Package Leaflet: Information for the User
Glibenclamide / Metformin HCl 1.25 mg / 500 mg tablet Glibenclamide / Metformin HCl 2.5mg / 500 mg tablet Glibenclamide / Metformin HCl 5 mg / 500 mg tablet
What is in this leaflet
1. What Glibenclamide / Metformin HCl is and what it is used for
2. What you need to know before you take Glibenclamide / Metformin HCl 3. How to take Glibenclamide / Metformin HCl
4. Possible side effects
5. How to store Glibenclamide / Metformin HCl
1. What Glibenclamide / Metformin HCl is and what it is used for
The combination Glibenclamide / Metformin HCl is used to lower blood sugar levels in patients with diabetes mellitus type 2 (non-insulin dependent). It is used after diet, exercise, and one medicine only have failed to control your diabetes.
Glibenclamide (also known as Glyburide) belongs to a group of anti-diabetics called sulfonylureas. It works by increasing the amount of insulin released from your pancreas.
Metformin belongs to a group of anti-diabetics called biguanides. It works by helping your body make better use of insulin.
General information
What is diabetes mellitus type 2
Diabetes mellitus type 2 is a chronic disease where your body is notable to make enough insulin and/or respond normally to insulin. Insulin is a hormone secreted by the pancreas that lower sugar (glucose) levels in the blood. When this happens, glucose builds up in the blood. This can lead to serious medical problems.
Diabetes can be managed with a proper diet and regular exercise. When these are not enough, medication is added to control your blood sugar levels.
2. What you need to know before you take Glibenclamide / Metformin HCl Do not take Glibenclamide / Metformin HCl
If you’re allergic to Metformin, Glibenclamide, other sulfonylureas, sulfonamides or any other component of this medicine.
If you have diabetes mellitus type 1 (insulin dependent)
If you have liver problems.
If you have lactic acidosis or diabetic ketoacidosis (very high blood sugar levels and you experience nausea, vomiting, frequent urination, fatigue and muscle weakness).
If you are dehydrated (lost too much water from your body due to long-lasting or severe diarrhea, or if you have vomited several times in a row).
If you have a severe infection, such as an infection affecting your lung or your kidney.
If you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation or have breathing difficulties.
If you are taking a medicine called Bosentan for high blood pressure.
If you drink a lot of alcohol. Warnings and precautions
Talk to your doctor about all your medical conditions before taking this medicine including:
If you are recovering from an injury, operation, infections with fever, or from other forms of stress.
If you have liver or kidney problems.
If you have any heart problems.
If you have a deficiency in an enzyme called glucose-6-phosphate dehydrogenase (G6PD). The medicine must be stopped a period of time before a major surgery. Talk to your doctor.
This medicine may cause a rare but serious side effect called lactic acidosis, particularly if your kidneys are not working properly. Symptoms include abdominal pain, vomiting, muscle cramps, severe fatigue, difficulty breathing, and reduced body temperature and heartbeat.
This medicine may cause low blood sugar levels (hypoglycemia) especially if you miss a meal, exercise more or drink alcohol. Symptoms include: nausea, hunger, shaking, dizziness, confusion, sleepiness, restlessness, difficulty speaking and sweating. You may take a sugar cube or some sweet juice to help it.
Other medicines and Glibenclamide / Metformin HCl
Tell your doctor about all the medicines you are taking.
Glibenclamide / Metformin HCl interacts a lot of with the following medicines:
Other medicines used to treat diabetes
Medicines use for high blood pressure
Medicines used to lower blood cholesterol
Certain antibiotics
Anti-fungals
Medicines to treat pain and inflammation (phenylbutazone, azopropazone, oxyphenbutazone, aspirin-like medicines)
Medicines to treat mood disorders
Phenytoin
Steroids
Digoxin
Anti-coagulants such as Warfarin
Birth control pills
Some medicines used for asthma and nasal congestion
Certain anti-virals
Some medicines used for cancer
Contrast dyes used for xray Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or breast-feeding. Driving and using machines
Avoid driving or operating machinery if you have symptoms of low blood sugar levels (hypolgycemia). 3. How to take Glibenclamide / Metformin HCl
This medicine is intended for adults only.
Take as indicated by your doctor.
Take with meals.
It is important to follow the diet and exercise plan set by your doctor. How much to take
The usual starting dose is Glibenclamide 1.25 – 2.5 mg / Metformin 500 – 1000 mg. it is given once or twice daily.
If you take Glibenclamide / Metformin HCl more than you should
If you take Glibenclamide / Metformin HCl more than you should you might be at risk of having low blood sugar levels (hypoglycemia) or lactic acidosis, a serious complication. Symptoms include vomiting, stomach pain, with muscle cramps, severe tiredness, and difficulty breathing.
If you know you have exceeded the recommended daily dose, contact your doctor, poison center or the hospital immediately.
If you forgot to take Glibenclamide / Metformin HCl
Take a missed dose as soon as you think about it, with a meal. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.
4. Possible side effects
Stop using this product and seek immediate medical help if you develop rash; hives; itching; red, swollen, blistered, or peeling skin; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. This medicine may cause low blood sugar levels (hypoglycemia). Symptoms include nausea, hunger, shaking, dizziness, confusion, sleepiness, restlessness, difficulty speaking and sweating. You may take a sugar cube or some sweet juice to help it. If you develop these signs contact your doctor.
Rarely, this medicine may cause a serious condition called lactic acidosis. Symptoms include vomiting, stomach upset, muscle cramps, severe tiredness, and difficulty breathing. If you experience some of these symptoms, you should seek immediately medical attention, as lactic acidosis may lead to coma. Serious side effects
Allergic reactions
Low blood sugar levels (hypoglycemia)
Lactic acidosis
Liver problems
Common side effects (may affect up to 1 in 10 people)
Diarrhea
Nausea
Vomiting
Rash
Headache
Other side effects include: upper respiratory tract infections and hypoglycemia. 5. How to store Glibenclamide / Metformin HCl
Store at room temperature 68 to 77°F (20 to 25°C).
Keep this medicine out of reach of children.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of that month.
Contact with Saudi Food Drugs Authority
Call Center 19999 Phone 0118806000-0112038222 Free Phone 8002490000 Email: [email protected] Postal addressSaudi Food & Drugs Authority (3292) North Road – Al Nafal Unit (1)
Riyadh 13312 – 6288 Saudi Arabia
