Moventig
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
13-12-2023
Karatteristiċi tal-prodott
(SPC)
13-12-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
17-12-2014
Ingredjent attiv:
naloxegol oxalate
Disponibbli minn:
Kyowa Kirin Holdings B.V.
Kodiċi ATC:
A06AH03
INN (Isem Internazzjonali):
naloxegol
Grupp terapewtiku:
Peripheral opioid receptor antagonists, Drugs for constipation
Żona terapewtika:
Constipation; Opioid-Related Disorders
Indikazzjonijiet terapewtiċi:
Treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
Sommarju tal-prodott:
Revision: 15
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2014-12-07
Fuljett ta 'informazzjoni
26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVENTIG 12.5 MG FILM-COATED TABLETS
MOVENTIG 25 MG FILM-COATED TABLETS
naloxegol
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Moventig is and what it is used for
2.
What you need to know before you take Moventig
3.
How to take Moventig
4.
Possible side effects
5.
How to store Moventig
6.
Contents of the pack and other information
1.
WHAT MOVENTIG IS AND WHAT IT IS USED FOR
Moventig contains the active substance naloxegol. It is a medicine
used in adults to treat constipation
specifically caused by pain medicines, called opioids, (e.g. morphine,
oxycodone, fentanyl, tramadol,
codeine) taken on a regular basis. It is used when laxatives have not
provided acceptable relief of
constipation.
Constipation related to opioids can result in symptoms such as:
•
stomach pain
•
rectal straining (having to push very hard to move the stool out of
the rectum, which can also
cause pain in the anus during pushing)
•
hard stools (stools which are hard “like a rock”)
•
incomplete emptying of the rectum (after having a bowel movement, the
feeling as if a stool is
still in the rectum which needs to come out)
In patients taking opioids with constipation, who have tried at least
one laxative and had incomplete
relief of constipation, Moventig has been shown in clinical trials to
increase the number of bowel
movements and improve symptoms of constipation caused by opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVENTI
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Moventig 12.5 mg film-coated tablets
Moventig 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Moventig 12.5 mg film-coated tablets
Each film-coated tablet contains naloxegol oxalate equivalent to 12.5
mg naloxegol.
Moventig 25 mg film-coated tablets
Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg
naloxegol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Moventig 12.5 mg film-coated tablet (tablet).
Oval, 10.5x5.5 mm, mauve tablet.
Moventig 25 mg film-coated tablet (tablet).
Oval, 13x7 mm, mauve tablet.
Tablets are engraved with “nGL” on one side and the strength of
the tablet on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moventig is indicated for the treatment of opioid-induced constipation
(OIC) in adult patients who
have had an inadequate response to laxative(s).
For definition of inadequate response to laxative(s), see section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Moventig is 25 mg once daily.
Moventig may be used with or without laxatives. Moventig treatment
must be withdrawn when
systemic opioid therapy is stopped.
_Special populations _
_Elderly _
No dose adjustment is recommended based on age (see section 5.2).
_Renal impairment _
The starting dose for patients with moderate or severe renal
insufficiency is 12.5 mg. If side effects
impacting tolerability occur, naloxegol should be discontinued. The
dose can be increased to 25 mg if
12.5 mg is well tolerated by the patient (see section 5.2).
3
No dosage adjustment is required for patients with mild renal
impairment.
_Hepatic impairment _
No dose adjustment is required for patients with mild to moderate
hepatic impairment.
Safety and efficacy have not been established in patients with severe
hepatic impairment (see
section 5.2). Use in patients with severe hepatic impairment is not
recommended.
_CYP3A4 inhibitors _
The starting dose for patients
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