Constella

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

linaclotide

Saatavilla:

AbbVie Deutschland GmbH & Co. KG

ATC-koodi:

A06AX04

INN (Kansainvälinen yleisnimi):

linaclotide

Terapeuttinen ryhmä:

Drugs for constipation

Terapeuttinen alue:

Irritable Bowel Syndrome

Käyttöaiheet:

Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.

Tuoteyhteenveto:

Revision: 25

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-11-26

Pakkausseloste

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CONSTELLA 290 MICROGRAMS HARD CAPSULES
linaclotide
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 Constella is and what it is used for
2.
What you need to know before you take Constella
3.
How to take Constella
4.
Possible side effects
5.
How to store Constella
6.
Contents of the pack and other information
1.
WHAT CONSTELLA IS AND WHAT IT IS USED FOR
WHAT CONSTELLA IS USED FOR
Constella contains the active substance linaclotide. It is used to
treat the symptoms of moderate to severe
irritable bowel syndrome (often just called “IBS”) with
constipation in adult patients.
IBS is a common gut disorder. The main symptoms of IBS with
constipation include:

stomach or abdominal pain,

feeling bloated,

infrequent, hard, small or pellet-like stools (faeces).
These symptoms may vary from person to person.
HOW CONSTELLA WORKS
Constella acts locally in your gut, helping you to feel less pain and
less bloated, and to restore the normal
functioning of your bowels. It is not absorbed into the body, but
attaches to receptor called guanylate cyclase
C on the surface of your gut. By attaching to this receptor, it blocks
the sensation of pain and allows liquid to
enter from the body into the gut, thereby loosening the stools and
increasing your bowel movements.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CONSTELLA
DO NOT TAKE CONSTELLA
-
if you are allergic to linaclotide or any of the other ingredients of
this medicine (listed in se

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Constella 290 micrograms hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 290 micrograms of linaclotide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
White to off-white-orange opaque capsule (18 mm x 6.35 mm) marked
“290” with grey ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Constella is indicated for the symptomatic treatment of moderate to
severe irritable bowel syndrome with
constipation (IBS-C) in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one capsule (290 micrograms) once daily.
Physicians should periodically assess the need for continued
treatment. The efficacy of linaclotide has been
established in double-blind placebo-controlled studies for up to 6
months. If patients have not experienced
improvement in their symptoms after 4 weeks of treatment, the patient
should be re-examined and the benefit
and risks of continuing treatment reconsidered.
_Special populations_
_Patients with renal or hepatic impairment_
No dose adjustments are required for patients with hepatic or renal
impairment (see section 5.2).
_Elderly patients_
For elderly patients, although no dose adjustment is required, the
treatment should be carefully monitored
and periodically re-assessed (see section 4.4).
_Paediatric population _
The safety and efficacy of Constella in children aged 0 to18 years
have not yet been established. No data are
available.
This medicinal product should not be used in children and adolescents
(see sections 4.4 and 5.1).
Method of administration
Oral use. The capsule should be taken at least 30 minutes before a
meal (see section 4.5).
4.3
CONTRAINDICATIONS
3
Hypersensitivity to linaclotide or to any of the excipients listed in
section 6.1.
Patients with known or suspected mechanical gastrointestinal
obstruction.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Constella should be used after organic diseases have