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GLIBENCLAMIDE 2.5 MG TABLETS - Patient leaflet, side effects, dosage

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Patient leaflet - GLIBENCLAMIDE 2.5 MG TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glibenclamide 2.5mg Tablets/

Glibenclamide 5mg Tablets

Read all of this leaflet carefully before you start to take this medicine.

  • – Keep this leaflet. You may need to read it again while you are receiving your treatment.

  • – If you have any further questions, please ask your doctor or pharmacist.

  • – This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • – If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What Glibenclamide Tablets are and what they are used for

  • 2. Before you take Glibenclamide Tablets

  • 3. How to take Glibenclamide Tablets

  • 4. Possible side effects

  • 5. How to store Glibenclamide Tablets

  • 6. Further information

  • 1. What Glibenclamide Tablets are and what they are used for

The name of your medicine is Glibenclamide Tablets. These tablets belong to a group of medicines called sulphonylureas.

Glibenclamide Tablets are used to lower blood sugar levels and are used in the treatment of late-onset diabetes (type II diabetes mellitus) in patients whose blood sugar is not controlled by diet alone and who are not suitable for insulin injections.

  • 2. Before you take Glibenclamide Tablets

You should not take Glibenclamide Tablets if you:

  • are allergic (hypersensitive) to glibenclamide, other sulphonylureas or any of the other ingredients in Glibenclamide Tablets (see section 6, Further information)
  • suffer from early onset or type I diabetes (requiring insulin)
  • suffer from severe kidney disease
  • suffer from liver problems
  • are suffering from ketoacidosis (caused by excessively high blood sugars in diabetics)
  • are suffering from a severe infection
  • are suffering from stress
  • are suffering from any condition likely to make controlling your blood sugar difficult
  • are due to undergo surgery
  • are pregnant
  • have reduced consciousness or coma resulting from your diabetes
  • have porphyria (a disease of blood proteins affecting the skin, gut and nervous system).
  • are elderly (over 70 years of age).

This medicine can cause low blood sugar (hypoglycaemia) particularly in the following situations, so patients should use caution:

Symptoms of low blood sugar include sweating, hunger, increased heart rate, reduced consciousness, coma or seizures.

Low blood sugar may occur:

  • in patients whose diabetes is controlled by diet alone
  • if you take too high doses of Glibenclamide Tablets
  • if you are malnourished
  • if you take meals irregularly or skip meals altogether
  • if you increase your physical activity and carbohydrate intake does not match this increase
  • if you are unwell
  • if your kidney function is decreased
  • if you suffer from hormone-induced disorders (functional disorders of the pituitary or adrenalglands)
  • if you drink alcohol, especially in combination with skipped meals.

Low blood sugar may occur if you are in stress situations (e.g. accidents, surgical operations, fever etc.). During such times you should inform your doctor you are taking Glibenclamide Tablets, as your doctor may adjust your dose of medicine or may temporarily switch you to insulin therapy.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by Glibenclamide Tablets:

  • medicines used to reduce pain and inflammation (e.g. aspirin, other non-steroidal anti-inflammatory drugs, azapropazone and phenylbutazone)
  • medicines used to treat bacterial infections (e.g. isoniazid, rifamycins, chloramphenicol, co-trimoxazole, sulphonamides and tetracyclines)
  • medicines used to treat depression (e.g. monoamine oxidase inhibitors [MAOIs])
  • medicines used to treat fungal infections (e.g. miconazole)
  • medicines used to treat gout (e.g. allopurinol, sulfinpyrazone and probenecid)
  • medicines used to treat high blood pressure (e.g. diazoxide, captopril, enalapril and beta-blockers)
  • medicines used to treat and prevent malaria (e.g. quinine and quinidine)
  • medicines used to thin the blood and prevent clotting (e.g. warfarin and disopyramide)
  • medicines used to treat psychosis and other mental illness (e.g. chlorpromazine)
  • medicines used to treat stomach ulcers (e.g. cimetidine and ranitidine)
  • medicines used in the treatment of cancer (e.g. crisantaspase)
  • medicines used to treat water retention and heart failure (e.g. loop and thiazide diuretics)
  • medicines used to reduce cholesterol (e.g. clofibrate)
  • lithium (used to treat manic depression/bipolar disorder)
  • hormone treatments and contraceptives (e.g. testosterone, oestrogens, progesterones, oral contraceptives, anabolic steroids, corticosteroids and ocreotides)
  • thyroid hormone (used to treat an underactive thyroid gland)
  • ciclosporin, used to prevent organ transplant rejection
  • bosentan, used to treat high blood pressure.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant. Talk to your doctor or pharmacist before taking them if you are breastfeeding a baby.

Driving and using machinery

If your blood sugar is not well controlled then this can affect your vision and/or concentration. If you are affected in any way do not drive or operate machinery.

Important information about some of the ingredients in Glibenclamide Tablets

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. how to take glibenclamide tablets

Always take Glibenclamide Tablets as your doctor has told you. Your doctor will decide the right dose for you, this will be on the pharmacist’s label. This medicine should be swallowed whole.

Adults

  • the usual starting dose is 2.5 to 5mg daily, taken with or immediately after breakfast or your first main meal
  • this dose will be adjusted by your doctor according to your response to treatment
  • total daily dose rarely exceeds 15mg
  • your total daily dose should normally be taken as a single dose at breakfast, or with your first main meal.

Infirm patients

Such patients may be more at risk of hypoglycaemia, therefore treatment should be started with one 2.5mg tablet daily.

Children

  • Glibenclamide tablets like any other medicine belonging to its class, is not recommended for use in children.

You may be changed to glibenclamide from other drugs. Your doctor will decide the right dose for you.

Your urine and blood sugar levels should be tested regularly, particularly when you first start taking Glibenclamide Tablets.

If you take more Glibenclamide Tablets than you should

If you (or anybody else, including a child) take more Glibenclamide Tablets than you should, contact your nearest hospital casualty department or your doctor immediately. Always take the container and this leaflet with you. Signs that could indicate you have taken too many are symptoms of low blood sugar which include sweating, hunger, increased heart rate, reduced consciousness, coma or seizures.

If you forget to take Glibenclamide Tablets

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

4. possible side effects

Like all medicines, Glibenclamide Tablets can cause side effects, although not everybody gets them.

As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, seek medical help immediately:

  • rash, itching and/or difficulty breathing.

Side effects that have been reported with Glibenclamide Tablets are:

  • rash
  • itching
  • sensitivity to light
  • skin inflammation
  • jaundice (yellowing of the skin or the whites of the eyes)
  • blistering of the skin, mouth, eyes and genitals
  • changes in blood cells
  • fever
  • liver problems
  • low blood sugar (hypoglycaemia, refer to section 2 of this leaflet)
  • water retention
  • feeling and being sick (nausea/vomiting)
  • problems with blood salt levels
  • anorexia
  • heartburn
  • increased appetite
  • weight gain
  • metallic taste in mouth
  • diarrhoea

Reporting of side effects

If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below:

United Kingdom:

Yellow Card Scheme

Website:

Malta:

ADR Reporting

Website:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store glibenclamide tablets

Keep out of the reach and sight of children.

  • Do not store above 25°C.
  • Store in the original package in order to protect from light and moisture.
  • Glibenclamide Tablets should not be taken after the expiry date on the carton; the expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

  • 6. Further information

What Glibenclamide Tablets look like and the contents of the pack

Glibenclamide 2.5mg Tablets are white circular tablets marked CP on one face and GL2.5 on the other.

Glibenclamide 5mg Tablets are white capsule shaped tablets marked CP on one face and GL5 on the other.

Glibenclamide Tablets are supplied in a blister pack of 28 tablets within an outer carton or plastic containers containing 100 or 500 tablets. Not all pack sizes are marketed.

Marketing Authorisation Holder:

Austin McNeil Ltd., 772 Fulham Road, London, England, SW6 5SJ

Manufacturer:

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only).

Please be ready to give the following information:

Product name

Reference number

Glibenclamide 2.5mg Tablets

PL 53797/0028

Glibenclamide 5mg Tablets

PL 53797/0029

This is a service provided by the Royal National Institute of Blind People.

Leaflet last revised in October 2021

Frequently Asked Questions

What is Glibenclamide 2.5 mg used for?

Glibenclamide 2.5 mg is primarily used to help control blood sugar levels in patients with type 2 diabetes.

How does Glibenclamide work in the body?

Glibenclamide works by stimulating the pancreas to produce more insulin, which helps lower blood sugar levels.

Can I take Glibenclamide if I am pregnant?

If you are pregnant or planning to become pregnant, consult your doctor before taking Glibenclamide.

What should I do if I miss a dose of Glibenclamide?

If you miss a dose of Glibenclamide, take it as soon as you remember. If it’s close to the next dose, skip the missed dose and continue your normal schedule.

Are there any common side effects of Glibenclamide?

Yes, some common side effects may include low blood sugar (hypoglycemia), nausea, and dizziness.

Is Glibenclamide suitable for everyone with diabetes?

No, Glibenclamide is not suitable for everyone. Your doctor will determine if it's the right medication for your condition.

Can Glibenclamide be taken with other diabetes medications?

Yes, Glibenclamide can be taken with other diabetes medications, but always consult your healthcare provider first.

How should I store Glibenclamide tablets?

Store Glibenclamide tablets in a cool, dry place away from direct sunlight and out of reach of children.

Can lifestyle changes help when taking Glibenclamide?

Yes, adopting a healthy diet and regular exercise can enhance the effectiveness of Glibenclamide in managing blood sugar levels.

What should I do if I experience severe low blood sugar while on Glibenclamide?

If you experience severe low blood sugar symptoms like confusion or loss of consciousness, seek immediate medical assistance.

How often should I check my blood sugar while on Glibenclamide?

It’s recommended to monitor your blood sugar levels regularly as advised by your healthcare provider.

Can I drink alcohol while taking Glibenclamide?

Drinking alcohol can increase the risk of low blood sugar. Discuss alcohol consumption with your doctor.

How long does it take for Glibenclamide to start working?

Glibenclamide typically starts working within a few hours after ingestion to lower blood sugar levels.

What if I have kidney problems—can I still take Glibenclamide?

If you have kidney issues, inform your doctor as they may need to adjust your dosage or consider alternative medications.

Is there any specific diet I should follow while taking Glibenclamide?

A balanced diet that controls carbohydrate intake is essential. Consult a dietitian for personalized advice.

Can I stop taking Glibenclamide suddenly?

Do not stop taking Glibenclamide without consulting your doctor as this may lead to uncontrolled blood sugar levels.

What are signs of an allergic reaction to Glibenclamide?

Signs of an allergic reaction may include rash, itching, or difficulty breathing. Seek medical attention if these occur.

How does age affect the use of Glibenclamide?

Older adults may be more sensitive to the effects of Glibenclamide; dosage adjustments might be necessary.

Are there alternatives to Glibenclamide for managing diabetes?

Yes, there are several alternatives including metformin and insulin therapies. Your doctor can recommend the best option for you.

Can I take over-the-counter medication while on Glibenclamide?

Always consult your healthcare provider before taking any over-the-counter medications as they could interact with Glibenclamide.