ZOPRAL lansoprazole 30 mg enteric capsule blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

lansoprazole, Quantity: 30 mg

Inapatikana kutoka:

Alphapharm Pty Ltd

INN (Jina la Kimataifa):

Lansoprazole

Dawa fomu:

Capsule, enteric

Tungo:

Excipient Ingredients: purified talc; macrogol 6000; hyprolose; titanium dioxide; polysorbate 80; methacrylic acid copolymer; sucrose; maize starch; magnesium carbonate hydrate; colloidal anhydrous silica; brilliant blue FCF; purified water; sorbitan monolaurate; erythrosine; Gelatin; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

28, 30

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Adults . 1. Healing and long-term management of reflux oesophagitis. . 2. Healing and long-term management for patients with duodenal ulcer. . 3. 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. . 4. Lansoprazole is also effective in patients with benign peptic lesions that do not respond to H2-receptor antagonists. . 5. Eradication of H. pylori from the upper gastrointestinal tract in patients with peptic ulcer or chronic gastritis when used in combination with appropriate antibiotics (see Clinical Trials). . 6. Relief of reflux-like and/or ulcer-like symptoms associated with acid-related dyspepsia. . Paediatric patients 1 to 17 years of age. 1. Treatment of gastro-oesophageal reflux disease, including all grades of oesophagitis. . 2. Healing of erosive oesophagitis.

Bidhaa muhtasari:

Visual Identification: White to off-white colored pellets filled in hard gelatin capsule with pink opaque cap and pink opaque body imprinted with "MYLAN" over '8030' on both cap and body with black ink; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2010-01-08

Taarifa za kipeperushi

ZOPRAL & ZOPRAL
ODT
_lansoprazole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZOPRAL and
ZOPRAL ODT. 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 ZOPRAL or
ZOPRAL ODT 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 ZOPRAL AND
ZOPRAL ODT IS USED
FOR
PEPTIC ULCERS
ZOPRAL and ZOPRAL ODT are
used to treat peptic ulcers in adults.
Depending on the position of the
ulcer, it is called either 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.
Too much acid being made in the
stomach can cause these ulcers.
ZOPRAL and ZOPRAL ODT are
also used to help stop duodenal
ulcers from coming back.
REFLUX OESOPHAGITIS
ZOPRAL and ZOPRAL ODT are
used to treat the symptoms of reflux
oesophagitis or reflux disease in
adults and in children from 6 to 17
years of age.
This can be caused by backflow
(reflux) of food and acid from the
stomach into the food pipe or gullet,
also known as the oesophagus.
Reflux can cause a burning sensation
in the chest rising up to the throat,
also known as heartburn.
HEARTBURN AND STOMACH PAIN
ASSOCIATED WITH REFLUX OR PEPTIC
ULCER
ZOPRAL and ZOPRAL ODT are
used for the short-term treatment of
heartburn and peptic ulcer symptoms
in adults.
PEPTIC ULCERS ASSOCIATED WITH
HELICOBACTER PYLORI INFECTION
Most people who have a peptic ulcer
also have bacteria called
Helicobacter pylori in their stomach.
ZOPRAL and ZOPRAL ODT can be
taken in conjunction with certain
antibiotics to help eradicate
Helicobacter pylori and let your
peptic ulcer heal. However, it is
possible that the antibiotics may not
always get rid of Helicobacter pylori.

Tabia za bidhaa

AUSTRALIAN PRODUCT INFORMATION
ZOPRAL
®
ZOPRAL
® ODT
_Lansoprazole capsules and orally disintegrating tablets _
1
NAME OF THE MEDICINE
Lansoprazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ZOPRAL 15 mg and 30 mg enteric capsule contains 15 mg and 30 mg
of Lansoprazole active ingredient,
respectively.
Excipients with known effect: phenylalanine, sugars and sulfites.
Each ZOPRAL ODT 15 mg and 30 mg orally disintegrating tablet contains
15 mg and 30 mg of lansoprazole
active ingredient, respectively.
Excipients with known effect: contains sulfites and aspartame.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ZOPRAL enteric
capsules 15 mg
:
White to off-white coloured pellets filled in hard gelatin capsule
with green
opaque cap and green opaque body imprinted with ‘MYLAN’ over
‘8015’ on
both cap and body with black ink.
ZOPRAL enteric
capsules 30 mg
:
White to off-white coloured pellets filled in hard gelatin capsule
with pink
opaque cap and pink opaque body imprinted with ‘MYLAN’ over
‘8030’ on
both cap and body with black ink.
ZOPRAL ODT
orally disintegrating
tablets 15 mg
:
White to yellowish white round, flat-faced bevelled edged tablet
engraved with
“LP1” on one side and “M” on other side with orange to dark
brown speckles.
ZOPRAL ODT
orally disintegrating
tablets 30 mg
:
White to yellowish white round, flat-faced bevelled edged tablet
engraved with
“LP2” on one side and “M” on other side with orange to dark
brown speckles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
1.
Healing and long-term management of reflux oesophagitis.
2.
Healing and long-term management for patients with duodenal ulcer.
3.
Healing of benign gastric ulcer (see section 4.2 Dose and Method of
Administration). 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 recurren