Gliclazide 80mg Tablets
30
8
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLICLAZIDE 80mg TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Gliclazide Tablets are and what they are used for
2. What you need to know before you take Gliclazide Tablets
3. How to take Gliclazide Tablets
4. Possible Side Effects
5. How to Store Gliclazide Tablets
6. Contents of the pack and other information
1. What Gliclazide Tablets are and what they are used for
- Gliclazide 80 mg contains the active substance gliclazide, one of a group of medicines sulfonylureas. It is an oral hypoglycaemic medicine (blood sugar lowering drug).
- Gliclazide Tablets are used to keep blood sugar at the correct level in adults with non-insulin dependant diabetes (type 2) when it is not controlled by diet, physical exercise and weight loss alone.
2. What you need to know before you take Gliclazide Tablets Do not take these Tablets if you:
• are allergic to Gliclazide or any of the other ingredients of this medicine (listed in section 6), to other medicines of the same group (sulfonylureas), to other related medicines (hypoglycaemic sulfonamides)
• have insulin-dependant diabetes (type 1)
• suffer from severe kidney or liver problems
• have ketone bodies and sugar in your urine (this may mean you have keto-acidosis)
• suffer from a diabetic pre-coma and coma.
• are taking miconazole (a treatment for fungal infections) (see Taking Other medicines)
• are breast-feeding (see Pregnancy, breast-feeding and fertility)
Gliclazide Tablets are not recommended for use in children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide 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.
8
SAME SIZE ARTWORK
400 x 160 mm
Front
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 together, if you are fasting,
- you are malnourished, you change your diet,
- you increase your physical activity and carbohydrate intake does not match this increase,
- you drink alcohol, especially in combination with skipped meals,
- you take high doses of gliclazide,
- you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex),
- 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 compiled 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.
While taking Gliclazide Tablets you should:
• follow a regular diet: it is important to eat regular meals, including breakfast and never to miss or delay a meal
• take your medicine regularly (see How to take Gliclazide Tablets)
• check your blood glucose regularly as recommended by your doctor.
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.
Other medicines and Gliclazide Tablets
Tell your doctor or pharmacist if you are taking, have recently 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 antidiabetics, GLP-1 receptor inhibitors 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),
• painkiller or anti-rheumatics (phenylbutazone, ibuprofen),
• 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).
Gliclazide 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 into hospital tell the medical staff you are taking Gliclazide tablets.
Taking Gliclazide with food, drink and alcohol
Gliclazide Tablets can be taken with food and non-alcoholic drinks.
Pregnancy, breast-feeding and fertility
Gliclazide 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 for advice before taking this medicine.
You must not take this medicine while you are breast-feeding.
Driving and using machines
Provided your blood glucose levels are satisfactorily controlled on Gliclazide Tablets, 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:
• have frequent episodes of low blood sugar (hypoglycaemia),
• have few or no warning signals of low blood sugar (hypoglycaemia).
Gliclazide Tablets contain Lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
160 mm
400 mm
3. How to take Gliclazide 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.
• Swallow the tablets with a glass of water.
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 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.
Gliclazide tablets are for oral use. Take your tablet(s) with a glass of water before a meal.
If a combination therapy of Gliclazide 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 Gliclazide 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 (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 Gliclazide Tablets:
It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide tablets, take the next dose at the usual time. Do not take double dose to make up for forgotten dose.
If you stop taking Gliclazide 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 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 may sometimes cause side effects, although not everybody gets them.
STOP taking this medicine and contact your doctor immediately or the casualty department at your nearest hospital if you suffer from any of the following serious side effects:
Rare (may affect up to 1 in 1000 people)
- Skin rash progressing to widespread blistering or peeling of the skin (Stevens-Johnson syndrome or toxic epidermal necrolysis).
- Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially flu-like symptoms and a rash on the face then an extended rash with a high temperature.
- Decrease in blood cell numbers (e.g. platelets, red and white blood cells) - symptoms include unexplained bruising and bleeding, infections, paleness, tiredness, sore throat and fever. These symptoms usually vanish when the treatment is discontinued.
- Angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty)
Other side effects include:
Common (may affect up to 1 in 10 people):
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.
Uncommon (may affect up to 1 in 100people)
Digestive disorders:
- Abdominal pain, Nausea, Vomiting, Indigestion, Diarrhoea, Constipation
These effects are reduced when Gliclazide Tablets are taken with a meal as recommended.
Rare (may affect up to 1 in 1000 people)
Skin disorders:
- Rash, redness, itching and hives.
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.
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.
Very Rare (may affect up to 1 in 10000 people)
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), have been described. Symptoms of liver impairment (e.g. jaundice) have been observed which in most cases disappeared after withdrawal of the sulfonylureas, 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, 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. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Gliclazide Tablets
• Keep this medicine out of the sight and reach of children.
• Do not store above 250C. Store in the original package.
• Do not use this medicine after the expiry date (EXP.) which is stated in the carton. 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 Gliclazide Tablets contain
• The active substance is Gliclazide. Each tablet contains 80mg of gliclazide.
• The other ingredients are Lactose monohydrate, microcrystalline cellulose, magnesium stearate, purified talc, croscarmellose sodium and povidone.
What Gliclazide Tablets look like and contents of the pack
• Gliclazide 80mg Tablets are white to off-white, circular, flat, bevelled edged, uncoated tablets with ”80" on one side and a breakline on the reverse.
• These tablets are available in packs of 20, 28, 56, 60, 84, 100 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Name and address:
Telephone:
Fax:
Email:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, United Kingdom
0044 (0)1442 200922
0044 (0)1442 873717
Gliclazide 80mg Tablets; PL 17907/0068 This leaflet was revised in July 2016.
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V7 1 2-07-2016 D0
160 mm
400 mm
SAME SIZE ARTWORK
400 x 160 mm
Back
55
PACKAGE LEAFLET: INFORMATION FOR THE USER_
_GLICLAZIDE 80mg TABLETS_
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Gliclazide Tablets are and what they are used for
2. What you need to know before you take Gliclazide Tablets
3. How to take Gliclazide Tablets
4. Possible Side Effects
5. How to Store Gliclazide Tablets
6. Contents of the pack and other information
1. What Gliclazide Tablets are and what they are used for
- Gliclazide 80 mg contains the active substance gliclazide, one of a group of medicines sulfonylureas. It is an oral hypoglycaemic medicine (blood sugar lowering drug).
- Gliclazide Tablets are used to keep blood sugar at the correct level in adults with non-insulin dependant diabetes (type 2) when it is not controlled by diet, physical exercise and weight loss alone.
2. What you need to know before you take Gliclazide Tablets Do not take these Tablets if you:
• are allergic to Gliclazide or any of the other ingredients of this medicine (listed in section 6), to other medicines of the same group (sulfonylureas), to other related medicines (hypoglycaemic sulfonamides)
• have insulin-dependant diabetes (type 1)
• suffer from severe kidney or liver problems
• have ketone bodies and sugar in your urine (this may mean you have keto-acidosis)
• suffer from a diabetic pre-coma and coma.
• are taking miconazole (a treatment for fungal infections) (see Taking Other medicines)
• are breast-feeding (see Pregnancy, breast-feeding and fertility)
Gliclazide Tablets are not recommended for use in children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide 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 together, if you are fasting,
- you are malnourished, you change your diet,
- you increase your physical activity and carbohydrate intake does not match this increase,
- you drink alcohol, especially in combination with skipped meals,
- you take high doses of gliclazide,
- you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex),
- 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 compiled 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.
While taking Gliclazide Tablets you should:
• follow a regular diet: it is important to eat regular meals, including breakfast and never to miss or delay a meal
• take your medicine regularly (see How to take Gliclazide Tablets)
• check your blood glucose regularly as recommended by your doctor.
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. Other medicines and Gliclazide Tablets
Tell your doctor or pharmacist if you are taking, have recently 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 antidiabetics, GLP-1 receptor inhibitors 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),
• painkiller or anti-rheumatics (phenylbutazone, ibuprofen),
• 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). Gliclazide 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 into hospital tell the medical staff you are taking Gliclazide tablets.
Taking Gliclazide with food, drink and alcohol
Gliclazide Tablets can be taken with food and non-alcoholic drinks.
Pregnancy, breast-feeding and fertility
Gliclazide 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 for advice before taking this medicine.
You must not take this medicine while you are breast-feeding.
Driving and using machines
Provided your blood glucose levels are satisfactorily controlled on Gliclazide Tablets, your ability to drive or use machines should not be affected.
140 mm
8
430 mm
SAME SIZE ARTWORK
430 x 140 mm
Front
55
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:
• have frequent episodes of low blood sugar (hypoglycaemia),
• have few or no warning signals of low blood sugar (hypoglycaemia).
Gliclazide Tablets contain Lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
| 3. How to take Gliclazide 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.
• Swallow the tablets with a glass of water.
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 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.
Gliclazide tablets are for oral use. Take your tablet(s) with a glass of water before a meal.
If a combination therapy of Gliclazide 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 Gliclazide 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 (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 Gliclazide Tablets:
It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide tablets, take the next dose at the usual time. Do not take double dose to make up for forgotten dose.
If you stop taking Gliclazide 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 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 may sometimes cause side effects, although not everybody gets them. STOP taking this medicine and contact your doctor immediately or the casualty department at your nearest hospital if you suffer from any of the following serious side effects:
Rare (may affect up to 1 in 1000 people)
- Skin rash progressing to widespread blistering or peeling of the skin (Stevens-Johnson syndrome or toxic epidermal necrolysis).
- Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially flu-like symptoms and a rash on the face then an extended rash with a high temperature.
- Decrease in blood cell numbers (e.g. platelets, red and white blood cells) - symptoms include unexplained bruising and bleeding, infections, paleness, tiredness, sore throat and fever. These symptoms usually vanish when the treatment is discontinued.
- Angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty)
Other side effects include:
Common (may affect up to 1 in 10 people):
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.
Uncommon (may affect up to 1 in 100people)
Digestive disorders:
- Abdominal pain, Nausea, Vomiting, Indigestion, Diarrhoea, Constipation
These effects are reduced when Gliclazide Tablets are taken with a meal as recommended.
Rare (may affect up to 1 in 1000 people)
Skin disorders:
- Rash, redness, itching and hives.
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.
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.
Very Rare (may affect up to 1 in 10000 people)
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), have been described. Symptoms of liver impairment (e.g. jaundice) have been observed which in most cases disappeared after withdrawal of the sulfonylureas, 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, 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. By reporting side effects you can help provide more information on the safety of this medicine.
| 5. How to store Gliclazide Tablets |
• Keep this medicine out of the sight and reach of children.
• Do not store above 250C. Store in the original package.
• Do not use this medicine after the expiry date (EXP.) which is stated in the carton. 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 Gliclazide Tablets contain
• The active substance is Gliclazide. Each tablet contains 80mg of gliclazide.
• The other ingredients are Lactose monohydrate, microcrystalline cellulose, magnesium stearate, purified talc, croscarmellose sodium and povidone.
What Gliclazide Tablets look like and contents of the pack
• Gliclazide 80mg Tablets are white to off-white, circular, flat, bevelled edged, uncoated tablets with ”80" on one side and a breakline on the reverse.
• These tablets are available in packs of 20, 28, 56, 60, 84, 100 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Gliclazide 80mg Tablets; PL 17907/0068 This leaflet was revised in July 2016.
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above. S
V8 1 2-07-2016 D0 ><
140 mm
430 mm
SAME SIZE ARTWORK
430 x 140 mm
Back