Patient leaflet - Tolbutamide 500 mg tablets
1. What Tolbutamide Tablet is and what it is used for
- medicines used to prevent blood clotting (e.g. warfarin or dicoumarol)
2. What you need to know before you take Tolbutamide Tablets
- medicines used to treat depression such as Monoamine Oxidase Inhibitors (MAOIs), such as moclobemide
- How to take Tolbutamide Tablets
- Possible side effects
- medicines used to treat mental health problems such as lithium
- How to store Tolbutamide Tablets
- Contents of the pack and other information
- medicines to treat high blood pressure such as beta-blockers (e.g. propranolol, atenolol)
- diuretics (water tablets) such as
WHAT TOLBUTAMIDE TABLET IS AND WHAT IT IS USED FOR
hydrochlorothiazide, bendroflumethiazide
- the oral contraceptive pill
- cyclophosphamide (used to treat some cancers)
Tolbutamide is one of a group of medicines called oral hypoglycaemics. These medicines are used to control blood sugar levels in some types of diabetes.
- salicylates (used for muscular or skeletal disorders e.g. aspirin).
Tolbutamide Tablets with food, drink and alcohol
Tolbutamide tablets may be used to control blood sugar in patients with mild to moderate diabetes, which cannot be controlled by diet alone. Tolbutamide tablets should only be used to treat diabetes which occurs mainly in adults (type 2 or non-insulin dependent diabetes).
You are advised not to drink alcohol with this medicine. Talk to your doctor if you have any questions.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
If you are overweight, treatment with Tolbutamide tablets should not replace your dietary restrictions.
Driving and using machines
Make sure your blood sugar levels are under control before you drive or operate machinery.
- 2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOLBUTAMIDE TABLETS
Tolbutamide Tablet contains lactose
Do not take Tolbutamide tablets and tell your doctor if you:
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 medicinal product.
- are allergic to Tolbutamide tablets or any of the other ingredients of this medicine (listed in section 6).
- have ever had a severe diabetic reaction (such as “acidosis” or diabetic coma)
3. HOW TO TAKE TOLBUTAMIDE TABLETS
have diabetes that needs to be treated by insulin (type 1 or insulin dependent diabetes)
Always take Tolbutamide Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
- have severe kidney, liver, thyroid or adrenal gland disease
suffer from a condition called porphyria have a hereditary disease affecting the liver or bone marrow
The recommended dose is:
Untreated diabetes
Initially two tablets daily. The maintenance dose will depend upon your response to treatment; the usual daily dose is 1-3 tablets daily.
- are experiencing unusual stress or are breast-feeding
need an operation.
Change from other tablets
Warnings and precautions
Talk to your doctor before taking Tolbutamide tablets if:
- you are debilitated (“run down”) or are elderly
Change from insulin
Low insulin doses (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.
Taking with biguanides
If you do not achieve adequate control of your diabetes through diet and 4 tablets of tolbutamide daily then your doctor may also give you a biguanide drug, such as metformin, to help you control your blood sugar levels.
Elderly
If you are elderly your doctor may have initially started your treatment on a lower dose of Tolbutamide.
Children
This medicine is not recommended for children and adolescents.
Swallow these tablets with or immediately after the first main meal of the day or in smaller doses throughout the day with meals. Take this medicine for as long as your doctor tells you to.
If you take more Tolbutamide Tablets than you should:
If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include feeling or being sick, sweating, fast breathing or heart rate, low blood pressure, odd behaviour, drowsiness, fits or coma.
If you forget to take Tolbutamide Tablets
Take it as soon as you remember, unless it is nearly time for your next dose. Then carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Tolbutamide Tablets
Talk to your doctor before stopping treatment with this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tolbutamide Tablets can cause side effects although not everybody gets them. Stop taking Tolbutamide Tablets and contact your doctor at once if you experience:
- An allergic reaction: skin rash, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing. This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
- Blood: anaemia. Tolbutamide may change the number of certain types of cells in the blood, if you notice an increase in in the number of infections or sore throats you are getting, bruising and or nose bleeds, tell your doctor.
- Metabolism: low blood sugar (sweating, shaking, double vision, slurred speech, confusion)
- Ears: ringing in the ear
- Liver: jaundice (yellowing of the skin and/or eyes), changes in liver function (as seen in blood tests)
- Hypersensitivity effects: sensitivity to light, skin rashes
Nervous system: headache, tingling (pins and needles)
- Stomach: feeling or being sick, diarrhoea, constipation, increased or decreased appetite or weight gain
- Other effects: an intolerance to alcohol causing facial flushing.
Reporting of side effects
If you notice any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE TOLBUTAMIDE TABLETS
Keep this medicine out of the sight and reach of children. Store in the original package in order to protect from light. Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Tolbutamide Tablet contains
The active substance (the ingredient that makes the tablets work) is tolbutamide. Each tablet contains 500 mg of tolbutamide.
The other ingredients are lactose, maize starch, sodium starch glycollate, magnesium stearate, stearic acid, methylcellulose, pregelatinised starch.
What Tolbutamide Tablet looks like and contents of the pack
Tolbutamide tablets are white, flat, bevel-edged tablets with MP43 engraved on one side. Tolbutamide is available in blister pack of 28 tablets or in containers of 100, 112 or 500 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited,
41 - 43 Klimentos, Klimentos Tower,
Nicosia 1061, Cyprus
Manufacturer
Haupt Pharma Berlin GmbH,
Moosrosenstraße 7
12347 Berlin, Germany
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 05/2020.
GE0062/O/PIL/GE4