SUCRAMAL 2 G Granules for oral suspension

Зміст інструкції

1. SUCRAMAL 1 g compresse
   1. What is Sucramal and what is it used for
   2. What you need to know before taking Sucramal
   3. How to take Sucramal
   4. Possible side effects
   5. How to store Sucramal
   6. Contents of the pack and other information
2. SUCRAMAL 2 g granules for oral suspension
   1. What is Sucramal and what is it used for
3. Sucramal works by forming a protective barrier on the inner lining of the stomach and
4. Sucramal is indicated in adults and adolescents over the age of 14 for the
   1. What you need to know before taking Sucramal
   2. How to take Sucramal
   3. Possible side effects
   4. How to store Sucramal
   5. Contents of the pack and other information

SUCRAMAL 1 g compresse

Sucralfato

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Sucramal is and what it is used for
• 2. What you need to know before you take Sucramal
• 3. How to take Sucramal
• 4. Possible side effects
• 5. How to store Sucramal
• 6. Contents of the pack and other information

1. What is Sucramal and what is it used for

Sucramal contains the active ingredient sucralfate, a medicine that belongs to a group of
drugs used for the treatment of gastroduodenal ulcer (a lesion affecting the
internal lining of the stomach and part of the intestine) and gastroesophageal reflux disease (a condition that occurs when the acidic contents of the stomach pass
into the esophagus causing pain, inflammation and heartburn).
Sucramal works by forming a protective barrier on the internal lining of the stomach and the
upper part of the intestine.
Sucramal is indicated in adults and adolescents over the age of 14for the
treatment of the following diseases:

• lesion of the stomach (gastric ulcer) or the upper part of the intestine (duodenal ulcer),
• inflammation of the inner lining of the stomach of a transient type (acute gastritis) or of a chronic type (symptomatic chronic gastritis),
• stomach disorders due to the use of medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs),
• inflammation of the esophagus due to the backflow of acidic liquids and/or foods (reflux esophagitis).
• Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Sucramal

Do not take Sucramal

• if you are allergic to sucralfate or any of the other ingredients of this medicine (listed in section 6);
• if you are being treated with tetracycline, a type of antibiotic used to treat infections caused by bacteria (see section “Other medicines and Sucramal”).

Sucramal should not be administered to premature infants.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sucramal.
Inform your doctor and use this medicine with caution:

• if you suffer from a severe kidney disease (chronic renal failure).

Furthermore, if you are being treated in intensive care and, especially, have any of the following
conditions:

• suffer from problems with stomach emptying (following therapy with drugs or surgery) or diseases that reduce the motility of the stomach or intestines,
• are also fed through a tube that reaches the stomach or intestines, your doctor will monitor you closely as you have a higher risk of foreign material deposits forming that remain in the stomach and intestines (formation of bezoars) (see section 4 “Possible side effects”).

The doctor will be particularly careful when prescribing Sucramal to you if you are:

• in conditions of impaired swallowing, such as recent or prolonged intubation, surgical incision of the trachea (tracheotomy), risk of aspirating liquids or solids into the bronchi (history of aspiration, difficulty swallowing (dysphagia);
• any other condition that may alter the gag reflex for swallowing food (pharyngeal reflex) and the cough or reduce the coordination and ability to move the mouth and throat; because in these cases the risk increases that the Sucramal tablet passes into the bronchi instead of the esophagus (aspiration of the tablet), with resulting complications for breathing.

Children and adolescents
Sucramal is not recommended for children under 14 years of age.

Other medicines and Sucramal
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines: tetracyclines (a
type of antibiotic used to treat infections caused by bacteria), as use
together with sucralfate is contraindicated (see section “Do not take Sucramal”);

• phenytoin (a medicine used to treat epilepsy, a disease characterized by uncontrolled body movements and loss of consciousness);
• warfarin (a medicine used to prevent blood clots from forming);
• digoxin (a medicine used to treat heart disorders);
• fluoroquinolone antibiotics such as ciprofloxacin and norfloxacin (medicine used to treat infections caused by bacteria).

Allow at least 2 hours between taking Sucramal and taking other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
During pregnancy and breastfeeding, Sucramal should only be used when
strictly necessary and under the direct control of your doctor.

Driving and using machines
Sucramal does not impair the ability to drive vehicles or operate machinery.

Sucramal contains:

• hydrogenated castor oil:may cause stomach upset and diarrhea.
• benzyl alcohol:this medicine contains less than 0.3 benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been associated with the risk of serious side effects including breathing problems (respiratory distress syndrome) in young children. Do not administer to infants under 4 weeks of age unless otherwise recommended by your doctor. Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by your doctor or pharmacist. Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (such as metabolic acidosis). Ask your doctor or pharmacist if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (such as metabolic acidosis).
• ethanol:this medicine contains less than 0.35 mg of alcohol (ethanol) per tablet. The amount in each tablet is equivalent to less than 1 ml of beer and less than 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
• sodium:this medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Sucramal

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet 3-4 times a day as prescribed by your doctor, to be taken away from meals.

Use in children and adolescents
The use of Sucramal in children under 14 years of age is not recommended.

If you take more Sucramal than you should
In case of accidental ingestion/intake of an excessive dose of Sucramal, immediately notify your doctor or go to the nearest hospital.

If you forget to take Sucramal
Do not take a double dose to make up for the missed tablet.

If you stop taking Sucramal
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Rare (may affect up to 1 in 1,000 people):

• formation of deposits of foreign material ingested that remain in the stomach and intestines (bezoars)

Not known (frequency cannot be estimated from available data):

• dizziness
• constipation (with prolonged treatments)
• stomach and intestinal disorders, nausea
• dry mouth
• skin rash
• itching
• allergic reactions, including severe ones (anaphylactic reactions)
• sleep disorders (insomnia)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine .

5. How to store Sucramal

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is stated on the packaging after Scad.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sucramal contains
Sucramal 1 g tablets

• The active ingredient is sucralfate (1 g per each tablet).
• The other ingredients are microcrystalline cellulose, sodium carboxymethylcellulose, hydrogenated castor oilhydrogenated, magnesium stearate, cherry aroma (containing: benzyl alcohol, ethanol).

Description of the appearance of Sucramal and contents of the pack
Sucramal is presented as tablets contained in blisters.
Sucramal is available in packs of 40 tablets of 1 g.

Marketing Authorisation Holder
SCHARPER S.p.A.
Viale Ortles, 12
20139 Milano

Manufacturer
Delpharm Dijon- 6, Boulevard de l’Europe – 21800 Quétigny (France)

SUCRAMAL 2 g granules for oral suspension

Sucralfate

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Sucramal is and what it is used for
• 2. What you need to know before you take Sucramal
• 3. How to take Sucramal
• 4. Possible side effects
• 5. How to store Sucramal
• 6. Contents of the pack and other information

1. What is Sucramal and what is it used for

Sucramal contains the active ingredient sucralfate, a medicine that belongs to a group of
drugs used for the treatment of gastroduodenal ulcer (a lesion affecting the
internal lining of the stomach and part of the intestine) and gastroesophageal reflux disease (a condition that occurs when the acidic content of the stomach passes
into the esophagus causing pain, inflammation and heartburn).

Sucramal works by forming a protective barrier on the inner lining of the stomach and

the upper part of the intestine.

Sucramal is indicated in adults and adolescents over the age of 14 for the

treatment of the following conditions:

• lesion of the stomach (gastric ulcer) or the upper part of the intestine (duodenal ulcer),
• inflammation of the inner lining of the stomach of a transient type (acute gastritis) or of a chronic type (symptomatic chronic gastritis),
• stomach disorders due to the use of medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs),
• inflammation of the esophagus due to the backflow of acidic liquids and/or foods (reflux esophagitis).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Sucramal

Do not take Sucramal

• if you are allergic to sucralfate or any of the other ingredients of this medicine (listed in section 6);
• if you are being treated with tetracycline, a type of antibiotic used to treat infections caused by bacteria (see section Other medicines and Sucramal);

Sucramal should not be given to premature infants.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sucramal.
Tell your doctor and use this medicine with caution:

• if you suffer from a severe kidney disease (chronic renal failure). Also, if you are being treated in intensive care and, especially, if you have one of the following conditions:
• suffer from problems with stomach emptying (following medication or surgery) or diseases that reduce the motility of the stomach or intestines,
• are also fed through a tube that reaches the stomach or intestines, your doctor will monitor you closely as you have a higher risk of forming deposits of foreign material ingested that remain in the stomach and intestines (formation of bezoars) (see section 4 Possible side effects).

Children and adolescents
Sucramal is not recommended for children under 14 years of age.

Other medicines and Sucramal
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines: tetracyclines (a
type of antibiotic used to treat infections caused by bacteria), as use
together with sucralfate is contraindicated (see section “Do not take Sucramal”);

• phenytoin (a medicine used to treat epilepsy, a condition characterized by uncontrolled body movements and loss of consciousness);
• warfarin (a medicine used to prevent blood clots from forming);
• digoxin (a medicine used to treat heart disorders);
• fluoroquinolone antibiotics such as ciprofloxacin and norfloxacin (medicine used to treat infections caused by bacteria).

Leave at least 2 hours between taking Sucramal and other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
During pregnancy and breastfeeding, Sucramal should only be used when
strictly necessary and under the direct supervision of a doctor.

Driving and operating machinery
Sucramal does not impair the ability to drive vehicles or operate machinery.

Sucramal contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine

Sucramal contains sulphites and sulphur dioxide (E220) in trace amounts
Rarely, it can cause severe hypersensitivity reactions and bronchospasm.

Sucramal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, which is
essentially ‘sodium-free’.

Sucramal contains benzyl alcohol
This medicine contains less than 0.1 mg of benzyl alcohol per sachet.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious side effects including breathing problems (apnoe syndrome) in young children.
Do not administer to infants under 4 weeks of age unless otherwise recommended by the
doctor.
Do not use for more than one week in young children (under 3 years of age) unless
otherwise recommended by the doctor or pharmacist.
Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects
(such as metabolic acidosis).
Ask your doctor or pharmacist if you have a liver or kidney condition. This
because large amounts of benzyl alcohol can accumulate in the body and cause adverse
effects (such as metabolic acidosis).

3. How to take Sucramal

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 sachet 2 times a day on an empty stomach one hour before meals and
before going to bed, unless otherwise prescribed by your doctor.
Dissolve the granules in a little water, drink while stirring appropriately.

Use in children and adolescents
The use of Sucramal in children under 14 years of age is not recommended.

If you take more Sucramal than you should
In case of accidental ingestion/intake of an excessive dose of Sucramal, immediately notify your doctor or go to the nearest hospital.

If you forget to take Sucramal
Do not take a double dose to make up for a missed dose.

If you stop taking Sucramal
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Rare (may affect up to 1 in 1,000 people):

• formation of deposits of foreign material ingested that remain in the stomach and intestines (bezoars)

Not known (frequency cannot be estimated from available data):

• dizziness
• constipation (with prolonged treatments)
• stomach and intestinal disorders, nausea
• dry mouth
• skin rash
• itching
• allergic reactions, including severe ones (anaphylactic reactions)
• sleep disorders (insomnia)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
contact
your doctor or pharmacist. You can also report side effects directly through
the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine .

5. How to store Sucramal

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is reported on the packaging after
Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sucramal contains
Sucramal 2 g oral suspension granules

• The active ingredient is sucralfate (2 g per each sachet).
• The other components are orange juice granular (containing sucrose, sodium and traces of sulphites), orange aroma (containing benzyl alcohol and sulphur dioxide E220), mannitol, sodium saccharin, colloidal silica.

Description of the appearance of Sucramal and contents of the pack
Sucramal is presented as oral suspension granules contained in sachets.
Sucramal is available in packs of 30 sachets of 2 g.

Marketing Authorisation Holder
SCHARPER S.p.A.
Viale Ortles, 12
20139 Milano

Manufacturer
Sanofi Winthrop Industrie – 196, Avenue du Marechal Juin - Amilly (France)
Sanofi-Aventis Sp. Z.o.o. – 52 Lubelska Street – 35-233 Rzeszow, (Poland)