Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: KRKA, d.d., Novo mesto, ล marjeลกka cesta 6, 8501 Novo mesto, Slovenia
Symptomatic gastro-oesophageal reflux disease.
For long-term management and prevention of relapse in reflux oesophagitis.
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 (see section 4.4).
The recommended oral dose is one gastro-resistant tablet Nolpaza 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, when required. A switch to continuous therapy may be considered in case satisfactory symptom control cannot be maintained with on-demand treatment.
For long-term management, a maintenance dose of one gastro-resistant tablet Nolpaza 20 mg per day is recommended, increasing to 40 mg pantoprazole per day if a relapse occurs. Nolpaza 40 mg is available for this case. After healing of the relapse the dose can be reduced again to 20 mg pantoprazole.
The recommended oral dose is one gastro-resistant tablet Nolpaza 20 mg per day.
No dose adjustment is necessary in the elderly.
A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment (see section 4.4).
No dose adjustment is necessary in patients with impaired renal function.
Children below 12 years of age: Nolpaza is not recommended for use in children below 12 years of age due to limited data on safety and efficacy in this age group.
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 overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
5 years
HDPE container:
After first opening of the container, the product should be used within 3 months.
Blister pack: Store in the original package in order to protect from moisture.
Container: Keep the container tightly closed in order to protect from moisture.
Blister pack (OPA/Aluminium/PVC film and aluminium foil) in a carton box. Pack-sizes of 7, 14, 15, 28, 30, 56, 60, 84, 100, 100 × 1, 112 or 140 gastro-resistant tablets.
HDPE containers with a silica gel desiccant in a tamper evident PP screw-cap. Pack-size of 250 gastro-resistant tablets.
Not all pack sizes may be marketed.
No special requirements.
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