Propylthiouracil Macleods Tablets 50mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PROPYLTHIOURACIL

Available from:

Macleods Pharma UK Ltd Wynyard Park House, Wynyard Avenue, Wynyard, Billingham TS22 5TB , United Kingdom

ATC code:

H03BA02

INN (International Name):

PROPYLTHIOURACIL 50 mg

Pharmaceutical form:

TABLET

Composition:

PROPYLTHIOURACIL 50 mg

Prescription type:

POM

Therapeutic area:

THYROID THERAPY

Authorization status:

Withdrawn

Authorization date:

2016-08-11

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPYLTHIOURACIL MACLEODS 50MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING USING 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 Propylthiouracil Macleods are and what they are used for
2. What you need to know before you take Propylthiouracil Macleods
3. How to take Propylthiouracil Macleods
4. Possible side effects
5. How to store Propylthiouracil Macleods
6. Contents of the pack and other information
1. WHAT PROPYLTHIOURACIL MACLEODS ARE AND WHAT THEY ARE USED FOR
The active ingredient in Propylthiouracil Macleods is
Propylthiouracil.
Propylthiouracil Macleods 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 Macleods may also be given to
lower very high levels of
thyroid hormone before surgery or radioactive iodine treatment.
Children may be given
Propylthiouracil Macleods 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 MACLEODS
DO NOT TAKE PROPYLTHIOURACIL MACLEODS IF YOU:

Are allergic to Propylthiouracil or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Propylthiouracil Macleods.
PLEASE TELL YOUR DOCTOR BEFORE YOU START TO TAKE PROPYLTHIOURACIL
MA

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propylthiouracil Macleods 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).
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.
Page 2 of 7
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: Initial dose of 150-300mg (or 150mg/m2) daily
Maintenance dose is deter