Sucralfate 1 g/5 ml Oral Suspension

Sucralfate Suspension is indicated in adults and adolescents over 14 years old for the treatment of duodenal ulcer, gastric ulcer, acute gastritis, symptomatic chronic gastritis, gastropathy caused by NSAIDs (nonsteroidal anti-inflammatory drugs), reflux oesophagitis and the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients.

Posology

Duodenal ulcer, gastric ulcer, acute gastritis, symptomatic chronic gastritis, gastropathy caused by NSAIDs, reflux oesophagitis:

Adults: The usual dose is 2 grams twice daily to be taken on rising and at bedtime, or 1 gram 4 times a day to be taken 1 hour before meals and at bedtime unless otherwise prescribed by your doctor. Maximum daily dose: 8 grams.

Four to six weeks treatment is usually needed for ulcer healing, but up to twelve weeks may be necessary in resistant cases.

Antacids may be used as required for relief of pain but should not be taken half an hour before or after Sucralfate Suspension.

Paediatric population: The safety and efficacy of Sucralfate Suspension in children under 14 years of age has not been established.

Currently available data are described in section 5.1 but no recommendation on posology can be made.

Elderly: see below.

Prophylaxis of gastrointestinal haemorrhage from stress ulceration:

Adults: The usual dose is 1 gram six times a day. A maximum dose of 8 grams daily should not be exceeded. Antacids may be used as required for relief of pain but should not be taken half an hour before or after Sucralfate Suspension.

Paediatric population: The safety and efficacy of Sucralfate Suspension in children under 14 years of age has not been established.

Currently available data are described in section 5.1.

Elderly: There are no special dosage requirements for elderly patients but as with all medicines, the lowest effective dose should be used.

Method of administration

For oral administration.

Sucralfate Suspension must not be administered intravenously.

The suspension must be shaken before use.

A 5 ml measuring spoon with intermediate graduation at 2.5 ml is also provided.

Sucralfate suspension should be taken on an empty stomach, approximately one hour before meals and at bedtime.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Sucralfate suspension must not be administered intravenously. Inadvertent intravenous administration of insoluble sucralfate and its insoluble excipients may induce fatal complications, including pulmonary and cerebral emboli. Other severe complications including aluminium intoxication are reported after intravenous administration.

The product should only be used with caution in patients with renal dysfunction, due to the possibility of increased aluminium absorption.

Sucralfate is not recommended for use in individuals on dialysis.

In patients with severe or chronic renal impairment, Sucralfate Suspension 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.

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

This medicinal product contains 5 mg sodium methyl parahydroxybenzoate in each 5 ml of oral suspension which may cause allergic reactions (possibly delayed).

This medicinal product contains less than 1 mmol sodium (23 mg) per 20 ml of oral suspension, that is to say essentially 'sodium-free'.

Bezoars have been reported after administration of sucralfate mainly to severely ill patients in intensive care units. The majority of these patients (including neonates in whom sucralfate is not recommended) 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 Suspension is not recommended for use in children under 14 years of age due to insufficient data on safety and efficacy.

Concomitant administration of Sucralfate Suspension may reduce the bioavailability of certain drugs including fluoroquinolones such as ciprofloxacin and norfloxacin, tetracycline, ketoconazole, sulpiride, digoxin, warfarin, phenytoin, theophylline, levothyroxine, quinidine and H₂ antagonists. The bioavailability of these agents may be restored by separating the administration of these agents from Sucralfate Suspension by two hours. This interaction appears to be non-systemic in origin presumably resulting from these agents being bound by Sucralfate Suspension in the gastrointestinal tract. Because of the potential of Sucralfate Suspension to alter the absorption of some drugs from the gastrointestinal tract, the separate administration of Sucralfate Suspension from that of other agents should be considered when alterations in bioavailability are felt to be critical for concomitantly administered drugs.

Sucralfate should not be co-administered with citrate preparations. Co-administration of citrate preparations with sucralfate may increase the blood concentrations of aluminium. The mechanism may be due to chelation of aluminium, which is assumed to increase its absorption.

The administration of Sucralfate Suspension and enteral feeds by nasogastric tube should be separated by one hour in patients receiving Sucralfate Suspension for the prophylaxis of stress ulceration. In rare cases bezoar formation has been reported when Sucralfate Suspension and enteral feeds have been given too closely together.

Pregnancy

Teratogenicity studies in mice, rats and rabbits at dose up to 50 times the human dose have revealed no evidence of harm to the foetus.

Safety in pregnant women has not been established and Sucralfate Suspension should be used during pregnancy only if clearly needed.

Breast-feeding

It is not known whether this drug is excreted in human milk. Caution should be exercised when Sucralfate Suspension is administered to breast-feeding women.

Fertility

No human data on the effect of sucralfate on fertility are available.

Do not drive if you feel dizzy or drowsy.

The frequency of possible undesirable effects is defined using the following convention:

Common (≥ 1/100 to < 1/10)

Uncommon (≥ 1/1 000 to < 1/100)

Rare (≥ 1/10 000 to < 1/1 000)

Not known (cannot be estimated from the available data)

Tabulated list of adverse reactions

¹Reported in patients with impaired gastric emptying, patients with enteral tube feeding or low birth weight infants.

²Reported in patients with chronic renal impairment.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In a clinical trial on healthy men of overdose with sucralfate, most cases remained asymptomatic, but symptoms of abdominal pain, nausea, and vomiting were reported in a few cases.

Acute oral toxicity studies in animals, using doses up to 12 g/kg body weight, could not find a lethal dose. Risks associated with overdose, should, therefore, be minimal.

Pharmacotherapeutic group: Alimentary tract and metabolism, ATC code: A02B X02

Mechanism of action

The action of Sucralfate Suspension is non-systemic as the drug is only minimally absorbed from the gastro-intestinal tract. The small amounts that are absorbed are excreted primarily in the urine. Sucralfate Suspension exerts a generalised cytoprotective effect by preventing gastro-intestinal mucosal injury.

Studies in humans and animal models show that Sucralfate Suspension forms an ulcer adherent complex with the proteinaceous exudate of the ulcer site. This property enables Sucralfate Suspension to form a protective barrier over the ulcer lesion giving sustained protection against the penetration and action of gastric acid, pepsin and bile. Studies both in humans and animals demonstrate that Sucralfate Suspension protects the gastric mucosa against various irritants such as alcohol, acetylsalicylic acid and sodium taurocholate.

Sucralfate Suspension also directly inhibits pepsin activity and absorbs bile salts. It has only weak antacid activity. It does not alter gastric emptying time, nor normal digestive function. Sucralfate Suspension has no demonstrated pharmacological effect on the cardiovascular or central nervous systems.

Paediatric population

In the literature, there are limited clinical data on the use of sucralfate in children, mainly for stress ulcer prophylaxis, reflux oesophagitis and mucositis. The dose used in these studies was 0.5-1 g four times a day, depending on the children's age and the severity of the underlying disease, and was applied without major safety concerns. In view of the limited data, use of sucralfate in children under 14 years of age is currently not recommended.

Absorption

Sucralfate is only minimally absorbed from the gastro-intestinal tract. The small amounts that are absorbed are excreted primarily in the urine. Absorption of aluminium from sucralfate may be increased in patients on dialysis or with renal dysfunction (see also "other special warnings and precautions").

There was no evidence of carcinogenesis in mice and rats receiving oral sucralfate in dosages of up to 1 g/kg daily (12 times the usual human dosage) for 2 years. In animal studies there was no effect evidence of impaired fertility. The effect of sucralfate on human fertility is not known.

Glycerol (E422)

Sodium dihydrogen phosphate dihydrate (E339)

Sodium methyl parahydroxybenzoate (E219)

Xanthan gum (E415)

Saccharin sodium (E954ii)

Aniseed flavour (including propylene glycol, E1520)

Caramel flavour (including propylene glycol, E1520)

Purified Water

Not applicable.

30 months.

After first opening use within 1 month.

This medicinal product does not require any special storage conditions.

Amber type III glass bottle safely closed with a child-resistant screw cap with tamper evident closure. Each bottle contains 200 ml of this medicinal product.

A 5 ml measuring spoon with intermediate graduation at 2.5 ml is also provided.

No special requirements.