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TOLBUTAMIDE 500MG TABLETS

Active substance(s): TOLBUTAMIDE / TOLBUTAMIDE / TOLBUTAMIDE

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Other Medicines and Tolbutamide
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
The activity and safety of this treatment may be
affected if this medicine is taken at the same time
as certain other medicines. Conversely, other
medicines may be affected if they are taken at the
same time as this medicine. The blood sugar
lowering effects of your medicine may be
strengthened and signs of low blood sugar levels
may occur when one of the following drugs is
taken:
• medicines to treat high blood pressure such as
beta blockers (e.g. propranolol, atenolol), ACE
inhibitors (e.g. captopril) and fibrates (e.g.
clofibrate).
• adrenaline (epinephrine).
• allopurinol and sulfinpyrazone (used in the
treatment of gout).
• antibiotics used to treat infections, such as
chloramphenicol, rifampicin, fluoroquinolones,
tetracyclines or sulphonamides such as
sulfafurazole and co-trimoxazole.
• certain antifungal medicines (e.g. fluconazole).
• cimetidine and ranitidine (used for stomach
ulcers).
• medicines used to prevent blood clotting (e.g.

If your treatment plan is not correct you may
suffer from the following conditions:
• low blood sugar (hypoglycaemia)
Symptoms include: sweating, paleness,
headache, faintness or drowsiness
• high blood sugar (hyperglycaemia)
Symptoms include: thirst, frequent urination, dry
mouth, dry itching skin, fungal or skin infections
Please inform your doctor if you experience any
of these symptoms so that your dose can be
changed.
Tolbutamide with food and drink
Alcohol can enhance or diminish the ability of
your medicine to reduce blood sugar in an
unpredictable manner. You are advised NOT to
drink alcohol with this medicine.
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.
This medication should not be taken during
pregnancy. If pregnancy is planned you should
discuss the treatment plan with your doctor. If you
become pregnant during your treatment you
should inform your doctor immediately. Do not
take Tolbutamide 500mg Tablets if you are
breast-feeding.
Driving and using machines
Your ability to concentrate or react may be
impaired if your blood sugar is lowered
(hypoglycaemia), or raised (hyperglycaemia) or if
you develop visual problems as a result of such
conditions. Make sure your abilities are not
affected before you drive or operate machinery.

3.

HOW TO TAKE YOUR MEDICINE

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
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 forget to take Tolbutamide 500mg
Tablets
If you forget to take a dose, take your next dose
as soon as you remember, unless it is nearly time
to take the next one. Take the remaining doses at
the correct time. Do not take a double dose to
make up for a missed dose.
If you stop taking Tolbutamide 500mg Tablets
If you interrupt or stop the treatment you should
be aware that the desired blood sugar lowering
effect will not be achieved and you may
experience hyperglycaemia. If any change is
necessary it is important for you to contact your
doctor first.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

6.

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Tolbutamide 500mg Tablets contains
• The active substance is Tolbutamide.
• The other ingredients are maize starch,
magnesium stearate, stearic acid, povidone
(K90) and sodium starch glycollate.
What Tolbutamide 500mg Tablets looks like
and contents of the pack
Tolbutamide 500mg Tablets are white, biconvex
tablets with a breakline containing 500mg
tolbutamide. Each tablet is marked with the
characters “T” and “500”.
• Pots are available in pack sizes of 28, 50, 100
& 500 tablets.
• Blister pack is available in a pack size of 28
tablets.
Not all pack sizes or pack types may be
marketed.
Marketing Authorisation Holder and
Manufacturer
Kent Pharmaceuticals Limited, Crowbridge Road,
Ashford, Kent TN24 0GR, U.K
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.
Distributor
Kent Pharmaceuticals Limited,
Repton Road, Measham, DE12 7DT, U.K.
PL 08215/0007
This leaflet was revised February 2017.

Like all medicines, Tolbutamide 500mg Tablets
can cause side effects, although not everybody
gets them. Most side effects are dose-dependent
and disappear when the dose is reduced or if the
medicine is no longer taken. Side effects occur
most often at the start of treatment. Side effects
are generally mild and temporary.
If you experience any of the following events
you should tell your doctor immediately, as
these are signs of an allergic reaction and
your medication may need to be discontinued:
• itchy skin, rash and hives.
• swelling of the face, lips, tongue or throat or
difficulty breathing or swallowing.
• your skin or eyes appear yellow (liver failure/
hepatitis).
The following events are less serious but you
may wish to discuss them with your doctor or
pharmacist if they become troublesome or
last a long time.
• sensitivity to light, skin rashes.
• anaemia.
• low blood sugar (sweating, shaking, double
vision, slurred speech, confusion).
• headache, tingling sensation.
• ringing in the ear.
CP.TOL.500T.ID.V5P4

Revision:
ARTWORK FOR SUBMISSION
Supersedes: n/a

Warnings and precautions
Talk to 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.
• you have an inherited condition where your red
blood cells don’t produce enough of the
enzyme G6PD (glucose 6 phosphate
dehydrogenase).

Take special care with Tolbutamide 500mg
Tablets
This medication should be taken as part
of a treatment plan, which includes diet,
physical exercise and, where necessary,
weight reduction. During Tolbutamide
treatment regular monitoring of your
blood sugar is necessary. Your doctor
may also take blood tests to monitor your
blood cell levels and liver function.

If you take more Tolbutamide 500mg Tablets
than you should
Call a doctor straight away or go immediately to
the nearest hospital casualty department, taking
the remaining tablets with you. There is a danger
of low sugar levels (symptoms may include
sweating, paleness, headache,
faintness or drowsiness) and therefore
you should instantly consume sugar (e.g.
sugar cubes, sweet juice, sweetened
tea). Persons in a state of
unconsciousness must not be given food
or drink.

KEEP THIS MEDICINE OUT OF THE SIGHT
AND REACH OF CHILDREN.
Do not use after the expiry date that is stated on
the outer packaging.
Do not store above 25ºC. Store in the original
container or package.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These
measures will help to protect the environment.

09 FEB 17

Do not take Tolbutamide 500mg Tablets if you:
• have ever had an allergic reaction to
tolbutamide or any of the ingredients in
the tablet. An allergic reaction may include a
rash, itching, difficulty breathing or swelling of
the face, lips, throat or tongue.
• have diabetes that needs to be treated by
insulin (type 1 or insulin dependent diabetes).
• have ever had a severe diabetic reaction such
as “acidosis” (a complication of diabetes with
rapid weight loss, nausea or vomiting) or
diabetic coma.
• have severe kidney, liver, thyroid or adrenal
gland disease.
• are particularly stressed.
• are breast-feeding.
• suffer from a condition called porphyria (a
hereditary disease affecting the liver or bone
marrow).
If you need to have an operation, tell your doctor
you are taking Tolbutamide.

Use in Children
These tablets are generally not suitable for
children, as children usually have insulindependent (type 1) diabetes, which should not be
treated with tolbutamide.

HOW TO STORE YOUR MEDICINE

Proof No and Date: 4

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE YOUR MEDICINE

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.

5.

Pantone Blue
280 C

2.

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 another
drug, such as metformin, to help you control your
blood sugar levels.

Item Code: CP.TOL.500T.ID.V5P4

Tolbutamide 500mg Tablets is a medicine used to
reduce blood sugar levels. It is one of a group of
medicines called oral hypoglycaemics, which
control blood sugar levels in some types of
diabetes (type 2 diabetes mellitus). Tolbutamide is
used to treat diabetes of the non-insulin
dependent type, which does not respond to
dietary measures. This generally only occurs in
adults. It lowers the sugar content in your blood if
this is too high.

warfarin, heparin or dicoumarol).
• medicines used to treat depression such as
monoamine oxidase inhibitors (MAOIs) and
tricyclic antidepressants.
• medicines used to treat mental health
problems such as lithium.
• corticosteroids (strong anti-inflammatory
medicines).
• cyclophosphamide (used to treat some
cancers).
• phenylbutazone and azapropazone
(non-steroidal anti-inflammatory pain killers).
• diuretics (water tablets) such as
bendroflumethiazide, hydrochlorothiazide.
• the contraceptive pill.
• salicylates (used for muscular or skeletal
disorders).
• octreotide (used to treat certain tumours).
• some herbal medicines such as St John’s Wort
and Ginkgo biloba.

Pharma Code

1.

WHAT YOUR MEDICINE IS AND WHAT
IT IS USED FOR

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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. By
reporting side effects you can help provide more
information on the safety of this medicine.

Dimensions: 150mm x 360mm

WHAT IS IN THIS LEAFLET
1. What your medicine is and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information

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. If you notice any side effects not
mentioned in this leaflet, please inform your
doctor or pharmacist.

Product: Tolbutamide 500mg Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

• nausea, vomiting, diarrhoea, constipation,
increased or decreased appetite or weight
gain.
• an intolerance to alcohol causing facial
flushing.

Colours

TOLBUTAMIDE 500mg TABLETS

The dose is fixed by the doctor, depending on
your blood and urine sugar levels. Changes in
external factors (e.g. weight reduction, change in
life style, stress) or improvements in the disease
may require changed tolbutamide doses.
The recommended doses are given below.
• 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. Initially two tablets
daily. The maintenance dose will depend upon
your response to treatment.
• 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.

Originator: Kent Pharma (SCY)

Package Leaflet: Information for the Patient

Customer: ID

CP.TOL.500T.ID.V5P4

Expand Transcript

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.

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