|SECADINE Syrup||: Each 5 mL syrup contains 200 mg cimetidine as the hydrochloride|
Preserved with methyl p-hydroxybenzoate 0,10% m/v and propyl p-hydroxybenzoate 0,02% m/v
Contains ethyl alcohol 2,9% v/v
|1.||The treatment of duodenal and benign gastric ulceration and peptic oesophagitis; recurrent ulceration; stomal ulceration and other conditions where reduction of gastric acid secretion has been shown to be beneficial.|
|2.||In patients with a history of recurrent duodenal ulceration relapse after healing is prevented during treatment at reduced dosage for up to 1 year.|
|3.||Management of pathological hypersecretion (such as Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).|
|4.||SECADINE is indicated in the management of those patients who are of high risk from haemorrhage of the upper gastro-intestinal tract due to hepatic failure.|
In active duodenal, benign gastric and stomal ulceration:
The usual dose is 200 mg three times a day with meals and 400 mg at bedtime. 400 mg twice a day, with breakfast and at bedtime has also been shown to be effective. The preferred dose is 200 mg three times a day with meals and 400 mg at bedtime. If there is inadequate symptomatic improvement or other evidence of continuing ulceration, this dose may be increased to 400 mg four times a day, taken with meals, and at bedtime. Treatment should be continued for at least four weeks, even if symptomatic relief has been achieved in a shorter time.
In duodenal ulcer: the efficacy of a single bedtime dose of 800 mg has been shown to be comparable to that of a daily dose of 800 mg divided in two administrations (400 mg in the morning and 400 mg at bedtime).
Prophylaxis of Recurrent Ulcer:
In patients with a history of recurrent duodenal ulceration, relapse after healing is prevented during treatment at reduced dosage for a period of up to 1 year. It is recommended, after healing, to continue treatment of reduced dosage for as long as the physician deems necessary to prevent a relapse.
A maintenance dose of 400 mg at bedtime has been shown to confer protection against recurrence after duodenal ulceration, during this period of 1 year while on maintenance treatment; some patients may require 400 mg twice a day.
|3.||In Peptic Oesophagitis:|
400 mg four times a day, taken with meals and at bedtime for up to 12 weeks, is recommended. 0,8 to 1,6 g/day, depending on the degree of severity of the condition, may be used. A single bedtime dose of 800 mg may be effective in patients with peptic oesophagitis. 400 mg twice daily in the morning and at bedtime has also been shown to be effective. Severe cases may require up to 1,6g/day given in divided doses.
|4.||In Zollinger-Ellison syndrome and other cases of high gastric secretion:|
The usual dose is 200 mg three times a day with meals and 400 mg at bedtime, but it may be necessary to increase the dose to 400 mg four times a day. In some patients it may be necessary to administer SECADINE more frequently. Doses should be adjusted to individual needs and should continue as long as clinically indicated.
|5.||In the management of those patients who are of high risk from haemorrhage of the upper gastrointestinal tract due to hepatic failure and treatment with immuo-suppressive agents, following kidney transplant:|
Patients with hepatic failure who are at high risk from haemorrhage can be treated with normal doses of SECADINE. The usual dose is 200 mg three times a day with meals, and 400 mg at bedtime. It may be necessary to increase the dose to 400 mg four times a day.
For the dosage for patients following kidney transplant, please refer to "Side-effects and special precautions".
|SECADINE Tablets 200 mg||:||Pale green, film coated tablets|
|SECADINE Tablets 400 mg||:||Pale green, oblong shaped, film coated with convex faces and flat sides.|
|SECADINE Syrup||:||Clear, orange coloured peach flavoured syrup.|
|SECADINE Tablets 200 mg||:||Securitainers of 150 and 60 tablets.|
|SECADINE tablets 400 mg||:||Securitainers of 60 tablets.|
|SECADINE Syrup||:||Bottles containing 200 mL.|
|SECADINE Tablets 200 mg||:||27/11.4.3/0102|
|SECADINE Tablets 400 mg||:||27/11.4.3/0103|
|4 May 1993.||P1309|