Source: Health Products Regulatory Authority (ZA) Publisher: Dezzo Trading 392 (Pty) Ltd, Jespan Centre, Corner Garrick and Flagtail Street, Extension 8, Lenasia, 1821, South Africa
TUMSIGON is indicated in:
Adults:
Children:
20 mg once daily for two to four weeks. In some duodenal ulcer patients refractory to other treatment regimens, 40 mg once daily may be effective.
10 mg once daily.
If necessary the dose can be increased to 20–40 mg once daily.
The above, recommended dosage regimens, are inclusive of Helicobacter pylori–positive duodenal ulcers, as part of the eradication programme with appropriate antibiotics.
20 mg once daily for four to eight weeks.
In some gastric ulcer and reflux oesophagitis patients refractory to other treatment regimens, 40 mg once daily may be effective.
For the long-term management of patients with reflux oesophagitis, the recommended dose is 10 mg once daily. If necessary the dose can be increased to 20–40 mg once daily. In patients with severe or symptomatic recurrent reflux oesophagitis treatment can be continued with TUMSIGON at a dosage of 20 mg once daily.
20 mg once daily.
In most patients healing occurs within 4 weeks. For patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks of treatment. Prevention of NSAIDs–associated gastroduodenal lesions and dyspeptic symptoms 20 mg once daily.
20 mg once daily.
20 mg daily.
Patients may respond adequately to 10 mg daily, therefore individual dose adjustments should be considered.
If symptom control has not been achieved after 2 weeks of treatment with 20 mg daily, further investigation is recommended.
If gastroesophageal reflux disease (GERD) symptom control has not been achieved after four weeks of treatment with the prescribed daily dose, especially where differentiation of diagnosis of GERD with angina and congestive heart failure is present, further investigation is recommended.
60 mg once daily.
The dosage should be adjusted individually and treatment continued as long as clinically indicated. With doses above 80 mg daily, the dose should be divided and given twice daily. There is very limited experience with the use of TUMSIGON in children (see section 4.4).
| Weight: | Dosage: |
|---|---|
| 10–20 kg | 10 mg once daily. If needed increase to 20 mg once daily. |
| >20 kg | 20 mg once daily. If needed increase to 40 mg once daily. |
Dose reductions are not necessary in elderly patients.
The long-term safety of TUMSIGON in patients with renal and hepatic impairment has not been established (see sections 4.8 and 5.2).
Dose reductions are not necessary in renal impairment (see sections 4.4 and 5.2).
Bioavailability and plasma half-life of TUMSIGON are increased in patients with impaired hepatic function, therefore a daily dose of 10–20 mg is generally sufficient (see sections 4.4, 4.8 and 5.2).
There is very limited experience with the use of TUMSIGON in children (see sections 4.4, 4.8 and 5.2).
TUMSIGON should not be used in children under 1 year of age or <10 kg.
TUMSIGON is recommended to be given in the morning and swallowed whole with a half glass of liquid. The capsule should not be chewed or crushed.
Blurred vision, confusion, diaphoresis, flushing, headache, malaise, nausea, and tachycardia have been reported from over-dosage with omeprazole. There is no specific antidote for overdose with omeprazole.
TREATMENT IS SYMPTOMATIC AND SUPPORTIVE.
Due to extensive protein binding, omeprazole is not readily dialysable. Patients in whom overdose is confirmed or suspected should be referred for medical practitioner/doctor consultation.
24 months.
Store at or below 25°C. Protect from light. Keep the aluminium strip packs in the outer carton until required for use.
6 capsules in aluminium strip pack:
5 of these strips in one carton i.e. 30 capsules pack.
7 capsules in aluminium strip pack:
4 of these strips in one carton i.e. 28 capsules per pack.
10 capsules in aluminium strip pack:
3 of these strips in one carton i.e. 30 capsules per pack. or 10 of these strips in one carton i.e. 100 capsules per pack.
14 capsules in aluminium strip pack:
1 of these strips in one carton i.e. 14 capsules per pack or 2 of these strips in one carton i.e. 28 capsules per pack.
Not all pack sizes may be marketed.
No special requirements.
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