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AQUEOUS IODINE ORAL SOLUTION BP

Active substance(s): IODINE / POTASSIUM IODIDE

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Transcript
• An allergy to iodine, iodides or any of the
ingredients listed in section 6.
• Or 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.

• Having tests carried out on your thyroid as
this medicine may interfere with the results.

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Suf fix

11577

Reason for
Change

Addition of reporting of side
effects statement

AqueousKeyline
Iodine(Does
Oral
is a dark brown
notSolution
print)
liquid.
It is dispensed for you by the pharmacist.

Marketing authorisation holder and
manufacturer
Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.

This leaflet was last revised in October 2014

A

22647308

15.10.2014
Date

2

210 x 148mm (70 x 148mm folded)
Dimensions

Process
Black
What the
medicine
looks likeHelvetica

Issued by
Date

MHRA/IMB
submission Yes
required

22647308

The active ingredients are:
iodine 5% w/v, potassium iodide 10% w/v.
The other ingredient is:
Colours
Used
Fonts Used
purified
water.

Artwork No 536464
CRN

IG Code

What is in this medicine

Approved by
Date

jade.cerff

500ml

6. Further information

Proof No.

• Keep it out of the sight and reach of children.
• Do not store above 25°C.
• Do not use after the expiry date shown on the
pharmacist’s label.
• Medicine should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of any unused
medicine. These measures will help to protect
the environment.

Process Black

5. Storing this medicine

Keyline (Does not print)

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

Helvetica

22647308

PCP Header Box
Operator

Take the next dose as soon as you remember.
Do not take a double dose. You can then carry
on with the normal dose at the correct time.

Leaflet

Proof
No. these2or any other side
Date effect
If you
notice
not
15.10.2014
included above, stop use and tell your doctor or
pharmacist. They will tell you what to do.


If you forget a dose

Pack Size

Other
effects:
Component
Leaflet
• Spots or acne-like skin eruptions.
Size
500ml
• DPack
epression.
• Sleeplessness.
IG Code
22647308
• Impotence.
148mm (70
x 148mm folded)
• DDimensions
iarrhoea which 210
mayx contain
blood.

If you accidentally take too much, see a doctor
immediately. Take the pack with you to show
which medicine you have swallowed.

Component

Effects on the mouth may occur including:
• M
etallicHeader
taste. Box
MHRA
• An increase in saliva.
Productor pain. Aqueous Iodine Oral Solution
• Burning
• STitle
welling and inflammation of the throat.

Ask your doctor or pharmacist for advice before
using this medicine if you are pregnant, might
be pregnant or are breastfeeding. Aqueous
Iodine Oral Solution should not be used in
pregnancy unless the doctor has told you to do
so.

If you take too much

Fonts Used

Like all medicines Aqueous Iodine Oral Solution
can have side effects, although these don’t
affect everyone.
Allergic reactions may occur including:
• Itching.
• Blistering.
• Bleeding or bruising of the skin.
• Fever.
• Pains in the joints.
• Enlarged lymph nodes.
• An increase in the number of white blood cells
in the blood.
• Cold-like symptoms.
• Headache.
• Excessive tears or irritation and inflammation
in the eyes.
• Hoarseness.
• Pain or difficulty in speaking.
• Bronchitis.
• Pain in the salivary glands.

Pregnant or breastfeeding….

DO NOT EXCEED THE STATED DOSE.

Colours Used

4. Possible side effects

Talk to your doctor or pharmacist if
you or your child are….

Adults, the elderly and children
• Measure 0.1 – 0.3ml in a small 1ml syringe
and add it to the water or milk.
• Repeat three times a day for 6 days.
• Take extra care when giving this medicine to
children.

Data Matrix: 22647308 VERIFIED

Do not use the medicine if you or
your child have….

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.

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 effects not listed in this
leaflet, please tell your doctor or pharmacist.

REVERSE FACE TOP

2. Before you use this
medicine

• The normal dose is given below but your
doctor may prescribe a different amount for
you. Always follow the instructions given by
the doctor or pharmacist.
• Each time you take this medicine, dilute it in a
glass of water or milk and drink it all straight
away.

Aqueous Iodine Oral Solution

FRONT FACE TOP

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.

Aqueous Iodine Oral Solution is taken before an
operation to correct an overactive thyroid gland.
It helps reduce the risk of bleeding during the
operation.

3. How to use this medicine

Product
Title

(iodine, potassium iodide)

1. What the medicine is for

MHRA Header Box

Aqueous Iodine Oral
Solution

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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