Tolbutamide 500mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Tolbutamide

Prieinama:

Kent Pharma (UK) Ltd

ATC kodas:

A10BB03

INN (Tarptautinis Pavadinimas):

Tolbutamide

Dozė:

500mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 06010201; GTIN: 5015201006480

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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. 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
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.
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.
If you are run down or elderly or suffer from

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tolbutamide 500mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Tolbutamide 500mg
3.
PHARMACEUTICAL FORM
Tablet.
White biconvex tablets, 13mm in diameter with a breakline;
“T” above breakline and “500 below.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tolbutamide is indicated for the oral treatment of patients with
non-insulin dependent
diabetes (maturity-onset or type II diabetes) who respond inadequately
to dietary
treatment alone.
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.
1.
Treatment
of
previously
untreated
diabetes.
Stabilisation
can
be
achieved
by
commencing with 2 tablets daily, and adjusting in the light of the
patient’s individual
response. The average daily dose is 1-3 tablets as a single or divided
dose. In
general, patients who do not respond to 4 tablets daily do not respond
to higher doses.
2.
Change over from other oral antidiabetics can usually be carried out
without a break
in therapy, starting with 2 tablets daily, followed by a maintenance
dose depending on
response
3.
Combination with biguanides: If adequate control is not achieved with
diet and 4
tolbutamide 500mg tablets daily, it can often be achieved by combined
administration
with biguanides.
4.
Change-over from insulin: Some cases of non-insulin dependent diabetes
previously
treated with insulin can be changed to tolbutamide. Low insulin doses
(less than 20
units) can be replaced immediately. With higher doses a gradual change
is advisable.
Children:
Not recommended
Elderly:
treatment at a lower dose.
Method of administration
For oral use
4.3
Contraindications
Hypersensitivity to the active ingredient or any of the excipients
Should not be used in patients who have or have ever had diabetic
ketoacidosis, who
have insulin-dependent diabetes, serious impairment of ren