Propylthiouracil 50 mg tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Propylthiouracil

Доступна с:

Halewood Chemicals Limited

код АТС:

H03BA; H03BA02

ИНН (Международная Имя):

Propylthiouracil

дозировка:

50 milligram(s)

Фармацевтическая форма:

Tablet

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Thiouracils; propylthiouracil

Статус Авторизация:

Authorised

Дата Авторизация:

2017-02-10

тонкая брошюра

_Title:_
_Ref:_
_Date:_
_Size (mm):_
_Modified:_
Propylthiouracil PIL
HP/Binal
27/06/17
375(H) x 135(W)
10/01/18
_Colours_
_(Printed)_
_Colours_
_(Non printed)_
SPECIAL
CUTTER
PROCESS
BLACK
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 se

Характеристики продукта

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.
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