Iodine aqueous oral solution

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Iodine; Potassium iodide

متاح من:

Special Order

ATC رمز:

D08AG03

INN (الاسم الدولي):

Iodine; Potassium iodide

جرعة:

50mg/1ml ; 100mg/1ml

الشكل الصيدلاني:

Oral solution

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 06020200

نشرة المعلومات

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

خصائص المنتج

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