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Active substance: TOLBUTAMIDE

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Tolbutamide 500mg tablets
Read all of this leaflet carefully before
you start taking this medicine.
• Keep this leaflet. You may need to read it
• 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.

1 What Tolbutamide tablets are
and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Tolbutamide tablets are and what they
are used for

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.
Tolbutamide tablets may be used to:
• control blood sugar in patients with mild to moderate
diabetes which cannot be controlled by diet alone.
Tolbutamide should only be used to treat diabetes which
occurs mainly in adults (type 2 or non-insulin dependent
If you are overweight treatment with Tolbutamide
tablets should not replace your dietary restrictions.

2 Before you take

Do not take Tolbutamide tablets and tell your
doctor if you:

• have ever had an allergic reaction to Tolbutamide
tablets or any of the ingredients in the tablet. (Please
refer to section 6, further information) An allergic
reaction may include a rash, itching, difficulty
breathing or swelling of the face, lips, throat or tongue
• have ever had a severe diabetic reaction (such as
“acidosis” or diabetic coma)
• have diabetes that needs to be treated by insulin
(type 1 or insulin dependent diabetes)
• have severe kidney, liver, thyroid or adrenal gland
• are experiencing unusual stress or are breastfeeding.
• need an operation
• suffer from a condition called porphyria (a hereditary
disease affecting the liver or bone marrow).
Continued top of next column

Check with your doctor or pharmacist before
taking Tolbutamide tablets if:

• you are debilitated (“run down”) or are elderly
• the number of sore throats or fevers you experience
increases or you develop spontaneous bruising or
bleeding. Your doctor may wish to test your blood
• you have mild kidney disease.
• have an inherited condition where your red blood cells
don’t produce enough of the enzyme G6PD (glucose 6
phosphate dehydrogenase).

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. Especially:
• medicines to treat high blood pressure such as beta
blockers (eg propranolol, atenolol)
• adrenaline (epinephrine)
• antibiotics used to treat infections such as
chloramphenicol, rifampicin or sulphonamides such as
• medicines used to prevent blood clotting (eg warfarin
or dicoumarol)
• medicines used to treat depression such as
monoamine oxidase inhibitors (MAOIs e.g.
• medicines used to treat mental health problems such
as lithium
• corticosteroids used to reduce inflammation in the
body (e.g. prednisolone)
• cyclophosphamide (used to treat some cancers)
• phenylbutazone (a non steroidal anti-inflammatory
pain killer)
• diuretics (water tablets) such as bendroflumethiazide,
• oestrogen (a hormone used in the contraceptive pill)
• salicylates (used for muscular or skeletal disorders e.g.

Taking Tolbutamide tablets with food and drink:

You are advised not to drink alcohol with this medicine.
Discuss this with your doctor if you have any questions.

Pregnancy and breast-feeding:

If you are pregnant, planning to become pregnant or are
breast-feeding ask your doctor or pharmacist for advice
before taking this medicine.

Driving and using machines:

Make sure your blood sugar levels are under control
before you drive or operate machinery.

Continued over page

3 How to take

Always take Tolbutamide tablets exactly as your doctor
has told you. If you are not sure, check with your doctor or
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.
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.
Change from other tablets
You can usually change between different diabetes tablets
without a break in treatment. 2 tablets initially then
maintenance dose will depend on response.
Change from insulin
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.
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.
If you are elderly your doctor may have initially started your
treatment on a lower dose of tolbutamide.
These tablets are generally not suitable for children, as
children usually have insulin-dependent (type 1) diabetes
which should not be treated with tolbutamide.

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 or drowsiness.

If you forget to take Tolbutamide tablets:

Tell your doctor if you notice any of the following side effects
or notice any other effects not listed:
• Hypersensitivity effects: sensitivity to light, skin rashes.
• Blood: anaemia. Tolbutamide may change the number
and type of cells in the blood, if you notice an increase in
bruising or nose bleeds or in the number of sore throats or
infections you are getting, tell your doctor.
• Metabolism: low blood sugar (sweating, shaking, double
vision, slurred speech, confusion).
• Nervous system: headache, tingling (pins and needles).
• Ears: ringing in the ear.
• Stomach: feeling or being sick, diarrhoea, constipation,
increased or decreased appetite or weight gain.
• Liver: jaundice (Yellowing of the skin and/or eyes), changes
in liver function (as seen in blood tests).
• Other effects: an intolerance to alcohol causing facial
If you notice any side effects, they get worse, or if you notice
any not listed, please tell your doctor or pharmacist.

5 How to store

Keep out of the reach and sight of children.
Store below 25°C in a dry place. Do not use Tolbutamide
tablets after the expiry date stated on the label/carton/bottle.
The expiry date refers to the last day of that 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 to
protect the environment.

6 Further information

What Tolbutamide tablets contain

• The active substance (the ingredient that makes the tablets
work) is tolbutamide. Each tablet contains 500mg of
• The other ingredients are maize starch, stearic acid,
magnesium stearate, microcrystalline cellulose (E460).

What Tolbutamine tablets look like and size of the pack

Tolbutamide tablets are white circular uncoated tablets which
come in one strength. Pack size is 28.
Marketing Authorisation Holder and
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in November 2009.

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 missed dose.

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, or difficulty breathing or swallowing.
This is a very serious but rare side effect. You may need
urgent medical attention or hospitalisation.

Continued top of next column

If you would like a
leaflet with larger
text, please contact
01271 311257.

Actavis, Barnstaple, EX32 8NS, UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.