Nodia

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Loperamide hydrochloride 2mg

Sẵn có từ:

Multichem NZ Limited

INN (Tên quốc tế):

Loperamide hydrochloride 2 mg

Liều dùng:

2 mg

Dạng dược phẩm:

Tablet

Thành phần:

Active: Loperamide hydrochloride 2mg Excipient: Brilliant blue FCF Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Povidone Purified talc Quinoline yellow Sodium starch glycolate Starch

Các đơn vị trong gói:

Blister pack, PVC/PVDC/AL, 16 tablets

Lớp học:

Pharmacy only

Loại thuốc theo toa:

Pharmacy only

Sản xuất bởi:

Olon SpA

Chỉ dẫn điều trị:

Relief of diarrhoea

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/AL - 16 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture. Protect from heat

Ngày ủy quyền:

2002-10-07

Tờ rơi thông tin

Multichem New Zealand Ltd
Page 1 of 3
NEW ZEALAND CONSUMER MEDICINE INFORMATION
NŌDIA
_Loperamide hydrochloride 2 mg tablets_
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about NŌDIA. It does not
contain all the available information. It
does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits.
Your doctor or pharmacist has weighed
the risks of you taking NŌDIA against the
benefits it can offer you.
If you have any concerns about using
NŌDIA, ask your doctor or pharmacist.
Keep this leaflet with your medicine. You
may want to read it again.
WHAT NŌDIA IS USED FOR
AND HOW IT WORKS
NŌDIA tablets contain loperamide
hydrochloride, a medicine that makes the
stools more solid and less frequent. It
does this by restoring the muscle
contractions of the intestine to normal.
This allows the bowel time to absorb water
and produce a more solid stool.
NŌDIA IS USED TO TREAT SUDDEN (ACUTE)
DIARRHOEA.
NŌDIA is also prescribed by doctors to
treat long-lasting (chronic) diarrhoea or
diarrhoea in patients who have had part of
their intestines removed by surgery
(intestinal resection).
BEFORE YOU TAKE NŌDIA
When you must not take it
Do not take NŌDIA if:
-
you have an allergy to loperamide
hydrochloride or any of the other
ingredients listed at the end of this
leaflet
-
you are constipated or have to avoid
being constipated
-
you have severe diarrhoea with blood in
the stools or a fever
-
your doctor has diagnosed an
inflammation of the lower bowel such
as ulcerative colitis or antibiotic
associated pseudomembranous colitis
-
you are breast-feeding
-
the packaging is torn or shows signs of
tampering.
Do not take NŌDIA after the expiry or use-
by date printed on the pack. Medicines
may not be effective if taken after their
expiry date.
Do not give NŌDIA to children under the
age of 12 years.
Before you take it
Tell your doctor or pharmacist if you have
allergies to any other medicines, foods,
preservatives or dyes. Symptoms of an
allergic reaction may i

Đặc tính sản phẩm

NEW ZEALAND DATA SHEET
NODIA
Page 1 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Nōdia2 mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg loperamide hydrochloride and typically
weighs 160 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Green, capsule-shaped tablets with a break-line on one side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Nōdia is indicated for the symptomatic control of acute and chronic
diarrhoea. In patients
with an ileostomy, colostomy or other intestinal resection it can be
used to reduce the
number and volume of stools and to harden their consistency.
4.2
Dose and method of administration
Adults and children over 12 years
Acute diarrhoea: The initial dose is 2 tablets followed by 1 tablet
after every subsequent
loose stool.
Chronic diarrhoea: The initial dose is 2 tablets daily; this initial
dose should be adjusted until
1-2 solid stools a day are obtained which is usually achieved with a
maintenance dose of 1-6
tablets daily.
The maximum dose for acute and chronic diarrhoea is 8 tablets daily.
Do
not
halve
the
tablets.
Dose
equivalence
when
the
tablet
is
divided
has
not
been
established.
Patients should be advised to drink plenty of clear fluids, water,
unsweetened juices or clear
soups.
4.3
Contraindications
Nōdia is contraindicated in patients with known hypersensitivity to
Ioperamide or to any of
the excipients.
Nōdia should not be used as the primary therapy:
•
in patients with acute dysentery, which is characterised by blood in
stools and high fever;
•
in patients with acute ulcerative colitis;
NEW ZEALAND DATA SHEET
NODIA
Page 2 of 10
•
in patients with bacterial enterocolitis caused by invasive organisms
including _Salmonella, _
_Shigella _and _Campylobacter; _
•
in patients with pseudomembranous colitis associated with the use of
broad-spectum
antibiotics.
In general, Nōdia should not be used when inhibition of peristalsis
is to be avoided due to the
possible risk of significant sequelae