Methylthioninium chloride Proveblue 5 mg/ml solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Methylthioninium chloride Proveblue is and what it is used for
2. What you need to know before you are given Methylthioninium chloride Proveblue
3. How Methylthioninium chloride Proveblue is given
4. Possible side effects
5. How to store Methylthioninium chloride Proveblue
6. Contents of the pack and other information

• if you are allergic to methylthioninium chloride or other thiazine dyes
• if your body does not produce enough of the enzyme G6PD (glucose-6-phosphate dehydrogenase)
• if your body does not produce enough of the enzyme NADPH (nicotinamide adenine dinucleotide phosphate) reductase
• if your blood disorder has been caused by nitrite during treatment of cyanide poisoning
• if your blood disorder has been caused by chlorate poisoning.

Talk to your doctor or nurse before you are given Methylthioninium chloride Proveblue

• if you have moderate or severe renal disease; lower doses (< 1 mg/kg) may be needed
• if your blood disorder has been caused by a chemical called aniline, which is contained in dyes; lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3 of this package leaflet)
• if your blood disorder has been caused by a medicine called dapsone (used to treat leprosy and other skin conditions); lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3)
• if you suffer from hyperglycaemia or diabetes mellitus, as these conditions may be worsened by the glucose solution used for the dilution of the medicine
• your urine and stools may turn a blue-green colour; and skin may possibly turn a blue colour when you are treated with Methylthioninium chloride Proveblue. This discolouration is expected and will disappear after the treatment has ended

If any of the above applies to you, please consult your doctor.

Methylthioninium chloride may cause a photosensitivity reaction in the skin (sunburn-like reaction) when exposed to strong light sources, such as light therapy, lights in operating rooms and pulse oximeters.

Protective measures against exposure to light should be taken.

You will undergo monitoring tests during and after treatment with Methylthioninium chloride Proveblue.

Special care must be taken with Methylthioninium chloride Proveblue:

• in newborns and infants 3 months old or younger, lower doses are recommended (see section 3 of this package leaflet).

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

You should not be given methylthioninium chloride at the same time you are taking certain medicines to treat depression or anxiety which affect a brain chemical called serotonin. When used in combination with these medicines methylthioninium chloride may cause serotonin syndrome, which can be potentially life-threatening. Such medicines include:

• Selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline and zimelidine
• bupropion
• buspirone
• clomipramine
• mirtazapine
• venlafaxine
• Monoamine oxidase inhibitors

However, if the intravenous use of methylthioninium chloride cannot be avoided, you should be administered the lowest possible dose and observed closely for up to 4 hours after administration.

If you have any doubts about whether this medicine should be given to you, consult your doctor.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

The use of Methylthioninium chloride Proveblue during pregnancy is not recommended unless it is clearly necessary, for example in a life-threatening situation.

Due to a lack of available data on whether methylthioninium chloride passes into human breast milk, breast-feeding should be discontinued for up to 8 days after treatment with this medicine.

Do not drive or use any tools or machines as methylthioninium chloride has moderate influence on the ability to drive and use machines.

The usual dose is 1 to 2 mg per kilogram of your body weight, i.e. 0.2 to 0.4 ml per kilogram given over a period of 5 minutes. A second dose may be given after one hour if required.

The maximum recommended cumulative dose for the course of treatment is 7 mg/kg.

If your blood disorder has been caused by aniline or dapsone, total cumulative dose should not exceed 4 mg/kg (see section 2).

Usually, treatment should not exceed one day.

The recommended dose is 0.3 to 0.5 mg/kg body weight, i.e. 0.06 to 0.1 ml/kg, over a period of 5 minutes.

A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg) may be given after one hour in case of persistence or recurrence of symptoms. Usually, treatment should not exceed one day.

This medicine may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in children.

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too much or too little, however, tell your doctor if you notice one of the following adverse reactions:

• feeling sick,
• stomach pain,
• chest pain,
• dizziness,
• headache,
• sweating,
• confusion,
• an increase in methaemoglobin (an abnormal form of haemoglobin in the blood),
• high blood pressure,
• shortness of breath,
• abnormally fast beating of the heart,
• tremor,
• skin discolouration. Your skin may turn blue
• reduction in red blood cells which may turn your skin pale and make you breathless and weak,
• jaundice (yellowing of the skin and eyes), this has only been reported in infants.

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 (See details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

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• The active substance is methylthioninium chloride.
  Each ml of solution contains 5 mg methylthioninium chloride.
  Each 10 ml ampoule contains 50 mg methylthioninium chloride.
• The other ingredient is water for injections.

Methylthioninium chloride Proveblue is a clear dark blue solution for injection (injection) and is supplied in clear glass ampoules.

Each box contains a tray with 5 ampoules of 10 ml.