Module

Module 1.3.3
Package Leaflet

Glimepiride
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What is Glimepiride and what it is used for
2. Before you take Glimepiride
3. How to take use Glimepiride
4. Possible side effects
5 Storing Glimepiride
Glimepiride Tablets
Glimepiride
- The active substance is glimepiride
- The other ingredients are Lactose, Starch, Talcum, Magnesium Stearate and Colour Red

Marketing Authorisation Holder and Manufacturer
1. WHAT IS GLIMEPIRIDE AND WHAT IT IS USED FOR

This medicine contains glimepiride. Glimepiride is one of a group of medicines called
sulphonylurea hypoglycaemics. These medicines work by helping control blood sugar
(glucose) levels.
Glimepiride is used with diet and exercise to treat type 2 diabetes (condition in which the
body does not use insulin normally and therefore cannot control the amount of sugar in
the blood). Glimepiride stimulates your pancreas to make more insulin and also makes
your body more sensitive to insulin. Glimepiride may be used with or without insulin.

2. BEFORE YOU TAKE GLIMEPIRIDE
Do not take Glimepiride if you:
- have ever had an allergic reaction to glimepiride, other sulphonylureas (e.g.
glibenclamide, gliclazide, tolbutamide) or sulphonamides (e.g. sulfamethoxazole). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue - have type 1 insulin dependent diabetes
- have been told by your doctor that you have 'ketoacidosis' (your breath may smell
- have severe kidney or liver problems

Inform your doctor what prescription and nonprescription medications you are taking,
especially other antidiabetics, antibiotics, anticoagulants ('blood thinners') such as
warfarin (Coumadin), dexamethasone, diuretics ('water pills'), estrogens, isoniazid (INH),
MAO inhibitors (phenelzine, tranylcypromine), medications for high blood pressure or
heart disease, niacin, oral contraceptives, phenytoin, prednisone, probenecid and
vitamins.
It is important to take regular meals at regular times of the day whilst taking treatment
with these tablets. Skipping or taking irregular meals whilst taking glimepiride tablets
may lead to hypoglycaemia (low blood sugar). You are advised NOT to drink alcohol
with this medicine. Discuss this with your doctor if you have any questions.
Pregnancy and Breast-feeding
Tell your doctor if you are pregnant or planning a family. Your doctor will probably
change your treatment.
Remind your doctor if you are pregnant and diabetic as your blood glucose levels must be
closely monitored.
You should not breast-feed your baby whilst taking Glimepiride.

Your ability to concentrate and react may be impaired as a result of hypoglycaemia (low
blood sugar) or hyperglycaemia (high blood sugar). This may constitute a risk in
situations where these abilities are of special importance (e.g. driving a car or operating
machinery). You are advised to take precautions to avoid hypoglycemia while driving or
operating machinery.
3. HOW TO TAKE GLIMEPIRIDE
Glimepiride comes as tablets to be taken by mouth. It is usually taken once a day. The
tablet should be taken with breakfast or the first big meal of the day. Follow the directions
on your prescription label carefully, and ask your doctor or pharmacist to explain any part
you do not understand. Take this medicine exactly as directed. Do not take more or less of
it or take it more often than prescribed by your doctor.
Continue to take Glimepirid even if you feel well. Do not stop taking this medicine
without talking to your doctor.
If you have the impression that the effect of this medicine is too strong or too weak, talk
to your doctor or pharmacist.

If you take more of this medicine than you should:
If you (or someone else) swallow a lot of the tablets at the same time, or if you think a
child has swallowed any of the tablets, contact your nearest hospital casualty department
or your doctor immediately.
If you forget to take this medicine

Take the missed dose as soon as you remember it. If you will be having a snack soon,
take a dose with the snack. If it is almost time for the next dose, skip the missed dose and
continue your regular dosing schedule. Do not take a double dose to make up for a missed
one.

4. POSSIBLE SIDE EFFECTS

Like all medicines, glimepiride can have side effects.
This medication may cause changes in your blood sugar. You should know the symptoms
of low and high blood sugar and what to do if you have these symptoms.
You may experience hypoglycemia (low blood sugar) while you are taking this
medication. Your doctor will tell you what you should do if you develop hypoglycemia.
He or she may tell you to check your blood sugar, eat or drink a food or beverage that
contains sugar, such as hard candy or fruit juice, or get medical care. Follow these
directions carefully if you have any of the following symptoms of hypoglycemia:
- shakiness
- dizziness or lightheadedness
- sweating
- nervousness or irritability
- sudden changes in behavior or mood
- headache
- numbness or tingling around the mouth
- weakness
- pale skin
- hunger
- clumsy or jerky movements
If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family,
friends, and other people who spend time with you know that if you have any of the
following symptoms, they should get medical treatment for you immediately.
- confusion
- seizures
- loss of consciousness
Call your doctor immediately if you have any of the following symptoms of
hyperglycemia (high blood sugar):
- extreme thirst
- frequent urination
- extreme hunger
- weakness
- blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic
ketoacidosis could develop. Call your doctor immediately if you have any of the these
symptoms:
- dry mouth
- upset stomach and vomiting
- shortness of breath
- breath that smells fruity
- decreased consciousness
Glimepiride may cause other side effects. Call your doctor if you have any unusual
problems while taking this medication.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or
pharmacist.

5. STORING GLIMEPIRIDE
Keep out of the reach and sight of children.
Do not store above 30°C
Store in the original package
Do not use after the expiry date stated on the strip

Source: http://creativeconsultantsindia.com/Package%20Leaflet.pdf

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