Indications
- Lozide is a medicine that reduces
blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea
group). Lozide 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 Lozide: Tell
your doctor or pharmacist if you are taking or have recently taken any other
medicines.
The blood sugar lowering effect
of Lozide 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 Lozide 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
Lozide especially in elderly patients.
Lozide 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 Lozide.
Lozide with food and drink:
Lozide 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)
Lozide 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, Lozide 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 Lozide 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
Lozide. 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 Lozide 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
Lozide,
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 Lozide 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 Lozide 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.
Lozide 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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