Propylthiouracil 100mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Kjøp det nå

Last ned Preparatomtale (SPC)
18-02-2022

Aktiv ingrediens:

Propylthiouracil

Tilgjengelig fra:

Macleods Pharma UK Ltd

ATC-kode:

H03BA02

INN (International Name):

Propylthiouracil

Dosering :

100mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 06020200; GTIN: 18901463153571

Informasjon til brukeren

                                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’

                                
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Preparatomtale

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Propylthiouracil 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propylthiouracil 100mg
Excipient with known effect: This medicine contains less than 1 mmol
sodium
(23 mg) per dosage unit, that is to say essential ‘sodium-free’.
3
PHARMACEUTICAL FORM
White, circular, biconvex uncoated tablets with “F” and “I2”
debossed on
either side of breakline on one side and plain on other side
(Approximate
Size: 8 mm)
The tablet can be divided 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 Hype
                                
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