Propylthiouracil 50mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Propylthiouracil

Disponibil de la:

DE Pharmaceuticals

Codul ATC:

H03BA02

INN (nume internaţional):

Propylthiouracil

Dozare:

50mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 06020200

Prospect

PACKAGE LEAFLET
INFORMATION FOR THE USER
PROPYLTHIOURACIL 50MG TABLETS
(PROPYLTHIOURACIL)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, please ask your doctor or
pharmacist.
− This medicine has been prescribed for you personally and you
should
not pass it on to others. It may harm them, even if their symptoms are
the same as yours.
The name of your medicine is Propylthiouracil 50mg Tablets. In the
rest
of this leaflet it is called Propylthiouracil Tablets.
IN THIS LEAFLET:
1. WHAT PROPYLTHIOURACIL TABLETS ARE AND WHAT THEY ARE USED FOR
2. BEFORE YOU TAKE PROPYLTHIOURACIL TABLETS
3. HOW TO TAKE PROPYLTHIOURACIL TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PROPYLTHIOURACIL TABLETS
6. FURTHER INFORMATION
1. WHAT PROPYLTHIOURACIL TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in Propylthiouracil Tablets is propylthiouracil,
which
belongs to a group of medicines called antithyroid drugs. These
medicines work by reducing the production of a hormone called
thyroxine
by the thyroid gland (a gland located beneath the box in the throat
that
produces thyroid hormone and helps to regulate growth and metabolism).
Propylthiouracil Tablets are used in the treatment and management of
an
overactive thyroid gland (hyperthyroidism).
2. BEFORE YOU TAKE PROPYLTHIOURACIL TABLETS
DO NOT TAKE PROPYLTHIOURACIL TABLETS IF YOU:
•
are SEVERELY ALLERGIC TO PROPYLTHIOURACIL OR ANY OF THE OTHER
INGREDIENTS OF PROPYLTHIOURACIL TABLETS (see section 6 ‘What
Propylthiouracil Tablets contain’ for a full list of ingredients).
•
have a RARE HEREDITARY CONDITION affecting the way your BODY
HANDLES SOME SUGARS
If any of the above apply to you, you should not take Propylthiouracil
Tablets.
PROPYLTHIOURACIL TABLETS ARE NOT RECOMMENDED FOR USE IN CHILDREN
UNDER SIX YEARS OF AGE.
CHECK WITH YOUR DOCTOR IF ANY OF THE FOLLOWING APPLIES TO YOU:
•
Some cases of severe liver reactions, including cases with fatal
o

Caracteristicilor produsului

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: