Інструкція із застосування LUMEBLUE
Зміст інструкції
Lumeblue 25 mg prolonged-release tablets
methylthioninium chloride
Read this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of 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
1. What is Lumeblue and what is it used for
Lumeblue contains methylthioninium chloride (also known as methylene blue). This medicine is a
blue dye.
This medicine is used in adults to temporarily color the colon (large intestine) before
colonoscopy, in which a flexible instrument is inserted into the rectum to visually inspect
the intestine. The coloration allows the doctor to see the inner lining of the colon more clearly and improves the detection of abnormalities.
2. What you need to know before taking Lumeblue
Do not take Lumeblue
- if you are allergic to methylthioninium chloride, to peanutsor to soybeansor to any of the other ingredients of this medicine (listed in section 6);
- if you have been told you have a glucose-6-phosphate dehydrogenase (G6PD) deficiency;
- if you are pregnant, if you suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, as your doctor may decide that you do not need to take this medicine before the procedure.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
- if you are taking certain antidepressant medicines or a medicine for mental health problems. For example:
- selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram and zimeldine;
- bupropion, venlafaxine, mirtazapine, clomipramine, buspirone;
- medicines classified as monoamine oxidase inhibitors (often used to treat depression). Injection of methylthioninium chloride (into a vein) in patients taking these medicines has sometimes caused a potentially life-threatening complication called serotonin syndrome.
It is not known whether serotonin syndrome can occur when methylthioninium chloride is administered as a tablet. The doctor will decide how to proceed if you are taking an antidepressant or another medicine for mental health problems.
This medicine may cause a skin reaction of photosensitivity (a reaction similar to sunburn) when the skin is exposed to strong light sources, such as phototherapy, operating room lights or pulse oximeters. Protective measures against light exposure must be taken.
Urine and stools may become blue-green in colour; the skin may become blue during treatment with this medicine. This colour change is expected and disappears at the end of treatment.
This medicine may affect the results of monitoring instruments used to measure blood oxygen levels or the depth of anaesthesia.
Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age, as it is not known whether 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.
Taking other medicines together with Lumeblue can negatively affect the functioning of each of them or how they are broken down and eliminated from the body.
In addition to the antidepressants and other medicines for mental health problems mentioned in "Warnings and precautions", tell your doctor if you are also taking or have recently been given:
- medicines for the treatment of irregular heartbeat, such as amiodarone, digoxin and quinidine
- warfarin, for the prevention of blood clots
- medicines for the treatment of cancer, such as alectinib, everolimus, lapatinib, nilotinib and topotecan
- medicines for the prevention of organ rejection after transplantation, such as ciclosporin, sirolimus and tacrolimus
- medicines for the treatment of HIV infections, such as ritonavir and saquinavir
- medicines for the treatment of migraine, such as dihydroergotamine and ergotamine
- medicines used for the treatment of anxiety or insomnia, such as diazepam
- sedative medicines, such as midazolam and propofol
- antihistamine medicines for the treatment of allergies, such as diphenhydramine or promethazine
- probenecid for the treatment of gout
- phenytoin for the treatment of epilepsy
- pimozide for the treatment of psychosis or schizophrenia
- medicines for the treatment of severe pain, such as alfentanil, fentanyl and pethidine (also known as meperidine)
- cimetidine for the treatment of stomach ulcers and acid reflux
- metformin for the treatment of type 2 diabetes
- aciclovir for the treatment of herpes simplex virus infections (for example, cold sores and genital warts) and varicella-zoster virus infections (for example, chickenpox and shingles)
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, do not use this medicine as it is not known whether it may be harmful to the unborn child.
If you are breastfeeding, 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 need a colonoscopy during breastfeeding.
Driving and using machines
It is unlikely that taking Lumeblue will negatively affect your ability to drive or use machines. However, if you experience side effects that may impair your ability to drive vehicles or use machines safely, such as headache, dizziness or vision changes, you should avoid driving vehicles or using machines until you feel better.
Lumeblue contains soybean lecithin
If you are allergic to peanutsor soybeans, do not take this medicine.
3. How to take Lumeblue
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The medicine is supplied in the form of tablets. These must be swallowed whole as they
have a special coating that ensures their passage through the stomach and breaking only
in the intestine to release methylthioninium chloride which colors the colon blue. You must not
crush or chew them.
You will be given a pack containing 8 tablets (for a total of 200 mg of methylthioninium
chloride). The tablets must be taken within 2 hours, the night before the colonoscopy. Your
doctor will explain how to take the tablets, which are generally taken together with a
bowel cleansing preparation (a medicine to empty the colon).
Take the tablets according to your doctor's instructions.
Generally the instructions are:
- 1. after drinking at least 1 liter of the bowel cleansing preparation (or water), take a first dose of 3 tablets;
- 2. wait 1 hour then take a 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 a complete dose of Lumeblue. Therefore, you cannot take more Lumeblue than
you should. However, if you take more tablets than you should, some of the
undesirable effects listed in section 4 may occur. If you think you have taken a quantity of medicine
greater than you should, contact your doctor or nurse as soon as possible.
Contact your doctor immediately if you notice any of the following symptoms:
- nausea or vomiting, or stomach pain
- abnormally fast heartbeat or chest pain
- chest tightness or difficulty breathing (for example, shortness of breath)
- confusion, dizziness or headache
- sweating, tremor, feeling weak, paler than usual or bluish discoloration of the skin
- increased methemoglobin (an abnormal form of hemoglobin in the blood)
- high blood pressure.
If you forget to take one or more doses of Lumeblue
Do not take a double dose to make up for forgotten tablets; take the next
dose according to the bowel cleansing schedule indicated 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 the time of the colonoscopy, tell your doctor that you have not taken all the tablets.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are common, but contact your doctor or nurse if you experience any side effect that worries you.
Very common (may affect more than 1 in 10 people)
- change in urine color
- change in stool color
- dizziness
- changes in taste
- pins and needles, tingling or prickling sensation
- pain or discomfort in hands or feet
- bluish discoloration 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 stuffy or runny nose
- migraine
- low blood pressure
- cough
- vomiting blood
- skin discoloration resembling bruising
- night sweats
- itchy skin
- skin rash
- spider veins
- back or flank pain
- abnormally high amount of urine, or pain or difficulty passing urine
- general pain
- chills
Not known (frequency cannot be estimated from available data)
- signs of serotonin syndrome, such as muscle spasms, lack of coordination, tremors, confusion or other mental changes
- signs of anaphylactic reaction, such as itchy rash, swelling of the throat or tongue, shortness of breath
- sensitivity to light
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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lumeblue
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 package and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice damage to the packaging or signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Lumeblue contains
- The active ingredient is methylthioninium chloride. Each prolonged-release tablet contains 25 mg of methylthioninium chloride.
- The other ingredients are: tablet core: stearic acid 50 (E570), soybean lecithin (E322) - see paragraph 2 in "Lumeblue contains soybean lecithin", microcrystalline cellulose (E460), hypromellose 2208 (E464), mannitol (E421), talc (E553b), anhydrous colloidal silica (E551), magnesium stearate (E470b) film coating: methacrylic acid - methyl methacrylate copolymer, talc (E553b), titanium dioxide (E171), triethyl citrate (E1505)
Description of the appearance of Lumeblue and contents of the pack
Lumeblue prolonged-release tablets are tablets of colour from off-white to light blue,
round, biconvex, with enteric coating. The prolonged-release tablets are supplied in
blisters containing 8 tablets.
Marketing Authorisation Holder
Cosmo Technologies Ltd
Riverside II
Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer
Cosmo S.p.A
Via C. Colombo, 1
20045, Lainate
Milano,
Italy
Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu

- Країна реєстрації
- Лікарська формаExtended-release tablet, 25 MG
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до LUMEBLUEЛікарська форма: Oral solution, 75MG/10MLДіюча речовина: 13C-мочевинаВиробник: AB ANALITICA S.R.L.Потрібен рецептЛікарська форма: Powder for oral solution, 75 MGДіюча речовина: 13C-мочевинаВиробник: RICHEN EUROPE S.R.L.Рецепт не потрібенЛікарська форма: Soluble tablet, 100 MGДіюча речовина: 13C-мочевинаВиробник: ALFASIGMA S.P.A.Рецепт не потрібен
Аналоги LUMEBLUE в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог LUMEBLUE у Іспанія
Лікарі онлайн щодо LUMEBLUE
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на LUMEBLUE онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
LUMEBLUE потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
LUMEBLUE виробляється компанією COSMO TECHNOLOGIES LIMITED. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування LUMEBLUE з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати LUMEBLUE у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною () включають BREATQUALITY-UBT, KITREDIKI UBT KIT, EXPIROBAKTER. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















