PANTOPRAZOLE 20mg Gastro-resistant tablets Ref.[7032] Active ingredients: Pantoprazole

Posology

Adults and adolescents 12 years of age and above

Symptomatic gastro-oesophageal reflux disease

The recommended oral dose is one gastro-resistant tablet Pantoprazole 20 mg per day. Symptom relief is generally accomplished within 2-4 weeks. If this is not sufficient, symptom relief will normally be achieved within a further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20 mg once daily, taking one tabletwhen required. A switch to continuous therapy may be considered in case satisfactory symptom control cannot be maintained with on-demand treatment.

Long-term management and prevention of relapse in reflux oesophagitis

For long-term management, a maintenance dose of one gastro-resistant tablet Pantoprazole 20 mg per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Pantoprazole 40 mg is available for this case. After healing of the relapse the dose can be reduced again to 20 mg pantoprazole.

Adults

Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment The recommended oral dose is one gastro-resistant tablet Pantoprazole 20 mg per day.

Special populations

Patients with hepatic Impairment

A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment (see section 4.4).

Patients with renal Impairment

No dose adjustment is necessary in patients with impaired renal function (see section 5.2).

Older people

No dose adjustment is necessary in elderly patients (see section 5.2).

Paediatric population

Pantoprazole is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group.

Method of administration

Oral use.

The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.

There are no known symptoms of overdose in man.

Systemic exposure with up to 240 mg administered intravenously over 2 minutes were well tolerated. As pantoprazole is extensively protein bound, it is not readily dialysable.

In the case of an overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

Blisters of Polyamide/Aluminium/PVC-Aluminium in a blister carton, and white opaque round HDPE container with white opaque polypropylene closure.

Pack sizes:

Blister: 7, 14, 15, 28, 30, 56, 60, 98, 100 and 500 gastro-resistant tablets.

HDPE: 14, 28, 56, 60, 98, 100 and 500 gastro-resistant tablets.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.