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Nolpaza


1. Name of the medicinal product
Nolpaza gastroresistant tablets 40 mg


2. Qualitative and quantitative composition
Each gastroresistant tablet contains 40 mg pantoprazole as pantoprazole sodium sesquihydrate.
Excipient: sorbitol (36 mg).
For a full list of excipients, see section 6.1.


3. Pharmaceutical form
Gastroresistant tablet.
The tablets are light brownish yellow, oval, slightly biconvex, film-coated tablets.


4. Clinical particulars
4.1 Therapeutic indications

Treatment of moderate and severe reflux oesophagitis

Treatment of gastric ulcer
Treatment of duodenal ulcer
Treatment in combination with two appropriate antibiotics for eradication of Helicobacter pylori in patients with peptic ulcers for the prevention of duodenal and gastric ulcer relapse (see section 4.2)

Treatment of Zollinger-Ellison syndrome and other gastric acid hypersecretory states


4.2 Posology and method of administration
Moderate and severe reflux oesophagitis
The recommended dosage is one Nolpaza 40 mg tablet a day. A 4-week treatment period is usually required. If this is not sufficient, healing is mostly achieved within a further 4 weeks.


Gastric ulcer
The recommended dosage is one Nolpaza 40 mg tablet a day. A 4-week treatment period is usually required. If this is not sufficient, healing is mostly achieved within a further 4 weeks.


Duodenal ulcer
The recommended dosage is one Nolpaza 40 mg tablet a day. A 2-week treatment period is usually required. If this is not sufficient, healing is mostly achieved within a further 2 weeks.


Eradication of Helicobacter pylori
In patients with gastric and duodenal ulcers who are H. pylori-positive, combination therapy is required for the eradication of this bacterium.


For the eradication of Helicobacter pylori, the following combinations are recommended (depending on resistance):

(a) One Nolpaza 40 mg tablet twice daily
  + 1000 mg amoxicillin twice daily
  + 500 mg clarithromycin twice daily

(b) One Nolpaza 40 mg tablet twice daily
  + 500 mg metronidazole twice daily
  + 500 mg clarithromycin twice daily

(c) One Nolpaza 40 mg tablet twice daily
  + 1000 mg amoxicillin twice daily
  + 500 mg metronidazole twice daily


The first Nolpaza 40 mg tablet should be taken before breakfast, the second one before supper. The combination therapy usually lasts for 7 days. It can be prolonged to maximum 14 days. If further treatment is required, the recommended drug is Nolpaza at doses used for the treatment of gastric and duodenal ulcers.


Zollinger-Ellison syndrome and other gastric acid hypersecretory states
The starting dose in long-term treatment of Zollinger-Ellison syndrome and other gastric acid hypersecretory states is 80 mg pantoprazole (two Nolpaza 40 mg tablets) a day. Thereafter, the dosage can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dosage above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.


The duration of treatment of Zollinger-Ellison syndrome and other gastric acid hypersecretory states is not limited and should be adapted according to clinical needs.


Note
In patients with severe liver impairment, the daily dose should be reduced to one Nolpaza 40 mg tablet taken every other day. Furthermore, liver enzyme monitoring is required in these patients during the treatment. If liver enzymes are elevated, treatment should be discontinued.

 

In elderly patients and in patients with renal insufficiency, the daily dose of pantoprazole should not exceed 40 mg. An exception is the combination therapy for eradication of H. pylori, when elderly patients receive the usual pantoprazole dose (2 x 40 mg/day) for 1 week.


General instructions
Nolpaza tablets should not be chewed or crushed. The tablets should be swallowed whole, with some liquid, before a meal, usually before breakfast. If combined treatment is not required, e.g. if the patient is not infected with Helicobacter pylori, the dosage for gastric ulcer, duodenal ulcer and reflux oesophagitis may be doubled in individual cases (increased to two Nolpaza 40 mg tablets a day), especially if the patient did not respond to other treatment.


4.3 Contraindications
Hypersensitivity to pantoprazole or to any of the excipients.
Patients with severe hepatic or renal insufficiency should not take Nolpaza 40 mg tablets in combination with antibiotics in eradication of H. pylori because the available clinical data are limited.


4.4 Special warnings and precautions for use
Pantoprazole is not indicated for moderate gastrointestinal disturbances, such as neurotic dyspepsia.
In the event of combination therapy for the eradication of Helicobacter pylori, the Summaries of Product Characteristics of the respective drugs should be observed.


Prior to treatment, a malignant disease of the oesophagus or stomach should be excluded as treatment with pantoprazole may mask the symptoms of a malignant disease and thus delay diagnosis.

 

The diagnosis of reflux oesophagitis should be endoscopically confirmed.

To date there has been no experience with treatment in children. In patients with Zollinger-Ellison syndrome and other gastric acid hypersecretory states who need long-term treatment, pantoprazole may, like other acid-blocking medicines, reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be taken into account at the occurrence of typical clinical symptoms.


Important information about some of the excipients
Nolpaza contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.


4.5 Interaction with other medicinal products and other forms of interaction
Nolpaza 40 mg may reduce the absorption of drugs that are absorbed in acidic conditions (e.g. ketoconazole).


Pantoprazole is metabolized in the liver via the cytochrome P450 enzyme system. Interactions of pantoprazole with other agents that are metabolized via the same enzyme system cannot be excluded. However, no clinically significant interactions were observed in studies with digoxin, diazepam, diclotenac, ethanol, phenytoin, glibenclamide, carbamazepine, caffeine, metoprolol, naproxen, nifedipine, piroxicam, theophylline and oral contraceptives. Although no interactions were observed during concomitant administration of phenprocoumon or warfarin in clinical pharmacokinetic studies, a few isolated cases of changes in INR have been reported during concomitant treatment in the post-marketing period. In patients treated with coumarin anticoagulants, it is therefore recommended that prothrombin time or INR be monitored during concomitant treatment with pantoprazole.

 

There have also been no interactions with concomitantly administered antacids.


4.6 Pregnancy and lactation
Clinical experience in pregnant women is limited. In animal reproduction studies, slight fetotoxicity was observed at doses above 5 mg/kg. There is no information on the excretion of pantoprazole into human breast milk. The medicine should only be used when the benefit to the mother outweighs the potential risk to the foetus or baby.


4.7 Effects on ability to drive and use machines
There are no known effects on the ability to drive and use machines.

 

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