ANTEPSIN Tablet Ref.[6447] Active ingredients: Sucralfate

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, Antepsin should be used with extreme caution and only for shortterm 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.

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.

At the time of taking sucralfate tablets, aspiration may occur in patients with swallowing difficulty.

Paediatric Population

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

Concomitant administration of Antepsin 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 Antepsin by two hours. This interaction appears to be non systemic in origin presumably resulting from these agents being bound by Antepsin in the gastrointestinal tract. Because of the potential of Antepsin to alter the absorption of some drugs from the gastrointestinal tract, the separate administration of Antepsin 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 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 Antepsin Tablets 1 g and enteral feeds by nasogastric tube should be separated by one hour in patients receiving Antepsin Tablets 1 g for the prophylaxis of stress ulceration. In rare cases bezoar formation has been reported when Antepsin and enteral feeds have been given too closely together.

Pregnancy

Teratogenicity studies in mice, rats and rabbits at doses 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 Antepsin should be used during pregnancy only if clearly needed.

Lactation

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

Do not drive if you feel dizzy or drowsy.

Tabulated list of adverse reactions:

Immune system disorders

Not know (cannot be estimated from the available data): Anaphylactic reaction including pruritus, urticaria, oedema, dyspnoea

Nervous system disorders

Not known (cannot be estimated from the available data): Dizziness, headache, drowsiness

Ear and labyrinth disorders

Not known (cannot be estimated from the available data): Vertigo

Gastrointestinal disorders

Common (≥1% and <10%): Constipation

Uncommon (≥0.1% and <1%): Dry mouth, nausea,

Rare (≥0.01% and <0.1%): Bezoar formation¹

Not known (cannot be estimated from the available data): Diarrhoea, vomiting, gastric discomfort, indigestion, flatulence

Skin and subcutaneous tissue disorders

Rare (≥0.01% and <0.1%): Rash

Musculoskeletal and connective tissue disorders

Not known (cannot be estimated from the available data): Back pain

Injury, poisoning and procedural complications

Not known (cannot be estimated from the available data): Osteodystrophy², osteomalacia², encephalopathy², anaemia²

¹ Reported in patients with impaired gastric emptying, patients with enteral tube feeding or low birth weight infants.
² Reported 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.

Not applicable.