Rizmoic

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

Naldemedine tosilate

MAH:

Shionogi B.V.

ATC_code:

A06AH05

INN:

naldemedine

therapeutic_group:

Drugs for constipation, Peripheral opioid receptor antagonists

therapeutic_area:

Constipation

therapeutic_indication:

Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.

leaflet_short:

Revision: 10

authorization_status:

Authorised

authorization_date:

2019-02-18

PIL

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RIZMOIC 200 MICROGRAMS FILM-COATED TABLETS
naldemedine
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,
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.
WHAT IS IN THIS LEAFLET
1.
What Rizmoic is and what it is used for
2.
What you need to know before you take Rizmoic
3.
How to take Rizmoic
4.
Possible side effects
5.
How to store Rizmoic
6.
Contents of the pack and other information
1.
WHAT RIZMOIC IS AND WHAT IT IS USED FOR
Rizmoic contains the active substance naldemedine.
It is a medicine used in adults to treat constipation caused by pain
medicines, called opioids
(e.g morphine, oxycodone, fentanyl, tramadol, codeine, hydromorphone,
methadone).
Your opioid pain medicine may cause the following symptoms:
-
reduction in how often you pass stools
-
hard stools
-
stomach ache
-
pain in the rectum when pushing hard stools out
-
a feeling that the bowel is still not empty after passing stools.
Rizmoic can be used in patients using an opioid medicine for cancer
pain or long term non-cancer pain
after they have previously been treated with a laxative.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIZMOIC
DO NOT TAKE RIZMOIC:
-
if you are allergic to naldemedine or any of the other ingredients of
this medicine (listed in
section 6).
-
if your bowel is blocked or perforated, or if there is a high risk of
your bowel becoming
blocked, as a blockage may cause a hole to develop in the bowel wall.
DO NOT take this medicine if any of the above applies to you. If you
are not sure, talk to your doctor or
pharmacist before ta

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rizmoic 200 micrograms film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 micrograms naldemedine (as tosylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Round, approximately 6.5 mm diameter, yellow tablet debossed with
'222' and Shionogi logo on one
side and '0.2' on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rizmoic is indicated for the treatment of opioid-induced constipation
(OIC) in adult patients who have
previously been treated with a laxative.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of naldemedine is 200 micrograms (one tablet)
daily.
Rizmoic may be used with or without laxative(s). It may be taken at
any time of the day but it is
recommended to be taken at the same time every day.
Alteration of the analgesic dosing regimen prior to initiating Rizmoic
is not required.
Rizmoic must be discontinued if treatment with the opioid pain
medicinal product is discontinued.
_ _
_Special populations _
_Elderly _
No dose adjustment is required in patients older than 65 years of age
(see section 5.2).
Due to the limited therapeutic experience in patients 75 years old and
older, naldemedine therapy
should be initiated with caution in this age group.
_ _
_Renal impairment _
No dose adjustment is required in patients with renal impairment (see
section 5.2).
Due to the limited therapeutic experience, patients with severe renal
impairment should be clinically
monitored when initiating therapy with naldemedine (see section 4.4).
_ _
_Hepatic impairment _
No dose adjustment is required in patients with mild or moderate
hepatic impairment.
Use in patients with severe hepatic impairment is not recommended (see
sections 4.4 and 5.2).
_Paediatric population _
The safety and efficacy of naldemedine in children and adolescents
aged below 18 years have not yet
been established. No data are available.