Propylthiouracil 50mg Tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

PROPYLTHIOURACIL

Disponibil de la:

Wockhardt UK Limited

Codul ATC:

H03BA02

INN (nume internaţional):

PROPYLTHIOURACIL

Forma farmaceutică:

TABLET

Compoziție:

PROPYLTHIOURACIL 50 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

THYROID THERAPY

Statutul autorizaţiei:

Authorised

Data de autorizare:

2006-08-23

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

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Propylthiouracil 50mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Propylthiouracil 50mg
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, circular biconvex tablets with breakline embossed on one face
or breakline
embossed on one face and CP on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hyperthyroidism
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Adults and elderly: _
Initially 300 to 600mg 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 150mg daily and continued for 1-2 years.
IN RENAL _IMPAIRMENT_:
GFR 10 to 50ml/min, 75% dose
GFR < 10ml/min, 50% dose
IN HEPATIC DISEASE:
Reduced dose
_Children under 6 years:_
Not recommended
_Children 6-10 years:_
Initially
50
to
150mg
once
daily
or
in
divided doses
_Children over 10 years:_
Initially 150 to 300mg once daily or in
divided doses
Page 2 of 6
4.3
CONTRAINDICATIONS
Previous severe hypersensitivity reaction e.g. agranulocytosis,
hepatitis,
vasculitis, nephritis.
_ _
Owing to the presence of Lactose, patients with rare hereditary
problems of
galactose intolerance, the Lapp lactase deficiency or
glucose-galactose
malabsorption should not take this medicine.
_ _4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_ _
_ _
Because of 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
immediately if there is clinical or laboratory evidence of
neutropenia.
_ _
_ _
_ _
The prothrombin time should be monitored during therapy, especially
prior to
surgery, because propylthiouracil may cause thrombocytopenia.
_ _
_ _
Some cases of severe hepatic reactions, both in adults and children,
includin