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METHYLTHIONINIUM CHLORIDE EMBLUE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION

Active substance(s): METHYLTHIONINIUM CHLORIDE

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Package leaflet: Information for the patient
Methylthioninium Chloride EmBlue 10 mg/ml Concentrate for solution for injection
Methylthioninium Chloride
Read all of this leaflet carefully before you start 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.
• In this leaflet Methylthioninium Chloride EmBlue 10 mg/ml Concentrate is called
Methylthioninium Chloride
What is in this leaflet:
1. What Methylthioninium Chloride is and what it is used for
2. What you need to know before you use Methylthioninium Chloride
3. How to use Methylthioninium Chloride
4. Possible side effects
5. How to store Methylthioninium Chloride
6. Contents of the pack and other information
1. What Methylthioninium Chloride is and what it is used for
Methylthioninium Chloride Emblue 10 mg/ml Concentrate contains the active substance
Methylthioninium Chloride.
Methylthioninium Chloride is used to treat drug induced or genetic methaemoglobinaemia.
Methaemoglobinaemia is a condition where there is a presence of abnormal haemoglobin
(methaemoglobin) in the blood. This abnormal haemoglobin leads to a reduced ability of the
red blood cells to release oxygen to the tissues. This may cause you to suffer from your skin
and lips turning a blue colour (cyanosis), shortness of breath, headache, fatigue and
sickness.
2. What you need to know before you use Methylthioninium Chloride
Do not use Methylthioninium Chloride:
• If you are allergic to the active substance Methylthioninium Chloride
• If you are pregnant or breast feeding
• If you have severe kidney disease
• If you have methaemoglobinaemia due to chlorate poisoning. The Methylthioninium
Chloride can convert the chlorate into to a compound which is even more toxic.
• If you have been told that you have glucose-6-phosphate dehydrogenase deficiency.
This medicine may cause you to have haemolytic anaemia (where the there is an
abnormal breakdown of red blood cells.)
• Methylthioninium Chloride must not be injected into the spinal cord (intrathecal injection)
as this can result in damage to the nerves or nervous system.
Warnings and precautions
Talk to your doctor or pharmacist before using Methylthioninium Chloride




Long term use of Methylthioninium Chloride may result in significant anaemia, due to an
increased rate of destruction of red blood cells. If Methylthioninium Chloride is used for a
long time, your haemoglobin concentrations will be checked regularly.
If Methylthioninium Chloride is injected under the skin or if Methylthioninium Chloride
leaks out after an intravenouse injection the tissues of the skin around the injection may
die and form abscesses.

Other medicines and Methylthioninium Chloride
Tell your doctor or pharmacist, if you are taking, have recently taken or might take any other
medicines.
Pregnancy and breast-feeding
Do not use Methylthioninium Chloride if you are pregnant or breast-feeding.
Talk to your doctor if you think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before using Methylthioninium Chloride.
Driving and using machines

Methylthioninium Chloride may cause you to feel dizzy or confused. This may affect your
ability to drive or use machinery. If you experience these effects you should not drive or use
machinery.
3. How to use Methylthioninium Chloride
Always use Methylthioninium Chloride exactly as your doctor has told you. Check with your
doctor or pharmacist, if you are not sure.
Methylthioninium Chloride may be taken orally or be given as an injection into a vein. The
dose and the medicine is given to you depends on the severity of your symptoms of
methaemoglobinaemia, as well as your body weight. Your doctor will decide what is right for
you.
For treatment of severe methaemoglobinaemia
• Methylthioninium Chloride is usually injection into a vein



Usual dose for Adults and Children is given below:
• 1% solution in doses of 1-2mg/kg of bodyweight is injected over several minutes.
• A repeated dose may be given after one hour if required.
If large doses are used, your levels of methaemoglobin concentrations will be monitored.

For long term treatment of genetic methaemoglobinaemia
• This treatment is less urgent and tends to be given orally.
• Usual dose for Adults is given below:
• 3-6mg/kg (generally 300mg daily in adults) is given orally in divided doses over
24 hours with ascorbic acid 500mg daily.
• Suitable dilution for the oral dose would be 5-10ml of Methylthioninium Chloride diluted
to 100-200mL with water for injection.
• This large volume helps prevent the solution causing you to have an upset stomach or
painful or difficult urination.

If you use more Methylthioninium Chloride than you should
High doses of can cause a blue discolouration to the skin after methaemoglobin levels had
returned to normal. High doses can also increase methaemoglobinemia. This may cause to
you have chest pain, shortness of breath, restlessness, apprehension, tremors and a sense
of oppression.
If you take too much Methylthioninium Chloride general supportive care will be given and
the toxin will be removed. There is no specific antidote therapy. In severe cases blood
transfusions maybe necessary.
If you forget to use Methylthioninium Chloride
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Methylthioninium Chloride can cause side effects, although not everybody
gets them.
Methylthioninium Chloride causes your saliva, urine and faeces to turn blue.
Injection into vein may cause:
• Chest pain
• Stomach pain
• Feeling sick
• Being sick
• Headache
• Dizziness
• Mental confusion
• Excessive sweating
• Low blood pressure
• Methaemoglobinaemia (abnormal haemoglobin in the blood) and haemolysis (where
the red blood cells rupture and haemoglobin into the surrounding fluid) may occur
with very high doses. Infants and patients with glucose-6-phosphate dehydrogenase
deficiency are particularly likely to suffer from haemolysis when treated with
Methylthioninium Chloride.
Oral administration may cause:
• Diarrhoea
• Feeling sick
• Being sick
• Painful or difficult urination.
• High doses, if not adequately diluted, could cause thrombophlebitis. (This is
Inflammation of a vein related to a blood clot.)
• Up to 350 mg of Methylthioninium Chloride should be diluted in each 500 ml of
infusion fluid.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from
your local pharmacy. By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store Methylthioninium Chloride
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the ampoule label and the
outer carton after “EXP”. The expiry date refers to the last day of that month.
Use within 24 hours after dilution.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Methylthioninium Chloride contains
The active substance is Methylthioninium Chloride (trihydrate). Each ml of solution contains
10 mg of Methylthioninium Chloride.
The only other ingredient is water for injection.
What Methylthioninium Chloride EmBlue looks like and contents of the pack
Methylthioninium Chloride EmBlue 10 mg/ml Concentrate is a clear, blue coloured sterile
solution.
Methylthioninium Chloride comes in 5 ml clear glass ampoules. Each carton contains 5.
Marketing Authorisation Holder and Manufacturer
EmBlue LImited
Ternion Court,
264-268 Upper Fourth Street,
Central Milton Keynes,
Buckinghamshire,
MK9 1DP, UK.

This leaflet was last revised in April 2015.

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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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