LOSEC Capsule, Tablet Ref.[50844] Active ingredients: Omeprazole

LOSEC capsules and LOSEC MUPS tablets are recommended to be given in the morning and swallowed whole with half a glass of water. The contents of the capsule or MUPS tablet should not be chewed or crushed.

For patients with swallowing difficulties and for children who can drink or swallow semi-solid food

LOSEC MUPS Tablets: The tablets should be taken with half a glass of liquid. The tablets must not be chewed or crushed. The tablets can also be dispersed in half a glass of noncarbonated water or fruit juices. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of fluid and drink. The pellets must not be chewed or crushed. Do not use milk or carbonated water.

LOSEC Capsules: For patients with swallowing difficulties the capsule can be opened and the contents swallowed directly with half a glass of liquid or after mixing the contents in a slightly acidic fluid e.g. fruit juice, yoghurt or in non carbonated water. The dispersion should be taken immediately or within 30 minutes. Alternatively patients can suck the capsule and swallow the pellets with liquid. The pellets must not be chewed or crushed.

Reflux oesophagitis

The recommended dosage is LOSEC 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 week treatment period.

In patients with severe reflux oesophagitis LOSEC 40 mg once daily is recommended and healing is usually achieved within 8 weeks.

For the long-term management of patients with healed reflux oesophagitis the recommended dose is LOSEC 10 mg once daily. If needed the dose can be increased to LOSEC 20-40 mg once daily.

Severe reflux oesophagitis in children from one year and older

The management of severe reflux oesophagitis should be diagnosed or recommended by a specialist paediatrician or gastroenterologist.

The recommended dosage regime for healing is:

If needed dosage may be increased to 20 mg and 40 mg respectively.

Helicobacter pylori (Hp) eradication regimens in peptic ulcer disease

Triple therapy regimens

LOSEC 20 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice a day for one week

or

LOSEC 20 mg, clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg), all twice a day for one week

or

LOSEC 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg both three times a day for one week.

To ensure healing in patients with active peptic ulcer disease, see further dosage recommendations for duodenal and gastric ulcer.

In each regimen if the patient is still Helicobacter pylori positive, therapy may be repeated.

Duodenal ulcer

The recommended dosage in patients with an active duodenal ulcer is LOSEC 20 mg once daily. Symptom resolution is rapid and in most patients healing occurs within 2 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 2 week treatment period.

In patients with poorly responsive duodenal ulcer LOSEC 40 mg once daily is recommended and healing is usually achieved within 4 weeks.

For the prevention of relapse in patients with duodenal ulcer disease the recommended dose is LOSEC 10 mg once daily. If needed the dose can be increased to LOSEC 20-40 mg once daily.

For NSAID-associated duodenal ulcers see “NSAID-Associated Gastroduodenal Lesions”.

Gastric ulcer

The recommended dosage is LOSEC 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.

In patients with poorly responsive gastric ulcer LOSEC 40 mg once daily is recommended and healing is usually achieved within 8 weeks.

For the prevention of relapse in patients with poorly responsive gastric ulcer the recommended dose is LOSEC 20 mg once daily. If needed the dose can be increased to LOSEC 40 mg once daily.

For NSAID-associated gastric ulcers see “NSAID-Associated Gastroduodenal Lesions”.

NSAID-associated gastroduodenal lesions

For NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosions in patients with or without continued NSAID treatment, the recommended dosage of LOSEC 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 LOSEC is 20 mg once daily.

Symptoms of acid-related dyspepsia

For the 24-hour relief, and prevention of symptoms in patients with epigastric pain/discomfort with or without heartburn and indigestion, 20 mg LOSEC once daily in the morning for 14 –28 days*. If symptom control has not been achieved after 4 weeks treatment with LOSEC 20 mg daily, further investigation is recommended.

^* Patients may respond adequately to 10 mg daily and this dose could be considered as a starting dose.

Zollinger-Ellison syndrome

In patients with Zollinger-Ellison syndrome the dosage should be individually adjusted and treatment continued as long as is clinically indicated. The recommended initial dosage is LOSEC 60 mg daily. All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of LOSEC 20-120 mg daily. When doses exceed LOSEC 80 mg daily, the dose should be divided and given twice daily.

Impaired Renal Function

Dose adjustment is not needed in patients with impaired renal function.

Impaired Hepatic Function

As bioavailability and plasma half-life of omeprazole are increased in patients with impaired hepatic function a daily dose of 10 – 20 mg may be sufficient.

Elderly

Dose adjustment is not needed in the elderly.

Rare reports have been received of overdosage with omeprazole. 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, diarrhoea and headache have been reported from overdosage with omeprazole. Also apathy, depression and confusion have been described in single cases.

The symptoms described in connection to omeprazole 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.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764 766).

HDPE bottles – Capsules and tablets: 3 years when stored tightly closed in the original container.

Shelf-life of three months when stored in non-original container.

Aluminium Blisters – Tablets: 3 years

Store below 25°C.

HDPE bottles of 30 capsules.

HDPE bottles of 30 tablets (Not marketed in New Zealand).

Aluminium blisters containing 30 tablets (Not marketed in New Zealand).

Return unused and expired medicines to your local pharmacy for disposal.