Levothyroxine sodium 50microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levothyroxine sodium anhydrous

Available from:

Accord-UK Ltd

ATC code:

H03AA01

INN (International Name):

Levothyroxine sodium anhydrous

Dosage:

50microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06020100; GTIN: 5012617009258 5012617001382

Patient Information leaflet

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Levothyroxine Tablets
50 & 100’s x 28’s (UK)
148x210 (Reel Fed)
50920526
Leaflet for Blisters
7203
R.Wrey
17/02/17
148x210 Leaflet Reel Fed Profile (BST)
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LEVOTHYROXINE TABLETS 50MCG & 1000MCG X 28 & 100’S PIL -UK
Black
Profile
BBBA0535
C.Grant
20/02/17
148x210
7.75 pt
Actavis UK
N/A
01
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
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.
DO NOT PASS IT ON TO OTHERS. IT MAY HARM
THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME
AS YOURS.
•
THYROXINE IS A HORMONE PRODUCED BY
THE THYROID GLAND. LEVOTHYROXINE IS
USED TO REPLACE THYROXINE IN PEOPLE
WHOSE THYROID GLAND DOES NOT WORK
PROPERLY. YOU WILL USUALLY NEED TO TAKE
THIS MEDICINE FOR THE REST OF YOUR LIFE AND
MUST NOT STOP TAKING IT, OR CHANGE THE
DOSE, WITHOUT SPEAKING TO YOUR DOCTOR
FIRST.
•
THIS MEDICINE CAN AFFECT THE WAY OTHER
MEDICINES WORK (SEE SECTION 2 ‘TAKING
OTHER MEDICINES’). IF YOU TAKE MEDICINES
TO CONTROL DIABETES OR WARFARIN TO
PREVENT BLOOD CLOTS, THE DOSE MAY NEED
TO BE ADJUSTED BY YOUR DOCTOR WHEN YOU
START TAKING LEVOTHYROXINE TABLETS.
• YOU WILL START OFF TAKING A LOW DOSE OF THIS
MEDICINE (SEE SECTION 3 ’HOW TO TAKE’).
YOUR DOCTOR WILL THEN INCREASE THE DOSE
GRADUALLY AT 3-4 WEEK INTERVALS UNTIL
YOUR THYROXINE LEVELS ARE CORRECTED. THIS
WILL

Summary of Product characteristics

OBJECT 1
LEVOTHYROXINE TABLETS BP 50 MICROGRAMS
Summary of Product Characteristics Updated 21-Jul-2014 | Accord-UK Ltd
1. Name of the medicinal product
LEVOTHYROXINE TABLETS BP 50 micrograms
2. Qualitative and quantitative composition
Each tablet contains 50 micrograms anhydrous Levothyroxine Sodium.
3. Pharmaceutical form
White uncoated tablets.
White, circular, biconvex uncoated tablets impressed “C“ on one face
and the identifying letters “T“
and “A“ on either side of a central division line on the reverse.
4. Clinical particulars
4.1 Therapeutic indications
Recommended clinical indications:
1. control of hypothyroidism,
2. congenital hypothyroidism in infants
3. acquired hypothyroidism in children
4. juvenile myxoedema.
4.2 Posology and method of administration
_Posology_
It is recommended that the tablets should be administered before
breakfast or your first meal of the day.
_Adults: _Initially 50-100 micrograms daily, then adjusted at 3-4 week
intervals by 50 microgram
increments until normal metabolism is steadily maintained. This may
require doses of up to 100-200
micrograms daily.
_Patients over 50 years: _
It is not advisable to exceed 50 micrograms a day initially. The dose
may then be increased by 50
micrograms every 3-4 weeks until thyroxine levels are correct. A final
dose is between 50-200
micrograms daily.
In younger patients, and in the absence of heart disease, a serum
levothyroxine (T4) level of
approximately 70-160 nanomoles/litre or a serum thyrotrophin level of
less than 5 milli-units/litre should
be aimed at. In those aged over 50, and/or in the presence of heart
disease, clinical response is probably a
more acceptable criterion of dosage than serum levels.
A pre-therapy ECG is valuable, as changes induced by hypothyroidism
may be confused with ECG
evidence of ischaemia. If too rapid an increase of metabolism is
produced, dosage should be reduced or
withheld for a day or two, then recommenced at a lower level.
_Patients over 50 years with heart disease:_
Where there is cardiac disease