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Sucramed

RX : THIS DRUG IS FOR PRESCRIPTION ONLY
COMPOSITION : Active ingredient: Each sachet contains 1 gram sucralfate.
Excipients: Lactose monohydrate, aspartame, povidone K30, melon powder flavour.
PACKING : Box of 30 sachets
SHELF LIFE : 36 months from the manufacturing date
INDICATIONS : The treatment of gastric ulcer and active duodenal ulcer
Maintenance treatment of duodenal ulcer in patients who are not infected with Helicobacter pylori or cannot be eradicated in human.
Posology and Method of Administration

Gastric ulcers:

Take 1 sachet, 4 times daily, within 4 to 6 weeks, i.e

- 1 sachet, 30 - 60 minutes before each 3 main meals,

- 1 sachet, after meal, before bedtime about 2 hours

Active duodenal ulcer

Take 1 sachet, 4 times daily, within 4 to 6 weeks, i.e

- 1 sachet, 30 - 60 minutes before each 3 main meals,

- 1 sachet, after meal, before bedtime about 2 hours

OR

Take 2 sachets each time, twice a day in the morning and evening, within 4 - 6 weeks, i.e.

- 2 sachets in the morning, 30 - 60 minutes before breakfast.

- 2 sachets in the evening, about 2 hours after meal.

Prevention of Recurrent duodenal Ulcers

Take 1 sachet, BID, i.e

- 1 sachet in the morning, 30 - 60 minutes before breakfast.

- 1 sachet in the evening, 30 - 60 minutes before meal or before bedtime about 2 hours, after meal.

OR

Take 2 sachets in the evening, 30 - 60 minutes before meal or before bedtime about 2 hours, after meal

The concomitant use of other aluminium containing medications is not recommended in view of the enhanced potential for aluminium absorption and toxicity.

Paediatric population: the safety and efficacy of Sucrafate in children under 14 years of age has not been established.

 

METHOD OF ADMINISTRATION

For oral administration. Mix 1 sachet with a glass of water and shake well before using.

Hypersensitivity reactions to the active substance or to any of the excipients.

Premature infants and infants with maturation disorders.

Bezoars have been reportedafter administration of sucralfate mainly to severely ill patients in intensive care units.The majority of these patients (including neonates in whom sucralfate is not  ecommended) had underlying conditions that may predispose to bezoar formation (such as delayed gastric emptying due to surgery, drug therapy or diseases that reduce motility), or were receiving concomitant enteral tube feeding.

Paediatric Population: sucralfate is not recommended for use in children under 14 years of age due to insufficient data on safety and efficacy.

In patients with severe or chronic renal impairment, sucralfate should be used with extreme caution and only for short-term treatment. Small amounts of aluminium are absorbed through the gastrointestinal tract and aluminium may accumulate. Aluminium osteodystrophy, osteomalacia, encephalopathy, and anaemia have been reported in patients with chronic renal impairment. For patients with impairment of renal function, laboratory testing such as aluminium, phosphate, calcium, and alkaline phosphatase is recommended to be periodically performed due to excretion impairment.

Although there are no contraindications, sucralfate should not recommend for long-term treatment of subjects with hypophosphatemia (eg, primary hyperparathyroidism, dystrophic rickets, vitamin resistance)

In the case of gastric ulcers, it is necessary to check the benignity of the ulcer before treatment.

Excipients: This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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