MOVENTIG 12.5 MG

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

NALOXEGOL AS OXALATE

Disponível em:

ABIR THERAPEUTICS LTD, ISRAEL

Código ATC:

A06AH03

Forma farmacêutica:

FILM COATED TABLETS

Composição:

NALOXEGOL AS OXALATE 12.5 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

ASTRA ZENECA AB, SWEDEN

Área terapêutica:

NALOXEGOL

Indicações terapêuticas:

Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).

Data de autorização:

2017-07-10

Folheto informativo - Bula

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
Dispensing this medicine requires a doctor’s prescription
MOVENTIG 12.5 MG
MOVENTIG 25 MG
FILM-COATED TABLETS
EACH TABLET CONTAINS:
Moventig 12.5 mg: Active ingredient: Naloxegol 12.5 mg
Moventig 25 mg: Active ingredient: Naloxegol 25 mg
For the list of inactive ingredients, see section 6: ‘Additional
information’.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
Keep this leaflet. You may need to read it again.
This leaflet contains concise information about this medicine. If you
have any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
This medicine is intended for adults over 18 years old.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Moventig is intended to treat adults with constipation caused by
treatment with opioid pain
medicine where treatment with other laxatives has not produced
sufficient relief.
Opioid pain medicine such as: morphine, oxycodone, fentanyl, tramadol,
codeine.
Constipation related to treatment with opioids can result in symptoms
such as:

stomach pain

rectal straining (pain in the anus as a result of having to push very
hard to move very hard
stool out of the rectum)

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 and needs to come out)
THERAPEUTIC GROUP: Medicines for constipation, peripheral opioid
receptor antagonist.
2.
BEFORE USING THIS MEDICINE
X DO NOT USE THIS MEDICINE IF:

you are hypersensitive to the active ingredient naloxegol or any of
the ingredients
that this medicine contains (see Section 6: 'Additional information',
below).

your bowels are, or may be, blocked (obstructed) or you have been
warned that
your bowels are at risk of becoming blocked.

you have cancer in

Características técnicas

1
THIS LEAFLET FORMAT WAS DETERMINED BY THE MINISTRY OF HEALTH AND THE
CONTENT THEREOF WAS CHECKED AND
APPROVED IN
JULY 2017
AND UPDATED ACCORDING TO THE MINISTRY OF HEALTH GUIDELINES IN JANUARY
2018
1.
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, mauve tablet.
Moventig 25 mg film-coated tablet (tablet).
Oval, 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.
When naloxegol therapy is initiated, it is recommended that all
currently used maintenance laxative
therapy should be halted, until clinical effect of naloxegol is
determined.
_Special populations _
_Elderly Patients _
No dose adjustment is recommended based on age (see section 5.2).
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). 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