Propylthiouracil 50mg Tablets

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

PROPYLTHIOURACIL

Pieejams no:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATĶ kods:

H03BA02

SNN (starptautisko nepatentēto nosaukumu):

PROPYLTHIOURACIL 50 mg

Zāļu forma:

TABLET

Kompozīcija:

PROPYLTHIOURACIL 50 mg

Receptes veids:

POM

Ārstniecības joma:

THYROID THERAPY

Autorizācija statuss:

Withdrawn

Autorizācija datums:

2006-08-23

Lietošanas instrukcija

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

Produkta apraksts

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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
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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.
Propylthiouracil may cause hypothrombinaemia and bleeding so
prothrombin
time should be monitored during therapy, especially prior to surgery.
Some cases of severe hepatic reactions, both in adults and children,
including fatal
cases
and
cases
requiring
a
liver
transplant
have
bee