provance 500/5

provance 500/5

provance 500/5

Anti-Diabetes drugs

Properties

- 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.

- Diabetes mellitus type 2 is a chronic disease where your body is not able

  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.

Indecation

Indications

- Provance® 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.

Dosage & Administration

Dosage and administration

- Provance® 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.

-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 Provance® 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 Provance® : 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.

Composition

 

- Each film coated tablet of  Provance® 500 /5 contains

  Metformin Hydrochloride       500 mg

  Glibenclamide                         5 mg

- Each film coated tablet of  Provance® 500/ 2.5 contains

  Metformin Hydrochloride       500 mg

  Glibenclamide                         2.5 mg

 

 

Contraindications

  Do not take Provance®

- 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 severe kidney 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.

Drug interactions

- Tell your doctor about all the medicines you are taking.

  Provance® 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

- Bosentan

- 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

Use in Pregnancy And lactation

- Do not take this medicine if you are pregnant or breast-feeding.

Side Effects

- Stop using Provance® 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.

Precautions and Warnings

  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.

 

Packaging

- Provance® 5 / 500: Blister of 15 tablets, pack of 2 blisters.

- Provance® 2.5 / 500: Blister of 15 tablets, pack of 2 blisters.

 

Storage

- Store in a dry place at a temperature not exceeding 25 ºC.