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Glicomel MR Tablet

Generic Name(s): Gliclazide

Why it's used

Glicomel MR Tablet is a prescription medicine that is used to treat diabetes that occurs before the age of 25 years (called as maturity onset diabetes mellitus). This medicine works by raising the level of insulin produced by the pancreas. This medicine helps by lowering the blood glucose level.
When not to use
Glicomel MR Tablet should not be used to treat high blood sugar level due to the little or absence of insulin production (juvenile onset diabetes mellitus).
Sulfonylurea
Glicomel MR belongs to the Sulfonylurea class of medicines. Sulfonylureas are a class of antidiabetic drugs used in the management of diabetes mellitus type 2. These medicines act by increasing the release of insulin from the pancreas.

How to use

Read the directions on the product label, patient guide, or medicine guide provided by the medicine company or your pharmacist before starting to use Glicomel MR Tablet. If you have any questions related to this medicine, ask your doctor or pharmacist. Eat this medicine as recommended by your doctor.
You should keep track of your blood sugar regularly. Share your results with the doctor and discuss if your blood sugar measurements are too low or too high. Your treatment plan may need changes.
Glicomel MR Tablet is eaten with or without food. To minimize low blood sugar, take this medicine with food. This medicine should be taken a whole with a glass of water.
The typical dose of Glicomel MR is 40-80 mg daily based on patient's response if higher dose required then taken twice daily and single dose should not be increased above 160 mg (not more than 320 mg/day). The maximum adult dose of Glicomel MR is 320 mg in two divided doses daily in a day. Glicomel MR is commonly used at the same time every day. This medicine is not known to be habit-forming.
This medicine is to be used for longer periods of time.
Talk to your doctor if you develop new symptoms. Tell your doctor if feeling ill, fever, stress, infection, injury, and need surgery.
Your doctor may recommend a lower initial dose of this medicine to see the impact of this medicine on the body. Please follow your doctor's directions.
The safety and effectiveness of using Glicomel MR Tablet in children has not been established.
To decrease the possibility of side-effects, you might be recommended to use the extended-release form of this medicine by your doctor. The extended-release medicine helps in maintaining a steady level of the medicine in your body for a longer period of time. Do not crush or chew the medicine, unless indicated on the package or by your doctor.
Avoid the consumption of alcohol with Glicomel MR.
You should store Glicomel MR Tablet below 25°C (77°F), and away from moisture. Store the medicine away from the reach of children and pets.
Medicines may be prescribed for uses other than those listed in the medicine guide. Do not use Glicomel MR Tablet for conditions for which it was not prescribed. Do not give Glicomel MR Tablet to other people who might have the same conditions or symptoms that you have. Self-medication may harm them.

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How to take Glicomel MR

The dose and frequency of using Glicomel MR will depend on the following factors:
  • response to the medicine

Glicomel MR Dosage

Dosage for diabetes that occur before the age of 25 years (called as maturity onset diabetes mellitus)

Adult
  • Recommended: 40-320 mg in two divided doses daily and single dose should be less than or up to 160 mg
  • Initial: 40-80 mg daily
  • Maximum: 320 mg daily

Forms

Tablet
Strength: 80 mg
Extended Release Tablet
Strength: 30 mg and 60 mg

Missed Dose

The missed dose of Glicomel MR should be taken immediately when you remember it, skip the dose if its almost time for the next dose. Then continue with the regular schedule. Do not take a double dose to make up for the missed dose.

Overdose

What to do if you overdose on Glicomel MR?
If this happens, contact your doctor immediately. Take some sugar or carbohydrates to raise blood sugar level to treat symptoms of low blood sugar. In such case, dosage adjustment, change in diet and strict monitoring are recommended. If the symptoms are severe or prolonged such as coma, seizures or other nervous system disorders (neurological disorders), it requires immediate hospitalization. In coma due to low blood sugar level, an injection of 50 ml of glucose solution (20-30%) should be given in the vein followed by infusion of a dilute glucose solution (10%) at a rate above 1000 mg/L. The patients should be monitored closely and depending on the patient's condition after this time, the doctor will decide if further monitoring is necessary.
Symptoms of an overdose of Glicomel MR
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
If you think you have overdosed on Glicomel MR Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Glicomel MR

Before you use Glicomel MR, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Discuss with your doctor if you are allergic to sulfonylureas, sulfonamide antibiotics, or thiazide diuretics.
Before you use Glicomel MR Tablet, tell your doctor of your medical history including kidney problems, liver problems, abnormal growth in the pancreas (called insulinoma), hormonal problems (adrenal, pituitary and thyroid problems), heart failure, or a genetic disorder called Glucose-6-Phosphate Dehydrogenase Deficiency (G6PD). Before having any surgery, discuss with your doctor and dentist about medicines you use including prescription medicines, non-prescription medicines, and herbal supplements.
The use of Glicomel MR Tablet may change blood glucose levels. This medicine may cause a low blood glucose level. It is advised to monitor blood glucose levels regularly.
Consult with your doctor on the use of Glicomel MR Tablet during pregnancy or if you are planning to become pregnant. If this medicine is used during pregnancy, it may affect the developing baby. Glicomel MR Tablet is not safe for use in women who are breastfeeding. If you are breastfeeding, discuss with your doctor if you should either discontinue breastfeeding, or stop using this medicine during this period. It is unknown if Glicomel MR passes into breast milk. However, other sulfonylureas pass into breast milk and increase the risk of low blood glucose in the baby. Consult with your doctor on the use of Glicomel MR Tablet, if you are trying to conceive.
Avoid drinking alcohol with Glicomel MR. Consumption of alcohol may cause a low blood glucose level, and coma.
Glicomel MR can make you feel sleepy. Be careful, especially while driving, while using heavy machinery, or when doing any activity that needs you to be completely alert. The consumption of alcohol with Glicomel MR can worsen the sleepiness. Glicomel MR may cause seizures in some people. Hence, you should discuss with your doctor before performing any activities where a loss of consciousness may cause harm to you or others.
This medicine may increase your sensitivity to sunlight and make you prone to sunburn. If this happens, limit your time outdoors to prevent sunburn. Use a sunscreen and cover your skin when you are outdoors. If you get sunburns on your body, consult with your doctor.
Older patients may have a higher incidence of side-effects when using Glicomel MR Tablet. Elderly patients may see an increased risk of low blood glucose level.

What precautions should be taken during Pregnancy and Nursing, and administering Glicomel MR to Children or the Older Adults?

Pregnant Women

Severe Precaution
Warning: If this medicine is used during pregnancy, it may affect the developing baby.

Breastfeeding

Contraindicated or Not Recommended
Warning: It is unknown if Glicomel MR passes into breast milk. However, other sulfonylureas pass into breast milk and increase the risk of low blood glucose in the baby.

Younger Adults Population

Contraindication
Warning: 

Older Adults Population

Precaution
Warning: These patients should use Glicomel MR with care, due to the increased risk of age-related low blood sugar level.

Glicomel MR Side-effects

The following side-effects may commonly occur when using Glicomel MR Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in older patients on the use of Glicomel MR Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
Rarely, the use of Glicomel MR Tablet may cause the following side-effects:
  • aggression
  • confusion
  • develop bruising or bleeding
  • dizziness (dizziness or giddiness)
  • double vision
  • drowsiness
  • fainting
  • fatigue
  • feeling of fullness in the stomach
  • feeling of powerlessness
  • feeling or being sick
  • flu-like symptoms, with blisters, red rashes, or sores around lips, mouth, genital and anal region
  • hay fever like symptoms
  • headache
  • heartburn
  • hives
  • hives on the skin
  • indigestion (dyspepsia)
  • insomnia
  • intense hunger
  • itching
  • itchy, red veins
  • lack of energy (lassitude)
  • lack of focus
  • language disorder (aphasia)
  • loss of appetite
  • loss of self-control
  • mild rash
  • mouth ulcers
  • nausea
  • numbness
  • pale skin
  • palpitations
  • rash (maculopapular rashes)
  • reddish or purplish patches under the skin
  • redness of the skin
  • reduced awareness and slowed reactions
  • sensory disorders
  • severe chills
  • severe itching
  • sore throat
  • speech disorders
  • stomach pain (abdominal pain)
  • stomach upset
  • sweating
  • sweaty skin (clammy skin)
  • swelling of the face, lips, tongue, throat or other parts of the body
  • trembling
  • tremor
  • weight loss
The following severe side-effects may also occur when using Glicomel MR Tablet:
  • stomach and intestinal disorders (gastrointestinal disturbances)
    Symptoms: stomach pain (abdominal pain), nausea, vomiting, indigestion (dyspepsia), diarrhea, constipation, vomiting blood, passing bloody black or tarry stools
    This medicine should be taken with a meal to avoid or decrease the incidence of such side-effects.
  • skin and soft tissue disorders (skin and subcutaneous tissue disorders)
    Symptoms: rash (maculopapular rashes), severe itching, hives, redness of the skin (erythema), blisters on the skin allergy to sunlight (photosensitivity skin reactions)
  • eye disorders
    Symptoms: temporary visual disturbances
  • chest pain due to the reduced blood supply to the heart (angina)
    Symptoms: chest pain
    If this happens, contact the doctor immediately.
  • low blood sugar level (hypoglycaemia) (coma and can be possibly fatal)
    Symptoms: headache, intense hunger, nausea, vomiting, lack of energy (lassitude), insomnia, agitation, aggression, lack of focus, reduced awareness, slowed reactions, depression, confusion, visual disorders, speech disorders, language disorders (aphasia), tremor, paralysis, sensory disorders, dizziness, feeling of powerlessness, loss of self-control, delirium, seizures, shallow breathing (shallow respiration), decreased heartbeat, drowsiness, loss of consciousness, sweating, sweaty skin (clammy skin), anxiety, increased heartbeat, high blood pressure, palpitation, chest pain irregular heartbeat
    If a severe episode of diabetes occurs, immediate treatment or hospitalization is needed even if briefly controlled by taking sugar.
  • blood and lymphatic system disorders (such as anaemia, granulocytopenia)
    These side-effects go away upon discontinuation of Glicomel MR.
  • liver diseases (hepatobiliary disorders) (life-threatening liver failure)
    Symptoms: increased level of liver enzymes (aspartate aminotransferase, alanine transaminase, alkaline phosphatase), inflammation of the liver (hepatitis), yellowing of the skin, yellowing of the eyes, dark urine, pale stools jaundice
    These side-effects go away upon discontinuation of Glicomel MR. This medicine should be discontinued if a liver disease such as cholestatic jaundice occurs.
  • allergic reactions
    Symptoms: shortness of breath, wheezing, difficulty in breathing, facial swelling, swelling of the lips, swelling of the tongue, swelling of the throat, swelling of other body parts, severe rash, itching, hives, fainting hay fever like symptoms
    This medicine should not be used if an allergic reaction occurs, and contact the doctor immediately.
  • flu like symptoms (can be fatal)
    Symptoms: red rashes, sores around the mouth, sores around the lips sores around the genital and anal region
    If such side effects occur, contact the doctor immediately.
Your doctor has prescribed Glicomel MR Tablet because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious side-effects. This page does not list all possible side-effects of Glicomel MR Tablet.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Glicomel MR by Severity and Frequency

Common Side-effects

Following are the common side-effects of this medicine:

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:

Severe Side-effects

Following are the severe side-effects of this medicine:

Side-effects in Older Adults

Following are the side-effects of this medicine in elderly patients:

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
  • difficulty in breathing
  • facial swelling
  • severe rash
  • shortness of breath
  • swelling of lips
  • swelling of other body parts
  • swelling of throat
  • swelling of tongue
  • wheezing
This medicine should not be used if an allergic reaction occurs, and contact the doctor immediately.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Patients with the risk of low blood sugar

The risk of low blood sugar and conditions that influence its development, symptoms, and treatment should be disclosed to the patient and family members. The importance of receiving dietary advice, regular exercise, and regular monitoring of blood glucose levels should be informed to the patient.

Low blood glucose level

Patients who intake low-calorie diet, skipping meals, lack of sufficient nutrients and the imbalance between carbohydrate intake and physical exercise are at an increased risk when using this medicine. Patients having irregular meal time, kidney insufficiency, severe liver insufficiency, hormonal disorders (such as thyroid disorders, adrenal insufficiency and decreased hormone secretion by the pituitary gland) and the overdose of Glicomel MR or alcohol intake are also at an increased risk when using this medicine. Such patients may have an increased risk of low blood glucose level. It is necessary to give proper instructions to the patient and the dosage should be carefully selected.

Kidney and liver insufficiency

Patients with kidney and liver an insufficiency are at increased risk when using this medicine. In these patients, low blood glucose level may occur for a prolonged time. If this happens, proper management should be started.

Poor blood glucose control

Patients receiving antidiabetic treatment are at an increased risk when using this medicine. In such patients, blood glucose control may be affected by fever, infection, trauma, or surgery. The blood glucose level lowering effect of oral antidiabetic medicines is reduced over time in several cases. This may be due to a rise in the severity of diabetes, or to a decreased response to treatment. This is known as a secondary failure. In some cases, this may be necessary to give insulin. The sufficient dose adjustment and proper diet should be given before assigning the patient as a secondary failure.

Anemia due to the breakdown of red blood cells (called as hemolytic anemia)

Patients with a genetic disorder called Glucose-6-Phosphate Dehydrogenase Deficiency (G6PD) are at an increased risk when using this medicine. These patients may develop hemolytic anemia. It is advised to use caution in these patients and a non-sulfonylurea as an alternative should be used.

Measurement of levels of glucose in hemoglobin (glycated hemoglobin levels)

Measurement of glycated hemoglobin levels is needed to estimate the blood glucose control. Self-monitoring of blood glucose level may also be useful.

Interactions with Glicomel MR

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
Glicomel MR Tablet may interact with miconazole, which is used to treat fungal infection. When Glicomel MR is used with miconazole, the blood glucose level lowering effect of Glicomel MR is increased and it may result in symptoms of low blood sugar level or even coma. This medicine should not be used in combination with miconazole.
There may be an interaction of Glicomel MR with phenylbutazone, which is used to treat mild to moderate pain, fever, and inflammation in the body. When Glicomel MR is used with phenylbutazone may increase the blood glucose lowering effect of Glicomel MR. It is advised to use another anti-inflammatory agent and tell the importance of self-monitoring to the patient. If required, the dose of Glicomel MR may be adjusted during and after treatment with phenylbutazone.
Glicomel MR Tablet interacts with alcohol. When the Glicomel MR is used with alcohol, the blood sugar level lowering effect of Glicomel MR is increased and it may lead to the onset of low blood sugar related coma. When using Glicomel MR, use of alcohol or alcohol containing medicines should be avoided.
Special instructions need to be followed while taking this medicine along with other blood sugar level lowering agents (for example, insulins, acarbose, biguanides), which are used to treat high blood sugar level. When one of these medicines is used with Glicomel MR, the blood sugar lowering effect is increased.
Your doctor's guidelines may need to be followed while taking this medicine along with danazol, which is used to treat abnormal growth of endometrial tissues (endometriosis) and breast lumps (fibrocystic breast disease) in women. When Glicomel MR is used with danazol, it can cause diabetes. Glicomel MR should not be used with danazol. The dose of an antidiabetic agent should be adjusted during and after treatment with danazol. The patient should be informed about the importance of blood sugar or urine monitoring.
Glicomel MR Tablet may interact with chlorpromazine, which is used to treat mental disorders. The high dosages of chlorpromazine raise blood glucose levels. The patient should use caution when using Glicomel MR and chlorpromazine together. Inform the patient about the monitoring of blood glucose level. The dose adjustment of antidiabetic agent may be necessary during and after treatment with chlorpromazine.
There may be an interaction of Glicomel MR with glucocorticoids and tetracosactrin, which are used to treat inflammation. Glucocorticoids and tetracosactrin may cause a rise in the blood glucose levels with possibly increased levels of ketone bodies (ketosis). The patient should use caution when using Glicomel MR and glucocorticoids or tetracosactrin together. The dose of an antidiabetic agent should be adjusted during and after treatment with glucocorticoids and tetracosactrin. The patient should be informed about the importance of blood sugar monitoring, especially at the starting of treatment.
Glicomel MR Tablet interacts with ritodrine and salbutamol, which are used to control premature labor and to treat asthma respectively. When Glicomel MR is used with ritodrine and salbutamol injection in the vein, the blood glucose level increases due to beta-2 agonist effect of ritodrine and salbutamol. The patients should be regularly monitored for changes in blood glucose level. Insulin can be used as an alternative medicine instead of Glicomel MR if required.
Special instructions need to be followed while taking this medicine along with terbutaline, which is used to treat asthma and to control premature labor. When Glicomel MR is used with terbutaline injection in the vein, the blood glucose level increases due to beta-2 agonist effect of terbutaline. In such patients, blood glucose level should be strictly monitored. Use insulin as an alternative medicine, if required.
Your doctor's guidelines may need to be followed while taking this medicine along with blood thinners (warfarin), which is used to prevent blood clots. When Glicomel MR is used with blood thinners such as warfarin, it may increase the risk of blood clot formation. The dose adjustment of the blood thinners may be required in such patients.
Glicomel MR Tablet may interact with octreotide, which is used to treat severe diarrhea or abnormal growth of cells (tumors) in intestine or pancreas. When Glicomel MR is used with octreotide, the blood glucose level lowering effect of Glicomel MR increases.
There may be an interaction of Glicomel MR with sulfinpyrazone, which is used to treat red, stiff and painful joints (gout). When Glicomel MR is used with sulfinpyrazone, the blood glucose level lowering effect of Glicomel MR increases.
Glicomel MR Tablet interacts with antibiotics (tetracycline compounds and chloramphenicol), aminoglutethimide, which is used to treat seizures and breast cancer and testosterone, which is used to treat hormonal imbalance. If Glicomel MR and aminoglutethimide are used together, there is an increase in the breakdown of Glicomel MR.
Special instructions need to be followed while taking this medicine along with fluconazole, histamine 2-receptor antagonists, monoamine oxidase inhibitor (MAOIs), and sulfonamides; which are used to treat fungal infection, stomach ulcers, depression, and bacterial infection respectively. When one of these medicines is used with Glicomel MR, the blood sugar lowering effect is increased.
Your doctor's guidelines may need to be followed while taking this medicine along with beta-blockers, angiotensin converting enzyme inhibitors (captopril, enalapril); which are used to treat high blood pressure and nonsteroidal anti-inflammatory agents, which are used to treat fever, mild to moderate pain and inflammation. When Glicomel MR is used with any one of these medicines, there is an increase in blood sugar lowering effect.
This page does not contain all the possible interactions of Glicomel MR Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Interactions of Glicomel MR by Severity

Severe

The following medicines are usually not to be taken together without consulting with your doctor or pharmacist.

Moderate

The following medicines may interact when taken together and can increase your risk of harmful effects. Please consult with your doctor or pharmacist before taking these medicines together.

When should Glicomel MR be not used?

Type 1 diabetes

This medicine is not recommended in patients with high blood sugar level due to the absence of insulin production (Type 1 diabetes).

Diabetes complicated by an excess of blood acids (ketosis or acidosis)

This medicine is not recommended in patients with diabetes complicated by ketosis or acidosis.

Diabetics undergoing surgery

This medicine is not recommended in patients with diabetics having surgery after trauma or during infection.

Diabetic pre-coma and coma

This medicine is not recommended in patients with diabetic pre-coma and coma.

Severe kidney or liver disease

This medicine is not recommended in patients with severe kidney or liver diseases.

Patients using miconazole

This medicine is not recommended in patients using miconazole, which is used to treat fungal infection. These patients are at an increased risk of blood glucose lowering (hypoglycaemic) effect with hypoglycaemic symptoms, or even coma.

Use of Glicomel MR in porphyria

This medicine should be avoided in patients with a build-up of a natural chemical (called as, porphyrin) in the blood (porphyria).

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Glicomel MR is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Glicomel MR Tablet .

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