Propylthiouracil 50mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Propylthiouracil

から入手可能:

RPH Pharmaceuticals AB

ATCコード:

H03BA02

INN（国際名）:

Propylthiouracil

投薬量:

50mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 06020200; GTIN: 5060064791318 5060064791301

情報リーフレット

PATIENT INFORMATION LEAFLET: PROPYLTHIOURACIL TABLETS BP 50 MG
(PROPYLTHIOURACIL)
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 or
pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
PET004675-UK
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 WHA
The active ingredient in Propylthiouracil Tablets is
Propylthiouracil.
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
giv
en 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).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PROPYLTHIOURACIL TABLETS
DO NOT TAKE PROPYLTHIOURACIL TABLETS IF YOU:
• Think you may be allergic to Propylthiouracil or to any
of the other ingredients of Propylthiouracil Tablets.
(These are listed in section 6.);
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING
WARNINGS AND PRECAUTIONS
PROPYLTHIOURACIL TABLETS IF YOU:
• Have ever had an adverse rea

製品の特徴

OBJECT 1
PROPYLTHIOURACIL TABLETS BP 50MG
Summary of Product Characteristics Updated 08-Dec-2022 | RPH
Pharmaceuticals AB
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Propylthiouracil Tablets BP 50mg
2. Qualitative and quantitative composition
Propylthiouracil 50mg
Excipient with known effect:
Lactose 25mg per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White biconvex uncoated tablets engraved Evans 184 on one face and
plain on the other.
4. Clinical particulars
4.1 Therapeutic indications
1. Management of hyperthyroidism, including the treatment of Graves'
disease and thyrotoxicosis.
2. Amelioration of hyperthyroidism in preparation for surgical
treatment.
3. An adjunct to radioactive iodine therapy.
4. In juvenile hyperthyroidism to delay ablative therapy.
5. To manage thyrotoxic crisis.
4.2 Posology and method of administration
Propylthiouracil is administered by the oral route.
Adults:
Management of Hyperthyroidism
The initial d