg Tablets should be stored in a dry place below 25°C
• Store in the original container to protect from light; do not transfer to another container
• Gliclazide 80mg Tablets should not be taken after the expiry date on the label; the expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Further information
What Gliclazide 80mg Tablets contain
The active ingredient is: gliclazide 80mg.
The other ingredients are: maize starch, lactose, povidone and magnesium stearate.
What Gliclazide 80mg Tablets look like and the contents of the pack
Gliclazide 80mg Tablets are white circular tablets with GZ80 and a breakline on one face and CP on the other.
Gliclazide 80mg Tablets are supplied in blister pack sizes of 28, 30, 56 or 60 tablets within an outer carton.
Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd,
Ash Road North, Wrexham LL13 9UF, UK.
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Please be ready to give the following information:
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Product name |
Reference number |
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Gliclazide 80mg Tablets |
29831/0103 |
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 03/2016