Propylthiouracil 50 mg tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Propylthiouracil

Inapatikana kutoka:

Halewood Chemicals (Ireland) Limited

ATC kanuni:

H03BA; H03BA02

INN (Jina la Kimataifa):

Propylthiouracil

Kipimo:

50 milligram(s)

Dawa fomu:

Tablet

Eneo la matibabu:

Thiouracils; propylthiouracil

Idhini ya tarehe:

2017-02-10

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPYLTHIOURACIL 50 MG TABLETS
propylthiouracil
Area reserved for Pharmacode
Area reserved for Pharmacode
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, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others as Iit may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
•
Propylthiouracil 50 mg Tablets are called ‘Propylthiouracil
Tablets’ in this leaflet.
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
Propylthiouracil Tablets contains the active substance
propylthiouracil.
Propylthiouracil is used to treat hyperthyroidism in adults (including
the elderly) and in children and
adolescents aged 6 to 18 years. Hyperthyroidism is a condition where
the thyroid gland is overactive
and makes too much thyroid hormone called thyroxine. Thyroxine helps
to regulate the body's growth
and metabolism.
This medicine helps restore thyroxine levels in your bloodstream to
normal levels: It may take several
weeks for this to happen. Hence it is important to keep taking the
medicine every day.
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).
•
if you have ever had a severe allergic reaction to propylthi

Tabia za bidhaa

Health Products Regulatory Authority
15 May 2023
CRN00DHFZ
Page 1 of 5
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 31.8 mg of lactose (as monohydrate).
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
Health Products Regulatory Authority
15 May 2023
CRN00DHFZ
Page 2 of 5
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, ma