Երկիր: Միացյալ Թագավորություն
Լեզու: անգլերեն
Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)
Propylthiouracil
Morningside Healthcare Ltd
H03BA02
Propylthiouracil
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06020200; GTIN: 5055132718229 5055132718236
PACKAGE LEAFLET: INFORMATION FOR THE USER Propylthiouracil 50 mg and 100 mg Tablets 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. 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). 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 pharmacist before taking Propylthiouracil Tablets if you: • have ever had an adverse reaction to propylthiouracil or to Կարդացեք ամբողջական փաստաթուղթը
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Propylthiouracil 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains propylthiouracil 50mg. Excipient with known effect: Each tablet contains 20.19 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White to off-white coloured, round shaped, biconvex, uncoated tablets debossed with P1 on one side and plain on other side. Thickness 3.10 mm and diameter 6.50 mm approximately. 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 Posology Adults: Management of Hyperthyroidism The initial dose of propylthiouracil is between 300mg and 600mg given as a single daily dose. This dose should be maintained until the patient becomes euthyroid. The dose should then be reduced gradually to a maintenance dose of between 50mg and 150mg, taken as a single daily dose. Daily doses can be divided if preferred. Preparation for Surgery As for management of hyperthyroidism, until the patient becomes euthyroid. Adjunct to Radioactive Iodine Therapy As for management of hyperthyroidism, for several weeks prior to radio- iodine treatment. Withdraw propylthiouracil 2 to 4 days before irradiation. The dosage of radio-iodine may need to be adjusted because propylthiouracil may have a radioprotective effect. Management of Thyrotoxic Crisis 200mg every 4 to 6 hours for the first 24 hours, decrease the dose as the crisis subsides. Elderly The adult dose should apply, but caution is advised in the presence of renal or hepatic impairment, where a dosage reduction may be justified. Children: Juvenile Hyperthyroidism Children aged 6 - 10 years: Initial dose of Կարդացեք ամբողջական փաստաթուղթը