Tolbutamide Tablets Bp 500mg
Patient Information Leaflet GB797-9172-APIL
Tolbutamide 500 mg Tablets
Read all of this leaflet carefully before you start taking this medicine.
• Please 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. 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 become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Tolbutamide 500 mg Tablets are and what they are used for
2. Before you take Tolbutamide 500 mg Tablets
3. How to take Tolbutamide 500 mg Tablets
4. Possible side effects
5. How to store Tolbutamide 500 mg Tablets
6. Further information
1. WHAT TOLBUTAMIDE 500 MG TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Tolbutamide 500 mg Tablets. The active ingredient is tolbutamide.
Tolbutamide is one of a group of medicines called oral hypoglycaemics. These are used to treat diabetes of the non-insulin dependent type (type 2 or maturity onset diabetes), which does not respond to dietary measures. This usually only occurs in adults. Tolbutamide Tablets lower the sugar content in your blood if this is too high.
2. BEFORE YOU TAKE TOLBUTAMIDE 500 MG TABLETS Do not take this medicine if you:
• have ever had an allergic reaction to tolbutamide or any of the other ingredients of this medicine;
• have diabetes that needs to be treated by insulin (type 1 or insulin dependent diabetes);
• have ever had diabetic ketoacidosis (the symptoms of this include unusual smelling breath, drowsiness, confusion, feeling or being sick and difficulty breathing);
• have serious liver or kidney problems;
• have serious problems with your adrenal or thyroid glands;
• are under unusual stress;
• are in the first trimester of pregnancy;
• have an uncommon inherited blood disorder called porphyria.
Check with your doctor or pharmacist before taking this medicine if you:
• experience the symptoms of low blood sugar (such as sweating, pallor, hunger, faster heart beat and feeling unwell);
• are debilitated ('run down') or are elderly;
• have had any problems taking medicines used to treat diabetes;
• have an infection.
Check with your doctor or pharmacist if you are taking other medicines such as:
• medicines which provide contraception e.g. oral contraceptives (the pill);
• medicines known as beta-blockers and thiazide diuretics which are used to treat a range of heart problems such as chest pain, irregular heartbeats heart failure or high blood pressure and generalised swelling (oedema);
• medicines used to treat diabetes;
• medicines used to prevent blood clotting e.g. warfarin or coumarins;
• a herbal medicine called Ginkgo biloba extract;
• a medicine used to suppress the immune system known as cyclophosphamide;
• medicines known as corticosteroids e.g. prednisolone;
• the antibiotics called chloramphenicol and rifampicin and antibiotics belonging to a group commonly know as sulphonamides;
• voriconazole, fluconazole and ketoconazole which are used to treat fungal infections;
• a medicine called lithium which is used to treat mental depression;
• monoamine oxidase inhibitors (MAOIs), for which you may carry a warning card and which are used to treat depression;
• salicylates, e.g. aspirin used to treat pain;
• adrenaline.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or if you are breast-feeding. Driving and using machines
If you experience the symptoms of low blood sugar (hypoglycaemia), especially at the beginning of treatment, you should not drive or operate machinery.
Taking Tolbutamide 500 mg Tablets with food and drink:
• ask your doctor or pharmacist about your specific dietary requirements;
• you are advised NOT to drink alcohol with this medicine.
3. HOW TO TAKE TOLBUTAMIDE 500 MG TABLETS
Doses
Your doctor will tell you how and when to take your medicine. Follow the instructions on the pharmacy label, which should tell you how many tablets to take in a day. If it does not or you are unsure, consult your doctor or pharmacist.
These tablets should be taken either with or immediately after the first main meal of the day or in smaller doses throughout the day with meals.
Treatment of previously untreated diabetes: The usual starting dose is two tablets daily, but your doctor may advise you to increase or reduce this until he/she is satisfied that your blood sugar is properly under control.
Change over from other oral hypoglyaiemic (e.g. chlorpropamide):
You can usually change between different oral hypoglycaemic drugs without a break in treatment. Initially, 1 g (2 tablets) is given.
The maintenance dose will depend on response.
Change over from insulin: For some cases of non-insulin dependent diabetes, low insulin doses (less than 20 units) can be replaced immediately. With high insulin doses a gradual change is required. Insulin and tolbutamide will be given together, and the insulin dose will be gradually reduced.
If you do not achieve adequate control of your diabetes through diet and 2 g (4 tablets) of tolbutamide daily then your doctor may also give you a biguanide drug, such as metformin, to help control your blood sugar levels.
Your doctor will inform you on your specific dosage needs if you are changing over from other medicines which you have been taking for this condition, or if Tolbutamide 500 mg Tablets must be used together with another medicine to keep your illness in control.
If you are run-down or elderly or suffer from kidney problems, you will be advised specifically on how many and how often to take the tablets.
Do not exceed the prescribed dose.
Continue to take them for as long as your doctor tells you to, it is dangerous to stop without their advice.
THESE TABLETS ARE NOT RECOMMENDED FOR CHILDREN.
If you take more tablets than you should:
If you take too many Tolbutamide Tablets, this may result in a very low blood sugar level, which may make you feel very ill. Tell your doctor at once or go to your nearest hospital casualty department where you may be given sugar water. In certain cases you may also need an injection or intravenous drip. If possible take this leaflet and the tablets with you to show the doctor what you have taken.
If you forget to take your tablets:
If you miss a dose take another as soon as you remember unless it is nearly time for the next dose. Never double-up on the next dose to make up for the one you missed.
4. POSSIBLE SIDE EFFECTS
Like all medicines Tolbutamide 500 mg Tablets can cause unwanted side effects in some people, although they are generally well tolerated.
If the following symptoms occur, please tell your doctor immediately. Symptoms of hypoglycaemia (low blood glucose levels):
• quickening ofyour heart rate;
• sweating;
• pallor;
• feeling dizzy or hungry;
• blurred vision;
• inability to concentrate.
Such symptoms are more common in elderly and debilitated patients. Symptoms of allergic reactions:
• itching and/or rash;
• swelling of face, lips, tongue and/or throat;
• difficultly in swallowing;
• difficulty breathing.
If you feel very tired, experience unexpected bruising or bleeding, or more infections (e.g. colds and sore throats) than usual please tell your doctor. Your doctor may decide to conduct tests on your blood periodically as a result of these symptoms.
Other side effects may include:
• headache;
• sensitivity to light, which may mean that your skin is more sensitive to the effects of the sun;
• tingling in hands or feet (pins and needles);
• feeling or being sick;
• diarrhoea;
• constipation;
• increased or decreased appetite or weight gain;
• skin or eyes appearing yellowish (jaundice);
• tinnitus;
• an intolerance to alcohol, which may mean that alcohol affects you more than usual or makes you feel unwell.
If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
5. HOW TO STORE TOLBUTAMIDE 500 MG TABLETS.
Do not store above 25°C. Keep in the original container in which they were
packed. Do not use after the expiry date that is stated on the
carton.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN Return any unused medicines to your pharmacist.
6. FURTHER INFORMATION
What Tolbutamide 500 mg Tablets contain
Each tablet contains 500 mg of the active substance, tolbutamide.
The other ingredients are: starch, povidone, sodium starch glycollate, stearic acid and magnesium stearate.
What Tolbutamide 500 mg Tablets look like and the contents of the pack
Tolbutamide 500 mg Tablets are round, biconvex white tablets. Marked on one side with "T" above a breakline and "500" below it. They are available in containers of 28,50 and 500 and blister packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer responsible for release:
Waymade Pic. Sovereign House, Miles Gray Road, Basildon. Essex. SS14 3FR.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This information in this leaflet applies only to Tolbutamide 500 mg Tablets.
This leaflet was last approved in: April 2011