Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
PROPYLTHIOURACIL
Macleods Pharma UK Ltd Wynyard Park House, Wynyard Avenue, Wynyard, Billingham TS22 5TB , United Kingdom
H03BA02
PROPYLTHIOURACIL 50 mg
TABLET
PROPYLTHIOURACIL 50 mg
POM
THYROID THERAPY
Withdrawn
2016-08-11
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER PROPYLTHIOURACIL MACLEODS 50MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING USING 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 Macleods are and what they are used for 2. What you need to know before you take Propylthiouracil Macleods 3. How to take Propylthiouracil Macleods 4. Possible side effects 5. How to store Propylthiouracil Macleods 6. Contents of the pack and other information 1. WHAT PROPYLTHIOURACIL MACLEODS ARE AND WHAT THEY ARE USED FOR The active ingredient in Propylthiouracil Macleods is Propylthiouracil. Propylthiouracil Macleods 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 Macleods may also be given to lower very high levels of thyroid hormone before surgery or radioactive iodine treatment. Children may be given Propylthiouracil Macleods 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 MACLEODS DO NOT TAKE PROPYLTHIOURACIL MACLEODS 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 before taking Propylthiouracil Macleods. PLEASE TELL YOUR DOCTOR BEFORE YOU START TO TAKE PROPYLTHIOURACIL MA Lue koko asiakirja
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Propylthiouracil Macleods 50mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Propylthiouracil 50mg 3 PHARMACEUTICAL FORM White circular biconvex uncoated tablets with “I and II” debossed either side of breakline on one side and plain on other side (Approximate Size: 6.5 mm). 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 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. Page 2 of 7 Adjunct to Radioactive Iodine Therapy As for management of hyperthyroidism, for several weeks prior to radioiodine 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 50-150mg daily Children over 10 years: Initial dose of 150-300mg (or 150mg/m2) daily Maintenance dose is deter Lue koko asiakirja