MESALAZINA 400 mg Modified-Release Hard Capsule

Зміст інструкції

1. Mesalazina EG 800 mg gastro-resistant tablets
   1. What is Mesalazina EG and what is it used for
   2. What you need to know before taking Mesalazina EG
   3. How to take Mesalazina EG
   4. Possible side effects
   5. How to store Mesalazina EG
   6. Contents of the pack and other information
2. Mesalazina EG 400 mg modified-release hard capsules
   1. What is Mesalazina EG and what is it used for
   2. What you need to know before taking Mesalazina EG
   3. How to take Mesalazina EG
   4. Possible side effects
   5. How to store Mesalazina EG
   6. Contents of the pack and other information
3. Mesalazina EG 2 g/60 ml rectal gel, 4 g/60 ml rectal gel
   1. What is Mesalazina EG and what is it used for
   2. What you need to know before using Mesalazina EG
   3. How to use Mesalazina EG
   4. Possible side effects
   5. How to store Mesalazina EG
   6. Contents of the pack and other information

Mesalazina EG 800 mg gastro-resistant tablets

Generic medicine

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

1. What is Mesalazina EG and what is it used for

Mesalazina EG contains the active ingredient mesalazine, belonging to the category of intestinal anti-inflammatory drugs.
This medicine is used in adults and children over 6 years of age for the treatment of ulcerative colitis and Crohn's disease (long-lasting inflammatory bowel diseases) and unclassifiable chronic inflammatory bowel disease (IBD).
The medicine is indicated both in the treatment of active phases of the disease and in the prevention of relapses. In the severe active phase, association with a corticosteroid medicine is recommended.
Contact your doctor if you do not feel better or if you feel worse after the prescribed treatment period.

2. What you need to know before taking Mesalazina EG

Do not take Mesalazina EG

• if you are allergic to mesalazine, to other related medicines (such as salicylates), or to any of the other ingredients of this medicine (listed in section 6);
• if your liver and kidneys are functioning significantly below normal (severe impairment of hepatic or renal function);
• if you suffer from severe kidney diseases (severe nephropathies);
• if you have a lesion of the internal lining of the stomach or intestinal mucosa (gastric or duodenal ulcer, active peptic ulcer);
• if you have a predisposition to the development of bleeding (haemorrhagic diathesis);
• in children under 2 years of age. In children under 6 years of age, the doctor will assess the need for treatment with tablets (see section “Children”);
• in the last weeks of pregnancy and during breastfeeding (see section “Pregnancy and breastfeeding”).

INFORM YOUR DOCTOR BEFORE USING mesalazine:

• if you have ever developed a severe skin rash or skin exfoliation, blisters and/or ulcers in the mouth after using mesalazine.

Warnings and precautions
Consult your doctor or pharmacist before taking Mesalazina EG.
Avoid using the tablets in children under 6 years of age.
Before starting treatment with Mesalazina EG, you must perform clinical investigations necessary to
clarify the diagnosis and therapeutic indications.
Before starting and during treatment with Mesalazina EG, your doctor will ask you
to undergo blood tests, tests to evaluate liver enzyme levels (ALT, AST,
serum creatinine) and/or urine tests. Your doctor will decide how often to repeat
these tests.
Mesalazine may cause a red-brown discoloration of the urine after contact with
sodium hypochlorite contained in bleach present in the toilet water. This is caused by a
harmless chemical reaction that occurs between mesalazine and bleach.
In case of severe or recurrent headache, visual disturbances, ringing or whistling in the ears, contact
your doctor immediately.
Pay particular attention and inform your doctor if any of the following applies to you:

• if you suffer from kidney disorders. If you have known renal dysfunction, your doctor will carefully assess the appropriateness of treatment with mesalazine since mesalazine induces toxicity to the kidneys;
• if you are being treated with drugs that can alter kidney function, such as non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, because they may increase the risk of kidney reactions. The doctor will assess renal function for all patients before starting therapy, and periodically during treatment, especially in the presence of kidney disease. The medicine will be discontinued if renal dysfunction develops during treatment;
• if your liver is functioning abnormally or reduced;
• if you are being treated with azathioprine or 6-mercaptopurine or thioguanine because they are drugs that can increase the risk of blood dyscrasias (blood disorders). Treatment should be reduced or discontinued if these adverse reactions occur;
• if you are taking one or more of the following medicines:
• medicines to lower blood sugar levels (oral hypoglycemic agents),
• medicines to increase the amount of urine produced (diuretics),
• medicines to prevent blood clotting (coumarins, e.g. warfarin),
• medicines to treat inflammation (corticosteroids);
• if you have particularly slow gastric digestion or have pyloric stenosis (narrowing of the part of the stomach that leads into the small intestine);
• if you suffer from lung disorders (in particular asthma);
• if you have heart disease affecting the myocardium and pericardium (myocarditis or pericarditis);
• if you have had adverse effects to preparations containing sulfasalazine in the past.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with treatment with mesalazine. Stop using mesalazine and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
The use of mesalazine can cause the formation of kidney stones. Symptoms may include
pain on the sides of the abdomen and blood in the urine. It is recommended to drink a sufficient amount of
liquids during treatment with mesalazine.
Prolonged use of the medicine can lead to allergic reactions.
Stop treatment (see also section “Possible side effects”):

• If, following treatment with Mesalazina EG, you experience bleeding, bruising, red spots on the skin due to leakage of superficial blood vessels (purpura), decreased hemoglobin levels in the blood (anemia), fever or sore throat.
• In the case of suspected acute intolerance syndrome which can manifest with symptoms such as, cramps, acute abdominal pain and diarrhea with blood, sometimes fever, severe headache and erythema.

Children
Mesalazina EG is contraindicated in children under 2 years of age (see section “Do not
take Mesalazina EG”). Mesalazina EG is not recommended for use in children under
6 years of age, unless after careful evaluation by the doctor.

Other medicines and Mesalazina EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Avoid the simultaneous administration of lactulose or other preparations that, by lowering the pH
of the colon, can hinder the release of mesalazine.
Use with caution the medicine together with:

• Sulfonylureas (used for the treatment of diabetes) whose effect can be potentiated (reduction of blood sugar levels).
• Coumarin drugs (used to slow down or inhibit the blood clotting process, e.g. warfarin).
• Methotrexate (medicine used in subjects affected by psoriasis, Crohn's disease, rheumatoid arthritis and in the treatment of some forms of cancer).
• Probenecid (medicine used to decrease the concentration of uric acid in the blood).
• Sulfinpyrazone (medicine used in prevention following a heart attack).
• Spironolactone (potassium-sparing diuretic).
• Furosemide (diuretic medicine, which increases urine production, used in case of fluid retention).
• Rifampicin (antibiotic).
• Non-steroidal anti-inflammatory drugs (NSAIDs).
• Azathioprine (drug with anti-inflammatory and immunosuppressive action).
• Drugs to treat blood cancers (leukemias), such as 6-mercaptopurine or thioguanine.

The use of Mesalazina EG together with corticosteroids, may potentiate the undesirable effects of these
latter on the stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
If pregnancy is confirmed or suspected, take the medicine only if absolutely necessary
and under strict medical control.
Do not take Mesalazina EG in the last weeks of pregnancy and during breastfeeding (see
section “Do not take Mesalazina EG”).
Blood disorders have been observed in newborns of mothers treated with Mesalazina EG.
Mesalazina EG should be used during breastfeeding only if absolutely necessary and
under strict medical control.
Allergic reactions such as diarrhea in infants cannot be ruled out.
If the newborn develops diarrhea, discontinue breastfeeding.

Driving and operating machinery
Mesalazina EG does not alter or alters negligibly the ability to drive vehicles or operate
machinery.

Mesalazina EG 800 mg gastro-resistant tablets contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Mesalazina EG

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The doctor will adjust the dosage based on the extent and severity of your illness.
In case of first-time treatment, it is advisable to gradually increase the dosage for a few
days before reaching the maximum dosage.
The recommended dose is 1 gastro-resistant tablet, 3 times a day.
The dosage may be increased up to 5 tablets of 800 mg per day in patients with severe
forms, according to the doctor's judgement.

Use in children and adolescents
Mesalazina EG is contraindicated in children under 2 years of age. Mesalazina EG is not
recommended for use in children under 6 years of age. The doctor, after careful evaluation,
may decide to administer reduced doses.
Children over 6 years:

• Active phase of the disease:the doctor will determine the correct dose on a case-by-case basis. The recommended average dose is 30-50 mg/kg per day in divided doses. Maximum dose: 75 mg/kg per day in divided doses. The total dose should not exceed 4 g per day (maximum dose in adults).
• Maintenance treatment:the doctor will determine the correct dose on a case-by-case basis. The recommended average dose is 15-30 mg/kg per day in divided doses. The total dose should not exceed 2 g per day (recommended dose in adults).

Take the tablets whole, without breaking or chewing them, preferably with a glass
of water and away from meals.
The duration of treatment for active phases is on average 4-6 weeks and may vary, at the doctor's
discretion, according to the patient's condition and the evolution of the disease.
In long-term treatments to prevent relapses, the daily dosage and the duration of
treatment must be established by the doctor according to the patient's condition and the evolution
of the disease.

If you take more Mesalazina EG than you should
In case of accidental intake of an excessive dose of the medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to take Mesalazina EG
Do not take a double dose to compensate for the forgotten dose, but resume the normal dosage of
intake as indicated.

If you stop taking Mesalazina EG
After stopping treatment, a recurrence of symptoms may occur (see paragraph
“Warnings and precautions”).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor immediately

• In case of severe or recurrent headache, vision disturbances, ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension). [Frequency not known (cannot be estimated based on available data)]

If you notice any of the following side effects, stop treatment and contact your doctor immediately:

• Allergic reactions (skin rashes, itching).
• Episodes of acute intestinal intolerance with abdominal pain.
• Presence of blood in watery stools (bloody diarrhea).
• Cramps.
• Headache.
• Fever.
• Skin rash.
• Reddish, non-raised patches on the trunk, shaped like a target or circular, often with central blisters, skin exfoliation, ulcers in the mouth, throat, nose, genitals and eyes, widespread rash, fever and swollen lymph nodes. These severe skin rashes may be preceded by fever and flu-like symptoms.

During the use of Mesalazina EG, the following side effects may occur:
Common(may affect up to 1 in 10 people):

• Headache.
• Skin rashes.
• Nausea.
• Diarrhea.
• Tense abdomen.
• High blood pressure (hypertension).
• Weakness (asthenia).
• Fever (pyrexia).

Uncommon(may affect up to 1 in 100 people):

• Itching.
• Pain in the upper abdomen (epigastralgia).
• Presence of blood in watery stools (bloody diarrhea).
• Cramps and abdominal pain.
• Increased heart rate (tachycardia).
• Low blood pressure (hypotension).
• Drowsiness.
• Tremor.
• Fatigue.
• Swelling of the face (facial edema).

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

• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).
• Dizziness.
• Emission of gas from the intestine (flatulence).
• Vomiting.

Very rare(may affect up to 1 in 10,000 people):

• Allergic reactions (allergic rash, drug fever, lupus erythematosus syndrome, pancolitis) and Stevens-Johnson syndrome (SJS).
• Inflammatory diseases affecting the heart and the membrane surrounding it (pericarditis, myocarditis).
• Decreased number of white blood cells in the blood (leukopenia, neutropenia, agranulocytosis), decreased number of platelets in the blood (thrombocytopenia), a form of anemia characterized by insufficient production in the bone marrow of all types of blood cells (aplastic anemia), decreased number of cells present in the blood (pancytopenia).
• Inflammation of the liver (hepatitis, cholestatic hepatitis).
• Inflammation of the pancreas (pancreatitis, including acute).
• Temporary changes in tests to assess liver function (increased transaminases and cholestasis).
• Gallstones (cholelithiasis).
• Kidney inflammation (acute and chronic interstitial nephritis), pathology at the renal and urinary level (nephrotic syndrome) and reduced kidney function (renal insufficiency).
• High fever (hyperpyrexia).
• Disease of the nerves that causes abnormalities of sensation and movement, including internal organs (peripheral neuropathy).
• Hair loss (alopecia).
• Muscle and joint pain (myalgia and arthralgia).
• Decreased number of sperm produced (oligospermia). This side effect is reversible.
• Allergic reactions and inflammation of the lungs (including difficulty breathing, cough, bronchospasm, alveolitis, eosinophilic pneumonia, interstitial pneumonia, lung infiltration, pneumonia).

Not known(frequency cannot be estimated based on available data):

• Swelling of the face, lips and throat caused by an allergic reaction (angioedema).
• Kidney stones and associated kidney pain (see also paragraph 2).

It has also been reported

• Pleuropericarditis, i.e. an inflammation of the membrane surrounding the lungs and the heart.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Mesalazina EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Avoid exposure to direct sunlight and sources of heat.
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 Mesalazina EG contains

• The active ingredient is mesalazine (5-aminosalicylic acid, 5-ASA). One tablet contains 800 mg of mesalazine.
• The other ingredients are: lactose, polyvinylpyrrolidone, sodium croscarmellose, magnesium stearate, methacrylic copolymers, triethyl citrate, talc, red iron oxide.

Description of the appearance of Mesalazina EG and contents of the pack
Gastro-resistant tablets, pack of 24 or 60 tablets of 800 mg.

Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan

Distributor
S.F. Group S.r.l., Via Tiburtina, 1143 – 00156 Rome

Manufacturer
Fine Foods & Pharmaceuticals NTM S.p.A. – Via Grignano, 43 – 24041 Brembate (BG)

Mesalazina EG 400 mg modified-release hard capsules

Generic medicine

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 Mesalazina EG is and what it is used for
• 2. What you need to know before you take Mesalazina EG
• 3. How to take Mesalazina EG
• 4. Possible side effects
• 5. How to store Mesalazina EG
• 6. Contents of the pack and other information

1. What is Mesalazina EG and what is it used for

Mesalazina EG contains the active ingredient mesalazine, belonging to the category of intestinal anti-inflammatory drugs.
This medicine is used in adults and children over 2 years of age for the treatment of
ulcerative colitis and Crohn's disease (long-lasting inflammatory bowel diseases) and of
unclassifiable chronic inflammatory bowel disease (IBD).
The medicine is indicated both in the treatment of active phases of the disease and in the prevention
of relapses. In the severe active phase, association with a corticosteroid medicine is recommended.
Consult your doctor if you do not feel better or if you feel worse after the prescribed treatment
period.

2. What you need to know before taking Mesalazina EG

Do not take Mesalazina EG

• if you are allergic to mesalazine, to other related medicines (such as salicylates), or to any of the other ingredients of this medicine (listed in section 6);
• if your liver and kidneys are functioning much less than normal (severe impairment of hepatic or renal function);
• if you suffer from severe kidney diseases (severe nephropathies);
• if you have a lesion of the inner lining of the stomach or intestinal mucosa (gastric or duodenal ulcer, active peptic ulcer);
• if you have a predisposition to the development of bleeding (haemorrhagic diathesis);
• in children under 2 years of age (see section “Children”);
• in the last weeks of pregnancy and during breastfeeding (see section “Pregnancy and breastfeeding”).

INFORM YOUR DOCTOR BEFORE USING mesalazine:

• if you have ever developed a severe skin rash or skin exfoliation, blisters and/or ulcers in the mouth after using mesalazine.

Warnings and precautions
Consult your doctor or pharmacist before taking Mesalazina EG.
Before starting treatment with Mesalazina EG, you will need to undergo clinical investigations
necessary to define the diagnosis and therapeutic indications.
Before starting treatment and during treatment with Mesalazina EG, the doctor will ask you
to undergo blood tests, tests to evaluate liver enzyme levels (ALT, AST,
serum creatinine) and/or urine tests. The doctor himself will decide how often to repeat
these tests.
Mesalazine may cause a red-brown discoloration of the urine after contact with
sodium hypochlorite contained in bleach present in the toilet water. This is caused by a
harmless chemical reaction that occurs between mesalazine and bleach.
In case of severe or recurrent headache, visual disturbances, ringing or whistling in the ears, contact
your doctor immediately.
Pay particular attention and inform your doctor if any of the following applies to you:

• if you suffer from kidney disorders. If you have known renal dysfunction, the doctor will carefully assess the appropriateness of treatment with mesalazine since mesalazine induces toxicity to the kidneys;
• if you are being treated with drugs that can alter kidney function, such as non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, because they may increase the risk of kidney reactions. The doctor will assess renal function in all patients before starting therapy, and periodically during treatment, especially in the presence of kidney disease. The medicine will be discontinued if kidney dysfunction develops during treatment;
• if your liver is functioning abnormally or reduced;
• if you are being treated with azathioprine or 6-mercaptopurine or thioguanine because they are drugs that can increase the risk of blood dyscrasias (blood disorders). Treatment should be reduced or discontinued if these adverse reactions occur;
• if you are taking one or more of the following medicines:
• medicines to lower blood sugar levels (oral hypoglycemic agents),
• medicines to increase the amount of urine produced (diuretics),
• medicines to prevent blood clotting (coumarins, e.g. warfarin),
• medicines to treat inflammation (corticosteroids);
• if you have heart disease affecting the myocardium and pericardium (myocarditis or pericarditis);
• if you suffer from lung disorders (particularly asthma);
• if you have had adverse effects to preparations containing sulfasalazine in the past.

In association with treatment with mesalazine, serious skin reactions have been reported,
including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis (TEN). Stop using mesalazine and
contact your doctor immediately if you observe any of the symptoms related to these serious
skin reactions described in section 4.
The use of mesalazine may cause the formation of kidney stones. Symptoms may include
pain on the sides of the abdomen and blood in the urine. It is recommended to drink a sufficient amount of
liquids during treatment with mesalazine.
Prolonged use of the medicine may lead to allergic reactions.
Stop treatment (see also section “Possible side effects”):

• If, following treatment with Mesalazina EG, you experience bleeding, bruising, red spots on the skin due to leakage of superficial blood vessels (purpura), decreased hemoglobin levels in the blood (anemia), fever or sore throat.
• In the case of suspected acute intolerance syndrome which can manifest with symptoms such as, cramps, acute abdominal pain and diarrhea with blood, sometimes fever, severe headache and erythema.

Children
Mesalazina EG is contraindicated in children under 2 years of age (see section “Do not
take Mesalazina EG”).

Other medicines and Mesalazina EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Avoid the simultaneous administration of lactulose or other preparations that, by lowering the pH
of the colon, can hinder the release of mesalazine.
Use with caution the medicine together with:

• Sulfonylureas (used for the treatment of diabetes) whose effect can be potentiated (reduction of blood sugar levels).
• Coumarin drugs (used to slow down or inhibit the blood clotting process, e.g. warfarin).
• Methotrexate (medicine used in subjects affected by psoriasis, Crohn's disease, rheumatoid arthritis and in the treatment of some forms of cancer).
• Probenecid (medicine used to decrease the concentration of uric acid in the blood).
• Sulfinpyrazone (medicine used in prevention following a heart attack).
• Spironolactone (potassium-sparing diuretic).
• Furosemide (diuretic medicine, which increases urine production, used in case of fluid retention).
• Rifampicin (antibiotic).
• Non-steroidal anti-inflammatory drugs (NSAIDs).
• Azathioprine (drug with anti-inflammatory and immunosuppressive action).
• Drugs for treating blood cancers (leukemia), such as 6-mercaptopurine or thioguanine.

The use of Mesalazina EG together with corticosteroids, may potentiate the undesirable effects of these
latter on the stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If pregnancy is confirmed or suspected, take the medicine only if absolutely necessary
and under strict medical supervision.
Do not take Mesalazina EG in the last weeks of pregnancy and during breastfeeding (see
section “Do not use Mesalazina EG”).
Blood disorders have been observed in newborns of mothers treated with Mesalazina EG.
Mesalazina EG should be used during breastfeeding only if absolutely necessary and
under strict medical supervision. Allergic reactions such as diarrhea in
children cannot be ruled out.
If the newborn develops diarrhea, stop breastfeeding.

Driving and using machines
Mesalazina EG does not alter or alters negligibly the ability to drive vehicles or operate
machinery.

Mesalazina EG modified-release capsules contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Mesalazina EG

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The doctor will adjust the dosage based on the extent and severity of your disease.
In case of first-time treatment, it is advisable to gradually increase the dosage for a few
days before reaching the maximum dosage.
The recommended dose in adults is 1-2 capsules, 3 times a day.
In patients with severe forms, the dosage may be increased up to 10 capsules, according to the
doctor's judgement.

Use in children and adolescents
Children over 2 years: the dose will be proportionally reduced at the doctor's discretion.
Children from 6 years of age:

• Active phase of the disease:the doctor will determine the correct dose on a case-by-case basis. The average recommended dose is 30-50 mg/kg per day in divided doses. Maximum dose: 75 mg/kg

per day in divided doses. The total dose should not exceed 4 g per day (maximum dose
in adults).

• Maintenance treatment: the doctor will determine the correct dose on a case-by-case basis. The average recommended dose is 15-30 mg/kg per day in divided doses. The total dose should not exceed 2 g per day (recommended dose in adults).

Take the capsules whole, preferably with a glass of water and away from meals. If you are
unable to swallow the capsules whole, open the capsule and take all the microgranules
after dispersing them in an aqueous solution. Caution: do not chew the microgranules.
The duration of treatment for active phases is on average 4-6 weeks and may vary, at the doctor's discretion,
according to the patient's condition and the evolution of the disease.
In long-term treatments to prevent relapses, the daily dosage and the duration of
treatment must be established by the doctor according to the patient's condition and the evolution
of the disease.

If you take more Mesalazina EG than you should
In case of accidental intake of an excessive dose of the medicine, immediately inform
your doctor or go to the nearest hospital.

If you forget to take Mesalazina EG
Do not take a double dose to compensate for the forgotten dose, but resume the normal dosage of
intake as indicated.

If you stop taking Mesalazina EG
After stopping treatment, a recurrence of symptoms may occur (see paragraph
“Warnings and precautions”).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor immediately

• In case of severe or recurrent headache, vision disturbances, ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension). [Frequency not known (cannot be estimated based on available data)]

If you notice any of the following side effects, stop treatment and contact your
doctor immediately:

• Allergic reactions (skin rashes, itching).
• Episodes of acute intestinal intolerance with abdominal pain.
• Presence of blood in liquid stools (bloody diarrhea).
• Cramps.
• Headache.
• Fever.
• Skin rash.
• Reddish, non-raised patches on the trunk, shaped like a target or circular, often with central blisters, skin exfoliation, ulcers in the mouth, throat, nose, genitals and eyes, widespread rash, fever and swollen lymph nodes. These severe skin rashes may be preceded by fever and flu-like symptoms.

During the use of Mesalazina EG, the following side effects may occur:
Common(may affect up to 1 in 10 people):

• Headache.
• Skin rashes.
• Nausea.
• Diarrhea.
• Tense abdomen.
• High blood pressure (hypertension).
• Weakness (asthenia).
• Fever (pyrexia).

Not common(may affect up to 1 in 100 people):

• Itching.
• Pain in the upper abdomen (epigastralgia).
• Presence of blood in liquid stools (bloody diarrhea).
• Cramps and abdominal pain.
• Increased heart rate (tachycardia).
• Low blood pressure (hypotension).
• Drowsiness.
• Tremor.
• Fatigue.
• Swelling of the face (facial edema).

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

• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).
• Dizziness.
• Emission of gas from the intestines (flatulence).
• Vomiting.

Very rare(may affect up to 1 in 10,000 people):

• Allergic reactions (allergic rash, drug fever, lupus erythematosus syndrome, pancolitis) and Stevens-Johnson syndrome (SJS).
• Inflammatory diseases affecting the heart and the membrane lining it (pericarditis, myocarditis).
• Decreased number of white blood cells in the blood (leukopenia, neutropenia, agranulocytosis), decreased number of platelets in the blood (thrombocytopenia), a form of anemia characterized by insufficient production in the bone marrow of blood cells of

all types (aplastic anemia), decreased number of cells present in the blood
(pancytopenia).

• Inflammation of the liver (hepatitis, cholestatic hepatitis).
• Inflammation of the pancreas (pancreatitis, including acute).
• Temporary changes in tests to assess liver function (increased transaminases and cholestasis).
• Gallstones (cholelithiasis).
• Kidney inflammation (acute and chronic interstitial nephritis), pathology at the renal and urinary level (nephrotic syndrome) and reduced kidney function (renal insufficiency).
• High fever (hyperpyrexia).
• Disease of the nerves that causes abnormalities in sensation and movement, including internal organs (peripheral neuropathy).
• Hair loss (alopecia).
• Muscle and joint pain (myalgia and arthralgia).
• Decreased number of sperm produced (oligospermia). This side effect is reversible.
• Allergic reactions and inflammation of the lungs (including difficulty breathing, cough, bronchospasm, alveolitis, eosinophilic pneumonia, interstitial pneumonia, lung infiltration, pneumonia).

Not known(frequency cannot be estimated based on the available data)

• Swelling of the face, lips and throat caused by an allergic reaction (angioedema).
• Kidney stones and associated kidney pain (see also paragraph 2).

It has also been reported

• Pleuropericarditis, i.e. inflammation of the membrane surrounding the lungs and heart.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 Mesalazina EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which 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 waste water 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 Mesalazina EG contains

• The active ingredient is mesalazine (5-aminosalicylic acid, 5-ASA). One capsule contains 400 mg of mesalazine.
• The other ingredients are: talc, methacrylic acid copolymer, diethyl phthalate, sugar spheres (composed of sucrose and starch). Capsule constituents: gelatin, titanium dioxide, indigotine, quinoline yellow.

Description of the appearance of Mesalazina EG and contents of the pack
Hard modified-release capsules, blister pack of 50 capsules containing 400 mg.

Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milano

Distributor
S.F. Group S.r.l., Via Tiburtina, 1143 – 00156 Roma

Manufacturer
Sirton Pharmaceuticals S.P.A. - Piazza XX Settembre 2 - Villa Guardia (CO)

Mesalazina EG 2 g/60 ml rectal gel, 4 g/60 ml rectal gel

Generic medicine

Read this leaflet carefully before using 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 Mesalazina EG is and what it is used for
• 2. What you need to know before you use Mesalazina EG
• 3. How to use Mesalazina EG
• 4. Possible side effects
• 5. How to store Mesalazina EG
• 6. Contents of the pack and other information

1. What is Mesalazina EG and what is it used for

Mesalazina EG contains the active ingredient mesalazine, belonging to the category of intestinal
anti-inflammatory drugs.
This medicine is used in adults and children over 2 years of age for the treatment of
ulcerative colitis (a long-lasting inflammatory bowel disease affecting the final parts
of the intestine) localized in the rectosigmoid area.
The medicine is indicated both in the treatment of active phases of the disease and in the prevention
of relapses. In the active phase of severe degree, association with a corticosteroid medicine is recommended.
Contact your doctor if you do not feel better or if you feel worse after the prescribed
treatment period.

2. What you need to know before using Mesalazina EG

Do not use Mesalazina EG

• if you are allergic to mesalazine, to other related medicines (such as salicylates) or to any of the other ingredients of this medicine (listed in section 6), especially to metabisulfites;
• if your liver and kidneys are functioning much less than normal (severe impairment of hepatic or renal function);
• if you suffer from severe kidney diseases (severe nephropathies);
• if you have a lesion of the inner lining of the stomach or intestinal mucosa (gastric or duodenal ulcer);
• if you have a predisposition to the development of bleeding (haemorrhagic diathesis);
• in children under 2 years of age (see section “Children”).
• in the last weeks of pregnancy and during breastfeeding (see section “Pregnancy and breastfeeding”).

INFORM YOUR DOCTOR BEFORE USING mesalazine:

• if you have ever developed a severe skin rash or skin exfoliation, blisters and/or mouth ulcers after using mesalazine.

Warnings and precautions
Consult your doctor or pharmacist before using Mesalazina EG.
Before starting treatment with Mesalazina EG, you must perform clinical investigations necessary to
clarify the diagnosis and therapeutic indications.
Before starting and during treatment with Mesalazina EG, your doctor will ask you
to undergo blood tests, tests to evaluate liver enzyme levels (ALT, AST,
serum creatinine) and/or urine tests. Your doctor will decide how often to repeat
these tests.
Mesalazine may cause a red-brown discoloration of the urine after contact with
sodium hypochlorite contained in bleach present in the toilet water. This is caused by a
harmless chemical reaction that occurs between mesalazine and bleach.
In case of severe or recurrent headache, visual disturbances, ringing or whistling in the ears, contact
your doctor immediately.
Pay particular attention and inform your doctor if any of the following applies to you:

• if you suffer from kidney disorders. If you have known renal dysfunction, your doctor will carefully assess the appropriateness of treatment with mesalazine since mesalazine induces toxicity to the kidneys;
• if you are being treated with drugs that can alter kidney function, such as non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, because they may increase the risk of kidney reactions. The doctor will assess kidney function for all patients before starting therapy, and periodically during treatment, especially in the presence of kidney disease. The medicine will be discontinued if kidney dysfunction develops during treatment;
• if your liver is functioning abnormally or reduced;
• if you are being treated with azathioprine or 6-mercaptopurine or thioguanine because they are drugs that can increase the risk of blood dyscrasias (blood disorders). Treatment should be reduced or discontinued if these adverse reactions occur;
• if you are taking one or more of the following medicines:
• medicines to lower blood sugar levels (oral hypoglycemic agents),
• medicines to increase the amount of urine produced (diuretics),
• medicines to prevent blood clotting (coumarins, e.g. warfarin),
• medicines to treat inflammation (corticosteroids);
• if you have heart disease affecting the myocardium and pericardium (myocarditis or pericarditis);
• if you suffer from lung disorders (especially asthma);
• if you have had adverse effects to preparations containing sulfasalazine in the past.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with treatment with mesalazine. Stop using mesalazine and
contact your doctor immediately if you observe any of the symptoms related to these severe
skin reactions described in section 4.
The use of mesalazine may cause the formation of kidney stones. Symptoms may include
pain in the sides of the abdomen and blood in the urine. It is recommended to drink a sufficient amount of
liquids during treatment with mesalazine.
Prolonged use of the medicine may lead to allergic reactions.
Stop treatment (see also section “Possible side effects”):

• if, following treatment with Mesalazina EG, you experience bleeding, bruising, red spots on the skin due to leakage of superficial blood vessels (purpura), decreased hemoglobin levels in the blood (anemia), fever or sore throat;
• in the case of suspected acute intolerance syndrome which can manifest with symptoms such as, cramps, acute abdominal pain and diarrhea with blood, sometimes fever, severe headache and erythema.

Children
Mesalazina EG is contraindicated in children under 2 years of age (see section “Do not use
Mesalazina EG”).

Other medicines and Mesalazina EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Use with caution the medicine together with:

• Sulfonylureas (used for the treatment of diabetes) whose effect hypoglycemic (reduction of blood sugar levels) may be potentiated.
• Coumarin medicines (used to slow down or inhibit the blood clotting process, e.g. warfarin).
• Methotrexate (medicine used in patients with psoriasis, Crohn's disease, rheumatoid arthritis and in the treatment of some forms of cancer).
• Probenecid (medicine used to decrease the concentration of uric acid in the blood).
• Sulfinpyrazone (medicine used in prevention following a heart attack).
• Spironolactone (potassium-sparing diuretic).
• Furosemide (diuretic medicine, which increases urine production, used in case of fluid retention).
• Rifampicin (antibiotic).
• Non-steroidal anti-inflammatory drugs (NSAIDs).
• Azathioprine (drug with anti-inflammatory and immunosuppressive action).
• Medicines for treating blood cancers (leukemia), such as 6-mercaptopurine or thioguanine.

The use of Mesalazina EG together with corticosteroids, may potentiate the undesirable effects of these
latter on the stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If pregnancy is confirmed or suspected, use the medicine only if absolutely necessary and
under strict medical supervision. Do not use Mesalazina EG in the last weeks of pregnancy and
during breastfeeding (see section “Do not use Mesalazina EG”).
Blood disorders have been observed in newborns of mothers treated with Mesalazina EG.
Mesalazina EG should be used during breastfeeding only if absolutely necessary and
under strict medical supervision.
Allergic reactions such as diarrhea in infants cannot be ruled out.
If the newborn develops diarrhea, discontinue breastfeeding.

Driving and operating machinery
Mesalazina EG does not alter or alters negligibly the ability to drive vehicles or operate
machinery.

Mesalazina EG rectal gel contains sodium metabisulfite
Rarely may cause severe hypersensitivity reactions and bronchospasm.

3. How to use Mesalazina EG

Use this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended average dose is: one 2 g single-dose container 1-2 times a day, in the morning
and/or evening before bedtime, or one 4 g single-dose container, 1 time a day, in the evening
before bedtime.

Use in children and adolescents
Children over 2 years: the dose will be proportionally reduced at the doctor's discretion.

Method of administration of the rectal gel
For using the single-dose container, apply the rectal cannula and hold the container
with your right hand, keeping your index finger above the cap of the dispensing valve.

• Lie on your left side, keeping your left leg straight and bending your right leg.
• Gently insert the cannula into the anal opening and press the cap of the dispensing valve with your index finger, without removing the cannula, until completely emptied.

After introducing the preparation, turn onto both sides several times to facilitate better
distribution of the medicine and remain lying down for at least 30 minutes.
Better efficacy of the product is obtained by retaining the medicine for as long as possible, or
better, leaving it in place all night. Therefore, it is preferable that at least one of the
daily applications is performed before bedtime.
The duration of treatment for active phases is on average 4-6 weeks and may vary, at the doctor's discretion,
according to the patient's condition and the evolution of the disease.
In long-term treatments to prevent relapses, the daily dosage and duration of
treatment must be established by the doctor according to the patient's condition or the evolution
of the disease.

If you use more Mesalazina EG than you should
No cases of overdose following rectal administration are known.

If you forget to use Mesalazina EG
Do not use a double dose to make up for the forgotten dose, but resume the normal dosage of
administration as indicated.

If you stop using Mesalazina EG
After stopping treatment, a recurrence of symptoms may occur (see paragraph
“Warnings and precautions”).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects
Inform your doctor immediately

• In case of severe or recurrent headache, vision disturbances, ringing or buzzing in the ears. These could be symptoms of increased pressure inside the skull (idiopathic intracranial hypertension). [Frequency not known (cannot be defined based on available data)]

If you notice any of the following side effects, stop treatment and contact your doctor immediately:

• Allergic reactions (skin rashes, itching).
• Episodes of acute intestinal intolerance with abdominal pain.
• Presence of blood in watery stools (bloody diarrhea).
• Cramps.
• Headache.
• Fever.
• Skin rash.
• Reddish, non-raised patches on the trunk, shaped like a target or circular, often with central blisters, skin exfoliation, ulcers in the mouth, throat, nose, genitals and eyes, widespread rash, fever and swollen lymph nodes. These severe skin rashes may be preceded by fever and flu-like symptoms.

During the use of Mesalazina EG, the following side effects may occur:
Common(may affect up to 1 in 10 people):

• Headache.
• Skin rashes.
• Nausea.
• Diarrhea.
• Tense abdomen.
• High blood pressure (hypertension).
• Weakness (asthenia).
• Fever (pyrexia).

Uncommon(may affect up to 1 in 100 people):

• Itching.
• Pain in the upper abdomen (epigastralgia).
• Presence of blood in watery stools (bloody diarrhea).
• Cramps and abdominal pain.
• Increased heart rate (tachycardia).
• Low blood pressure (hypotension).
• Drowsiness.
• Tremor.
• Fatigue.
• Facial swelling (facial edema).

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

• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).
• Dizziness.
• Emission of gas from the intestines (flatulence).
• Vomiting.

Very rare(may affect up to 1 in 10,000 people):

• Allergic reactions (allergic rash, drug fever, lupus erythematosus syndrome, pancolitis) and Stevens-Johnson Syndrome (SJS).
• Inflammatory diseases affecting the heart and the membrane surrounding it (pericarditis, myocarditis).
• Decreased number of white blood cells in the blood (leukopenia, neutropenia, agranulocytosis), decreased number of platelets in the blood (thrombocytopenia), a form of anemia characterized by insufficient production in the bone marrow of all types of blood cells (aplastic anemia), decreased number of cells present in the blood (pancytopenia).
• Inflammation of the liver (hepatitis, cholestatic hepatitis).
• Inflammation of the pancreas (pancreatitis, including acute).
• Temporary changes in tests to assess liver function (increased transaminases and cholestasis).
• Gallstones (cholelithiasis).
• Kidney inflammation (acute and chronic interstitial nephritis), pathology at the renal and urinary level (nephrotic syndrome) and reduced kidney function (renal insufficiency).
• High fever (hyperpyrexia).
• Disease of the nerves that causes abnormalities in sensation and movement, including internal organs (peripheral neuropathy).
• Hair and hair loss (alopecia).
• Muscle and joint pain (myalgia and arthralgia).
• Decreased number of sperm produced (oligospermia). This side effect is reversible.
• Allergic reactions and inflammation of the lungs (including difficulty breathing, cough, bronchospasm, alveolitis, eosinophilic pneumonia, interstitial pneumonia, lung infiltration, pneumonia).

Not known(frequency cannot be estimated based on available data):

• Swelling of the face, lips and throat caused by an allergic reaction (angioedema).
• Kidney stones and associated kidney pain (see also paragraph 2).

It has also been reported

• Pleuropericarditis, i.e. inflammation of the membrane surrounding the lungs and heart.

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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. How to store Mesalazina EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Pressurized container. Store at a temperature not exceeding 50°C and do not expose to direct sunlight.
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 Mesalazina EG contains

• The active ingredient is mesalazine (5-aminosalicylic acid, 5-ASA). 60 ml of gel contains 2 g of mesalazine ( Mesalazina EG 2 g/60 ml rectal gel) or 4 g of mesalazine ( Mesalazina EG 4 g/60 ml rectal gel).
• The other ingredients are: microcrystalline cellulose + sodium carboxymethylcellulose, sodium acetate trihydrate, sodium metabisulfite, hydroxyethylcellulose, disodium edetate, glacial acetic acid, purified water.

Description of the appearance of Mesalazina EG and contents of the pack
Mesalazina EG is presented as a rectal gel.
Pack of 7 single-dose containers of 2 or 4 g of mesalazine in 60 ml of gel with an applicator for
rectal administration.

Marketing Authorisation Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan

Distributor
S.F. Group S.r.l., Via Tiburtina, 1143 – 00156 Rome

Manufacturer
Sirton Pharmaceuticals S.P.A. - Piazza XX Settembre 2 - Villa Guardia (CO)