Amitiza 24microgram capsules

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Lubiprostone

Tersedia dari:

Sucampo Pharma Europe Ltd

Kode ATC:

A06AX03

INN (Nama Internasional):

Lubiprostone

Dosis:

24microgram

Bentuk farmasi:

Oral capsule

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 01060700; GTIN: 7640157441016 7640157441511

Selebaran informasi

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE
USER
AMITIZA 24 MICROGRAM SOFT CAPSULES
Lubiprostone
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to report
side effects
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What AMITIZA is and what it is used for?
2.
Before you take AMITIZA
3.
How to take AMITIZA
4.
Possible side effects
5.
How to store AMITIZA
6.
Further information
1.
WHAT AMITIZA IS AND WHAT IT IS USED FOR?
AMITIZA capsules work by increasing the amount of fluids into the
bowels. This helps the passage of stool and
reduces the feeling of uncomfortable and difficult bowel movements
that occurs with constipation.
AMITIZA is used to treat chronic constipation.
2.
BEFORE YOU TAKE AMITIZA
DO NOT TAKE AMITIZA:
-
If you are allergic (hypersensitive) to lubiprostone or any of the
other ingredients of AMITIZA.
-
If you have a blockage in your bowels (intestine).
-
If you are less than 18 years of age. There is no information
available on the use of AMITIZA in people
under 18 years of age.
This medicinal product contains the sugar sorbitol, if you have been
told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicinal product.
Do not take AMITIZA if you think any of these apply to you.
TAKE SPECIAL CARE WITH AMITIZA:
-
It is possible that you may feel like getting sick (nausea) whilst
taking AMITIZA. Taking AMITIZA
with food will help to reduce this feeling.

Karakteristik produk

OBJECT 1
AMITIZA 24 MICROGRAM SOFT CAPSULES
Summary of Product Characteristics Updated 04-Apr-2016 | Takeda UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions
1. Name of the medicinal product
AMITIZA 24 microgram soft capsules.
2. Qualitative and quantitative composition
Each soft capsule contains 24 micrograms of lubiprostone. Excipient:
sorbitol liquid, partially dehydrated,
less than 10 mg.
For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Capsules, soft.
An oval, amber capsule imprinted with SPI.
4. Clinical particulars
4.1 Therapeutic indications
Lubiprostone is indicated for the treatment of chronic idiopathic
constipation in adults when response to
diet and other non-pharmacological measures (e.g., educational
measures, physical activity) are
inappropriate.
4.2 Posology and method of administration
In adults (>18 years of age)
The recommended dose is one 24 microgram capsule taken twice daily. A
course of treatment for
constipation with Lubiprostone is 2 to 4 weeks.
Efficacy beyond 4 weeks has not been demonstrated in
placebo-controlled studies (see section 5.1).
Treatment with lubiprostone should be stopped if there is no response
to lubiprostone after at least 2
weeks.
In the elderly (>65 years of age)
No dosage changes are required based on age (see Section 5.1).
Paediatric population (<18 years of age)
The safety and efficacy of Lubiprostone in children and adolescents
aged under 18 have not yet been
established. Currently available data are described in Section 5.2 but
no recommendation on a posology
can be made.
Patients with renal impairment
No dosage adjustment is required in patients with renal impairment.
Patients with hepatic impairment
No dosage adjustment is required for patients with mild hepatic
impairment. For patients with moderate
or severe hepatic impairment (C