Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lumeblue

Document Subject

Generated Narrative: MedicinalProductDefinition mp5a0e77a26a98f2eac352c48d66309743

identifier: http://ema.europa.eu/identifier/EU/1/20/1470/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Lumeblue 25 mg prolonged-release tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5a0e77a26a98f2eac352c48d66309743

identifier: http://ema.europa.eu/identifier/EU/1/20/1470/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - lumeblue

Attesters

What is in this leaflet

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

Lumeblue contains methylthioninium chloride (also known as methylene blue). This medicine is a blue dye.

This medicineis used in adults to temporarily stain the colon (large bowel) before colonoscopy, in which a flexible instrument is inserted into the rectum to view inside the bowel. The staining allows the doctor to see the lining of the colon more clearly and improves the detection of abnormalities.

Do not take Lumeblue

• if you are allergic to methylthioninium chloride, peanut or soya, or any of the other ingredients of this medicine (listed in section 6);
• if you have been told you have glucose-6-phosphate dehydrogenase (G6PD) deficiency;
• if you are pregnant or think you may be pregnant, or are breastfeeding as your doctor may decide that you do not need to take this medicine before your procedure.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• If you are taking certain antidepressant medicine or a medicine for psychiatric illness. Such as:

• selective serotonin reuptake inhibitor (SSRI) antidepressants such as fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram and zimeldine;
• bupropion, venlafaxine, mirtazapine, clomipramine, buspirone;
• medicines classified as monamine oxidase inhibitors (often used for treating depression). Giving methylthioninium chloride injection (into a vein) in patients also taking these medicines has sometimes resulted in a life-threatening complication called serotonin syndrome. It is not known if serotonin syndrome can occur when methylthioninium chloride is given as a tablet. Your doctor will decide what to do if you are taking an antidepressant or another medicine for a psychiatric illness.
  Children and adolescents Lumeblue should not be given to children and adolescents under 18 years of age as it is not known if the medicine is safe and effective in this age group.

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

Other medicines and Lumeblue taken together may affect how they each work or are processed and removed from the body.

In addition to antidepressants and the other medicines for psychiatric illness mentioned under Warnings and Precautions , you should tell your doctor before you take this medicine if you are also taking or have recently been given:

• Medicines to treat irregular heart beats such as amiodarone, digoxin and quinidine
• Warfarin, to prevent blood clots
• Medicines to treat cancer such as alectinib, everolimus, lapatinib, nilotinib and topotecan
• Medicines to prevent organ transplant rejection such as ciclosporin, sirolimus and tacrolimus
• Medicines to treat HIV infection such as ritonavir and saquinavir
• Medicines to treat migraine such as dihydroergotamine, ergotamine
• Medicines used to treat anxiety or insomnia, such as diazepam
• Sedative medicines such as midazolam and propofol
• Antihistamine medicines to treat allergies such as diphenhydramine or promethazine
• Probenecid to treat gout
• Phenytoin to treat epilepsy
• Pimozide to treat psychosis or schizophrenia
• Medicines to treat severe pain such as alfentanil, fentanyl and pethidine (also known as meperidine)
• Cimetidine to treat stomach ulcers and acid reflux
• Metformin to treat type 2 diabetes
• Aciclovir to treat herpes simplex virus infections (e.g. cold sores, genital warts) and varicella zoster virus infections (e.g. chicken pox, shingles)

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, do not use Lumeblue as it is not known whether this medicine can harm your unborn baby. If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor may decide that you do not need to take this medicine if you require a colonoscopy whilst breast-feeding.

Driving and using machines It is unlikely that taking Lumeblue will affect your ability to drive or use machines. However if you experience any side effects that could impair your ability to drive or use machines safely, such as migraine, feeling dizzy, or disturbance to your vision, then you should not drive or use machines until you feel better.

Lumeblue contains soya lecithin If you are allergic to peanut or soya, do not take this medicine.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The medicine is supplied as tablets. These must be swallowed whole because they have a special coating to make sure that they pass through your stomach and only break up in your intestines to release the methylthioninium chloride that stains the colon blue. You must not crush or chew them.

You will be given a pack containing 8 tablets (a total of 200 mg methylthioninium chloride). These must all be taken over a period of 2 hours, the night before your colonoscopy. Your doctor will explain how you should take the tablets, which are normally taken together with a bowel cleansing preparation (a medicine to clear out your colon).

Take the tablets as instructed by your doctor.

Typical instructions are:

1. After drinking at least 1 litre of the bowel cleansing preparation (or water) take the first dose of 3 tablets.

2. Wait 1 hour then take the second dose of 3 tablets.

3. Wait another hour, then take the final dose of 2 tablets.

If you take more Lumeblue than you should The box contains one complete dose of Lumeblue. Therefore you cannot take more Lumeblue than you should. However, if you take more tablets than you should, you might get some of the side effects listed in section 4. If you think you have taken more of this medicine than you should, tell your doctor or nurse as soon as possible.
If you notice any of the following symptoms you should tell your doctor straight away:

• Feeling or being sick, or stomach pain
• Abnormally fast beating of the heart, or chest pain
• Tight chest or difficulty breathing (e.g. breathlessness)
• Confusion, dizziness, or headache
• Sweating, tremor, feeling weak, paler skin than usual, or skin turning blue

An increase in methaemoglobin (an abnormal form of haemoglobin in the blood);

High blood pressure.

If you forget to take one or more of the doses of Lumeblue Do not take a double dose to make up for a forgotten tablets, take the next dose of tablets according to the bowel cleansing schedule given to you by your doctor, it may be helpful to set an alarm to remind you when to take the medicine.

If you stop taking Lumeblue At your colonoscopy, tell your doctor that you did not take all the tablets.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are common, but tell your doctor or nurse if you are worried about any side effect you get:

Very common (may affect more than 1 in 10 people)

• Discoloured urine
• Discoloured faeces
• Dizziness
• Changes in your sense of taste
• Pins and needles sensation, tingling or prickling
• Pain or discomfort in your hands or feet
• Blue discolouration of the skin
• Sweating

Common (may affect up to 1 in 10 people)

• Nausea
• Vomiting
• Stomach or chest pain
• Headache
• Anxiety

Uncommon (may affect up to 1 in 100 people)

• Cold-like symptoms, including blocked or runny nose
• Migraine
• Low blood pressure
• Cough
• Vomiting blood
• Bruising-like discolouration of the skin,
• Night sweats
• Itchy skin
• Rash
• Spidery veins
• Pain in the back or sides
• Abnormally large amounts of urine, or pain or difficulty when passing urine
• General pain
• Chills
• Signs of serotonin syndrome, such as muscle spasms, clumsiness, tremors, confusion or other mental changes
• Signs of an anaphylactic reaction, such as itchy rash, throat or tongue swelling, shortness of breath.

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 national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if the pack is damaged or shows signs of tampering.

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.

What Lumeblue contains
The active substance is methylthioninium chloride. Each prolonged-release tablet contains 25 mg methylthioninium chloride.

• The other ingredients are:

Tablet core: stearic acid 50 (E570), soya lecithin (E322) see section 2 under Lumeblue contains soya lecithin , microcrystalline cellulose (E460), hypromellose 2208 (E464), mannitol (E421), talc (E553b), silica colloidal anhydrous (E551), magnesium stearate (E470b)

• Film coating: methacrylic acid methyl methacrylate copolymer, talc (E553b), titanium dioxide (E171), triethyl citrate (E1505)

What Lumeblue looks like and contents of the pack Lumeblue prolonged-release tablets are off-white to light blue, round, biconvex, enteric-coated tablets. The prolonged-release tablets are provided in blister packs containing 8 tablets.

Marketing Authorisation Holder Alfasigma S.p.A. Via Ragazzi del 99, n. 5 40133 Bologna Italy +39 0516489info.it@alfasigma.com

Manufacturer Cosmo S.p.A Via C. Colombo, 1 20045, Lainate Milan,
Italy

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: