Propylthiouracil 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Propylthiouracil

Available from:

A A H Pharmaceuticals Ltd

ATC code:

H03BA02

INN (International Name):

Propylthiouracil

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06020200; GTIN: 5016192790129 5025903002512

Patient Information leaflet

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

Summary of Product characteristics

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