Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Propylthiouracil
Alliance Healthcare (Distribution) Ltd
H03BA02
Propylthiouracil
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06020200
Package leaflet: Information for the patient PROPYLTHIOURACIL 50 MG TABLETS 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. 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 The active ingredient in Propylthiouracil Tablets is propylthiouracil, which belongs to a group of medicines called antithyroid drugs. 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 (an immune system disorder that affects the thyroid gland), 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). 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). WARNINGS AND PRECAUTIONS Talk to your doctor or Đọc toàn bộ tài liệu
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 Đọc toàn bộ tài liệu