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.