Patient Information Leaflet: Glucovance

Glucovance 500 mg / 2.5 mg Film-Coated Tablets

Glucovance 500 mg / 5 mg Film-Coated Tablets

Metformin Hydrochloride / Glibenclamide

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

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 only. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What This Leaflet Contains:

1. What Glucovance Is and What It Is Used For

Glucovance is a combination of two antidiabetic medicines belonging to the groups of medicines called biguanides (metformin hydrochloride) and sulfonylureas (glibenclamide).

Insulin is a hormone that allows your body to absorb glucose (sugar) from the blood into tissues, where it is used for energy or stored. In type 2 diabetes (non-insulin-dependent diabetes), your pancreas does not produce enough insulin, or your body does not respond properly to the insulin it produces. This causes an increase in blood glucose levels.

Glucovance helps lower blood sugar levels to normal values in patients with type 2 diabetes.

Glucovance is used to treat type 2 diabetes in adults when oral medication is appropriate. It is prescribed as a replacement for the combination of metformin and glibenclamide taken separately in patients previously treated with this combination, where the combination has been effective in controlling blood sugar levels.

2. What You Need to Know Before You Take Glucovance

Do Not Take Glucovance:

If you are allergic to metformin hydrochloride, glibenclamide, any other sulfonamide, or any of the other ingredients of this medicine (listed in section 6).
If you have severely reduced kidney function.
If you have liver problems.
If you have type 1 diabetes (insulin-dependent diabetes).
If you have uncontrolled diabetes with symptoms such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of Lactic Acidosis" below), or ketoacidosis. Ketoacidosis is a condition where "ketone bodies" accumulate in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a fruity breath odor.
If you have a severe infection (e.g., respiratory or urinary tract infection).
If you are dehydrated (e.g., due to prolonged or severe diarrhea or repeated vomiting).
If you are being treated for heart failure or have recently had a heart attack, or if you have severe circulatory problems (such as shock) or breathing difficulties. This can reduce oxygen supply to tissues and increase the risk of lactic acidosis (see "Warnings and Precautions").
If you have porphyria (a rare inherited disease caused by an enzyme deficiency, leading to excessive production and excretion of porphyrins, which are involved in the formation of the blood pigment responsible for oxygen transport in the blood).
If you are taking miconazole (a medicine used to treat certain fungal infections), even if applied locally.
If you drink alcohol excessively (daily or occasionally).
If you are breastfeeding.

Talk to Your Doctor:

If you need to undergo radiological examinations involving the injection of iodinated contrast agents into the bloodstream.
If you need to undergo surgery under general, spinal, or epidural anesthesia.

You may need to stop taking Glucovance for a certain period before and after the examinations or surgery. Your doctor will decide if you need alternative treatment during this time. It is important to follow your doctor's instructions carefully.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Glucovance.

Risk of Lactic Acidosis

Glucovance can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting, alcohol consumption, dehydration (see below), liver problems, and any medical conditions where part of the body has reduced oxygen supply (such as acute severe heart disease).

If any of these apply to you, talk to your doctor for further advice.

Temporarily stop taking Glucovance if you have a condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Talk to your doctor for further advice.

Stop taking Glucovance and seek immediate medical attention or go to the nearest hospital if you experience symptoms of lactic acidosis, as this condition can lead to a coma.

Symptoms of lactic acidosis include:

Vomiting
Abdominal pain
Muscle cramps
General feeling of discomfort with severe fatigue
Difficulty breathing
Decreased body temperature and slow heart rate

Lactic acidosis is a medical emergency and must be treated in a hospital.

If you need to undergo major surgery, you must stop taking Glucovance during and for some time after the surgery. Your doctor will decide when you should stop and restart Glucovance.

Risk of Hypoglycemia

If you experience symptoms of low blood sugar (hypoglycemia). Warning signs may appear suddenly and include cold sweat, pale skin, confusion, headache, rapid heartbeat, nausea, intense hunger, temporary vision problems, dizziness, unusual tiredness and weakness, nervousness, or involuntary trembling, anxiety, confusion, difficulty concentrating.
Patients aged 65 and older are particularly sensitive to the hypoglycemic effects of glibenclamide and are therefore at higher risk of hypoglycemia. In older adults, it may be more difficult to recognize low blood sugar levels. Your doctor must carefully determine the initial and maintenance doses of glibenclamide to avoid hypoglycemic reactions.

If you notice any of these signs:

First, take a glucose tablet or a snack with high sugar content (honey, candy, cake, fruit juice).
Immediately stop taking this medicine and inform your doctor, as you may need to be hospitalized to restore blood sugar control.
Rest.

General advice: Inform your family, friends, and colleagues to turn you on your side and seek immediate medical help if you become unconscious. When you are unconscious, do not give yourself any food or drink, as this could cause choking.

Low blood sugar levels may occur if:

You eat too little or skip meals.
Your diet contains insufficient or unbalanced sugar.
You consume alcohol.
You exercise more than usual.
You have liver, kidney, or certain hormonal problems.
You take too high a dose of the medicine.
You are older.
You take Glucovance with certain other medicines (see section 2, "Other Medicines and Glucovance").

If you frequently experience severe symptoms of low blood sugar or have difficulty recognizing them, talk to your doctor about whether Glucovance is the right treatment for your diabetes.

If you have an infectious disease such as flu, respiratory, or urinary tract infection.
If you have an inherited condition where your red blood cells do not produce enough of the enzyme G6PD (G6PD deficiency), taking Glucovance may cause rapid breakdown of red blood cells (hemolytic anemia). Tell your doctor if you have this condition, as Glucovance may not be suitable for you.
During treatment with Glucovance, continue the diet recommended by your doctor and regular exercise.
Regularly consult your doctor for blood sugar and kidney function tests.

Talk to your doctor if you think any of the above applies to you or if you have any concerns about taking this medicine.

During treatment with Glucovance, your doctor will check your kidney function at least once a year or more frequently if you are older and/or if your kidney function is deteriorating.

Other Medicines and Glucovance

While taking Glucovance, do not take the following medicines:

Miconazole, even if applied locally (see section 2, "Do Not Take Glucovance").

If you need to receive an injection of an iodinated contrast agent into a blood vessel, for example, during X-ray or scanning procedures, you must stop taking Glucovance before or during the injection. Your doctor will decide when you should stop and restart Glucovance.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need more frequent blood glucose tests or kidney function tests, or your doctor may need to adjust the dose of Glucovance. It is especially important to mention the following:

Medicines that increase urine production (diuretics).
Medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
Certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Beta-blockers (used to treat various cardiovascular conditions such as high blood pressure and certain other diseases).
Beta-2 agonists (used to treat asthma, such as ritodrine, salbutamol, or terbutaline).
Bosentan (used to treat pulmonary hypertension).
Corticosteroids and tetracosactide (a group of hormones used to treat various conditions, such as severe skin inflammation or asthma).
Fluconazole (used to treat certain fungal infections).
Chlorpromazine (a neuroleptic that affects brain function).
Desmopressin (generally used to control bedwetting).
Danazol (used to treat endometriosis, a condition where tissue from the lining of the uterus is found outside the uterus).
Bile acid sequestrants (medicines used to lower blood cholesterol levels).
Medicines that may alter the amount of Glucovance in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Special precautions include self-monitoring of blood glucose levels, blood tests, and dose adjustments.

Glucovance with Alcohol

Avoid excessive alcohol consumption while taking Glucovance, as this can increase the risk of lactic acidosis (see "Warnings and Precautions").

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist for advice before taking this medicine. During pregnancy, insulin must be used to treat diabetes. If you become pregnant while taking Glucovance, talk to your doctor, as they may need to change your treatment.

If you are breastfeeding or planning to breastfeed, do not take Glucovance.

Driving and Using Machines

Do not drive or operate machinery:

If your vision is blurred (this can occur at the start of treatment due to lowering blood sugar levels).
If you experience symptoms of low blood sugar.

Important Information About the Ingredients of Glucovance

Glucovance tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered negligible.

3. How to Take Glucovance

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

This medicine is for adults only. Your doctor will adjust the dose based on its effects on your blood test results. Continue following the dietary advice given by your doctor. Glucovance cannot replace the benefits of a healthy lifestyle. Stick to a regular meal schedule with adequate and balanced sugar intake. This will reduce the risk of low blood sugar levels.

The usual starting dose is equivalent to the individual doses of metformin hydrochloride and glibenclamide you were taking before switching to Glucovance tablets. If you are an older adult, the usual starting dose is one Glucovance 500 mg / 2.5 mg tablet daily.

Maximum Daily Dose:

For Glucovance 500 mg / 2.5 mg: 6 tablets.
For Glucovance 500 mg / 5 mg: 3 tablets. In exceptional cases, your doctor may prescribe 4 tablets.

Dose Adjustment in Older Adults

If you are an older adult, be especially careful. The dose of Glucovance tablets will be increased gradually based on your blood sugar levels and kidney function. Regularly attend medical check-ups.

Dose Adjustment in Patients with Reduced Kidney Function

If you have reduced kidney function, your doctor may prescribe a lower dose.

Method of Administration

Swallow the tablet whole with a glass of water during a meal. Do not crush or chew the tablets before swallowing.

Take the tablets:

Once daily in the morning (during breakfast) if you take 1 tablet daily.
Twice daily in the morning (during breakfast) and in the evening (during dinner) if you take 2 or 4 tablets daily.
Three times daily in the morning (during breakfast), at noon (during lunch), and in the evening (during dinner) if you take 3, 5, or 6 tablets daily.

Your doctor will instruct you on how to take Glucovance if you need to take it in combination with cholesterol-lowering medicines (bile acid sequestrants). Glucovance must be taken at least 4 hours before the cholesterol-lowering medicine.

If You Take More Glucovance Than You Should

If you have taken more Glucovance tablets than you should, you may experience symptoms of lactic acidosis or low blood sugar (see section 2, "Warnings and Precautions"). Contact your doctor immediately.

If You Forget to Take Glucovance

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If You Stop Taking Glucovance

Stopping Glucovance treatment usually does not cause side effects. However, if you stop treating your diabetes, complications may arise due to lack of treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been observed during clinical trials and routine treatment of patients.

Glucovance can cause a very rare (may affect less than 1 in 10,000 people) but very serious side effect called lactic acidosis (see "Warnings and Precautions"). If this happens to you, you must stop taking Glucovance and seek immediate medical attention or go to the nearest hospital, as lactic acidosis can lead to a coma.

Vision Disorders: At the start of treatment with this medicine, you may experience vision disorders due to a decrease in blood sugar levels. However, this usually goes away after some time.

Low Blood Sugar: See section 2, "Warnings and Precautions," for symptoms of low blood sugar.

Very Common Side Effects (May Affect More Than 1 in 10 People):

Gastrointestinal disorders such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These side effects occur most frequently at the beginning of treatment. To avoid these symptoms, divide the dose into multiple daily doses and take the tablet with meals. If these symptoms persist, stop taking the medicine and consult your doctor.

Common Side Effects (May Affect Less Than 1 in 10 People):

Taste disturbances.
Reduced or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, tongue pain and redness (glossitis), tingling and numbness (paresthesia), or pale or yellow skin). Your doctor may order tests to determine the cause of your symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

Uncommon Side Effects (May Affect Less Than 1 in 100 People):

Abnormal urea and creatinine levels in the blood, indicating changes in kidney function.
Crises of certain types of porphyria (hepatic or cutaneous porphyria; see section 2, "Do Not Take Glucovance"), which may occur in patients with an enzyme deficiency.

Rare Side Effects (May Affect Less Than 1 in 1,000 People):

Reduced number of white blood cells (leukocytes), increasing the risk of infections.
Reduced number of platelets, increasing the risk of bleeding or bruising.
Skin reactions, including itching, hives, rash.

Very Rare Side Effects (May Affect Less Than 1 in 10,000 People):

Severe reduction in the number of white blood cells (agranulocytosis), anemia due to increased breakdown of red blood cells (hemolytic anemia), insufficient production of new blood cells by the bone marrow (aplastic anemia), and very severe reduction in the number of blood cells (pancitopenia; may cause pale skin, weakness, shortness of breath, increased risk of bleeding, bruising, or increased susceptibility to infections).
Abnormal liver function test results or liver inflammation (hepatitis; may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). In this case, treatment with Glucovance must be discontinued.
Severe skin sensitivity to sunlight, severe allergic reactions of the skin or blood vessels.
Alcohol intolerance (with symptoms of general discomfort, facial flushing, rapid heartbeat).
Low sodium levels in the blood, which can cause fatigue, confusion, muscle twitching, seizures, or coma.

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Glucovance

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the box after {EXP}. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Glucovance Contains:

The active substances are metformin hydrochloride and glibenclamide.
Each Glucovance 500 mg / 2.5 mg film-coated tablet contains 500 mg of metformin hydrochloride (equivalent to 390 mg of metformin) and 2.5 mg of glibenclamide.
Each Glucovance 500 mg / 5 mg film-coated tablet contains 500 mg of metformin hydrochloride (equivalent to 390 mg of metformin) and 5 mg of glibenclamide.
Other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch, povidone K30, magnesium stearate, and Opadry OY-L-24808 (orange) (lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol, iron oxide yellow (E 172), iron oxide red (E 172), and iron oxide black (E 172)) for Glucovance 500 mg / 2.5 mg, or Opadry 31-F-22700 (yellow) (lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol, iron oxide yellow (E 172), iron oxide red (E 172), quinoline yellow lake (E 104)) for Glucovance 500 mg / 5 mg.

What Glucovance Looks Like and Contents of the Pack:

Glucovance 500 mg / 2.5 mg is an orange, biconvex, film-coated tablet in the shape of a capsule, with "2.5" embossed on one side.
Glucovance 500 mg / 5 mg is a yellow, biconvex, film-coated tablet in the shape of a capsule, with "5" embossed on one side.
The tablets are packaged in clear or opaque blisters (PVC/Al) in a box; each box contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Merck d.o.o., Oreškovićeva ulica 6H/1, Zagreb, Croatia.

Manufacturer: Merck Santé/SEMOY, 2, Rue du Pressoir Vert, 45400 Semoy, France.

Prescription and Dispensing Information

This medicine is available on prescription only and should be dispensed in a pharmacy.

This leaflet was last revised in May 2022.

References: Glucovance Package Insert

Packaging of Glucovance medication, strengths 500mg/2.5mg and 500mg/5mg. — Image of Glucovance medication packaging used in the treatment of type 2 diabetes, in two different strengths.

Glucovance - Patient Information: Diabetes Treatment, Dosage, Side Effects, Storage - A Comprehensive Guide Download

Close-up image of several packages of — Glucovance 500mg/5mg medication packages, a product of Alphapharm.

جلوكوفانس: الفوائد والآثار الجانبية ونصائح الخبراء لإدارة مرض السكري