Propylthiouracil 50mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Propylthiouracil

Disponible des:

Morningside Healthcare Ltd

Codi ATC:

H03BA02

Designació comuna internacional (DCI):

Propylthiouracil

Dosis:

50mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 06020200; GTIN: 5055132718229 5055132718236

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
Propylthiouracil
50 mg and 100 mg Tablets
Read all of this leaflet carefully before you start taking 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 Tablets are and what they are used for
2. What you need to know before you take Propylthiouracil Tablets
3. How to take Propylthiouracil Tablets
4. Possible side effects
5. How to store Propylthiouracil Tablets
6. Contents of the pack and other information.
1.
What Propylthiouracil Tablets are and what they are used
for
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 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 or pharmacist before taking
Propylthiouracil Tablets if you:
•
have ever had an adverse reaction to propylthiouracil or to

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Propylthiouracil 50 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains propylthiouracil 50mg.
Excipient with known effect:
Each tablet contains 20.19 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White to off-white coloured, round shaped, biconvex, uncoated tablets
debossed with
P1 on one side and plain on other side. Thickness 3.10 mm and diameter
6.50 mm
approximately.
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
Posology
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
radio-
iodine 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