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Gasec
Gasec -10/20/40 Gastrocaps
Proton pump inhibitor

Composition
Active substance: omeprazole
Excipients: colour E132 (indigotine) and other excipients.

Galenical form and amount of active substance per unit
Gasec-10 Gastrocaps
Each capsule contains: omeprazole 10 mg

Gasec-20 Gastrocaps
Each capsule contains: omeprazole 20 mg

Gasec-40 Gastrocaps

Each capsule contains: omeprazole 40 mg

Indications/Possibilities for use
For Gasec-20 and Gasec-40
Duodenal ulcer, gastric ulcer, reflux oesophagitis and Zollinger-Ellison syndrome. If possible, the diagnosis should be confirmed endoscopically.


Long-term therapy and prophylaxis in patients suffering from reflux oesophagitis, prophylaxis of duodenal ulcer relapse in the case of therapy-resistant Helicobacter pylori.

 

Eradication of Helicobacter pylon in the case of peptic ulcers, with simultaneous administration of two antibiotics.


Peptic ulcers or gastroduodenal erosions caused by NSAIDs.


Symptomatic gastrooesophageal reflux (dyspepsia, heartburn, acidic eructation).

 

For Gasec-10
Prophylaxis of a relapse of cured reflux oesophagitis.


Acid-related functional dyspepsia.


For children up to 12 years of age
Severe reflux oesophagitis


Gasec-20 and Gasec-40 can be also used for prophylaxis of gastric ulcer relapse.

Posology/Method of administration
In general, the following dosage recommendation applies:
Children up to 12 years of age
Reflux oesophagitis


Up to the age of 5 months:
The experience in this group of age is limited. The indication must therefore be strictly set. The
initial dose is 0.5 mg/kg per day. If the clinical response is insufficient, the dose can be increased to 1 mg/kg per day.


Over the age of 5 months with a body weight of < 20 kg:
1 mg/kg per day. If the response is insufficient, this can be increased to 1.4 mg/kg per day.


Children with a body weight of ≥ 20 kg:
1 x 20 mg per day. If the clinical response is insufficient, the dose can be increased to 1 x 40 mg per day.


Treatment should be carried out for 4 weeks, up to a maximum of 8 weeks.


Adults and adolescents of 12 years and older

Gasec-20 and Gasec-40, respectively

Duodenal ulcer.
In general 20 mg of Gasec once per day.


Relief from symptoms occurs quickly and the ulcer is usually cured within two weeks. If a treatment period of 2 weeks is not sufficient, cure is in most cases achieved during a further 2-week therapy. Duodenal ulcer patients who responded unsatisfactorily to other forms of treatment should be treated with 40 mg of Gasec once per day At this dosage a cure is usually achieved within 4 weeks.


For relapse prophylaxis in patients suffering from duodenal ulcer, the recommended dosage is 20-40 mg of Gasec once per day.


Gastric ulcer, reflux oesophagitis: In general, 20 mg of Gasec once per day. Relief from symptoms occurs quickly and in most patients the ulcer is cured within four weeks. If a treatment period of 4 weeks is not sufficient, the cure is in most cases achieved during a further 4-week therapy.


Gastric ulcer or reflux oesophagitis patients who responded unsatisfactorily to other forms of treatment should be treated with 40 mg of Gasec once per day. At this dosage, a cure is in most cases achieved within eight weeks.


For relapse prophylaxis in patients suffering from gastric ulcer, the recommended dosage is 20 mg of Gasec once per day. If required, the dosage can be increased to 40 mg of Gasec once per day.


The following short-term therapy schedules for eradicating Helicobacter pylon in cases of peptic ulcer have been testes' in clinical studies:
Two times per day: 20 mg of omeprazole in combination with amoxicillin 1 g and clarithromycin 500 mg.

Duration of treatment: 1 week

or
Two times per day: 20 mg of omeprazole in combination with clarithromycin 250 mg and metronidazole 500 mg (or tinidazole 500 mg).

Duration of treatment: 1 week

or
40 mg of omeprazole once per day in combination with amoxicillin 500 mg and metronidazole 500 mg, each three times per day.

Duration of treatment: 1 week.


The therapy can be repeated if the patient is still Helicobacter pylori positive after a one-week short-term therapy.


To ensure that active peptic ulcers are cured, please also refer to the dosage recommendations for duodenal ulcer and gastric ulcer.


Gastroduodenal ulcers or erosions caused by NSAIDs: For patients with or without simultaneous NSAID therapy, the recommended dosage is 20 mg of Gasec once per day. Relief from symptoms occurs quickly and cure is usually achieved within a period of 4 weeks.


If a treatment period of 4 weeks is not sufficient, cure is in most cases achieved during a further 4-week therapy. If required, the dosage can be increased to 40 mg once daily.

 

The recommended dosage for relapse prophylaxis in the case of peptic ulcers, gastroduodenal erosions and dyspeptic symptoms caused by NSAIDs is 20 mg of Gasec once per day.

 

Symptomatic gastrooesophageal reflux: The recommended dosage is 20 mg of Gasec once per day. Relief from symptoms occurs rapidly.


Further examinations should be caned out if a treatment period of 4 weeks with Gasec 20 mg is not sufficient.


Zollinger-Ellison syndrome:
The dosage should be adapted individually. The recommended initial dose is 60 mg of Gasec once per day. Treatment should be continued as long as clinically required. More than 90% of the patients suffering from the most severe form of the disease, who showed an insufficient response to other forms of therapy, were successfully stabilised using doses between 20 mg and 120 mg of omeprazole per day. If more than 80 mg per day is required, the daily dose should be divided into two administrations.


Gasec-10
The recommended dose for relapse prophylaxis of cured reflux oesophagidis is 10 mg of Gasec once per day. However, clinical studies have shown that the relapse rate at a dosage of 10 mg omeprazole once daily is higher than the relapse rate at a standard dosage. If required, the dose can be increased to 20-40 mg once per day.


Acid-related functional dyspepsia:
The recommended dosage for the treatment of the symptoms of epigastric pain/complaints with or without heartburn is 10 mg of Gasec once per day. If there is no palliation of symptoms after four weeks, further examinations should be carried out.


Method and duration of use
The capsules are best taken in the morning without chewing and with liquid.


For patients having difficulties in swallowing, and for children who can only take liquid and semi-solid food, the content of the capsule can be taken in non-carbonated water or mixed with a slightly acidic drink (for example juices, yoghurt or sour milk). Such a preparation should be taken immediately (within 30 minutes). Rinse the glass with half a glass of water and drink it. Milk or carbonated water should not be used. The capsule must neither be chewed nor crushed.


Special dosage instructions
In patients with impaired kidney function an adjustment of the dose is not necessary.


Bioavailability and plasma half-life of omeprazole are increased in patients with impaired liver function.


No dose adjustment is necessary in elderly patients.

 

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