Skip to Content

GLICLAZIDE NOUMED 80MG TABLETS

Active substance(s): GLICLAZIDE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gliclazide 80 mg Tablets
(gliclazide)

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, 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 of the 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 GliclazideTablets 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 is one of a group of medicines called sulfonylureas. It is an oral hypoglycaemic
medicine (blood sugar lowering drug). Gliclazide 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 Gliclazide tablets
Do not take Gliclazide 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),
• if you have insulin-dependent diabetes (type 1),
• if you have ketone bodies and sugar in your urine (this may mean you have keto-acidosis), a diabetic pre-coma or coma,
• if you have severe kidney or liver disease,
• if you are taking miconazole (a treatment for fungal infections) (see Taking other medicines),
• if you are breast-feeding (see Pregnancy and breast-feeding).
Gliclazide is not recommended for use in children.
If you have been told by your doctor that you have an intolerance to some sugars (e.g.
glucose, lactose, galactose), contact your doctor before taking this medicinal product.
Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide
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;
Low blood sugar (hypoglycaemia) may occur if you:
• take meals irregularly or skip meals altogether, if you are fasting,
• are malnourished,
• change your diet,
• increase your physical activity and carbohydrate intake does not match this increase,
• drink alcohol, especially in combination with skipped meals,

• take other medicines or natural remedies at the same time,
• take too high doses of gliclazide,
• suffer from particular hormone-induced disorders (Functional disorders of the thyroid
gland, of the pituitary gland or adrenal cortex),
• 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
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.
Symptom 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 (those acting on the central nervous system and ß-blockers).
Symptoms of high blood sugar (Hypeglycaemia) 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 or in special stress situations. These may include thirst, frequent
urination, dry mouth, dry itchy skin, skin infections and reduced performance.
If these symptoms occurred you must contact your doctor or pharmacist.
While taking this medicine 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 taken any other medicines,
including medicines obtained without a prescription, as they may interact with your tablet.
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. sulphonamides, chloramphenicol)
• 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 antirheumatics (phenylbutazone, ibuprofen),
• medicines containing alcohol.
The blood sugar 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).
1216242-V2

Gliclazide 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.
Taking Gliclazide Tablets with food, drink and alcohol
Gliclazide Tablets 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
Do not take this medicine if you are pregnant, thinking of becoming pregnant or
breast-feeding. Tell your doctor if you are taking Gliclazide tablets and are breastfeeding or
planning to breast-feed your baby.
Driving and using machines
Provided your blood glucose levels are satisfactorily controlled on this medicine, 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).
3. How to take Gliclazide Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
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.
Gliclazide Tablets should be taken orally with food, either with breakfast or the first main
meal of the day. The usual dosage is as follows:
Adults and Elderly: The usual starting dose is 40 to 80mg (½ or 1 tablet) daily, adjusted
according to your response, up to a maximum of 320mg (four tablets) daily. Up to 160mg
(two tablets) can be taken at one time.
Your starting dose will be reduce if you are elderly or have liver or kidney problems.
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.
Children: Gliclazide is not recommended for use in children.
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
If you forget to take a dose, do not worry, just wait until it is time for your next dose. Do not
take a double dose to make up for a forgotten tablet.
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 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
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea and
constipation. These effects are reduced when Gliclazide is taken with a meal as
recommended.
Skin disorders: Skin reactions such as rash, redness, itching, hives, 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. These symptoms usually stop 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 drug 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.
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 (e.g.
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 of the side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet (See section 4).
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 out of sight and reach of children.
Do not use your medicine after the expiry date stated on the label. The expiry date refers to
the last day of that month. Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist to dispose of medicines no longer required. These measures will help to 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, silicon dioxide, pregelatinised maize
starch, talcand magnesium stearate.
What Gliclazide Tablets looks like and contents of the pack
Gliclazide 80mg tablets are white, round tablets scored on one side with G80 on the other
side.
The registered pack sizes are 28 and 60 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

NOUMED LIFE SCIENCES LIMITED

Noumed House, Shoppenhangers Road
Maidenhead, Berkshire, SL6 2RB, United Kingdom.

Gliclazide 80mg Tablets - PL 44041/0022

Manufacturer:
MEDREICH PLC

Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
E-mail : info@medreich.co.uk

This leaflet was last revised in January 2017
1216242-V2

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide