INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ASPEN-LANSOPRAZOLE 15 [S2]
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ASPEN-LANSOPRAZOLE 15 [S2]
(capsules)

COMPOSITION:
ASPEN-LANSOPRAZOLE 15 capsule contains lansoprazole 15 mg

PHARMACOLOGICAL CLASSIFICATION:
A.11.4.3 Medicines acting on the gastrointestinal tract.

PHARMACOLOGICAL ACTION:
Lansoprazole is an inhibitor of the gastric H+, K+-ATPase (proton pump). Lansoprazole inhibits gastric acid secretion in a dose related manner irrespective of the source of stimulation. Gastric secretory functions recover gradually following discontinuation of the medicine. Lansoprazole has no effect on histamine, gastrin or cholinergic receptors.
Pharmacokinetics:
Following oral administration, lansoprazole is well absorbed with a resultant bioavailability of approximately 78%. The bioavailability is decreased if lansoprazole is taken with food. Peak serum concentrations are achieved approximately 1-2 hours following ingestion. Lansoprazole is highly protein bound (97%).
Lansoprazole is extensively metabolised via the hepatic cytochrome P450 system to the inactive, sulfated metabolites, sulphone, sulphide and 5-hydroxyllansoprazole. The half-life for lansoprazole is 1,4 to 1,5 hours. The main route of elimination is via the bile with 15-30% of lansoprazole being excreted via the kidneys as the hydroxylated metabolite.

INDICATIONS:
ASPEN-LANSOPRAZOLE 15 is indicated for the short-term symptomatic relief of heartburn and hyperacidity at a maximum daily dose of 15 mg for a maximum period of 14 days.

CONTRA-INDICATIONS:
• Hypersensitivity to lansoprazole or to any of the other ingredients.
• Pregnancy and lactation.
• Liver impairment.

WARNINGS:
Safety and efficacy in children has not been established.
Treatment with ASPEN-LANSOPRAZOLE may alleviate the symptoms of malignant ulcers and can delay diagnosis. Therefore, the possibility of malignancy of a gastric ulcer or a malignant disease of the oesophagus should be excluded prior to treatment with ASPEN-LANSOPRAZOLE.
This medicine may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

INTERACTIONS:
• Since ASPEN-LANSOPRAZOLE is a weak inducer of the cytochrome P450 system, the possiblity exists for interactions with drugs which are metabalised via this system.
• Monitoring of patients receiving concomitant warfarin is recommended, since a minor reduction in the concetration of warfarin may occur.

PREGNANCY AND LACTATION:
Adequate and well-controlled studies in humans have not been done.
It is not known whether lansoprazole is distributed into breast milk. However, lansoprazole or its metabolites are distributed into the milk of rats. Because lansoprazole has been shown to cause tumorigenic effects in animals, a decision should be made as to whether nursing should be discontinued or the medication withdrawn, taking into account the importance of lansoprazole to the mother.

DOSAGE AND DIRECTIONS FOR USE:
ASPEN-LANSOPRAZOLE should preferably be taken before a meal. Heartburn and hyper acidity:One Aspen Lansoprazole capsule (15 mg) daily for up to 14 days.
Patients should be advised to consult their doctor in the event of symptoms persisting, getting worse or continuing for 14 days.
Elderly:No dose adjustment is necessary.
Renal impairment: No dose adjustment is necessary in renal failure. This also applies to patients on dialysis.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Haematological disorders:
Less frequent: Thrombocytopenia, anaemia, leucopenia, neutropenia eosinophilia.
Cardiovascular disorders:
Less frequent: Oedema.
Neurological disorders:
Less frequent: Headache, dizziness, somnolence, insomnia, tremor.
Gastrointestinal disorders:
Frequent: Diarrhoea, nausea, vomiting, constipation, abdominal pain.
Less frequent: Dry mouth, glossitis, taste abnormalities, ulcerative colitis.
Endocrine disorders:
Less frequent: Gynaecomastia, galactorrhoea.
Hepatobiliary disorders:
Less frequent: Elevation in hepatic enzymes.
Musculoskeletal disorders:
Less frequent: Asthenia, arthralgia, myalgia.
Ocular:
Less frequent: Blurred vision.
Skin and subcutaneous tissue disorders:
Frequent: Skin rash, pruritus, urticaria.
Less frequent: Alopecia.
Other:
Less frequent: Fever.
Special Precautions:
Diagnosis of reflux oesophagitis should be confirmed by endoscopy.
Effects related to acid inhibition:
During long-term treatment, gastric glandular cysts have been reported in increased frequency. These physiological changes result from pronounced inhibition of gastric acid secretion.
Decreased gastric acidity increases gastric counts of bacteria normally present in the gastro-intestinal tract. Treatment with ASPEN-LANSOPRAZOLE may lead to an increased risk of gastro-intestinal infections such as Salmonella and Campylobacter.
In the presence of symptoms such as, significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena, and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with ASPEN-LANSOPRAZOLE may alleviate symptoms and delay diagnosis.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT:
(See "SIDE-EFFECTS AND SPECIAL PRECAUTIONS".) Treatment is symptomatic and supportive.

IDENTIFICATION:
ASPEN-LANSOPRAZOLE 15:
White to off-white, enteric coated pellets in hard gelatin capsule shells, size '3', with blue cap and white body

PRESENTATION:
ASPEN-LANSOPRAZOLE 15:
PVC/PDC aluminium blisters containing 7 capsules.

STORAGE INSTRUCTIONS:
Store in a cool, dry place, below 25ºC. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
ASPEN-LANSOPRAZOLE 15:        37/11.4.3/0237

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF PACKAGE INSERT:
25 July 2008

New addition to this site: February 2010
Source: Pharmaceutical Industry

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