INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ASPEN-LANSOPRAZOLE 15 (Capsules)
ASPEN-LANSOPRAZOLE 30 (Capsules)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ASPEN-LANSOPRAZOLE 15 (Capsules)
ASPEN-LANSOPRAZOLE 30 (Capsules)

COMPOSITION:
Each Aspen-lansoprazole 15 capsule contains lansoprazole 15 mg.
Each Aspen-lansoprazole 30 capsule contains lansoprazole 30 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- hydroxylansoprazole. 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 30 is indicated for the short-term treatment of gastric and duodenal ulcers and reflux oesophagitis.
•	Aspen-lansoprazole 15 is indicated for:
	- The short-term management of mild functional dyspepsia.
	- The prevention of relapse of gastro-oesophageal reflux.
•	Aspen-lansoprazole is indicated for Helicobacter pylori-positive duodenal ulcers in conjunction with appropriate antibiotics as part of an eradication programme.

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 possibility exists for interactions with drugs which are metabolised via this system.
•	Monitoring of patients receiving concomitant warfarin is recommended, since a minor reduction in the concentration 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.
Gastric ulcer:
30 mg once a day for up to eight weeks.
Duodenal ulcer:
30 mg once a day for up to four weeks.
Aspen-lansoprazole is indicated for Helicobacter pylori-positive ulcers in conjuction with appropriate antibiotics, as part of an eradication program.
Oesophagitis due to gastro-oesophageal reflux:
30 mg once a day for four weeks. Depending on the endoscopic results, a repeat course of 4 weeks may be necessary.
Maintenance treatment for the prevention of gastro-oesophageal reflux: 15 mg once a day for a maximum period of one year.
Functional dyspepsia:
Adults: 15-30 mg once a day for 2 to 4 weeks.
Elderly: No dose adjustment is necessary. However, 30 mg per day is the maximum daily dose.
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: Anaemia, eosinophilia, leucopenia, neutropenia, thrombocytopenia.
Cardiovascular disorders:
Less frequent: Oedema.
Neurological disorders:
Less frequent: Dizziness, headache, insomnia, somnolence, 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.
Visual disorders:
Less frequent: Blurred vision.
Skin and subcutaneous tissue disorders:
Frequent: Rash, pruritus, urticaria.
Less frequent: Alopecia.
General disorders:
Less frequent: Fever.

Special Precautions:
It is important to confirm the diagnosis of reflux oesophagitis 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 OVERDOSAGE 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 gelatine capsule shells, size ‘3’, with blue cap and white body.
Aspen-lansoprazole 30:	White to off-white, enteric coated pellets in hard gelatine capsule shells, size ‘1’, with red cap and white body.

PRESENTATION:

Aspen-lansoprazole 15:	Blister-packed capsules in packs of 7, 14 and 30’s.
Aspen-lansoprazole 30:	Blister-packed capsules in packs of 14 and 30’s.

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

REGISTRATION NUMBER:

Aspen-lansoprazole 15:	37/11.4.3/0237
Aspen-lansoprazole 30:	37/11.4.3/0154

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Rosen Heights, Pasita Street,
Rosen Park, Bellville 7530

MARKETED AND DISTRIBUTED BY:
Pharmacare Ltd trading as Aspen Pharmacare

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 2005

© CIPLA MEDPRO (PTY) LTD

New addition to this site: October 2005
Source: Pharmaceutical Industry
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