Components:
Sucralfate
Method of action:
Antacid, Antiulcer, Drugs For Acid Related Disorders, Gastroprotective, Hepatoprotective
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Medically reviewed by Militian Inessa Mesropovna, PharmD Last updated on 2019.06.24

Name of the medicinal product

Gelactive Sucra

Qualitative and quantitative composition

Sucralfate

Therapeutic indications

The information provided in Therapeutic indications of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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Gelactive Sucra is indicated in adults and adolescents over 14 years old for treatment of duodenal ulcer, gastric ulcer, chronic gastritis, and the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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For oral administration.

Gelactive Sucra must not be administered intravenously.

Duodenal ulcer, gastric ulcer, chronic gastritis:

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. 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 Gelactive Sucra.

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

Elderly: see below

Prophylaxis of gastrointestinal haemorrhage from stress ulceration:

Adults: The usual dose is 1 gram six times a day.

Contraindications

The information provided in Contraindications of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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Gelactive Sucra 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, Gelactive Sucra 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.

Contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).

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 medical 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

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

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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Do not drive if you feel dizzy or drowsy.

Undesirable effects

The information provided in Undesirable effects of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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Tabulated list of adverse reactions

Immune system disorders

Not known (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

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.

Overdose

The information provided in Overdose of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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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.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Alimentary tract and metabolism, ATC code: A02B X02

Mechanism of action

The action of Gelactive Sucra 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. Gelactive Sucra exerts a generalised cytoprotective effect by preventing gastro-intestinal mucosal injury.

Studies in humans and animal models show that Gelactive Sucra forms an ulcer adherent complex with the proteinaceous exudate of the ulcer site. This property enables Gelactive Sucra 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 Gelactive Sucra protects the gastric mucosa against various irritants such as alcohol, acetylsalicyclic acid and sodium taurocholate.

Gelactive Sucra 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. Gelactive Sucra 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.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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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”).

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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Alimentary tract and metabolism, ATC code: A02B X02

Preclinical safety data

The information provided in Preclinical safety data of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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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.

Incompatibilities

The information provided in Incompatibilities of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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Not applicable

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Gelactive Sucra is based on data of another medicine with exactly the same composition as the Gelactive Sucra of the medicine (Sucralfate). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Gelactive Sucra directly from the package or from the pharmacist at the pharmacy.
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No special requirements.