Propylthiouracil 50mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Propylthiouracil

Inapatikana kutoka:

Dowelhurst Ltd

ATC kanuni:

H03BA02

INN (Jina la Kimataifa):

Propylthiouracil

Kipimo:

50mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 06020200

Taarifa za kipeperushi

Talk to your doctor before taking Propylthiouracil Tablets.
CHECK WITH YOUR DOCTOR IF ANY OF THE FOLLOWING APPLIES TO YOU:
Ÿ
Have ever had an adverse reaction to Propylthiouracil or to any of
the other ingredients of this medicine. (listed in section 6.);
Ÿ
Are pregnant, may become pregnant or are breastfeeding;
OTHER MEDICINES AND PROPYLTHIOURACIL TABLETS
Ÿ
Are older than 40 years of age.
PLEASE TELL YOUR DOCTOR BEFORE YOU START TO TAKE PROPYLTHIOURACIL
TABLETS IF YOU:
Ÿ
Have ever had any problems with your liver or kidneys;
Some cases of severe liver reactions, including cases with fatal
outcome or requiring liver transplant, have been reported in both
children and adults treated with propylthiouracil. You should inform
your doctor immediately if you develop symptoms of liver disease,
such as nausea, feeling sick, diarrhoea, yellow discolouration of the
skin or eyes, dark urine, pale stools, bleeding easily, itching or
chills.
Ÿ
Are allergic to Propylthiouracil or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
DO NOT TAKE PROPYLTHIOURACIL TABLETS IF YOU:
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPYLTHIOURACIL
TABLETS
Propylthiouracil Tablets are used in the treatment of hyperthyroidism.
Hyperthyroidism is where an overactive thyroid gland produces too
much thyroid hormone. They are also used to treat Graves' disease,
thyrotoxicosis and thyrotoxic crisis (when levels of thyroid hormone
are dangerously high). Propylthiouracil Tablets may also be given to
lower very high levels of thyroid hormone before surgery or
radioactive iodine treatment. Children may be given Propylthiouracil
Tablets to delay the need for surgery (or other treatment to remove
part of an overactive thyroid gland).
The active ingredient in Propylthiouracil Tablets is Propylthiouracil.
1.

WHAT PROPYLTHIOURACIL TABLETS ARE AND WHAT THEY ARE USED FOR
6.


Contents of the pack and other information
5.


How to store Propylthiouracil Tablets
Some medicines can interfere with your treatment. Tel

Tabia za bidhaa

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