Tolbutamide 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tolbutamide

Available from:

A A H Pharmaceuticals Ltd

ATC code:

A10BB03

INN (International Name):

Tolbutamide

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010201; GTIN: 5012252102628

Patient Information leaflet

Accord logo
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.
• 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 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.
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
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
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)
• 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 heredita

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tolbutamide Tablets BP 500mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg tolbutamide BP
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Round, biconvex white tablets, marked on one side with “T” above a
scoreline and
“500” below it.
The scoreline is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of non - insulin dependent diabetes in patients who
respond
inadequately to dietary treatment. It should not be used to replace
dietetic therapy in
the obese diabetic patient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY_
The tablets may be taken as a single dose with, or immediately after,
the first
main meal of the day, or as a divided dose for optimum control of
blood sugar.
_Treatment of previously untreated diabetes_: stabilisation can be
achieved
commencing with 2 tablets (1 g) daily, and adjusting in the light of
the
patient's individual response. The average daily dose is 1-3 tablets
(0.5 –
1.5 g) which can be taken as a single or divided dose. In general,
patients
who do not respond to 4 tablets (2 g) do not respond to higher doses.
_Change over from other oral hypoglycaemics:_ It is possible to freely
inter-
change hypoglycaemic agents (including chlorpropamide) without a break
in treatment, starting with 2 tablets (1 g) daily, followed by a
maintenance
dose depending on response.
_Combination with biguanides_: If adequate control is not achieved
with diet
and 4 tablets (2 g) of tolbutamide daily, it can often be achieved by
combined administration with a biguanide derivative.
_Change over from insulin_: Some patients with non - insulin dependent
diabetes and who are already taking insulin may be changed to
tolbutamide. Low insulin doses (less than 20 units) can be replaced
immediately. With higher doses a gradual change is advisable by giving
insulin and tolbutamide concurrently and gradually reducing the dose
of
insuli