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TOLBUTAMIDE TABLETS BP 500MG

Active substance(s): TOLBUTAMIDE / TOLBUTAMIDE / TOLBUTAMIDE

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Package Leaflet: Information for the user

Tolbutamide 500mg tablets
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• K
 eep 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
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.

• have severe kidney, liver, thyroid or adrenal gland disease
• are experiencing unusual stress or are breast-feeding.
• need an operation
• suffer from a condition called porphyria (a hereditary
disease affecting the liver or bone marrow).

What is in this leaflet
1 What Tolbutamide tablets are and
what they are used for
2 Before you take Tolbutamide tablets
3 How to take Tolbutamide tablets
4 Possible side effects
5 How to store Tolbutamide tablets
6 Contents of the pack and other
information

Children and adolescents

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
diabetes).
If you are overweight treatment with Tolbutamide tablets
should not replace your dietary restrictions.

2 Before you take Tolbutamide tablets
Do not take Tolbutamide tablets if you:

• 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)
• have diabetes that needs to be treated by insulin (type 1 or
insulin dependent diabetes)

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.
• have an inherited condition where your red blood cells
don’t produce enough of the enzyme G6PD (glucose 6
phosphate dehydrogenase).
This medicine is not recommended for children and
adolescents.

Other medicines and Tolbutamide tablets

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription.
• medicines to treat high blood pressure such as beta blockers
(e.g. propranolol, atenolol)
• adrenaline (epinephrine)
• antibiotics used to treat infections such as chloramphenicol,
rifampicin or sulfonamides such as Sulfafurazole
• medicines used to prevent blood clotting (e.g. warfarin or
dicoumarol)
• medicines used to treat depression such as monoamine
oxidase inhibitors (MAOIs e.g. moclobemide)
• 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,
hydrochlorothiazide
• the oral contraceptive pill
• salicylates (used for muscular or skeletal disorders e.g.
aspirin)

Tolbutamide tablets and alcohol:

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 or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

Continued top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Tolbutamide Tablets
500mg x all sizes (UK)

Tolbutamide 500mg 28 Tablets PIL - UK
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Item no:

BBBA1159

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

JDE No.:

S.Anson
18.08.17
23.08.17
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
148 x 210
Min Body Text Size: 7pt
Supplier:
Actavis UK

50939462

Colours

Non Printing Colours

1. Black

1. Profile

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

2.

2.

Pharmacode: 3999

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Date Sent:
14/08/17
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Driving and using machines:

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

3 How to take Tolbutamide tablets

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

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.
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.
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.

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.
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 flushing.

Reporting of side effects

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

5 How to store Tolbutamide tablets

Keep out of the sight and reach of children. Store below 25°C in a
dry place. Do not use this medicine after the expiry date stated on
the carton after EXP. 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 C
 ontents of the pack and other
information

What Tolbutamide tablets contain

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

What Tolbutamide tablets look like and
contents of the pack

Tolbutamide tablets are white circular uncoated tablets
which come in one strength. Pack sizes are 28 and 112.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in August 2017

4 Possible side effects

Like all medicines, this medicine can cause side-effects although
not everybody gets them.

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

Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

50939462 BBBA1159

148x210 Leaflet Reel Fed Profile (BST)

Tolbutamide Tablets
500mg x all sizes (UK)

Tolbutamide 500mg 28 Tablets PIL - UK
approved for print/date

Proof Round

3

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA1159

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

JDE No.:

S.Anson
18.08.17
23.08.17
S.Anson

Date sent:
N/A
Date received: N/A

Dimensions:
148 x 210
Min Body Text Size: 7pt
Supplier:
Actavis UK

50939462

Colours

Non Printing Colours

1. Black

1. Profile

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

2.

2.

Pharmacode: 3999

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Date Sent:
14/08/17
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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