Lumeblue (previously known as Methylthioninium chloride Cosmo)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

methylthioninium chloride

Available from:

Alfasigma S.p.A.

ATC code:

V04CX

INN (International Name):

methylthioninium chloride

Therapeutic group:

Other diagnostic agents

Therapeutic area:

Colorectal Neoplasms; Colonoscopy

Therapeutic indications:

Lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

Product summary:

Revision: 3

Authorization status:

Authorised

Authorization date:

2020-08-19

Patient Information leaflet

22
B. PACKAGE LEAFLET
_ _
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LUMEBLUE 25 MG PROLONGED-RELEASE TABLETS
methylthioninium chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
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.
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
1.
WHAT LUMEBLUE IS AND WHAT IT IS USED FOR
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LUMEBLUE
_ _
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 s

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lumeblue 25 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 25 mg of methylthioninium
chloride.
Excipients with known effect
Lumeblue contains 3 mg soya lecithin per prolonged-release tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Off white to light blue, round, biconvex, enteric coated tablets, with
approximate dimensions of
9
.
5 mm x 5.3 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lumeblue is indicated as a diagnostic agent enhancing visualisation of
colorectal lesions in adult
patients undergoing screening or surveillance colonoscopy (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults including the elderly (_
≥
_65 years) _
The recommended total dose is 200 mg methylthioninium chloride,
corresponding to eight 25 mg
tablets.
The total dose of the medicinal product must be taken orally during or
after the intake of low-volume
(e.g. 2 L) or high-volume (e.g. 4 L) polyethylene glycol (PEG) based
bowel cleansing preparation and
should be completed the evening prior to the colonoscopy to ensure
there is enough time for the tablets
to reach the colon and locally release the methylthioninium chloride
prior to the colonoscopy.
_Special populations _
_ _
_Elderly population _
No dose adjustment is required for elderly patients (aged ≥ 65
years) (see section 5.2).
_Renal impairment _
No dose adjustment is required in patients with mild renal impairment.
The medicinal product should
be used with caution in patients with moderate to severe renal
impairment as there are no data in this
patient group and methylthioninium chloride is predominantly renally
eliminated (see section 5.2).
_ _
3
_Hepatic impairment _
No dose adjustment is required in patients with mild or moderate
hepatic impairment. There is no
experience in patients with severe hepatic impairment (see section
5.2).
_ _