GLIBENCLAMIDE 5MG TABLETS BP

Active substance: GLIBENCLAMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Glibenclamide 2.5mg Tablets
Glibenclamide 5mg Tablets
(Glibenclamide)
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 any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Glibenclamide Tablets are and what they are used for
2. Before you take Glibenclamide Tablets
3. How to take Glibenclamide Tablets
4. Possible side effects
5. How to store Glibenclamide Tablets
6. Further information
1. WHAT GLIBENCLAMIDE TABLETS ARE AND WHAT THEY ARE
USED FOR
Glibenclamide belongs to a group of medicines known as oral hypoglycaemics
which are used for the treatment of diabetics who do not need insulin but who
need more than just diet to control their diabetes.
2. BEFORE YOU TAKE GLIBENCLAMIDE TABLETS
Do not take Glibenclamide Tablets:
• If you are allergic (hypersensitive) to Glibenclamide
• If you have severe liver or kidney problems
• If you have severe thyroid or adrenal gland problems
• If you have ever had a diabetic coma
• When you are under unusual stress such as surgery, trauma or severe infection
Take special care with Glibenclamide Tablets:
When you are about to do strenuous exercise as this medicine can cause blood
sugar levels to get too low, known as “hypoglycaemia”. Early warning symptoms
of low blood sugar include faintness, sweating, trembling, confusion or headache.
You will need to eat and drink something sugary quickly.
Ask your doctor for more information about the symptoms of hypoglycaemia
and what you should do if it happens. It is important that relatives and close
workmates know that you have diabetes and are taking medication so that they
can recognize the symptoms of hypoglycaemia and help if necessary.

Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
The dose of Glibenclamide may need to be reduced if you are taking the following:
• drugs which are used to treat infections e.g. fluconazole, sulphonamides
• pain killers e.g. aspirin, phenylbutazone
• blood thinning agents e.g. heparin
• cholesterol lowering agents e.g. clofibrate
• anti-depressants e.g. MAOIs, nortriptyline
• drugs for high blood pressure and heart failure e.g. captopril, enalapril
• medicines for stomach ulcers and dyspepsia e.g. cimetidine, ranitidine
• drugs for obesity and gout
The dose of Glibenclamide may need to be increased if you are taking the
following:
• rifampicin.
• tablets for getting rid of water in the body.
• drugs for high blood pressure and heart trouble.
• some products purchased at the chemists may have a high sugar content
which may raise blood sugar levels.
Taking Glibenclamide Tablets with food and drink:
Glibenclamide should be taken with or immediately after food.
Alcohol may cause flushes in some patients and can affect the levels of sugar in
your blood.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, planning to become pregnant or breastfeeding.
Do not breastfeed whilst on Glibenclamide Tablets without advice from your
doctor.
Effects on the ability to drive and use machines:
If you experience the symptoms of low blood sugar (hypoglycaemia) you should
not drive or operate machinery. Low blood sugar may occur at the beginning of
treatment while your doctor is trying to find the dose that bests suits you. Your
doctor will give you further advice. When your blood sugar is stabilized you may
drive or operate machinery.
Important information about some of the ingredients of Glibenclamide
Tablets
These tablets contain lactose so take care if you have been told by your doctor
that you have intolerance to some sugars such as lactose.

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3. HOW TO TAKE GLIBENCLAMIDE TABLETS

- Stomach upsets such as nausea, vomiting, abdominal pain, diarrhoea, loss of
appetite or a metallic taste. Taking doses with food may reduce these problems.

Always take Glibenclamide Tablets exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

They often get better spontaneously so you should continue to take the tablets
unless your stomach is upset and shows no sign of getting better after a few days.
- Increased appetite and weight gain
- decrease in the amount of sodium level in your blood (shown by blood tests)
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.

These tablets should be taken orally once a day with or immediately after breakfast
or the first main meal of the day.
The usual starting dose for Glibenclamide is 2.5 – 5mg which can be increased
if necessary. Your doctor will decide the dose which is best for you.
You should continue to take these tablets for as long as your doctor tells you to.

5. HOW TO STORE GLIBENCLAMIDE TABLETS

If you take more Glibenclamide than you should
If you accidentally take too many Glibenclamide Tablets seek immediate medical
advice by contacting your doctor or nearest hospital casualty department.

Keep out of the reach and sight of children.

If you forget to take Glibenclamide Tablets

The expiry date refers to the last day of the month.

If you forget to take a dose, take the missing dose as soon as you remember, with
your next meal. If it is time for the next dose do not double the dose to make
up for the one you missed.

These tablets should not be stored above 25°C and should be kept in their original
container to protect them from light and moisture.

If you stop taking Glibenclamide Tablets
Do not stop taking this medicine without consulting your doctor or pharmacist.

Do not use your medicine after the expiry date shown on the label.

Medicines should not be disposed of via wastewater or household water. Ask
your pharmacist how to dispose of medicines no longer required. These measures
will help protect the environment.
6. FURTHER INFORMATION

If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

What Glibenclamide Tablets contain:

4. POSSIBLE SIDE EFFECTS

The active substance is Glibenclamide.

Like all medicines Glibenclamide Tablets can cause some side effects although
not everybody gets them.
If the following happens, stop taking this medicine and tell your doctor immediately
or go to the casualty department at your nearest hospital:
- 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 reaction,
which causes severe blistering of the skin, mouth, eyes and genitals.
- Severe hypoglycameia including loss of consciousness, seizures or coma. Some
patients experienced the following side effects whilst taking this medicine. Tell
your doctor if you experience any of the following symptoms:
Rare side effects (affects more than 1 patient in 10,000 and less than 1 patient
in 1000 people)
- Lower blood sugar than normal (hypoglycaemia) (See Section 2 - Take special
care with Glibenclamide)
- Decrease in the number of blood cells:
- Blood platelets (which makes infections more likely)
- Red blood cells (which can make the skin pale and cause weakness or
breathlessness)
Very rare (affects less than 1 patient in 10,000)

The 2.5mg tablet contains 2.5mg of glibenclamide and the 5.0mg tablet contains
5.0mg glibenclamide.
The other ingredients are lactose, maize starch, povidone K30 and magnesium
stearate.
What Glibenclamide Tablets look like and the contents of the pack:
Glibenclamide 2.5mg Tablets are white, circular tablets marked CP on one face
and GL2.5 on the other.
The registered pack sizes are 10, 14, 28, 100, 500 and 1000 tablets.
Glibenclamide 5mg Tablets are white, capsule-shaped tablets marked CP on one
face and GL5 on either side of a breakline, on the other face.
The registered pack sizes are 28, 100, 500 and 1000 tablets.
Marketing Authorization Holder and Manufacturer
Aurobindo Pharma Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom
PL 20532/0079

POM

PL 20535/0080
This leaflet was last approved in {08/2011}.
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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.

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