Indications
- Radizid XR is a medicine that reduces blood sugar levels
(oral antidiabetic medicine belonging to the sulphonylurea group). Radizid XR
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.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Pharmacology
- Gliclazide is a second generation sulfonylurea drug that has
hypoglycaemic and potentially useful hematological properties. It stimulates
the release of insulin from pancreatic β-cells by facilitating Ca+2 transport across the β-cell membranes and
decreases hepatic glucose output.
Dosage & Administration
- Film-coated tablet: The usual initial dose is 40 to 80 mg
daily. The dose can be increased up to 320 mg daily in divided doses when
needed. The drug should be taken before meal. For children, Gliclazide is not
used because it is contraindicated in juvenile-onset diabetes.
- Modified release preparation: 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, lifestyle, stress) or improvements in the blood sugar
control may require changed gliclazide doses.
- 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. Gliclazide MR tablet is 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 whole tablet(s) in one piece. Do not chew or crush. You must
always eat a meal after taking your tablet(s).
- 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.
- 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). 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 Gliclazide tablet: It is important to
take your medicine every day as regular treatment works better. However, if you
forget to take a dose of Gliclazide MR tablet, 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 Gliclazide MR tablet: As the treatment
for diabetes is usually lifelong, 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 product, ask
your doctor or pharmacist.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Interaction
Other medicines and Radizid XR: Tell your doctor or
pharmacist if you are taking or have recently taken any other medicines.
The blood sugar lowering effect of Radizid XR may be
strengthened and signs of low blood sugar levels may occur when one of the
follow ng medicines is taken:
other medicines used to treat high blood sugar (oral
antidiabetics, GLP-1 receptor agonists or insulin),
antibiotics (sulphonamides, 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 antirheumatics (phenylbutazone, ibuprofen)
medicines containing alcohol
The blood-glucose-lowering effect of Radizid XR 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)
St John's Wort- Hypericum perforatum- preparations
Blood glucose disturbance (low blood sugar and high blood sugar)
can occur when a medicine belonging to a class of antibiotics called
fluoroquinolones is taken at the same time as Radizid XR especially in elderly
patients.
Radizid XR may increase the effects of medicines that 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 Radizid XR.
Radizid XR with food and drink: Radizid XR 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.
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 (for
instance 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)
Radizid XR 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.
Contraindications
Do not take Gliclazide:
if you are allergic to gliclazide or to other medicines of
the same group (sulfonylurea), or 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 diabetic ketoacidosis), a diabetic pre-coma or coma
if you have severe kidney or liver disease
if you are taking medicines to treat fungal infections
if you are breastfeeding
Side Effects
Like all medicines, Radizid XR can cause side effects,
although not everybody gets them. The most commonly observed side effect is low
blood sugar (hypoglycaemia). 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.
Liver disorders: There have been isolated reports of
abnormal iiver 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 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) have been reported. Rash may progress to widespread blistering or
peeling of the skin. If you develop this, stop taking, seek urgent advice from
a doctor and tell him that you are taking this medicine. Exceptionally, signs
of severe hypersensitivity reactions 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 have been reported. These
symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting,
indigestion, diarrhoea, and constipation. These effects are reduced when
Radizid XR is taken with a meal as recommended.
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 another sulfonylurea, 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. This includes any possible side effects not
listed in this leaflet. By reporting side effects, you can help provide more
information on the safety of this medicine.
Pregnancy & Lactation
Gliclazide is 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
Gliclazide while you are breastfeeding.
Precautions & Warnings
Talk to your doctor before taking Radizid XR. You should
observe the treatment plan prescribed by your doctor to achieve proper blood
sugar levels. This means, apart from regular tablet intake, to observe the
dietary regimen, have physical exercise and, where necessary, reduce weight
During Radizid XR 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 Radizid XR,
if you suffer from particular hormone-induced disorders
(functional disorders of the thyroid gland, 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, 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 stressful 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
Radizid XR 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 or in special stress
situations. These may include thirst, frequent urination, dry mouth, dry itchy
skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold
sugar) can occur when Radizid XR is prescribed at the same time as medicines to
a class of antibiotics called fluoroquinolone, 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.
Radizid XR is not recommended for use in children due to
lack of data.
Therapeutic Class
Sulfonylureas
Storage Conditions
Keep out of the reach and sight of children. Do not use this
medicine after the expiry date which is stated on the carton and the blister.
The expiry date refers to the last day of that month. Store below 30°C.
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 to protect the environment.
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