Propylthiouracil 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Propylthiouracil

Available from:

Macleods Pharma UK Ltd

ATC code:

H03BA02

INN (International Name):

Propylthiouracil

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06020200; GTIN: 8901463122235 8901463122242

Patient Information leaflet

PROPYLTHIOURACIL
25 MG, 50 MG AND
100 MG TABLETS
ARTWORK CODE 05
3.
How to take Propylthiouracil Tablets
4.
Possible side effects
-


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.
PROPYLTHIOURACIL 25MG, 50MG & 100MG TABLETS
1.
What Propylthiouracil Tablets are and what they are used for
2.
What you need to know before you take Propylthiouracil Tablets
WHAT IS IN THIS LEAFLET
-
If you have any further questions, ask your doctor or pharmacist.
1.
WHAT PROPYLTHIOURACIL TABLETS ARE AND WHAT THEY ARE USED FOR
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
6.
Contents of the pack and other information
5.
How to store Propylthiouracil Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
-
Keep this leaflet. You may need to read it again.
The active ingredient in Propylthiouracil Tablets is Propylthiouracil.
Propylthiouracil Tablets are used in the treatment of hyperthyroidism.
Hyperthyroidism is where an overactive thyroid gland produces too
much thyroid hormone. They are also used to treat Graves' disease,
thyrotoxicosis and thyrotoxic crisis (when levels of thyroid hormone
are
dangerously high). Propylthiouracil Tablets may also be given to lower
very high levels of thyroid hormone before surgery or radioactive
iodine
treatment. Children may be given Propylthiouracil Tablets to delay the
need for surgery (or other treatment to remove part of an overactive
thyroid gland).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPYLTHIOURACIL TABLETS
DO NOT TAKE PROPYLTHIOURACIL TABLETS
Ÿ
if you are allergic to Propylthiouracil or any of the other
ingredients
of this medicine (listed in section 6).
This medicine contains less than 1 mmol sodium (23 mg) per dosage
unit, that is to say essentially 'sodium-free’

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Propylthiouracil 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propylthiouracil 50mg
3 PHARMACEUTICAL FORM
White circular biconvex uncoated tablets with “I and II” debossed
either side
of breakline on one side and plain on other side (Approximate Size:
6.5 mm).
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1. Management of hyperthyroidism, including the treatment of Graves’
disease and thyrotoxicosis.
2. Amelioration of hyperthyroidism in preparation for surgical
treatment.
3. An adjunct to radioactive iodine therapy.
4. In juvenile hyperthyroidism to delay ablative therapy.
5. To manage thyrotoxic crisis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Propylthiouracil is administered by the oral route.
Adults:
Management of Hyperthyroidism
The initial dose of propylthiouracil is between 300mg and 600mg given
as a single
daily dose.
This dose should be maintained until the patient becomes euthyroid.
The dose should
then be reduced gradually to a maintenance dose of between 50mg and
150mg, taken
as a single daily dose.
Daily doses can be divided if preferred.
Preparation for Surgery
As for management of hyperthyroidism, until the patient becomes
euthyroid.
Adjunct to Radioactive Iodine Therapy
As for management of hyperthyroidism, for several weeks prior to
radioiodine
treatment.
Withdraw propylthiouracil 2 to 4 days before irradiation. The dosage
of radio-iodine
may need to be adjusted because propylthiouracil may have a
radioprotective effect.
Management of Thyrotoxic Crisis
200mg every 4 to 6 hours for the first 24 hours, decrease the dose as
the crisis
subsides.
Elderly
The adult dose should apply, but caution is advised in the presence of
renal or hepatic
impairment, where a dosage reduction may be justified.
Children:
Juvenile Hyperthyroidism
Children aged 6 - 10 years: Initial dose of 50-150mg daily
Children over 10 years: