Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Acino Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686
ALTOSEC 20 is indicated for:
The recommended dosage is 20 mg ALTOSEC 20 once daily for two to four weeks. In some duodenal ulcer patients refractory to other treatment regimes, 40 mg once daily may be effective.
ALTOSEC 20 is indicated for H. pylori-positive duodenal ulcers, as part of the eradication programme with appropriate antibiotics.
The recommended dosage is 20 mg once daily for four to 8 eight weeks. In some patients with gastric ulcer and reflux oesophagitis patients refractory to other treatment regimens, 40 mg ALTOSEC 20 once daily may be effective. In patients with severe or symptomatic recurrent reflux oesophagitis treatment can be continued with ALTOSEC 20 at a dosage of 20 mg once daily.
The recommended dose is 20 mg ALTOSEC 20 mg daily.
If symptom control has not been achieved after 2 weeks of treatment with 20 mg daily further investigation is recommended.
The recommended initial dose is 60 mg ALTOSEC 20 mg once daily.
The dosage should be adjusted individually, and treatment continued as long as it is clinically indicated. Patients with severe disease and inadequate response to other therapies have been effectively controlled with more than 90 % maintained on doses of 20 mg to 120 mg daily. With doses above 80 mg daily the dose should be divided and given twice daily.
NSAID associated gastric ulcers, duodenal ulcers or gastroduodenal erosions in patients with or without continued NSAID treatment, the recommended dosage of ALTOSEC 20 is 20 mg once daily.
Symptom resolution is rapid and in most patients healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment period.
For the prevention of NSAID associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms, the recommended dosage of ALTOSEC 20 is 20 mg once daily.
No dose adjustment is necessary in the elderly.
No dose adjustment is required in patients with impaired renal function.
As bioavailability and plasma half-life of omeprazole are increased in patients with impaired hepatic function a daily dose of 20 mg is generally sufficient.
The long-term safety of ALTOSEC 20 in patients with renal and hepatic impairment has not been established (see section 4.3).
There is no experience with ALTOSEC 20 in children. (See section 4.4).
Oral administration.
It is recommended to take ALTOSEC 20 capsules in the morning, preferably without food, swallowed whole with half a glass of water. The capsules must not be chewed or crushed.
For patients with swallowing difficulties who can drink or swallow semi-solid food. The capsule can be opened, and the contents swallowed directly with half a glass of water or after mixing the contents in a slightly acidic fluid, e.g., fruit juice or applesauce, or in non-carbonated water. The dispersion should be taken immediately (or within 30 minutes). Always stir just before drinking. Rinse it down with half a glass of water. Alternatively, patients can suck the capsule and swallow the pellets with half a glass of water. Ingest without chewing the enteric coated pellets.
There is limited information available on the effects of overdoses of omeprazole, as in ALTOSEC 20, in humans. In the literature, doses of up to 560 mg have been described, and occasional reports have been received when single oral doses have reached up to 2,400 mg omeprazole (120 times the usual recommended clinical dose).
Nausea, vomiting, dizziness, abdominal pain, headache, diarrhoea, blurred vision, confusion, diaphoresis, flushing, malaise, and tachycardia have been reported from overdosage with ALTOSEC 20. Also apathy, depression and confusion have been described in single cases.
The symptoms described in connection with omeprazole, as in ALTOSEC 20, overdosage have been transient, and no serious outcome due to omeprazole has been reported. The rate of elimination was unchanged (first order kinetics) with increased doses and no specific treatment has been needed.
Treatment is symptomatic and supportive.
36 months.
Store at or below 30°C.
Keep in the original packaging until required for use.
HDPE bottle, replace cap firmly after use.
14 or 28 capsules are packed into a white high-density polyethylene bottle sealed with a white polypropylene screw cap with a safety ring together with a white low-density polyethylene desiccant capsule. The bottle is placed in an outer cardboard carton together with a leaflet.
14 or 28 capsules are packed into polyvinyl chloride blister strips sealed with an aluminium foil backing. The blister strips are packed into an outer cardboard carton together with a leaflet.
Not all pack sizes may be marketed.
No special requirements.
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