Package leaflet: Information for the patient

Mesalazina EG 800 mg gastro-resistant tablets

Generic medicine
Please read this entire 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 give it to other people, even if their symptoms are the same as yours, as it could 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:

What Mesalazina EG is and what it is used for
What you need to know before taking Mesalazina EG
How to take Mesalazina EG
Possible side effects
How to store Mesalazina EG
Contents of the pack and other information

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

Mesalazina EG contains the active substance mesalazine, which belongs to the class of intestinal anti-inflammatory medicines.
This medicine is used in adults and children over 6 years of age for the treatment of ulcerative colitis, Crohn's disease (chronic inflammatory bowel diseases), and inflammatory bowel disease unclassified (IBDU).
The medicine is indicated both for the treatment of active disease phases and for the prevention of relapses. In severe active phases, concomitant use with a corticosteroid medicine is recommended.
If you do not feel better or if you feel worse after the prescribed treatment period, consult your doctor.

2. What you should 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 or kidneys are severely impaired (severe hepatic or renal dysfunction);
if you suffer from severe kidney disease (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 tendency to develop bleeding (hemorrhagic diathesis);
in children under 2 years of age. In children under 6 years of age, your doctor will evaluate the need for treatment with tablets (see section “Children”);
during the last weeks of pregnancy and while breastfeeding (see section “Pregnancy and breastfeeding”).

INFORM YOUR DOCTOR BEFORE USING mesalazine:

if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking mesalazine.

Warnings and precautions
Talk to 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, appropriate clinical investigations must be carried out to confirm the diagnosis and therapeutic indications.
Before starting and during treatment with Mesalazina EG, your doctor will ask you to undergo blood tests, liver enzyme tests (ALT, AST, serum creatinine) and/or urine tests. Your doctor will decide how often these tests should be repeated.
Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite contained in bleach present in toilet water. This is due to a harmless chemical reaction between mesalazine and bleach.
If you experience severe or recurrent headache, visual disturbances, ringing or buzzing in the ears, contact your doctor immediately.
Pay special attention and inform your doctor if any of the following apply to you:

if you have kidney disorders. If you have known renal dysfunction, your doctor will carefully evaluate whether treatment with mesalazine is appropriate, as mesalazine may induce kidney toxicity;
if you are taking medications that may affect kidney function, such as non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, because they may increase the risk of renal reactions. Your doctor will assess kidney function in all patients before starting therapy and periodically during treatment, especially if you have pre-existing kidney disease. The medicine will be discontinued if renal dysfunction develops during treatment;
if your liver function is impaired or reduced;
if you are being treated with azathioprine, 6-mercaptopurine or thioguanine, as these drugs may increase the risk of blood dyscrasias (blood disorders). Treatment should be reduced or discontinued if such adverse reactions occur;
if you are taking one or more of the following medicines:
- medicines to lower blood sugar levels (oral hypoglycemics),
- medicines to increase urine production (diuretics),
- medicines to prevent blood clotting (coumarins, e.g. warfarin),
medicines for treating inflammation (corticosteroids);
- if you have particularly slow gastric digestion or suffer from pyloric stenosis (narrowing of the part of the stomach leading into the small intestine);
- if you suffer from lung disorders (especially asthma);
- if you have heart conditions affecting the myocardium or pericardium (myocarditis or pericarditis);
- if you have previously experienced adverse effects from products containing sulfasalazine.

Severe cutaneous adverse 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 mesalazine treatment. Stop using mesalazine and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
The use of mesalazine may lead to 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 sufficient fluids during treatment with mesalazine.
Prolonged use of the medicine may cause allergic reactions.
Discontinue 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 from superficial blood vessels (purpura), decreased hemoglobin levels in the blood (anemia), fever, or sore throat.
In case of suspected acute intolerance syndrome, which may present with symptoms such as cramps, acute abdominal pain and bloody diarrhea, 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 carefully evaluated by a doctor.
Other medicines and Mesalazina EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid concomitant administration of lactulose or other preparations that lower the pH of the colon, as they may interfere with the release of mesalazine.
Use this medicine with caution together with:

Sulfonylureas (used in the treatment of diabetes), as the hypoglycemic effect (reduction of blood sugar levels) may be enhanced.
Coumarin drugs (used to slow down or inhibit blood clotting, e.g. warfarin).
Methotrexate (a medicine used in patients with psoriasis, Crohn's disease, rheumatoid arthritis, and in the treatment of certain cancers).
Probenecid (a medicine used to reduce blood uric acid levels).
Sulfinpyrazone (a medicine used for prevention following a heart attack).
Spironolactone (a potassium-sparing diuretic).
Furosemide (a diuretic that increases urine production, used in cases of fluid retention).
Rifampicin (an antibiotic).
Non-steroidal anti-inflammatory drugs (NSAIDs).
Azathioprine (an anti-inflammatory and immunosuppressive drug).
Medicines used to treat blood cancers (leukemias), such as 6-mercaptopurine or thioguanine.

The use of Mesalazina EG together with corticosteroids may enhance the adverse effects of corticosteroids on the stomach.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If pregnancy is confirmed or suspected, take the medicine only if clearly needed and under strict medical supervision.
Do not take Mesalazina EG during the last weeks of pregnancy and while 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 clearly necessary and under strict medical supervision.
Allergic reactions such as diarrhea in infants cannot be ruled out.
If the infant develops diarrhea, discontinue breastfeeding.
Driving and using machines
Mesalazina EG does not affect or has negligible effect on the ability to drive or use machinery.
Mesalazina EG 800 mg gastro-resistant tablets contain 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 exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will adjust the dosage according to the extent and severity of your condition.
When starting treatment for the first time, it is advisable to gradually increase the dose over a few days before reaching the maximum dosage.
The recommended dose is 1 gastro-resistant tablet, 3 times daily.
The dosage may be increased up to 5 tablets of 800 mg daily in patients with severe forms of the disease, according to the physician's judgment.

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. After careful evaluation, the doctor may decide to administer reduced doses.

Children over 6 years:

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

Swallow the tablets whole, without dividing or chewing them, preferably with a glass of water and away from meals.
The duration of treatment during active phases is generally 4–6 weeks and may vary, at the physician’s discretion, depending on the patient’s condition and disease progression.
For long-term treatment to prevent relapses, the daily dosage and duration of treatment must be determined by the doctor according to the patient’s condition and disease progression.

If you take more Mesalazina EG than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take Mesalazina EG
Do not take a double dose to make up for the forgotten dose. Instead, resume your normal dosing schedule as directed.

If you stop taking Mesalazina EG
After stopping treatment, symptoms may reappear (see section “Warnings and precautions”).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Serious adverse reactions
Inform your doctor immediately

If you experience severe or recurrent headache, visual 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 from available data)]

If you notice any of the following adverse reactions, 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 (haematochezia).
Cramps.
Headache.
Fever.
Skin rash.
Red, flat patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes. These severe skin reactions may be preceded by fever and flu-like symptoms.

The following adverse reactions may occur during treatment with Mesalazina EG:
Common (may affect up to 1 in 10 people):

Headache.
Skin rashes.
Nausea.
Diarrhoea.
Abdominal distension.
High blood pressure (hypertension).
Weakness (asthenia).
Fever (pyrexia).

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

Itching.
Pain in the upper abdomen (epigastric pain).
Presence of blood in liquid stools (haematochezia).
Cramps and abdominal pain.
Increased heart rate (tachycardia).
Low blood pressure (hypotension).
Drowsiness.
Tremor.
Fatigue.
Facial swelling (facial oedema).

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

Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).
Dizziness.
Excessive 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 (leucopenia, neutropenia, agranulocytosis), decreased number of platelets in the blood (thrombocytopenia), a form of anaemia characterised by insufficient production in the bone marrow of all types of blood cells (aplastic anaemia), decreased number of blood cells (pancytopenia).
Inflammation of the liver (hepatitis, cholestatic hepatitis).
Inflammation of the pancreas (pancreatitis, including acute pancreatitis).
Temporary changes in liver function tests (elevated transaminases and cholestasis).
Gallstones (cholelithiasis).
Kidney inflammation (acute and chronic interstitial nephritis), kidney and urinary tract disorders (nephrotic syndrome), and reduced kidney function (renal failure).
High fever (hyperpyrexia).
Nerve disease causing abnormalities in sensation and movement, including internal organs (peripheral neuropathy).
Loss of body hair and scalp hair (alopecia).
Muscle and joint pain (myalgia and arthralgia).
Decreased number of sperm produced (oligospermia). This adverse reaction is reversible.
Allergic reactions and lung inflammation (including breathing difficulty, cough, bronchospasm, alveolitis, eosinophilic pneumonia, interstitial pneumonia, lung infiltration, pneumonia).

Frequency not known (frequency cannot be estimated from available data):

Swelling of the face, lips and throat due to an allergic reaction (angioedema).
Kidney stones and associated kidney pain (see also section 2).

Additionally reported:

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

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Mesalazine EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Mesalazina EG contains

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

Description of the appearance of Mesalazina EG and package contents
Gastro-resistant tablets, pack sizes of 24 or 60 tablets of 800 mg.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan
Marketing Authorization Holder's Representative
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)

Patient information leaflet

Mesalazina EG 400 mg modified-release hard capsules

Generic medicine
Please read this entire 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Mesalazina EG is and what it is used for
What you need to know before taking Mesalazina EG
How to take Mesalazina EG
Possible side effects
How to store Mesalazina EG
Package contents and other information

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

Mesalazina EG contains the active substance mesalazine, which belongs to the group of
intestinal anti-inflammatory medicines.
This medicine is used in adults and children over 2 years of age for the treatment of
ulcerative colitis and Crohn's disease (chronic inflammatory bowel diseases), as well as
inflammatory bowel disease unclassified (IBDU).
The medicine is indicated both for the treatment of active phases of the disease and for the prevention
of relapses. In severe active phases, concomitant use of 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 or kidneys are severely impaired (severe hepatic or renal dysfunction);
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 tendency to develop bleeding (hemorrhagic diathesis);
in children under 2 years of age (see section “Children”);
during the last weeks of pregnancy and while breastfeeding (see section “Pregnancy and breastfeeding”).

INFORM YOUR DOCTOR BEFORE USING mesalazine:

if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking mesalazine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Mesalazina EG.
Before starting treatment with Mesalazina EG, you must undergo the necessary clinical tests to confirm diagnosis and establish appropriate therapeutic indications.
Before starting and during treatment with Mesalazina EG, your doctor will request blood tests, liver enzyme tests (ALT, AST, serum creatinine) and/or urine analyses. Your doctor will determine how often these tests should be repeated.
Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite contained in bleach present in toilet water. This is due to a harmless chemical reaction between mesalazine and bleach.
If you experience severe or recurrent headache, visual disturbances, or ringing or buzzing in the ears, contact your doctor immediately.
Pay special attention and inform your doctor if any of the following apply to you:

if you have kidney disorders. If you have known renal dysfunction, your doctor will carefully evaluate the appropriateness of treatment with mesalazine, as mesalazine may induce kidney toxicity;
if you are taking medicines that may affect kidney function, such as non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, because they may increase the risk of renal reactions. Your doctor will assess kidney function in all patients before starting therapy and periodically during treatment, especially if kidney disease is present. The medicine will be discontinued if renal dysfunction develops during treatment;
if your liver function is impaired or reduced;
if you are taking azathioprine, 6-mercaptopurine or thioguanine, because these medicines may increase the risk of blood dyscrasias (blood disorders). Treatment must be reduced or discontinued if these adverse reactions occur;
if you are taking one or more of the following medicines:
- oral medicines to lower blood sugar levels (oral hypoglycemics),
- medicines to increase urine production (diuretics),
- medicines to prevent blood clotting (coumarins, e.g. warfarin),
- medicines to treat inflammation (corticosteroids);
if you have heart conditions affecting the myocardium or pericardium (myocarditis or pericarditis);
if you have lung disorders (especially asthma);
if you have previously experienced adverse effects with sulfasalazine-containing preparations.

Severe cutaneous adverse 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 mesalazine treatment. Discontinue use of 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 may lead to 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 sufficient fluids during treatment with mesalazine.
Prolonged use of the medicine may cause allergic reactions.
Discontinue treatment (see also section “Possible side effects”):

If, following treatment with Mesalazina EG, you develop bleeding, bruising, red spots on the skin due to leakage from superficial blood vessels (purpura), decreased hemoglobin levels in the blood (anemia), fever, or sore throat.
In case of suspected acute intolerance syndrome, which may present with symptoms such as cramps, acute abdominal pain and bloody diarrhea, sometimes accompanied by 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid concomitant administration of lactulose or other preparations that lower colonic pH, as they may interfere with the release of mesalazine.
Use this medicine with caution together with:

Sulfonylureas (used in the treatment of diabetes), as the hypoglycemic effect (reduction of blood sugar levels) may be enhanced.
Coumarin anticoagulants (used to slow down or inhibit blood clotting, e.g. warfarin).
Methotrexate (a medicine used in patients with psoriasis, Crohn's disease, rheumatoid arthritis, and in the treatment of certain cancers).
Probenecid (a medicine used to reduce blood uric acid levels).
Sulfinpyrazone (a medicine used for prevention following myocardial infarction).
Spironolactone (a potassium-sparing diuretic).
Furosemide (a diuretic medicine that increases urine production, used in cases of fluid retention).
Rifampicin (an antibiotic).
Non-steroidal anti-inflammatory drugs (NSAIDs).
Azathioprine (an anti-inflammatory and immunosuppressive drug).
Medicines used to treat blood cancers (leukemias), such as 6-mercaptopurine or thioguanine.

The use of Mesalazina EG together with corticosteroids may enhance the adverse effects of corticosteroids on the stomach.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If pregnancy is confirmed or suspected, take the medicine only if clearly needed and under strict medical supervision.
Do not take Mesalazina EG during the last weeks of pregnancy and while 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 clearly 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 using machines
Mesalazina EG does not affect or has negligible effect on the ability to drive vehicles or use machinery.
Mesalazina EG modified-release hard capsules contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Mesalazina EG

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will adjust the dosage according to the extent and severity of your condition.
When starting treatment for the first time, it is advisable to gradually increase the dose over a few days before reaching the maximum dosage.
The recommended dose for adults is 1–2 capsules, taken 3 times a day.
In patients with severe disease, the dosage may be increased up to 10 capsules per day, according to the doctor's judgment.

Use in children and adolescents
Children over 2 years of age: 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 appropriate dose on a case-by-case basis. The recommended average dose is 30–50 mg/kg/day given in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total daily dose must not exceed 4 g per day (maximum dose in adults).
Maintenance treatment: the doctor will determine the appropriate dose on a case-by-case basis. The recommended average dose is 15–30 mg/kg/day given in divided doses. The total daily dose must not exceed 2 g per day (recommended dose in adults).

Swallow 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 usual duration of treatment for active phases is 4–6 weeks, but may vary according to the patient's condition and disease progression, at the doctor’s discretion.
For long-term treatment to prevent relapses, the daily dosage and duration of treatment must be determined by the doctor based on the patient's condition and disease progression.

If you take more Mesalazina EG than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take Mesalazina EG
Do not take a double dose to make up for the missed dose. Instead, resume your regular dosing schedule as directed.

If you stop taking Mesalazina EG
After stopping treatment, symptoms may recur (see section “Warnings and precautions”).
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Serious side effects
Contact your doctor immediately

If you experience severe or recurrent headache, visual 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 from available data)]

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

Allergic reactions (skin rash, itching).
Episodes of acute intestinal intolerance with abdominal pain.
Presence of blood in liquid stools (haematochezia).
Cramps.
Headache.
Fever.
Skin rash.
Reddish, flat patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes. These serious skin reactions may be preceded by fever and flu-like symptoms.

The following side effects may occur during treatment with Mesalazina EG:

Common (may affect up to 1 in 10 people):

Headache.
Skin rash.
Nausea.
Diarrhoea.
Abdominal distension.
High blood pressure (hypertension).
Weakness (asthenia).
Fever (pyrexia).

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

Itching (pruritus).
Upper abdominal pain (epigastric pain).
Presence of blood in liquid stools (haematochezia).
Abdominal cramps and pain.
Increased heart rate (tachycardia).
Low blood pressure (hypotension).
Drowsiness.
Tremor.
Fatigue.
Facial swelling (facial oedema).

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

Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).
Dizziness.
Passage 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 (leucopenia, neutropenia, agranulocytosis), decreased number of platelets in the blood (thrombocytopenia), a form of anaemia characterised by insufficient production in the bone marrow of all types of blood cells (aplastic anaemia), decreased number of blood cells (pancytopenia).
Inflammation of the liver (hepatitis, cholestatic hepatitis).
Inflammation of the pancreas (pancreatitis, including acute pancreatitis).
Temporary abnormalities in liver function tests (increased transaminase levels and cholestasis).
Gallstones (cholelithiasis).
Kidney inflammation (acute and chronic interstitial nephritis), kidney and urinary tract disorders (nephrotic syndrome), and reduced kidney function (renal failure).
High fever (hyperpyrexia).
Nerve disease causing abnormalities in sensation and movement, including of internal organs (peripheral neuropathy).
Loss of body and scalp hair (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).

Frequency not known (cannot be estimated from available data):

Swelling of the face, lips and throat due to an allergic reaction (angioedema).
Kidney stones and associated kidney pain (see also section 2).

In addition, the following has been reported:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mesalazina EG contains

The active substance is mesalazine (5-aminosalicylic acid, 5-ASA). One capsule contains 400 mg of mesalazine.
The other components 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 pack sizes
Modified-release hard capsules, carton pack containing 50 capsules of 400 mg.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan
Selling License Holder
S.F. Group S.r.l., Via Tiburtina, 1143 – 00156 Rome
Manufacturer
Sirton Pharmaceuticals S.P.A. - Piazza XX Settembre 2 - Villa Guardia (CO)

Package leaflet: information for the patient

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

Equivalent medicine
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Mesalazina EG is and what it is used for
What you need to know before using Mesalazina EG
How to use Mesalazina EG
Possible side effects
How to store Mesalazina EG
Package contents and other information

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

Mesalazina EG contains the active substance mesalazine, which belongs to the class of intestinal anti-inflammatory medicines.
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 lower parts of the intestine) localized at the recto-sigmoid level.
The medicine is indicated both for the treatment of active phases of the disease and for the prevention of relapses. In severe active phases, concomitant use with a corticosteroid medicine is recommended.
If you do not feel better or feel worse after the prescribed treatment period, consult your doctor.

2. What you should 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), particularly to metabisulphites;
if your liver or kidneys are severely impaired (severe hepatic or renal dysfunction);
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 are predisposed to bleeding (haemorrhagic diathesis);
in children under 2 years of age (see section “Children”);
during the last weeks of pregnancy and while breastfeeding (see section “Pregnancy and breastfeeding”).

INFORM YOUR DOCTOR BEFORE USING mesalazine:

if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking mesalazine.

Warnings and precautions
Talk to your doctor or pharmacist before using Mesalazina EG.
Before starting treatment with Mesalazina EG, appropriate clinical investigations must be carried out to confirm the diagnosis and establish therapeutic indications.
Before starting and during treatment with Mesalazina EG, your doctor will ask you to undergo blood tests, liver enzyme tests (ALT, AST, serum creatinine) and/or urine analysis. Your doctor will decide how often these tests should be repeated.
Mesalazine may cause a red-brown discoloration of urine after contact with sodium hypochlorite contained in bleach present in toilet water. This is due to a harmless chemical reaction between mesalazine and bleach.
If you experience severe or recurrent headache, visual disturbances, ringing or buzzing in the ears, contact your doctor immediately.
Pay special attention and inform your doctor if any of the following apply to you:

if you have kidney disorders. If you have known renal dysfunction, your doctor will carefully evaluate whether treatment with mesalazine is appropriate, as mesalazine may induce renal toxicity;
if you are taking medicines that may affect kidney function, such as non-steroidal anti-inflammatory drugs (NSAIDs) and azathioprine, because they may increase the risk of renal reactions. Your doctor will assess kidney function in all patients before starting therapy and periodically during treatment, especially if kidney disease is present. The medicine will be discontinued if renal dysfunction develops during treatment;
if your liver function is impaired or reduced;
if you are taking azathioprine or 6-mercaptopurine or thioguanine, as these medicines may increase the risk of blood dyscrasias (blood disorders). Treatment should be reduced or stopped if such adverse reactions occur;
if you are taking one or more of the following medicines:
- medicines to lower blood sugar levels (oral hypoglycaemics),
- medicines to increase urine production (diuretics),
- medicines to prevent blood clotting (coumarins, e.g. warfarin),
- medicines to treat inflammation (corticosteroids);
if you have heart conditions affecting the myocardium or pericardium (myocarditis or pericarditis);
if you suffer from lung disorders (particularly asthma);
if you have previously experienced adverse effects with sulfasalazine-containing preparations.

Serious cutaneous adverse 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 mesalazine treatment. Stop using mesalazine and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
The use of mesalazine may lead to 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 sufficient fluids during treatment with mesalazine.
Prolonged use of the medicine may cause allergic phenomena.
Discontinue treatment (see also section “Possible side effects”):

if, following treatment with Mesalazina EG, you develop bleeding, bruising, red spots on the skin due to leakage from superficial blood vessels (purpura), decreased haemoglobin levels in the blood (anaemia), fever or sore throat;
in case of suspected acute intolerance syndrome, which may present with symptoms such as cramps, acute abdominal pain and bloody diarrhoea, sometimes accompanied by 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
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Use this medicine with caution if taking:

Sulphonamides (used in the treatment of diabetes), as their hypoglycaemic effect (reduction of blood sugar levels) may be enhanced.
Coumarin derivatives (used to slow down or inhibit blood clotting, e.g. warfarin).
Methotrexate (a medicine used in patients with psoriasis, Crohn's disease, rheumatoid arthritis and in the treatment of certain cancers).
Probenecid (a medicine used to reduce uric acid concentration in blood).
Sulfinpyrazone (a medicine used for prevention following myocardial infarction).
Spironolactone (a potassium-sparing diuretic).
Furosemide (a diuretic medicine that increases urine production, used in cases of fluid retention).
Rifampicin (an antibiotic).
Non-steroidal anti-inflammatory drugs (NSAIDs).
Azathioprine (an anti-inflammatory and immunosuppressive medicine).
Medicines used to treat blood cancers (leukaemias), such as 6-mercaptopurine or thioguanine.

The use of Mesalazina EG together with corticosteroids may enhance the undesirable effects of corticosteroids on the stomach.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If pregnancy is confirmed or suspected, use this medicine only if clearly needed and under strict medical supervision. Do not use Mesalazina EG during the last weeks of pregnancy and while 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 clearly necessary and under strict medical supervision.
Allergic reactions such as diarrhoea in infants cannot be ruled out.
If the infant develops diarrhoea, discontinue breastfeeding.

Driving and using machines
Mesalazina EG does not affect or has negligible influence on the ability to drive vehicles or operate machinery.
Mesalazina EG rectal gel contains sodium metabisulphite
Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

3. How to use Mesalazina EG

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended average dose is: one single-dose container of 2 g, 1–2 times daily, in the morning and/or in the evening before going to bed, or one single-dose container of 4 g, once daily in the evening before going to bed.

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

Instructions for administration of the rectal gel

To use the single-dose container, attach the rectal cannula and hold the container in your right hand, placing your index finger over the cap of the delivery 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 down with your index finger on the cap of the delivery valve, without removing the cannula, until the container is completely emptied.

After administration, turn several times from one side to the other to help ensure better distribution of the medicine, and remain lying down for at least 30 minutes.

Optimal effectiveness is achieved by retaining the medication as long as possible, preferably leaving it in place overnight. Therefore, it is advisable that at least one daily application be performed before going to bed.

The duration of treatment for active phases is typically 4–6 weeks, but may vary according to the patient's condition and disease progression, as determined by the physician.

For long-term treatment to prevent relapses, the daily dosage and duration of therapy must be determined by the physician based on the patient's condition and disease progression.

If you use more Mesalazina EG than you should

No cases of overdose following rectal administration have been reported.

If you forget to use Mesalazina EG

Do not use a double dose to make up for the missed dose. Resume your regular dosing schedule as indicated.

If you stop using Mesalazina EG

After stopping treatment, symptoms may recur (see section "Warnings and precautions").

If you have any questions 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.

Serious side effects
Inform your doctor immediately

If you experience severe or recurring 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 from available data)]

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

Allergic reactions (skin rash, itching).
Episodes of acute intestinal intolerance with abdominal pain.
Presence of blood in liquid stools (bloody diarrhoea).
Cramps.
Headache.
Fever.
Skin rash.
Red, flat spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes. These serious skin reactions may be preceded by fever and flu-like symptoms.

The following side effects may occur during treatment with Mesalazina EG:

Common (may affect up to 1 in 10 people):

Headache.
Skin rash.
Nausea.
Diarrhoea.
Abdominal distension.
High blood pressure (hypertension).
Weakness (asthenia).
Fever (pyrexia).

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

Itching.
Upper abdominal pain (epigastric pain).
Presence of blood in liquid stools (bloody diarrhoea).
Cramps and abdominal pain.
Increased heart rate (tachycardia).
Low blood pressure (hypotension).
Drowsiness.
Tremor.
Fatigue.
Facial swelling (facial oedema).

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

Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity).
Dizziness.
Passage 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-like 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 (leucopenia, neutropenia, agranulocytosis), decreased number of platelets in the blood (thrombocytopenia), a form of anaemia characterised by insufficient production in the bone marrow of all types of blood cells (aplastic anaemia), decreased number of blood cells (pancytopenia).
Inflammation of the liver (hepatitis, cholestatic hepatitis).
Inflammation of the pancreas (pancreatitis, including acute pancreatitis).
Temporary abnormalities in liver function tests (increased transaminase levels and cholestasis).
Gallstones (cholelithiasis).
Kidney inflammation (acute and chronic interstitial nephritis), kidney and urinary tract disease (nephrotic syndrome), and reduced kidney function (renal failure).
High fever (hyperpyrexia).
Nerve disease causing sensory and motor disturbances, including internal organs (peripheral neuropathy).
Loss of hair and body hair (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 from available data):

Swelling of the face, lips and throat due to an allergic reaction (angioedema).
Kidney stones and associated kidney pain (see also section 2).

In addition, the following has been reported:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Pressurised container. Store below 50°C and do not expose to direct sunlight.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mesalazina EG contains

The active substance is mesalazine (5-aminosalicylic acid, 5-ASA). 60 ml of gel contain 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 components 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 package contents
Mesalazina EG is a rectal gel.
Carton pack containing 7 single-dose containers with 2 g or 4 g of mesalazine in 60 ml of gel, with an applicator for rectal administration.

Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan
Marketing Authorization Holder and 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)