Propylthiouracil 50mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Propylthiouracil

थमां उपलब्ध:

Halewood Chemicals Ltd

ए.टी.सी कोड:

H03BA02

INN (इंटरनेशनल नाम):

Propylthiouracil

डोज़:

50mg

फार्मास्यूटिकल फॉर्म:

Oral tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 06020200; GTIN: 5060306430302 5060306430241

सूचना पत्रक

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 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, 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 in this
medicine (listed in section 6)
• if you have ever had a severe allergic
reaction to propylthiouracil, including a
reduced white blood cell count, liver
problems, inflamed blood vessels and
kidney problems
WARNINGS AND PRECAUTIONS
Talk to your docto

उत्पाद विशेषताएं

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
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 dis