Ancool- SF Suspension

Sucralfate Suspension

Composition:

Each 5 ml contains:

Sucralfate IP……………… 500 mg

Colour: Carmoisine

Suspension, 500mg/5ml

4.1 Therapeutic Indication

Indicated in the treatment of gastric, duodenal and benign ulcer.

4.2 Posology and Method of Administration

The recommended adult oral dosage for duodenal ulcer is 1 gram (10ml) four times per day.

Maximum daily dose: 8 grams.

Ancool®-SF suspension should be administered on an empty stomach on an empty stomach.

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 Ancool®-SF suspension.

Paediatric population: The safety and efficacy of Ancool®-SF suspension in children under 14 years of age has not been established.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients

4.4 Special warnings and precautions for use

• Ancool®-SF 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, Ancool®-SF 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. 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.

4.5 Drugs interactions

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

4.6 Use in special populations

Pregnancy

Teratogenicity studies in mice, rats and rabits 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 Ancool®-SF 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 Ancool®-SF Suspension is administered to breast-feeding women.

4.7 Effects on ability to drive and use machines

There are no data on the effect of this product on driving capacity and use of machines. Do not drive if you feel dizzy or drowsy.

4.8 Undesirable effects

Tabulated list of adverse reactions

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 email to: medico@zuventus.com

Website link: https://www.zuventus.com/drug-safety-reporting

4.9 Overdose

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

5.1 Pharmacodynamic properties/ Mechanism of Action

Mechanism of action

The action of Ancool®-SF 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 exerts a generalised cytoprotective effect by preventing gastro-intestinal mucosal injury.

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

Sucralfate 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 has no demonstrated pharmacological effect on the cardiovascular or central nervous systems.

5.2 Pharmacokinetic properties

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.

6.1 Animal Toxicology or Pharmacology

There was no evidence of carcinogenesis in mice and rats receiving oral sucralfate in dosages of up to 1g/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.

Ancool®-SF Suspension contain sucralfate and sucralfate is an α-D-glucopyranoside, β-Dfructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.

Ancool®-SF Suspension for oral administration contains 0.5 g of sucralfate per 5 mL. Therapeutic category: antiulcer.

8.1 Incompatibilities

Not applicable.

8.2 Shelf-life

Refer on the pack

8.3 Packaging information

200 ml bottle, Sugar free

8.4 Storage and handing instructions

Store protected from light and moisture at a temperature not exceeding 30°C.

Keep out of reach of children.

SHAKE WELL BEFORE USE

• Take Ancool®-SF Suspension on an empty stomach, preferably 1 hour before a meal.
• Do not take antacids 30 minutes before or after taking this medication.
• Use caution while driving or doing anything that requires concentration as Sucralfate can cause dizziness and sleepiness.
• It may take 4-6 weeks or more for the ulcers to heal completely. Do not stop taking the medicine until your doctor tells you to.
• Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with sucralfate suspension is recommended. Adjustment of the antidiabetic treatment dose during the use of sucralfate suspension might be necessary.

July 2024