Foglio illustrativo

SUCRORIL 1g powder for oral suspension
SUCRORIL 2g powder for oral suspension
SUCRORIL 20g/100 ml oral suspension

PHARMACOTHERAPY CATEGORY
Peptic anti-ulcer agent.
THERAPEUTIC INDICATIONS
Gastric ulcer, duodenal ulcer, acute gastritis, chronic symptomatic gastritis, gastropathies from FANS
(non steroid anti-inflammatory drugs) reflux oesophagitis.
CONTRAINDICATIONS
Hypersensitivity to sucralfate or to any one of the inactive ingredients.
Do not administer during any treatment with tetracycline to avoid the formation of complex salts which
makes the antibiotic inactive.
Sucralfate must not be administered to premature babies.
Proven individual hypersensitivity to the components (active or inactive ingredient) or related substances
strictly from a chemical point of view. Patients suffering from phenylketonuria should not take this
medicine as it contains aspartame.
SUCRORIL 1g powder for oral suspension contains 3.965g of sorbitol per sachet;
SUCRORIL 2g powder for oral suspension contains 2.965g of sorbitol per sachet;
SUCRORIL 20g/100 ml oral suspension contains 0.525g of sorbitol in 5ml of suspension.
The recommended daily dose (4g of Sucralfate) provides 15.86g (sachets of powder for oral suspension
of 1g), 5.93g (sachets of powder for oral suspension of 2g), 2.1g (oral suspension) of sorbitol. The
medicine is not recommended in individuals with hereditary fructose intolerance.
PRECAUTIONS FOR USE
Use with care. Avoid prolonged treatments in patients with renal failure.
Its use during pregnancy must be carefully assessed and used only where it is clearly necessary.
The use of sucralfate in children is not recommended, as the safety and efficacy in the paediatric
population has not been established.
As no well controlled studies currently exist on pregnant women, it must only be used by pregnant
women where strictly required.
It is not known if sucralfate is eliminated through human milk; in any case the administration of the
product during breastfeeding must be done with care.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicine, also those without a
medical prescription.
Do not administer during any treatments with tetracycline, fenitoina, digoxin, fluoroquinolones,
cimetidine, ketoconazole, levothyroxine.
As it can alter the bioavailability of other medicines, it is recommended to keep an interval of at least 2
hours between the assumption of the product and another medicine.
Warfarin: sucralfate can obstruct the absorption of warfarin; take care while undergoing treatment with
these two medicines.
SPECIAL WARNINGS
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

Important information on some inactive ingredients:
Powder for oral suspension contains: sorbitol, if the doctor has diagnosed an intolerance to certain
sugars, contact him before you take this medicine; it contains aspartame, therefore the medicine contains
a source of phenylalanine, which can be harmful in individuals suffering from phenylketonuria.
The oral suspension contains: sorbitol, if the doctor has diagnosed an intolerance to certain sugars,
contact him before you take this medicine; it contains parahydroxybenzoates and their esters, which can
cause allergic reactions, including those of a delayed kind.

Effects on the ability to drive vehicles and use machinery
Sucralfate does not cause effects which can influence the ability to drive and use machinery.
Cases of bezoar formation have been reported associated with the administration of sucralfate. The
majority of these were represented by patients in intensive care and premature babies. Therefore, extreme
caution must be used in treating patients in intensive care, especially if they receive enteral nutrition, or in
patients who present predisposing factors such as delayed gastric emptying.
A study conducted in France on newborns who received sucralfate has highlighted that 73% of those
treated showed serious digestive problems and 36% presented an occlusive syndrome which required
medical treatment. The medicine can be administered to individuals suffering from celiac disease.

DOSE, METHOD AND TIME OF ADMINISTRATION
1g (1 sachet of 1g or 5ml of oral suspension) 4 times a day or 2g (1 sachet of 2g, 2 sachets of 1g or 10ml
of oral suspension) 2 times a day on an empty stomach, 1 hour before meals and before bedtime.
For maintenance therapy from 1g to 2g a day.
The suspension must be shaken before use.
OVERDOSE
No known data relating to the overdose of sucralfate in humans exists. Acute toxicity tests performed on
animals, using doses of up to 12g/kg of body weight, have not allowed to determine a lethal dose.
In the event of accidental ingestion/assumption of an overdose of Sucroril advise your doctor
immediately or contact your nearest hospital emergency room.

UNDESIRED EFFECTS
As with all medicines, Sucroril can cause undesired effects, though not all people manifest them.
The secondary effects of the clinical use of the product are minor and do not usually lead to suspension
of the therapy. The most frequent effect is constipation.
Other less commonly reported effects are: gastroenteric disorders, nausea, bad digestion, flatulence,
dryness of the mouth, rash, itching, dizziness, insomnia. Very rare cases of bezoar formation have been
reported (see Special precautions).
For the presence of sorbitol, SUCRORIL can cause gastric disorders and diarrhoea.
Compliance with the instructions contained in the product information leaflet reduces the risk of
undesired effects.
If any one of these undesired effects should worsen, or if you note the onset of any undesired effect not
listed in this product information leaflet, inform your doctor or pharmacist.

EXPIRY AND STORAGE
Expiry date: See the expiry date shown on the box.
The expiry date refers to the product unused, correctly stored.
CAUTION: Do not use the medicine after the expiry date shown on the box.
The medicines must not be thrown into waste water and into household refuse. Ask your pharmacist how
to eliminate the medicines you no longer use. This will help to protect the environment.
KEEP THE MEDICINE OUT OF CHILDREN’S REACH AND SIGHT.
COMPOSITION
SUCRORIL 1g powder for oral suspension
Each sachet contains:
Active ingredient: 1g Sucralfate
Inactive ingredient: sorbitol crystals, aspartame, pandoro flavouring
SUCRORIL 2g powder for oral suspension
Each sachet contains:
Active ingredient: 2g Sucralfate
Inactive ingredients: sorbitol crystals, aspartame, pandoro flavouring

SUCRORIL 20g/100 ml oral suspension
One 200ml bottle contains:
Active ingredient: 40g Sucralfate
Inactive ingredients: 70% non-crystallisable sorbitol, glycerol, caramellose sodium, colloidal hydrated
silica, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, blackberry flavouring, purified water
PHARMACEUTICAL FORM AND CONTENT
Powder for oral suspension in sachets of 1g; box of 30 sachets.
Powder for oral suspension in sachets of 2g; box of 30 sachets.
Oral suspension 20g/100ml; 200ml bottle.

MARKETING AUTHORISATION HOLDER
Quintiles Commercial Italia S.r.l.,Via Roma 108, Cassina de’ Pecchi (MI)

MANUFACTURER
SOFAR SpA, via Firenze 40, Trezzano Rosa (MI)

REVIEW OF THE PRODUCT INFORMATION LEAFLET BY THE MINISTRY OF HEALTH:
Ruling of Italian Pharmaceutical Agency: October 2010

Source: http://www.sofarfarm.com/html_ing/home/farmaci/prodotti/36.%20SUCRORIL%5CFoglietto%20Illustrativo%5CFi_sucroril.pdf