Gliclazide Tablets 80mg Technical Specification:

Product Name:     Gliclazide Tablets
Brand Name:Generics
Strength:30mg, 40mg, 60mg, 80mg
Dosage Form:Tablets (Uncoated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antidiabetic, hypoglycemic
Indication: Gliclazide is used to treat type 2 diabetes. It’s a medicine known as a sulfonylurea. Sulfonylureas increase the amount of insulin your pancreas makes. This lowers your blood sugar.
Storage:Protect form moisture at a temperature not exceeding 25˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Gliclazide Tablets 80mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Gliclazide Tablets 80mg
    Each uncoated tablet contains:
    Gliclazide BP……………………80mg
    Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

Gliclazide is used to treat type 2 diabetes. It’s a medicine known as a sulfonylurea. Sulfonylureas increase the amount of insulin your pancreas makes. This lowers your blood sugar.

CAUTION & WARNING:

CAUTION:  Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 25˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the Physician.

Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

Taj Pharma is your top choice for Gliclazide Tablets because of our commitment to quality, effectiveness, and patient well-being. Our pharmaceutical solutions are trusted worldwide, offering you:

  • Quality Assurance: We adhere to stringent quality control measures, ensuring that every Gliclazide Tablet meets international standards for safety and efficacy.
  • Expertise: Taj Pharma boasts years of pharmaceutical experience and a reputation for excellence in diabetes management solutions.
  • Innovation: We continuously invest in research and development to bring you the latest advancements in drug formulations, including Gliclazide Tablets.
  • Patient-Centric Approach: We prioritize patient well-being, delivering medications that enhance the quality of life for those managing diabetes.
  • Global Reach: With a worldwide presence, Taj Pharma is accessible and trusted by healthcare providers and patients alike.

Choose Taj Pharma for Gliclazide Tablets and experience the difference in pharmaceutical excellence.

What is Gliclazide Tablets and its use?

Gliclazide Tablets (British Pharmacopoeia) are a medication used in the management of type 2 diabetes. Gliclazide is an oral antidiabetic drug that belongs to a class of medications called sulfonylureas. The “Modified Release” formulation means that the medication is released slowly over time, providing a more consistent and extended effect compared to immediate-release formulations.

Use:

Gliclazide Tablets are primarily used to lower and control blood sugar levels in individuals with type 2 diabetes. It works by stimulating the pancreas to release insulin, a hormone that helps regulate blood sugar. Gliclazide helps increase the body’s insulin response, which in turn lowers elevated blood glucose levels.

Indications:

  • Type 2 Diabetes: Gliclazide Tablets are prescribed for people with type 2 diabetes who cannot adequately control their blood sugar levels through diet and exercise alone.

Key Points:

  • This medication is usually taken orally as a tablet.
  • The “Modified Release” formulation allows for a controlled and gradual release of the medication throughout the day, reducing the risk of hypoglycemia (low blood sugar) compared to immediate-release formulations.
  • It is typically used as part of a comprehensive diabetes management plan, which may include diet, exercise, and other medications.

It’s essential to take Gliclazide Tablets as prescribed by a healthcare professional and to monitor blood sugar levels regularly to ensure they are within the target range. Also, lifestyle modifications such as maintaining a healthy diet and regular physical activity are crucial components of managing type 2 diabetes. Always consult with a healthcare provider for personalized guidance on diabetes management and medication use.

How does Gliclazide Tablets Work?

Gliclazide Tablets work by targeting the underlying mechanisms of high blood sugar levels in individuals with type 2 diabetes. Here’s a detailed explanation of how Gliclazide operates:

  • Stimulation of Insulin Release: Gliclazide is a member of the sulfonylurea class of medications. It acts primarily by stimulating the beta cells in the pancreas to release insulin. These beta cells are responsible for producing and secreting insulin, a hormone that plays a key role in regulating blood sugar levels.
  • Insulin Action: When Gliclazide stimulates the pancreas to release insulin, the insulin enters the bloodstream. Insulin acts as a “key” that allows glucose (sugar) from the bloodstream to enter cells throughout the body. Inside the cells, glucose is either used for energy or stored for later use.
  • Glucose Utilization: Once inside the cells, glucose is utilized for various energy-producing processes. This reduces the concentration of glucose in the bloodstream, leading to lower blood sugar levels.
  • Reduced Hepatic Glucose Production: Gliclazide also has an effect on the liver. It decreases the liver’s production of glucose, which is a process that can contribute to elevated blood sugar levels in people with type 2 diabetes.
  • Improved Insulin Sensitivity: Some sulfonylureas, including Gliclazide, may also improve the body’s sensitivity to insulin, allowing cells to use insulin more efficiently.
  • Sustained Release: The “Modified Release” formulation of Gliclazide means that the medication is designed to be released slowly and steadily into the bloodstream over an extended period. This helps provide a more consistent and prolonged effect compared to immediate-release formulations, which can help in maintaining stable blood sugar levels throughout the day.

Gliclazide Tablets should be taken as directed by a healthcare provider, typically once daily with or without food. The dosage is individualized based on factors such as the patient’s blood sugar levels and overall health.

Benefits of Gliclazide Tablets :

  • Blood Sugar Control: Gliclazide Tablets are highly effective in lowering and controlling blood sugar levels in individuals with type 2 diabetes.
  • Stable Glucose Levels: The formulation provides a steady release of medication over time, which helps maintain more consistent blood sugar levels throughout the day.
  • Reduced Risk of Hypoglycemia: Compared to immediate-release formulations, the version of Gliclazide may be associated with a lower risk of hypoglycemia (low blood sugar). This is because it provides a more gradual and sustained effect.
  • Improved Insulin Sensitivity: Some sulfonylureas, including Gliclazide, may enhance the body’s sensitivity to insulin, allowing cells to utilize it more effectively.
  • Complement to Lifestyle Changes: Gliclazide is often prescribed as part of a comprehensive diabetes management plan, which includes a balanced diet, regular exercise, and other lifestyle modifications.

Side Effects of Gliclazide Tablets :

  • Hypoglycemia: While the formulation reduces the risk, hypoglycemia can still occur, especially if the medication is not taken consistently or if there are significant changes in diet or exercise habits.
  • Weight Gain: Some individuals may experience mild weight gain while taking Gliclazide, although this is not the case for everyone.
  • Gastrointestinal Disturbances: This can include nausea, upset stomach, or diarrhea. These effects are usually mild and tend to improve over time.
  • Allergic Reactions: In rare cases, individuals may experience allergic reactions to Gliclazide, which could include rash, itching, swelling, severe dizziness, or difficulty breathing.
  • Liver Function: There have been reports of changes in liver function in some individuals taking Gliclazide. Regular monitoring of liver enzymes may be recommended.
  • Skin Sensitivity to Sunlight: Some individuals may become more sensitive to sunlight while taking Gliclazide, leading to a higher risk of sunburn.
  • Blood Disorders: Although rare, Gliclazide can affect blood cell counts in some individuals.

It’s important to note that not everyone will experience these side effects, and some may experience benefits not listed here. Additionally, the benefits of controlling blood sugar levels often outweigh the potential side effects. Individuals taking Gliclazide Tablets should do so under the guidance of a healthcare provider who can monitor their response to the medication and make any necessary adjustments to their treatment plan. Always consult a healthcare professional for personalized advice and to address any concerns.

Frequently asked questions (FAQs) about Gliclazide Tablets :

  1. What is Gliclazide Tablets used for?

Gliclazide Tablets are used to manage and lower blood sugar levels in individuals with type 2 diabetes.

  1. How does Gliclazide work differently from immediaterelease Gliclazide?

The version provides a gradual and sustained release of the medication, leading to more consistent blood sugar control throughout the day compared to immediaterelease formulations.

  1. Is Gliclazide Tablets a standalone treatment for diabetes?

No, Gliclazide is usually part of a comprehensive diabetes management plan that includes diet, exercise, and other medications if necessary.

  1. What is the typical dosage of Gliclazide Tablets ?

Dosage varies depending on individual needs, but it is commonly taken once daily with or without food. Your healthcare provider will determine the appropriate dosage.

  1. What are the potential side effects of Gliclazide Tablets ?

Common side effects may include hypoglycemia, weight gain, gastrointestinal issues, and skin sensitivity to sunlight. However, not everyone will experience these side effects.

  1. How should I take Gliclazide Tablets to minimize the risk of hypoglycemia?

To reduce the risk of low blood sugar, take the medication as prescribed and maintain a consistent meal schedule. Monitor your blood sugar levels regularly and be aware of symptoms of hypoglycemia.

  1. Can I drink alcohol while taking Gliclazide Tablets ?

It’s important to consult your healthcare provider regarding alcohol consumption while taking this medication, as alcohol can affect blood sugar levels.

  1. What should I do if I miss a dose of Gliclazide Tablets ?

If you miss a dose, take it as soon as you remember unless it’s close to the time for your next dose. Do not double up on doses.

  1. Can Gliclazide Tablets be used during pregnancy or while breastfeeding?

Consult your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding, as they will assess the risks and benefits of using this medication during these times.

  1. Are there any drug interactions I should be aware of when taking Gliclazide Tablets ?

Gliclazide may interact with other medications, including some that affect blood sugar levels. Always inform your healthcare provider of all medications and supplements you are taking.

As Gliclazide Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Gliclazide Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Gliclazide Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Gliclazide Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Gliclazide Tablets 30mg
b) Gliclazide Tablets 40mg
c) Gliclazide Tablets 60mg
d) Gliclazide Tablets 80mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Gliclazide Tablets 30mg
Each uncoated tablet contains:
Gliclazide BP……………………30mg
Excipients………………………...q.s.

b) Gliclazide Tablets 40mg
Each uncoated tablet contains:
Gliclazide BP……………………40mg
Excipients………………………...q.s.

c) Gliclazide Tablets 60mg
Each uncoated tablet contains:
Gliclazide BP……………………60mg
Excipients………………………...q.s.

d) Gliclazide Tablets 80mg
Each uncoated tablet contains:
Gliclazide BP……………………80mg
Excipients………………………...q.s.


THERAPEUTIC INDICATIONS:

Gliclazide is used to treat type 2 diabetes. It's a medicine known as a sulfonylurea. Sulfonylureas increase the amount of insulin your pancreas makes. This lowers your blood sugar.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 25˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.