SUCRATE 1 G/5 ML Oral gel

Зміст інструкції

1. SUCRATE 1 g/5 ml oral gel
2. SUCRATE 2 g/10 ml oral gel

SUCRATE 1 g/5 ml oral gel

sucralfate gel
PHARMACOTHERAPEUTIC CATEGORY
Peptic ulcer treatment.

THERAPEUTIC INDICATIONS
Gastric ulcer, duodenal ulcer; acute gastritis, symptomatic chronic gastritis, gastropathies due to NSAIDs
(non-steroidal anti-inflammatory drugs), reflux esophagitis.

CONTRAINDICATIONS
Established individual hypersensitivity to the components or other substances closely related from a
chemical point of view.
The medicine contains Aspartame, a source of phenylalanine, and is therefore contraindicated in subjects
suffering from phenylketonuria.
Sucralfate is contraindicated in patients treated with tetracyclines (see also “Interactions”).
Sucralfate should not be administered to premature infants.

PRECAUTIONS FOR USE
The particular taste sensation experienced when taking the preparation is characteristic of the “gel” form of
Sucralfate used for preparation. This sensation can be immediately eliminated by following the intake of the
product with a sip of water or other liquid.

INTERACTIONS
“Inform your doctor or pharmacist if you have recently taken any other medicines, even those
available without a prescription”.
Sucralfate may alter the bioavailability of drugs including: cimetidine, ciprofloxacin,
ketoconazole, fluoroquinolone antibiotics (e.g. ciprofloxacin and norfloxacin), phenytoin,
digoxin, ranitidine and theophylline.
Aluminum salts can form complexes with tetracyclines, reducing absorption and therefore the
activity of these antibiotics administered orally.
The mechanism of these interactions appears to be of a non-systemic nature and is presumably
due to the binding of sucralfate with the concomitant drug in the gastrointestinal tract, therefore it is
advisable to allow an interval of at least two hours between taking SUCRATE and other
drugs.

SPECIAL WARNINGS
The product contains sorbitol in the amount of 1 g per package SUCRATE 1 g/5 ml oral gel. If
taken according to the recommended dosage, each dose of SUCRATE 1 g/5 ml oral gel provides up to
1 g of sorbitol. If you have been told by your doctor that you have an intolerance to certain sugars, contact
your doctor before taking this medicine. Sorbitol can also cause stomach upset and diarrhea.
The medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause
allergic reactions (even delayed), rarely immediate reactions with urticaria and bronchospasm.
The medicine contains aspartame, a source of phenylalanine, and is therefore contraindicated in subjects
suffering from phenylketonuria.
Sodium benzoate contained in the specialty 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 subjects undergoing a
low-sodium diet.
In patients with renal insufficiency, use the medicine with caution, avoiding prolonged treatments.
Avoid use in patients undergoing hemodialysis.
Cases of bezoar formation associated with the administration of sucralfate have been reported. The
majority of these were represented by patients in intensive care and premature infants.
Therefore, extreme caution must be exercised in the treatment of patients in intensive care
especially if they are receiving enteral nutrition, or in patients who present with predisposing factors such as
delayed gastric emptying.
A study conducted in France in newborns who received sucralfate highlighted that 73%
of those treated showed serious digestive problems and 36% presented an occlusive syndrome that
required medical treatment.
Cases of bezoar have been reported following the administration of sucralfate in patients with disorders
of gastrointestinal motility resulting from surgery, drug therapy or disease
reducing 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 teratogenicity and fertility studies have not shown any adverse effects.
Pregnancy
“Ask your doctor or pharmacist for advice before taking any medicine”.
Due to the very low gastrointestinal absorption in animal studies, no alterations have been reported in
mothers and newborns. Use during pregnancy should be carefully evaluated and
reserved for cases where it is clearly necessary.
Breastfeeding
It is not known whether Sucralfate is excreted in breast milk, however the administration
of the product during breastfeeding should be carried out with caution.
Effects on ability to drive and operate machinery
Sucralfate does not impair the ability to drive vehicles or operate machinery.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
The particular gel form of the product, due to its characteristics of prolonged bioadhesion, ensures
a prolonged clinical effect and normally allows the preparation to be administered twice a day.
The average dosage is 1 sachet of 1 g of Sucralfate, according to the doctor's judgment, 2 times a
day orally, on an empty stomach, 1 hour before meals, or in the morning and evening before
bedtime.
For maintenance treatments, the daily dosage is reduced by half, keeping
the single dose unchanged and halving the number of intakes (e.g. 1 sachet 1 time a
day, preferably in the evening).
The product is taken as is and each intake can eventually be followed by a sip
of water or other liquid.
The use of Sucrate in children under 14 years of age is not recommended due to insufficient
data.

OVERDOSAGE
No data are known regarding overdose in humans. Acute toxicity tests in animals,
using doses up to 12 g/kg of body weight, did not allow determination of a lethal dose.
“In case of accidental ingestion/intake of an excessive dose of Sucrate, immediately warn
your doctor or go to the nearest hospital”.

UNDESIRABLE EFFECTS
“Like all medicines, Sucrate can cause side effects, although not everyone
experiences them ”.

Gastrointestinal disorders:prolonged use of the drug may cause constipation.
Less frequently, other gastrointestinal disorders such as diarrhea, dry mouth, flatulence, nausea, vomiting and
heaviness of the stomach may be observed.
Very rare cases of bezoar formation have been reported (see “Special warnings”).
Skin and subcutaneous tissue disorders:rash, itching.

Immune system disorders:hypersensitivity reactions such as urticaria, angioedema, difficulty
breathing and rhinitis.

Nervous system disorders:insomnia, headache, back pain

Ear and labyrinth disorders: dizziness.
“ Reporting of side effects”
If you experience any side effects, including those not listed in this leaflet,
contact your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. Reporting of side effects helps to
provide more information on the safety of this medicine”.

EXPIRY DATE AND STORAGE
Expiry date: See the expiry date printed on the packaging.
The expiry date indicated refers to the product in intact packaging, stored correctly.
Caution: Do not use the medicine after the expiry date printed on the packaging.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.

COMPOSITION
Each sachet of 5 ml contains:

Active ingredient:
Sucralfate gel equivalent to sucralfate 1 g

Excipients:
Sorbitol 70%, Sodium benzoate (E 211), Methyl p-hydroxybenzoate sodium (E 219), Propyl p-
hydroxybenzoate sodium (E 217), Aspartame (E 951), Anise-licorice-mint flavor, Purified water.

Excipients with known effects:
Sorbitol, Sodium benzoate, Methyl p-hydroxybenzoate sodium (E 219), Propyl p-hydroxybenzoate sodium
(E 217), Aspartame (E 951)

PHARMACEUTICAL FORM AND CONTENT
Oral gel.
Pack containing 30 sachets of 5 ml of oral gel (1 g of 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)

DRUG

SUCRATE 2 g/10 ml oral gel

sucralfate gel
PHARMACOTHERAPEUTIC CATEGORY
Peptic ulcer.

THERAPEUTIC INDICATIONS
Gastric ulcer, duodenal ulcer; acute gastritis, symptomatic chronic gastritis, gastropathies due to NSAIDs
(non-steroidal anti-inflammatory drugs), reflux esophagitis.

CONTRAINDICATIONS
Established individual hypersensitivity to the components or other substances closely related from a
chemical point of view.
The medicine contains Aspartame, a source of phenylalanine, and is therefore contraindicated in subjects
suffering from phenylketonuria.
Sucralfate is contraindicated in patients undergoing treatment with tetracyclines (see also “Interactions”).
Generally contraindicated in pregnancy (see also Special Warnings).
Sucralfate should not be administered to premature infants.

PRECAUTIONS FOR USE
The particular taste sensation experienced when taking the preparation is characteristic of the “gel” form of sucralfate used for preparation. This sensation can be immediately eliminated
by following the intake of the product with a sip of water or another liquid.

INTERACTIONS
“Inform your doctor or pharmacist if you have recently taken any other medicines, even
those available without a prescription”.
Sucralfate can alter the bioavailability of drugs including: cimetidine, ciprofloxacin,
ketoconazole, fluoroquinolone antibiotics (e.g. ciprofloxacin and norfloxacin), phenytoin,
digoxin, ranitidine and theophylline.
Aluminum salts can form complexes with tetracyclines, reducing absorption and therefore
the activity of these antibiotics administered orally.
The mechanism of these interactions appears to be non-systemic in nature and is presumably
due to the binding of sucralfate with the concomitant drug in the gastrointestinal tract, therefore it is
advisable to allow an interval of at least two hours between the administration of SUCRATE and other
drugs.

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. If 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
respectively up to 1 g and up to 2 g of sorbitol. If you have been told by your doctor that you have
an intolerance to certain sugars, contact your doctor before taking this medicine. Sorbitol can also cause
stomach upset and diarrhea.
The medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause
allergic reactions (including delayed reactions), rarely immediate reactions with urticaria and bronchospasm.
The medicine contains aspartame, a source of phenylalanine, and is therefore contraindicated in subjects
suffering from phenylketonuria.
Sodium benzoate contained in the specialty 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 subjects undergoing a
low-sodium diet.
In patients with renal insufficiency, use the medicine with caution, avoiding prolonged treatments.
Avoid use in patients undergoing hemodialysis.
Cases of bezoar formation associated with the administration of sucralfate have been reported. The
majority of these were represented by patients in intensive care and premature infants.
Therefore, extreme caution must be exercised in the treatment of patients in intensive care
especially if they are receiving enteral nutrition, or in patients who present with predisposing factors such as
delayed gastric emptying.
A study conducted in France in newborns who received sucralfate highlighted that 73%
of those treated showed serious digestive problems and 36% presented an occlusive syndrome that
required medical treatment.
Cases of bezoar have been reported following the administration of sucralfate in patients with disorders
of gastrointestinal motility resulting from surgery, drug therapy or disease
reducing 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 the lack of
data.
Fertility
Animal teratogenicity and fertility studies have not shown any adverse effects.
Pregnancy
“Ask your doctor or pharmacist for advice before taking any medicine”.
Due to the very low gastrointestinal absorption in animal studies, no alterations have been reported
in mothers and newborns. Use during pregnancy should be carefully evaluated and
reserved for cases where it is clearly necessary.
Breastfeeding
It is not known whether Sucralfate is eliminated through breast milk, however, the administration
of the product during breastfeeding should be carried out with caution.
Effects on ability to drive and operate machinery
Sucralfate does not impair the ability to drive or operate machinery.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
The particular gel form of the product, due to its characteristics of prolonged bioadhesion, ensures
a prolonged clinical effect and normally allows the preparation to be administered twice a day.
The average dosage is 1 sachet of 1 g or 2 g of sucralfate, depending on the doctor's judgment, 2
times a day orally, on an empty stomach, 1 hour before meals, or in the morning and in the evening
before bedtime.
For maintenance treatments, the daily dosage is reduced by half, keeping
the single dose unchanged and halving the number of intakes (e.g. 1 sachet 1 time a day,
preferably in the evening).
The product is taken as is and each intake can eventually 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 the lack of
data.

OVERDOSE
No data are known regarding overdose in humans. Acute toxicity tests in animals,
using doses up to 12 g/kg of body weight, did not allow determination of a lethal dose.
“In case of accidental ingestion/intake of an excessive dose of Sucrate, immediately notify
your doctor or go to the nearest hospital”.

UNDESIRABLE EFFECTS
“Like all medicines, Sucrate can cause side effects, although not everyone
experiences them”.

Gastrointestinal disorders:prolonged use of the drug may cause constipation.
Less frequently, other gastrointestinal disorders such as diarrhea, dryness
of the mouth, flatulence, nausea, vomiting and stomach discomfort may be observed.
Very rare cases of bezoar formation have been reported (see Special Warnings).
Skin and subcutaneous tissue disorders:rash, itching.

Immune system disorders:hypersensitivity reactions such as urticaria, angioedema, difficulty
breathing and rhinitis.

Nervous system disorders:insomnia, headache, back pain

Ear and labyrinth disorders: vertigo
“Reporting of adverse reactions”
If you experience any side effects, including those not listed in this leaflet,
consult your doctor or pharmacist. Adverse reactions can also be reported
directly through 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.

EXPIRY DATE AND STORAGE
Expiry date: See the expiry date printed on the packaging.
The expiry date indicated refers to the product in intact packaging, stored correctly.
Caution do not use the medicine after the expiry date printed on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.

COMPOSITION
Each 10 ml sachet contains:

Active ingredient:
Sucralfate gel equal to sucralfate 2 g

Excipients:
Sorbitol 70%, Sodium benzoate (E 211), Methyl p-hydroxybenzoate sodium (E 219), Propyl-p-
hydroxybenzoate sodium (E 217), Aspartame (E 951), Anise-licorice-mint flavor, Purified water.

Excipients with known effects:
Sorbitol, Sodium benzoate, Methyl p-hydroxybenzoate sodium (E 219), Propyl-p-hydroxybenzoate sodium
(E 217), Aspartame (E 951)

PHARMACEUTICAL FORM AND CONTENT
Oral gel.
Pack containing 30 sachets of 10 ml of oral gel (2 g of 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)

OF THE MEDICINE
October 2015