Propylthiouracil 50mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Propylthiouracil

Disponible des:

Alliance Healthcare (Distribution) 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

Informació per a l'usuari

Package leaflet: Information for the patient
PROPYLTHIOURACIL 50 MG TABLETS
Propylthiouracil
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, which belongs to a group of
medicines called antithyroid drugs.
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 (an immune system disorder that
affects the thyroid gland), 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

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Propylthiouracil 50 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of propylthiouracil.
Excipient with known effect:
Each tablet contains 33.5 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, circular biconvex tablet of approximately 6.5 mm by 3 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Propylthiouracil 50 mg Tablets is indicated in adults (including the
elderly), children
and adolescents aged 6 to 18 years, for the treatment of
hyperthyroidism.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, including the elderly _
Initially 300 to 600 mg daily, once daily or in divided doses until
the patient
becomes euthyroid.
When the condition is controlled (usually after 1-2 months), the dose
is
reduced to 50 to 150 mg daily and continued for 1-2 years.
_Patients with renal failure_
GFR 10 to 50 ml/min, 75% dose.
GFR < 10 ml/min, 50% dose.
_Patients with hepatic disease_
Reduced dose.
_Paediatric population _
Children under 6 years of age: Propylthiouracil 50 mg Tablets should
not be
used in children under 6 years of age because of safety concerns.
Children aged 6 to 10 years: Initially 50 to 150 mg once daily or in
divided
doses.
Children aged over 10 years: Initially 150 to 300 mg once daily or in
divided
doses.
Method of administration
Oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in
section 6.1.
Previous severe hypersensitivity reaction e.g. agranulocytosis,
hepatitis, vasculitis and
nephritis with propylthiouracil.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Due to the risk of agranulocytosis it is advised that patients should
be warned
to report to their doctor in the event of a sore throat, fever, mouth
ulcers,
bruising, malaise, non-specific illness or other symptoms of infection
immediately. A full blood count should be performed and treatment
should be
discontinued immedia