Sucrate

PACKAGE LEAFLET

SUCRATE 1 g/5 ml oral gel

sucralfate gel
THERAPEUTIC PHARMACOLOGICAL CATEGORY
Peptic ulcer antiulcer agent.
THERAPEUTIC INDICATIONS
Gastric ulcer, duodenal ulcer; acute gastritis, symptomatic chronic gastritis, NSAID-induced gastropathy (non-steroidal anti-inflammatory drugs), reflux esophagitis.
CONTRAINDICATIONS
Known hypersensitivity to the components or to other substances closely related from a chemical standpoint.
The medicine contains aspartame, a source of phenylalanine, and is therefore contraindicated in patients with phenylketonuria.
Sucralfate is contraindicated in patients undergoing treatment with tetracyclines (see also "Interactions").
Sucralfate must not be administered to premature neonates.
PRECAUTIONS FOR USE
The particular taste sensation experienced when taking the product is characteristic of the "gel" form of sucralfate used in this preparation. This sensation can be immediately relieved by taking a sip of water or another liquid after administration.
INTERACTIONS
“Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those without a prescription.”
Sucralfate may alter the bioavailability of drugs such as: cimetidine, ciprofloxacin, ketoconazole, fluoroquinolone antibiotics (e.g. ciprofloxacin and norfloxacin), phenytoin, digoxin, ranitidine and theophylline.
Aluminium salts may form complexes with tetracyclines, reducing their absorption and thus the activity of these orally administered antibiotics.
The mechanism of these interactions appears to be non-systemic and is presumably due to binding of sucralfate with the concomitant drug in the gastrointestinal tract; therefore, it is advisable to leave an interval of at least two hours between the administration of SUCRATE and other medicinal products.
SPECIAL WARNINGS
The product contains sorbitol in the amount of 1 g per SUCRATE 1 g/5 ml oral gel package. When taken according to the recommended dosage, each dose of SUCRATE 1 g/5 ml oral gel provides up to 1 g of sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine. Sorbitol may also cause stomach discomfort and diarrhoea.
The medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions), and rarely immediate reactions such as urticaria and bronchospasm.
The medicine contains aspartame, a source of phenylalanine, and is therefore contraindicated in patients with phenylketonuria.
The sodium benzoate contained in this product is a mild irritant of the skin, eyes and mucous membranes and may increase the risk of neonatal jaundice.
Due to the presence of sodium salts, the product may be contraindicated in patients on a low-sodium diet.
Use with caution in patients with renal impairment, avoiding prolonged treatment. Avoid use in haemodialysis patients.
Cases of bezoar formation have been reported following administration of sucralfate. Most of these cases involved intensive care patients and premature neonates. Therefore, extreme caution should be exercised when treating intensive care patients, especially those receiving enteral nutrition, or patients with predisposing factors such as delayed gastric emptying.
A study conducted in France in neonates receiving sucralfate showed that 73% of treated patients developed severe digestive problems and 36% developed an obstructive syndrome requiring medical treatment.
Cases of bezoar formation have been reported following sucralfate administration in patients with gastrointestinal motility disorders due to surgery, pharmacological therapy or disease that reduce motility.
Use in children and adolescents under 14 years of age
The use of Sucrate in children under 14 years of age is not recommended due to insufficient data.
Fertility
Animal studies on teratogenesis and fertility have not shown any negative effects.
Pregnancy
“Ask your doctor or pharmacist for advice before taking any medicine.”
Due to the extremely low gastrointestinal absorption, animal studies have not reported any alterations in mothers or newborns. Sucralfate should be used during pregnancy only if clearly necessary and after careful evaluation.
Breast-feeding
It is not known whether sucralfate is excreted in human milk; however, the product should be administered during breast-feeding with caution.
Effects on ability to drive and use machines
Sucralfate does not impair the ability to drive or operate machinery.
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
The special gel formulation of the product, due to its prolonged bioadhesive properties, ensures a prolonged clinical effect and normally allows twice-daily administration.
The usual dosage is 1 sachet containing 1 g of sucralfate, taken orally twice daily on an empty stomach, 1 hour before meals, or in the morning and evening before bedtime, according to the physician's judgment.
For maintenance therapy, the daily dosage is reduced by half, maintaining the same single dose but halving the number of administrations (e.g., 1 sachet once daily, preferably in the evening).
The product should be taken as is, and each dose may optionally be followed by a sip of water or another liquid.
The use of Sucrate in children under 14 years of age is not recommended due to insufficient data.
OVERDOSE
No data on overdose in humans are available. Acute toxicity studies in animals using doses up to 12 g/kg body weight did not allow determination of a lethal dose.
“In case of accidental ingestion or overdose of Sucrate, contact your doctor immediately or go to the nearest hospital.”
UNDESIRABLE EFFECTS
“Like all medicines, Sucrate can cause adverse effects, although not everybody gets them.”
Gastrointestinal disorders: constipation may occur after prolonged use of the drug. Less frequently, other gastrointestinal disturbances such as diarrhoea, dry mouth, flatulence, nausea, vomiting and gastric heaviness may be observed.
Very rare cases of bezoar formation have been reported (see “Special warnings”).
Skin and subcutaneous tissue disorders: rash, pruritus.
Immune system disorders: hypersensitivity reactions such as urticaria, angioedema, breathing difficulties and rhinitis.
Nervous system disorders: insomnia, headache, lumbar pain.
Ear and labyrinth disorders: vertigo.
Following the instructions provided in this leaflet reduces the risk of adverse effects.
“Reporting of adverse effects”
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. Adverse effects can also be reported directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse effects contributes to providing more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: See the date on the packaging.
The expiry date refers to the product in its original, unopened packaging stored correctly.
Do not use the medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
COMPOSITION
Each 5 ml sachet contains:
Active substance:
Sucralfate gel equivalent to 1 g sucralfate
Excipients:
70% sorbitol, sodium benzoate (E 211), sodium methyl-p-hydroxybenzoate (E 219), sodium propyl-p-hydroxybenzoate (E 217), aspartame (E 951), anise-liquorice-mint flavour, purified water.
Excipients with known effects:
Sorbitol, sodium benzoate, sodium methyl-p-hydroxybenzoate (E 219), sodium propyl-p-hydroxybenzoate (E 217), aspartame (E 951)
PHARMACEUTICAL FORM AND CONTENT
Oral gel.
Box containing 30 sachets of 5 ml oral gel (1 g active ingredient).
MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
Lab. It. Biochim. Farm.co LISAPHARMA S.p.A.
Via Licinio, 11 – 22036 ERBA (CO).
Manufacturer
ZETA FARMACEUTICI S.p.A.
Via Galvani, 10
36066 – SANDRIGO (VI)
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY

INSTRUCTIONS FOR USE

SUCRATE 2 g/10 ml oral gel

sucralfate gel
PHARMACOTHERAPEUTIC CATEGORY
Peptic ulcer agent.
THERAPEUTIC INDICATIONS
Gastric ulcer, duodenal ulcer; acute gastritis, symptomatic chronic gastritis, NSAID-induced gastropathy (non-steroidal anti-inflammatory drugs), reflux esophagitis.
CONTRAINDICATIONS
Known hypersensitivity to the active substance, to any of the excipients, or to other substances closely related chemically.
The medicine contains aspartame, a source of phenylalanine, and is therefore contraindicated in patients with phenylketonuria.
Sucralfate is contraindicated in patients receiving tetracyclines (see also “Interactions”).
Generally contraindicated during pregnancy (see also Special Warnings).
Sucralfate must not be administered to premature neonates.
PRECAUTIONS FOR USE
The particular taste sensation experienced when taking the product is characteristic of the “gel” form of sucralfate used in this formulation. This sensation can be immediately alleviated by taking a sip of water or another liquid after administration.
INTERACTIONS
“Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those not requiring a prescription.”
Sucralfate may alter the bioavailability of drugs such as: cimetidine, ciprofloxacin, ketoconazole, fluoroquinolone antibiotics (e.g., ciprofloxacin and norfloxacin), phenytoin, digoxin, ranitidine, and theophylline.
Aluminum salts may form complexes with tetracyclines, reducing their absorption and thus the activity of these orally administered antibiotics.
The mechanism of these interactions appears to be non-systemic and is presumably due to binding of sucralfate to the concomitant drug in the gastrointestinal tract; therefore, it is advisable to separate the administration of SUCRATE and other drugs by at least two hours.
SPECIAL WARNINGS
The product contains sorbitol in the amount of 1 g per SUCRATE 1 g/5 ml oral gel pack and 2 g per SUCRATE 2 g/10 ml oral gel pack. When taken according to the recommended dosage, each dose of SUCRATE 1 g/5 ml oral gel and SUCRATE 2 g/10 ml oral gel provides up to 1 g and up to 2 g of sorbitol, respectively. If you have been told by your doctor that you have an intolerance to certain sugars, consult your doctor before taking this medicine. Sorbitol may also cause stomach discomfort and diarrhea.
The medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions), and rarely immediate reactions such as urticaria and bronchospasm.
The medicine contains aspartame, a source of phenylalanine, and is therefore contraindicated in patients with phenylketonuria.
The benzoic acid sodium salt contained in the product is a mild irritant to the skin, eyes, and mucous membranes, and may increase the risk of neonatal jaundice.
Due to the presence of sodium salts, the product may be contraindicated in patients on a low-sodium diet.
In patients with renal impairment, use the medicine with caution and avoid prolonged treatment.
Avoid use in hemodialyzed patients.
Cases of bezoar formation have been reported following sucralfate administration. Most of these occurred in intensive care patients and premature neonates. Therefore, extreme caution should be exercised when treating intensive care patients, especially those receiving enteral nutrition, or patients with predisposing factors such as delayed gastric emptying.
A French study in neonates receiving sucralfate showed that 73% of treated infants developed severe digestive problems and 36% developed an obstructive syndrome requiring medical treatment.
Cases of bezoar formation have been reported following sucralfate administration in patients with gastrointestinal motility disorders due to surgical procedures, pharmacological therapy, or diseases that reduce motility.
Use in children and adolescents under 14 years of age
The use of Sucrate in children under 14 years of age is not recommended due to insufficient data.
Fertility
Animal studies on teratogenesis and fertility have not shown any negative effects.
Pregnancy
“Consult your doctor or pharmacist before taking any medicine.”
Due to the extremely low gastrointestinal absorption, animal studies have not reported any alterations in mothers or newborns. However, use during pregnancy should be carefully evaluated and reserved only for cases where clearly necessary.
Breast-feeding
It is not known whether sucralfate is excreted in human breast milk; however, administration of the product during breast-feeding should be done with caution.
Effects on ability to drive and use machines
Sucralfate does not impair the ability to drive vehicles or operate machinery.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The special gel formulation of the product, due to its prolonged bioadhesive properties, ensures a sustained clinical effect and usually allows for twice-daily administration.
The usual dosage is 1 sachet containing 1 g or 2 g of sucralfate, according to the physician’s judgment, taken orally twice daily on an empty stomach, 1 hour before meals, or in the morning and evening before bedtime.
For maintenance therapy, the daily dosage is reduced by half, maintaining the same single dose but halving the number of administrations (e.g., 1 sachet once daily, preferably in the evening).
The product should be taken undiluted, and each dose may optionally be followed by a sip of water or another liquid.
The use of Sucrate in children under 14 years of age is not recommended due to insufficient data.
OVERDOSE
No data on overdose in humans are available. Acute toxicity studies in animals using doses up to 12 g/kg body weight did not determine a lethal dose.
“In case of accidental ingestion or overdose of Sucrate, contact your doctor immediately or go to the nearest hospital.”
UNDESIRABLE EFFECTS
“Like all medicines, Sucrate can cause side effects, although not everybody gets them.”
Gastrointestinal disorders: Constipation may occur after prolonged use of the medicine. Less frequently, other gastrointestinal disturbances such as diarrhea, dry mouth, flatulence, nausea, vomiting, and stomach heaviness may occur.
Very rare cases of bezoar formation have been reported (see Special Warnings).
Skin and subcutaneous tissue disorders: Rash, pruritus.
Immune system disorders: Hypersensitivity reactions such as urticaria, angioedema, breathing difficulties, and rhinitis.
Nervous system disorders: Insomnia, headache, lumbar pain.
Ear and labyrinth disorders: Vertigo.
“Following the instructions in this leaflet reduces the risk of side effects.”
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse events contributes to providing more information on the safety of this medicine.
Following the instructions in this leaflet reduces the risk of side effects.
EXPIRY DATE AND STORAGE
Expiry date: See the date on the packaging.
The expiry date refers to the product stored unopened and correctly stored.
Do not use the medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This helps protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
COMPOSITION
Each 10 ml sachet contains:
Active substance:
Sucralfate gel equivalent to 2 g sucralfate
Excipients:
Sorbitol 70%, sodium benzoate (E 211), sodium methyl-p-hydroxybenzoate (E 219), sodium propyl-p-hydroxybenzoate (E 217), aspartame (E 951), anise-liquorice-mint flavor, purified water.
Excipients with known effects:
Sorbitol, sodium benzoate, sodium methyl-p-hydroxybenzoate (E 219), sodium propyl-p-hydroxybenzoate (E 217), aspartame (E 951)
PHARMACEUTICAL FORM AND CONTENT
Oral gel.
Box containing 30 sachets of 10 ml oral gel (2 g active ingredient).
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Lab. It. Biochim. Farm.co LISAPHARMA S.p.A.
Via Licinio, 11 – 22036 ERBA (CO)
Manufacturer
ZETA FARMACEUTICI S.p.A.
Via Galvani, 10
36066 – SANDRIGO (VI)
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
October 2015