INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
LANCAP 15 mg (capsules)
LANCAP 30 mg (capsules)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

LANCAP 15 mg (capsules)
LANCAP 30 mg (capsules)

COMPOSITION:
LANCAP 15 mg: Each capsule contains 15 mg lansoprazole.
LANCAP 30 mg: Each capsule contains 30 mg lansoprazole.
PHARMACOLOGICAL CLASSIFICATION
A. 11.4.3 Medicines acting on the gastro-intestinal 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, sulphated 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 been excreted via the kidneys as the hydroxylated metabolite.

INDICATIONS

•	LANCAP 30 mg is indicated for the short-term treatment of gastric and duodenal ulcers and reflux oesophagitis.
•	LANCAP 15 mg is indicated for the short-term management of mild functional dyspepsia and for the prevention of relapse of gastro-oesophageal reflux.
•	LANCAP 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 ingredients.
•	Pregnancy and lactation.
•	Liver impairment.

WARNINGS
Safety and efficacy in children has not been established.
Treatment with LANCAP may alleviate the symptoms of malignant ulcers and can delay diagnosis. Therefore, the possibility of malignancy of gastric ulcer or a malignant disease of the oesophagus should be excluded prior to treatment with LANCAP.
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 LANCAP 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
LANCAP 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.
LANCAP is indicated for Helicobacter pylori positive ulcers, as part of an eradication program with appropriate antibiotics.
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:
Less frequent: Thrombocytopenia, anaemia, leucopenia, neutropenia, eosinophilia.
Cardiovascular:
Less frequent: Oedema.
Central nervous system:
Frequent: Headache, dizziness.
Less frequent: Somnolence, insomnia, tremor.
Gastrointestinal:
Frequent: Diarrhoea.
Less frequent: Nausea, abdominal pain, vomiting, constipation, dry mouth, glossitis, taste abnormalities, ulcerative colitis.
Endocrine disorders:
Less frequent: Gynaecomastia, galactorrhoea.
Liver:
Less frequent: Elevation in hepatic enzymes.
Musculoskeletal:
Less frequent: Asthenia, arthralgia, myalgia.
Ocular:
Less frequent: Blurred vision.
Skin:
Frequent: Skin rash or itching.
Less frequent: Alopecia, pruritus, urticaria.
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 LANCAP 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 LANCAP 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
LANCAP 15 mg: Capsules filled with white to light brown or slightly pink coloured pellets. The body of the hard gelatine capsule is white and the cap is red-brownish coloured.
LANCAP 30 mg: Capsules filled with white to light brown or slightly pink coloured pellets. The body and cap of the hard gelatine capsule are white.

PRESENTATION
LANCAP 15 mg capsules are available in white HDPE bottles closed with a polypropylene tamper-evident/child-resistant cap with mounted desiccant insert containing 30 capsules.
LANCAP 30 mg capsules are available in white HDPE bottles closed with a polypropylene tamper-evident/child-resistant cap with mounted desiccant insert containing 30 capsules.

STORAGE INSTRUCTIONS
Store in a dry place below 25°C.
Keep the capsules in the original container until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS
LANCAP 15 mg: 40/11.4.3/0247
LANCAP 30 mg: 40/11.4.3/0248

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Pharma Dynamics (Pty) Ltd.
F02 Grapevine House
Steenberg Office Park
Westlake
7945

DATE OF PUBLICATION OF THE PACKAGE INSERT:
27 September 2005

New addition to this site: March 2007
Source: Pharmaceutical Industry

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