ULCESEP Hard gelatin capsule Ref.[51141] Active ingredients: Omeprazole

Adults

Oesophageal reflux disease including reflux oesophagitis

The usual dosage is 20 mg Ulcesep once daily. The majority of patients are healed after 4 weeks. For those patients not fully healed after the initial course, healing usually occurs during a further 4-8 weeks treatment.

Ulcesep has also been used in a dose of 20 mg twice daily in patients with reflux oesophagitis refractory to other therapy. Healing usually occurred within 8 weeks.

Patients can be continued at a dosage of 20 mg once daily.

Acid reflux disease

For long-term management Ulcesep 20 mg once daily is recommended.

Duodenal and benign gastric ulcers

The usual dose is 20 mg Ulcesep once daily. The majority of patients with duodenal ulcer are healed after 4 weeks. The majority of patients with benign gastric ulcer are healed after 8 weeks. In severe or recurrent cases the dose may be increased to 40 mg Ulcesep daily. Long-term therapy for patients with a history of recurrent duodenal ulcer is recommended at a dosage of 20 mg Ulcesep once daily.

For prevention of relapse in patients with duodenal ulcer the recommended dose is Ulcesep 20 mg once daily for 6 to 12 months.

The following groups are at risk from recurrent ulcer relapse: those with Helicobacter pylori infection, younger patients (<60 years), those whose symptoms persist for more than one year and smokers. These patients will require initial longterm therapy with Ulcesep 20 mg once daily.

Helicobacter pylori (Hp) eradication regimens in peptic ulcer disease Ulcesep is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below:

Triple therapy regimens in duodenal ulcer disease:

Ulcesep and the following antimicrobial combinations:

40 mg (2 capsules) of ULCESEP once a day and amoxicillin 500 mg and metronidazole 400 mg three times a day for one week
or
20 mg (1 capsule) of ULCESEP and clarithromycin 250 mg and metronidazole

400 mg (or tinidazole 500 mg) twice a day for one week
or
20 mg (1 capsule) of ULCESEP and amoxicillin 1 g and clarithromycin 500 mg twice a day for one week.

Dual therapy regimens in duodenal ulcer disease:

Ulcesep 40-80 mg (2-4 capsules) of daily and amoxicillin 1.5 g in divided dosages for two weeks.

Alternatively, Ulcesep 40 mg (2 capsules) daily and clarithromycin 500 mg three times a day for two weeks.

Dual therapy regimens in gastric ulcer disease:

Ulcesep 40-80 mg (2-4 capsules) of daily and amoxicillin 1.5 g in divided dosages for two weeks.

In each regimen if symptoms return and the patient is Hp positive, therapy may be repeated or one of the alternative regimens can be used; if the patient is Hp negative then see dosage instructions for acid reflux disease.

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

Prophylaxis of acid aspiration

For patients considered to be at risk of aspiration of the gastric contents during general anaesthesia, the recommended dosage is Ulcesep 40 mg on the evening before surgery followed by Ulcesep 40 mg 2-6 hours prior to surgery.

Zollinger-Ellison syndrome

The recommended initial dosage is 60 mg Ulcesep once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated. More than 90% of patients with severe disease and inadequate response to other therapies have been effectively controlled on doses of 20-120 mg daily. With doses above 80 mg daily, the dose should be divided and given twice daily.

Acid-related dyspepsia

The usual dosage is Ulcesep 20 mg once daily for 2-4 weeks depending on the severity and persistence of symptoms. Patients who do not respond after 4 weeks or who relapse shortly afterwards, should be investigated.

For the treatment of NSAID-associated gastric ulcers, duodenal ulcers or gastroduodenal erosions

The recommended dosage of Ulcesep 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.

For the prophylaxis of NSAID-associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms in patients with a previous history of gastroduodenal lesions who require continued NSAID treatment

The recommended dosage of Ulcesep is 20 mg once daily.

Elderly

Dose adjustment is not required in the elderly.

Children

Experience of the use of Ulcesep in children is limited. In children 1 year and above with severe ulcerating reflux oesophagitis, Ulcesep is recommended for healing and symptom relief at the following doses:

Weight Dosage:

10-20 kg Ulcesep 10 mg once daily

>20 kg Ulcesep 20 mg once daily

If needed the dose may be increased to 20 mg and 40 mg respectively for 4 12 weeks.

Data suggest that approximately 65% of children will experience pain relief with this dose regimen. Treatment should be initiated by a paediatrician.

Impaired renal function

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

Impaired hepatic function

As bioavailability and half-life can increase in patients with impaired hepatic function, the dose requires adjustment with a maximum daily dose of 20 mg.

For patients (including children aged 1 year and above who can drink or swallow semi solid food) who are unable to swallow Ulcesep Capsules

The capsules may be opened and the contents swallowed directly with half a glass of water or suspended in 10 ml of non carbonated water, any fruit juice with a pH less than 5 e.g. apple, orange, pineapple, or in applesauce or yoghurt and swallowed after gentle mixing. The dispersion should be taken immediately or within 30 minutes. Stir just before drinking and rinse it down with half a glass of water. Alternatively the actual capsules may be sucked and then swallowed with half a glass of water. There is no evidence to support the use of sodium bicarbonate buffer as a delivery form. It is important that the contents of the capsules should not be crushed or chewed.

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 2400 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.

3 years.

Do not store above 30°C.

Blisters: Store in the original container.

Ulcesep Capsules are provided in Aluminium-PVC/Aluminium foil blister packs.

Packs of 28 capsules.

To be dispensed in original containers.