البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Iodine; Potassium iodide
Alliance Healthcare (Distribution) Ltd
D08AG03
Iodine; Potassium iodide
50mg/1ml ; 100mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06020200
PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes A jade.cerff 536464 11577 Addition of reporting of side effects statement MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Leaflet 500ml 22647308 210 x 148mm (70 x 148mm folded) 2 15.10.2014 Process Black Keyline (Does not print) Aqueous Iodine Oral Solution Helvetica PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes A jade.cerff 536464 11577 Addition of reporting of side effects statement MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Leaflet 500ml 22647308 210 x 148mm (70 x 148mm folded) 2 15.10.2014 Process Black Keyline (Does not print) Aqueous Iodine Oral Solution Helvetica FRONT FACE TOP REVERSE FACE TOP _Data Matrix:_ 22647308 VERIFIED AQUEOUS IODINE ORAL SOLUTION (iodine, potassium iodide) IMPORTANT INFORMATION ABOUT AQUEOUS IODINE ORAL SOLUTION • This medicine is taken before an operation to correct an overactive thyroid gland. The doctor will decide how much you should take and how often. DO NOT TAKE…. • For longer than 6 days before the operation unless the doctor tells you to do so. See section 3. • If you are pregnant or breastfeeding. • This medicine is not to be used as a long-term treatment. • The normal dose is a very small amount. Measure out the correct amount carefully using a 1ml syringe supplied by the pharmacist. See section 3. • Take extra care when giving this medicine to children. • Seek immediate medical help if you accidentally take too much. NOW READ THE REST OF THE LEAFLET BEFORE YOU USE THIS MEDICINE. IT INCLUDES OTHER INFORMATION WHICH MIGHT BE ESPECIALLY IMPORTANT FOR YOU. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need any more information or advice. • If you notice any side effec اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aqueous Iodine Oral Solution BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Iodine 5.0% w/v Potassium Iodide 10.0% w/v For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Solution 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For use in the pre-operative management of hyperthyroidism. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Oral. Dose: adults, children and the elderly: 0.1 – 0.3ml well diluted in milk or water. Dosage schedule: to be taken three times a day for six days. 4.3. CONTRA-INDICATIONS Contraindicated for patients hypersensitive to iodine or iodides, and use in pregnancy and lactation. 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Should not be used for long term treatment. Dispensing pack-not for retail sale. Keep all medicines away from children. Use with caution in children. 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Administration of this product may interfere with tests of thyroid function. 4.6. PREGNANCY AND LACTATION Not to be used during pregnancy and lactation. Iodides cross the placenta and are excreted in breast milk. There is a possibility of goitre in infants of mothers taking iodides. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8. UNDESIRABLE EFFECTS May cause allergic reactions, including urticaria, angioedema, cutaneous haemorrhage or purpuras, fever, arthralgia, lymphadenopathy and eosinophilia, coryza-like symptoms, headache, lachrymation, conjunctivitis, laryngitis, bronchitis, and pain in the salivary glands. In addition to the above, use may lead to adverse effects on the mouth such as metallic taste, increased salivation, burning or pain. Swelling and inflammation of the throat, acneform skin disorders, depression, insomnia, impotence and diarrhoea (which may be bloody) can also result. REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicinal product is import اقرأ الوثيقة كاملة