Solox

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Lansoprazole 15mg (Lansoprazole (R,S racemic mixture));  

Beschikbaar vanaf:

Douglas Pharmaceuticals Limited

INN (Algemene Internationale Benaming):

Lansoprazole 15 mg (Lansoprazole (R,S racemic mixture))

Dosering:

15 mg

farmaceutische vorm:

Capsule

Samenstelling:

Active: Lansoprazole 15mg (Lansoprazole (R,S racemic mixture))   Excipient: Gelatin   Hypromellose Macrogol 6000 Mannitol Meglumine Methacrylic acid - ethyl acrylate copolymer Polysorbate 80 Purified talc Purified water   Quinoline yellow   Sodium laurilsulfate Sugar spheres Titanium dioxide    

Eenheden in pakket:

Blister pack, Al/Al non peelable, 28 capsules

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Zhejiang Gold Pharma Co Ltd

therapeutische indicaties:

Healing and long-term management of reflux oesophagitis Healing and maintenance therapy for patients with duodenal ulcer Healing of benign gastric ulcer Lansoprazole is also effective in patients with benign peptic lesions that do not respond to H2-receptor antagonists

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, Al/Al non peelable - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, Aluminium/aluminium peelable - 28 capsules - 36 months unopened stored at or below 25°C - Blister pack, Al/Al non peelable - 35 capsules - 36 months from date of manufacture stored at or below 25°C

Autorisatie datum:

2005-03-09

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INFORMATION FOR
CONSUMERS
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Consumer Medicine
Information
SOLOX
Lansoprazole 15 mg and 30 mg Capsules
What is in this leaflet
This leaflet answers some of the common questions about SOLOX.
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 weighted the risks of you taking SOLOX with
the benefits they expect it will have for you.
If you have concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What SOLOX is used for
The name of your medicine is SOLOX. It contains the active ingredient lansoprazole. SOLOX belongs
to a group of medicines called proton pump inhibitors (PPI's). SOLOX works by decreasing the amount
of acid the stomach produces, to give relief from symptoms and allow healing to occur.
Ulcers
SOLOX is used to treat or help heal peptic ulcers of the stomach and duodenum. These can be caused
in part by too much acid being made in the stomach. SOLOX is also used to help stop duodenal ulcers
coming back.
Reflux Oesophagitis
SOLOX is used to treat reflux oesophagitis or reflux disease. This is caused by "washing back" (reflux)
of food and acid from the stomach into the oesophagus. Reflux can cause a burning sensation in the
of food and acid from the stomach into the oesophagus. Reflux can cause a burning sensation in the
chest rising up to the throat, also known as heartburn.
Helicobacter pylori
SOLOX can also be used in combination with certain antibiotics to help get rid of H. pylori infections in
certain people with ulcers

Productkenmerken

SOLOX
_LANSOPRAZOLE 15 MG AND 30 MG CAPSULES _
NAME OF THE MEDICINE
SOLOX
Lansoprazole 15 mg and 30 mg Capsules
DESCRIPTION
Lansoprazole is a substituted benzimidazole. It is a white to slightly
brownish
crystalline, acid-labile powder, slightly soluble in ethanol and
almost insoluble in
water (0.033 mg/mL), but more soluble at higher pH. It is a chiral
compound with
one centre (-SO) and is present as a racemic mixture. Lansoprazole
melts at
165.8 ° C with decomposition and has a pKa of 8.8. Lansoprazole is
chemically
identified as
2[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulphinyl]-1H-
benzimidazole. CAS number 103577-45-3, molecular weight is 369.36 and
the
molecular formula is C
16
H
14
F
3
N
3
0
2
S.
The
capsules
contain
as
excipients:
neutral
pellets
(made
of
corn
and
saccharose),
sodium
lauryl
sulphate,
N-Methylglucamine,
mannitol,
hydroxypropyl methylcellulose, polyethylene glycol 6000, talc,
polysorbate 80,
titanium
dioxide,
Eudragit
®
(a
methacrylic
acid
-
ethyl
acrylate
copolymer).
SOLOX 15 mg capsules contain gelatine, titanium dioxide and quinoline
yellow in
the capsule shell. SOLOX 30 mg capsules contain gelatine and titanium
dioxide
in the capsule shell.
PHARMACOLOGY
_MECHANISM OF ACTION _
Lansoprazole reduces gastric acid secretions by inhibiting the H
+
/K
+
-ATPase
(proton pump) of the parietal cells in the gastric mucosa, the
terminal phase of
acid secretion. The drug is effective in the treatment of acid-related
disorders of
the upper gastrointestinal tract.
A single dose of 30 mg lansoprazole inhibits stimulated acid secretion
by
approximately 80 %. Basal acid secretion and basal and stimulated
secretion
volumes are affected to a lesser degree.
After repeated dosing (for 7 days) 90 % inhibition of stimulated acid
secretion is
achieved. Despite its short elimination half-life, lansoprazole has a
prolonged
pharmacological action, providing effective suppression of gastric
acid secretion
over 24 hours.
When
used
in
combination
with
the
recommended
antibiotics,
SOLOX
is
associated