NOUMED LANSOPRAZOLE lansoprazole 30 mg capsule blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

lansoprazole, Quantity: 30 mg

Доступна с:

AVALLON PHARMACEUTICALS PTY LTD

Фармацевтическая форма:

Capsule

состав:

Excipient Ingredients: methacrylic acid - ethyl acrylate copolymer (1:1); hypromellose; indigo carmine; colloidal anhydrous silica; titanium dioxide; maize starch; purified talc; macrogol 300; sucrose; carmoisine; Gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid

Администрация маршрут:

Oral

Штук в упаковке:

28 and 30

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Adults:. LANZOPRAN capsules are indicated for. - Healing and long-term management of reflux oesophagitis. . - Healing and long-term management for patients with duodenal ulcer.. - Healing of benign gastric ulcer. Patients whose gastric or duodenal ulcer is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. . - Patients with benign peptic lesions that do not respond to H2-receptor antagonists.. - Eradication of H. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics. . - Relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia. . Paediatric and adolescent patients I to 17 years of age:. LANZOPRAN capsules are indicated for. - Treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. . - Healing of erosive oesophagitis.

Обзор продуктов:

Visual Identification: Purple cap/lavender body, self-locked hard gelatin capsules of size '1' imprinted 'L30' on both cap and body, containing white to off-white pellets; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизация:

Registered

Дата Авторизация:

2019-12-18

тонкая брошюра

NOUMED LANSOPRAZOLE
1
NOUMED LANSOPRAZOLE
_lansoprazole _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
LANSOPRAZOLE. 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 has weighed
the risks of you taking NOUMED
LANSOPRAZOLE against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
NOUMED LANSOPRAZOLE.
It contains lansoprazole as active
ingredient. Lansoprazole belongs to a
group of medicines called proton
pump inhibitors (PPIs). It works by
decreasing the amount of acid the
stomach makes, to give relief from
the symptoms and allow healing to
take place.
REFLUX OESOPHAGITIS (INFLAMMATION
OF OESOPHAGUS):
NOUMED
LANSOPRAZOLE is used to treat
the symptoms of reflux oesophagitis
or reflux disease in adults and in
children from 1 to 17 years of age.
This can be caused by backflow
(reflux) of food and acid from the
stomach into the food pipe, also
known as the oesophagus. Reflux can
cause a burning sensation in the chest
rising up to the throat, also known as
heart burn.
PEPTIC ULCERS (ULCERS OF STOMACH OR
DUODENUM):
NOUMED
LANSOPRAZOLE is used to treat
peptic ulcers in adults. Depending on
the position of the ulcer it is called a
gastric or duodenal ulcer.
A gastric ulcer occurs in the stomach.
A duodenal ulcer occurs in the
duodenum, which is the tube leading
out of the stomach. These can be
caused in part by too much acid
being made in the stomach.
NOUMED LANSOPRAZOLE is
also used to stop duodenal ulcers
from coming back.
NOUMED LANSOPRAZOLE is
also used for treatment of infections
caused by the bacteria Helicobacter
pylori when given in combination
with antibiotic therapy.
NOUMED LANSOPRAZOLE is
also used for the treatment of
hear

Характеристики продукта

Product Information - Australia
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION – NOUMED
LANSOPRAZOLE (LANSOPRAZOLE) CAPSULES
1. NAME OF THE MEDICINE
Lansoprazole
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each NOUMED LANSOPRAZOLE capsule contains enteric-coated delayed
release pellets with 30 mg of
lansoprazole.
Contains excipients with known effects: sucrose.
For the full list of excipients, see _section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
NOUMED LANSOPRAZOLE 30 mg capsules - Purple cap/lavender body,
self-locked hard gelatin capsules of
size ‘1’ imprinted with ‘L 30’ on both cap and body,
containing white to off-white pellets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
NOUMED LANSOPRAZOLE capsules are indicated for
•
Healing and long-term management of reflux oesophagitis.
•
Healing and long-term management for patients with duodenal ulcer.
•
Healing of benign gastric ulcer. Patients whose gastric or duodenal
ulcer is not associated with ingestion
of non-steroidal anti-inflammatory drugs require treatment with
antimicrobial agents in addition to
antisecretory drugs whether on first presentation or on recurrence.
•
Patients with benign peptic lesions that do not respond to H
2
-receptor antagonists.
•
Eradication of _H. pylori_ from the upper gastrointestinal tract in
patients with peptic ulcer or chronic gastritis
when used in combination with appropriate antibiotics.
•
Relief of reflux-like and/or ulcer-like symptoms associated with
acid-related dyspepsia.
PAEDIATRIC AND ADOLESCENT PATIENTS 1 TO 17 YEARS OF AGE
NOUMED LANSOPRAZOLE capsules are indicated for
•
Treatment of gastro-oesophageal reflux disease, including all grades
of oesophagitis.
•
Healing of erosive oesophagitis.
4.2 DOSE AND METHOD OF ADMINISTRATION
NOUMED LANSOPRAZOLE capsules contain 30 mg of lansoprazole as
enteric-coated delayed release capsules.
To
achieve
the
optimal
acid
inhibitory
effect,
and
hence
most
rapid
healing
and
symptom
relief,
NOUMED LANSOPRAZOLE capsules should be taken in t