Drug Ingredient Information
PIOGLITAZONE-15MG+GLIMEPIRIDE-2MG
PIOGLITAZONE
| Information for
patients
|
| Drug Information |
PIOGLITAZONE is a tablet that is used to improve the action of the body?s naturally produced insulin. It is used in the management of type 2 diabetes not controlled by diet. It helps to control the level of glucose in your blood when you have type 2 diabetes. This is the „adult onset? type of diabetes and is controlled by diet, certain oral medications and occasionally insulin.
This medicine is available as pioglitazone hydrochloride and belongs to a group of medicines called glitazones. Glitazones decrease insulin resistance.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
PIOGLITAZONE can be used alone (when diet and exercise is not enough to treat your diabetes) or together with other anti-diabetic medicines.
This medicine is available only with a doctor?s prescription.
The use of PIOGLITAZONE has not been studied in children. |
| Drug Alert |
| Alert |
no data available |
| Before Consuming
the Medicine
|
| Avoid Drug |
Do not take PIOGLITAZONE if you have:
heart failure requiring treatment. Talk to your doctor if you have heart failure
type 1 diabetes or diabetic ketoacidosis (often caused by very high blood glucose levels)
an allergy to any medicine containing pioglitazone hydrochloride or any of the ingredients listed in the contents.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Do not take this medicine after the date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor. |
| Drug Special Care |
Before you start to take it
• Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
• Tell your doctor if you have or have had any of the following medical conditions:
• heart disease with shortness of breath after minimal physical activity
• heart disease with severe symptoms at rest
• swelling of hands, ankles or feet
• problems with your liver
• problems with your kidneys that requires dialysis. PIOGLITAZONE is not recommended for use if you are on dialysis
• some women who do not have monthly periods and have not been through menopause may restart their periods when taking PIOGLITAZONE. These women may be at increased risk of pregnancy
• bone fractures, usually in the hand, upper arm or foot, have been seen in some women when taking PIOGLITAZONE. Talk to your doctor for advice on how to keep your bones healthy.
• Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.Things you must do
It is important that you remember to take PIOGLITAZONE daily and at the dose prescribed by your doctor.
Tell any other doctors, dentists and pharmacists who treat you that you are taking PIOGLITAZONE.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking PIOGLITAZONE.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Tell your doctor if you have gained weight since taking PIOGLITAZONE. Weight gain can be associated with improved blood sugar control however; it may also be a symptom of heart failure.
Things you must not do
Do not take PIOGLITAZONE to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if their symptoms seem similar to yours or they have the same condition as you. |
| Drug Drug Interactions |
Tell your doctor if you are using another medicine for diabetes. PIOGLITAZONE can enhance the action of other medicines. You may be at risk of low blood sugar (hypoglycaemia).
If this happens, your doctor may need to adjust the dose of your other medicines.
Tell your doctor if you suffer from lactose intolerance (because PIOGLITAZONE tablets contain lactose).
If you have not told your doctor about any of the above, tell him/her before you start taking PIOGLITAZONE.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and PIOGLITAZONE may interfere with each other. These include:
chlorpropamide
gemfibrozil
glibenclamide
gliclazide
insulin
metformin
oral contraceptives
rifampicin
tolbutamide
These medicines may be affected by PIOGLITAZONE or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking this medicine. |
| Drug Pregnancy Interaction |
It is not recommended for use during pregnancy. If there is a need to consider PIOGLITAZONE during your pregnancy, your doctor will discuss with you the benefits and risks of taking PIOGLITAZONE. |
| Drug Breast feeding Interaction |
It is recommended that you do not breast-feed while taking PIOGLITAZONE, as it is not known whether this drug passes into breast milk. |
| Drug Machinery Interaction |
PIOGLITAZONE alone is unlikely to affect your ability to drive or operate machinery. However, be careful to avoid hypoglycaemia whilst driving or operating machinery if using PIOGLITAZONE combination with other diabetes medicines. |
| Drug More Information |
no data available |
| How to take the
Medicine
|
| Consumption Info |
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the carton, ask your doctor or pharmacist for help. |
| Drug quanitty |
Your doctor will tell you how many PIOGLITAZONE tablets you should take. The dose your doctor will prescribe for you will usually be in the range of 15 mg to 45 mg per day.
PIOGLITAZONE tablets should be taken once a day as advised by your doctor. Your doctor may increase or decrease your dose in order to find the appropriate dose for your condition. |
| Drug Dose |
PIOGLITAZONE tablets should be swallowed whole with a glass of water.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
It does not matter if you take this medicine before or after food.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well. |
| Excess Drug Consumption |
Immediately telephone your doctor or the Poisons Information Centre or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much PIOGLITAZONE. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention. |
| Forgot Drug Consumption |
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do NOT take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints. |
| Stop Drug Consumption |
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects. |
| Possible Side
Effects
|
| General Information |
Tell your doctor or pharmacist as soon as possible if you experience any undesirable effect or feel unwell while you are taking PIOGLITAZONE.
This medicine helps most people with type 2 diabetes not controlled by diet, but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Some side effects may be related to the dose of PIOGLITAZONE. Accordingly, it is important that you tell your doctor as soon as possible about any unwanted effects. Your doctor may then decide to adjust the dose of PIOGLITAZONE you are taking.
Do not be alarmed by the following list of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have. |
| Common Drug Side Effects |
A few patients have experienced the following side effects whilst taking PIOGLITAZONE:
a small increase in weight
low blood sugar levels (hypoglycaemia). This occurs more often when PIOGLITAZONE is taken with a sulfonylurea or insulin
heart failure which may show as localised swelling of the ankles, feet and hands (oedema) and/or fluid in the lungs (pulmonary oedema). This has been reported in clinical trials mainly in patients who are taking PIOGLITAZONE in combination with insulin
increased risk of fracture in women
macular oedema (an eye disorder that can affect vision)
altered or impaired liver function. |
| Rare Drug Side Effects |
dark urine or pale stools, yellowing of the skin or eyes, severe cramps of the stomach, nausea or vomiting, loss of weight, tiredness
shortness of breath when at rest or after minimal physical activity with swelling of legs, feet and hands, rapid increase in weight
The above list includes serious side effects, which may require medical attention. Serious side effects are rare. |
| Very Rare Drug Side Effects |
no data available |
| Drug Side Effects Symptoms |
weight gain
signs of hypoglycaemia which may include weakness, trembling or shaking, sweating, light-headedness, headache, dizziness, lack of concentration, tearfulness or crying, irritability, hunger, numbness around the lips and fingers
eye problems including blurred or double vision. |
| How to Store the
Medicine
|
| How to Store the Medicine |
Storage
Keep your tablets in the aluminium blister pack until it is time to take them.
Keep your tablets in a cool, dry place where the temperature stays below 30 degree celcius.
Do not store PIOGLITAZONE or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking PIOGLITAZONE or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over. |
GLIMEPIRIDE
| Information for
patients
|
| Drug Information |
Glimepiride is a medicine taken by mouth to help lower blood
sugar. It belongs to a group of medicines called
sulfonylureas.
Glimepiride works by increasing the amount of insulin released
from your pancreas. The insulin then lowers your blood
sugar levels.
What Glimepiride is used for:
• Glimepiride is used to treat a certain form of diabetes (type 2
diabetes mellitus) when diet, physical exercise and weight
reduction alone have not been able to control your blood
sugar levels |
| Drug Alert |
| Alert |
You are allergic (hypersensitive) to: Glimepiride or other
sulfonylureas (medicines used to lower your blood
sugar such as glibenclamide) or sulfonamides
(medicines for bacterial infections such as
sulfamethoxazole) or any of the other ingredients of
Glimepiride (listed in Section 6 What Glimepiride contains)
• You have insulin dependent diabetes (type 1 diabetes
mellitus) |
| Before Consuming
the Medicine
|
| Avoid Drug |
You are allergic (hypersensitive) to: Glimepiride or other
sulfonylureas (medicines used to lower your blood
sugar such as glibenclamide) or sulfonamides
(medicines for bacterial infections such as
sulfamethoxazole) or any of the other ingredients of
Glimepiride (listed in Section 6 What Glimepiride contains)
• You have insulin dependent diabetes (type 1 diabetes
mellitus)
• You have diabetic ketoacidosis (a complication of diabetes
when your acid level is raised in your body and you may
have some of the following signs: fatigue, feeling sick
(nausea), frequent urination and muscular stiffness)
• You are in a diabetic coma
• You have severe kidney disease
• You have a severe liver disease
Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist
before taking Glimepiride |
| Drug Special Care |
Check with your doctor or pharmacist before taking
your medicine if:
• You are recovering from an injury, operation, infections
with fever, or from other forms of stress, inform your
doctor as temporary change of treatment may be
necessary
• You have a severe liver or kidney disorder
If you are not sure if any of these apply to you, talk to
your doctor or pharmacist before taking Glimepiride.
Lowering of the haemoglobin level and breakdown of red
blood cells (haemolytic anemia) can occur in patients
missing the enzyme glucose-6-phosphate dehydrogenase.
The information available on the use of Glimepiride in people
under 18 years of age is limited. Therefore, its use in
these patients is not recommende |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Your doctor may wish to change your dose of Glimepiride if
you are taking other medicines, which may weaken or
strengthen the effect of Glimepiride on the level of sugar in
your blood.
The following medicines can increase the blood sugar
lowering effect of Glimepiride. This can lead to a risk of
hypoglycaemia (low blood sugar):
• Other medicines to treat diabetes mellitus (such as
insulin or metformin)
• Medicines to treat pain and inflammation
(phenylbutazone, azopropazone, oxyphenbutazone,
aspirin-like medicines)
• Medicines to treat urinary infections (such as some long
acting sulfonamides)
• Medicines to treat bacterial and fungal infections
(tetracyclines, chloramphenicol, fluconazole,
miconazole, quinolones, clarithromycin)
• Medicines to inhibit blood clotting (coumarin
derivatives such as warfarin)
• Medicines supporting muscle build up (anabolics)
• Medicines used for male sex hormone replacement
therapy
• Medicines to treat depression (fluoxetine, MAO-
inhibitors)
• Medicines lowering high cholesterol level (fibrates)
• Medicines lowering high blood pressure (ACE inhibitors)
• Medicines called anti-arrhythmic agents used to control
abnormal heart beat (disopyramide)
• Medicines to treat gout (allopurinol, probenecid,
sulfinpyrazone)
• Medicines to treat cancer (cyclophosphamide,
ifosfamide, trofosfamide)
• Medicines used to reduce weight (fenfluramine)
• Medicines to increase circulation when given in a high
dose intravenous infusion (pentoxifylline)
• Medicines to treat nasal allergies such as hay fever
(tritoqualine)
• Medicines called sympatholytics to treat high blood
pressure, heart failure, or prostate symptoms
The following medicines may decrease the blood sugar
lowering effect of Glimepiride. This can lead to a risk of
hyperglycaemia (high blood sugar level):
• Medicines containing female sex hormones (oestrogens,
progestogens)
• Medicines to treat high blood pressure called thiazide
diuretics (water tablets)
• Medicines used to stimulate the thyroid gland (such as
levothyroxine)
• Medicines to treat allergies and inflammation
(glucocorticoids)
• Medicines to treat severe mental disorders
(chlorpromazine and other phenothiazine derivatives)
• Medicines used to raise heart beat, to treat asthma or
nasal congestion, coughs and colds, used to reduce
weight, or used in life-threatening emergencies
(adrenaline and sympathomimetics)
• Medicines to treat high cholesterol level (nicotinic acid)
• Medicines to treat constipation when they are used long
term (laxatives)
• Medicines to treat fits (phenytoin)
• Medicines to treat nervousness and sleep problems
(barbiturates)
• Medicines to treat increased pressure in the eye
(azetazolamide)
• Medicines to treat high blood pressure or lowering
blood sugar (diazoxide)
• Medicines to treat infections, tuberculosis (rifampicine)
• Medicines to treat severe low blood sugar levels
(glucagon)
The following medicines can increase or decrease the
blood sugar lowering effect of Glimepiride:
• Medicines to treat stomach ulcers (called H2
antagonists)
• Medicines to treat high blood pressure or heart failure
such as beta-blockers, clonidine, guanethidine and
reserpine. These can also hide the signs of
hypoglycaemia, so special care is needed when taking
these medicines
Glimepiride may either increase or weaken the effects of the
following medicines:
• Medicines inhibiting blood clotting (coumarin
derivatives such as warfarin) |
| Drug Pregnancy Interaction |
Glimepiride should not be taken during pregnancy. Tell your
doctor if you are, you think you might be or are planning
to become pregnant |
| Drug Breast feeding Interaction |
Glimepiride may pass into breast milk. Glimepiride should not be
taken during breast feeeding.
Ask your doctor or pharmacist for advice before taking
any medicine |
| Drug Machinery Interaction |
your blood sugar is lowered (hypoglycaemia), or raised
(hyperglycaemia) or if you develop visual problems as a
result of such conditions. Bear in mind that you could
endanger yourself or others (e.g. when driving a car or
using machines). Please ask your doctor whether you can
drive a car if you:
• have frequent episodes of hypoglycaemia,
• have fewer or no warning signals of hypoglycaemia |
| Drug More Information |
Important information about hypoglycaemia (low
blood sugar)
When you take Glimepiride, you may get hypoglycaemia (low
blood sugar). Please see below for additional information
about hypoglycaemia, its signs and treatment.
Following factors could increase the risk of you
getting hypoglycaemia:
• Undernourishment, irregular meal time, missed or
delayed meal or period of fasting
• Changes to your diet
• Taking more Glimepiride than needed
• Having kidneys that do not work properly
• Having severe liver disease
• If you suffer from particular hormone-induced
disorders (disorders of the thyroid glands, of the
pituitary gland or adrenal cortex)
• Drinking alcohol (especially when you skip a meal)
• Taking certain other medicines (See Taking other
medicines below)
• If you increase the amount of exercise you do and you
don''t eat enough food or eat food containing less
carbohydrate than usual.
Signs of hypoglycaemia include:
• Hunger pangs, headache, nausea, vomiting,
sluggishness, sleepiness, problems sleeping,
restlessness, aggression, problems with concentration,
reduced alertness and reaction time, depression,
confusion, problems with your speech and
sight, slurred speech, shakiness, partial
paralysis, dizziness, helplessness
• The following signs may also occur: sweating, clammy
skin, anxiety, fast or increased heart beat, high blood
pressure, awareness of your heart beat, sudden strong
pain in the breast that may radiate into neighbouring
areas (angina pectoris and cardiac arrhythmias)
If blood sugar levels continue to drop you may suffer
from considerable confusion (delirium), develop fits,
lose self control, breathing may be shallow and your
heart beat slowed down, you may fall into
unconsciousness. The clinical picture of a severe
reduced blood sugar level may resemble that of a
stroke.
Treating hypoglycaemia:
In most cases the signs of reduced blood sugar vanish
very quickly when you consume some form of sugar,
e.g. sugar cubes, sweet juice, sweetened tea.
You should therefore always take some form of sugar
with you (e.g. sugar cubes). Remember that artificial
sweeteners are not effective. Please contact your doctor
or go to the hospital if taking sugar does not help or if
the symptoms recur.
Laboratory Tests
The level of sugar in your blood or urine should be
checked regularly. Your doctor may also take blood tests
to monitor your blood cell levels and liver function. |
| How to take the
Medicine
|
| Consumption Info |
Glimepiride contains lactose. If you have been told by your
doctor that you cannot tolerate some sugars, contact your
doctor before taking this medicinal product.
Alcohol intake may increase or decrease the blood sugar
lowering action of Glimepiride in an unpredictable way. |
| Drug quanitty |
The dose of Glimepiride depends on your needs, condition
and results of blood and urine sugar tests and is
determined by your doctor. Do not take more tablets
than your doctor has prescribed.
• The usual starting dose is one Glimepiride 1 mg tablet once
a day
• If necessary, your doctor may increase the dose after
each 1 - 2 weeks of treatment
• The maximum recommended dose is 6 mg Glimepiride per day
• A combination therapy of glimepiride plus metformin
or of glimepiride plus insulin may be started. In such a
case your doctor will determine the proper doses of
glimepiride, metformin or insulin individually for you
• Your dose of Glimepiride may need to be adjusted if you
change weight, change your lifestyle, or if you are
under a lot of stress. Please speak to your doctor if any of these situations apply to you
• If you feel the effect of your medicine is too weak or
too strong do not change the dose yourself, but ask
your doctor |
| Drug Dose |
• Take this medicine by mouth, just before or with the
first main meal of the day (usually breakfast). If you do
not have breakfast you should take the product on
schedule as prescribed by your doctor. It is important
not to leave out any meal when you are on Glimepiride
• Swallow the tablets whole with at least half glass of
water. Do not crush or chew the tablets |
| Excess Drug Consumption |
If you happen to have taken too much Glimepiride or an
additional dose there is a danger of hypoglycaemia (signs
of hypoglycaemia see Section 2 - Take special care with
Glimepiride) and therefore you should instantly consume
enough sugar (e.g. a small bar of sugar cubes, sweet
juice, sweetened tea) and inform a doctor immediately.
When treating hypoglycaemia due to accidental intake in
children, the quantity of sugar given must be carefully
controlled to avoid the possibility of producing dangerous
hyperglycaemia. Persons in a state of unconsciousness
must not be given food or drink.
Since the state of hypoglycaemia may last for some time
it is very important that the patient is carefully
monitored until there is no more danger. Admission into
hospital may be necessary, also as a measure of
precaution. Show the doctor the package or remaining
tablets, so the doctor knows what has been taken.
Severe cases of hypoglycaemia accompanied by loss of
consciousness and coma are cases of medical emergency
requiring immediate medical treatment and admission
into hospital. It may be helpful to tell your family and
friends to call a doctor immediately if this happens to
you |
| Forgot Drug Consumption |
If you forget to take a dose, do not take a double dose to
make up for forgotten doses |
| Stop Drug Consumption |
If you interrupt or stop the treatment you should be
aware that the desired blood sugar lowering effect is not
achieved or that the disease will get worse again. Keep
taking Glimepiride until your doctor tells you to stop. |
| Possible Side
Effects
|
| General Information |
• Allergic reactions (including inflammation of blood
vessels, often with skin rash) which may develop into
serious reactions with difficulty in breathing, fall in
blood pressure and sometimes progressing to shock
• Abnormal liver function including yellowing of the skin
and eyes (jaundice), problems with the bile flow
(cholestasis), inflammation of the liver (hepatitis) or
liver failure
• Allergy (hypersensitivity) of the skin such as itching,
rash, hives and increased sensitivity to sun.
Some mild allergic reactions may develop into serious reactions
• Severe hypoglycaemia including loss of consciousness,
seizures or coma
Some patients experienced the following side effects
whilst taking |
| Common Drug Side Effects |
• Allergy (hypersensitivity) of the skin may occur such as
itching, rash, hives and increased sensitivity to sun.
Some mild allergic reactions may develop into serious
reactions with swallowing or breathing problems,
swelling of your lips, throat or tongue. Therefore in the
event of one of these side effects, tell your doctor
immediately
• Allergic reactions with sulfonylureas, sulfonamides, or
related drugs may occur
• Problems with your sight may occur when beginning
treatment with Glimepiride. This is due to changes in blood
sugar levels and should soon improve
• Increased liver enzymes
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist |
| Rare Drug Side Effects |
• Lower blood sugar than normal (hypoglycaemia)
(See Section 2 - Take special care with Glimepiride)
• Decrease in the number of blood cells:
• Blood platelets (which increases risk of bleeding or
bruising)
• White blood cells (which makes infections more likely)
• Red blood cells (which can make the skin pale and
cause weakness or breathlessness)
These problems generally get better after you stop taking
Glimepiride |
| Very Rare Drug Side Effects |
• Allergic reactions (including inflammation of blood
vessels, often with skin rash) which may develop into
serious reactions with difficulty in breathing, fall in
blood pressure and sometimes progressing to shock. If
you experience any of these symptoms, tell your
doctor immediately
• Abnormal liver function including yellowing of the skin
and eyes (jaundice), impairment of the bile flow
(cholestasis), inflammation of the liver (hepatitis) or
liver failure. If you experience any of these symptoms,
tell your doctor immediately
• Feeling or being sick, diarrhoea, feeling full or bloated,
and abdominal pain
• Decrease in the amount of sodium level in your blood
(shown by blood tests) |
| Drug Side Effects Symptoms |
|
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep out of the reach and sight of children.
Do not use Glimepiride after the expiry date which is stated
after ‘EXP’ on the blister and carton. The expiry date
refers to the last day of that month.
Glimepiride 1 mg, 2 mg, 3 mg, and 4 mg tablets: do not store
above 30°C.
Store in the original package in order to protect from moisture Do not use Glimepiride if you notice visible signs of
deterioration.
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. |
|
Substitute Drugs
|
Sign In
Create New Account