Mesalazine Sandoz

Patient Information Leaflet

Mesalazina Sandoz 500 mg enteric-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before you start taking 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Mesalazina Sandoz is a medicinal product containing mesalazine as the active substance, which belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Mesalazina Sandoz is indicated for the treatment of intestinal inflammations (ulcerative colitis, Crohn's disease) and for the prevention of relapses.
In more severe cases, your doctor may advise you to take cortisone together with mesalazine.

2. What you should know before taking Mesalazina Sandoz

Do not take Mesalazina Sandoz

• if you are allergic to mesalazine, to any medicine belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver problems;
• if you have ulcers or other lesions in the stomach or intestine;
• if you have a tendency to bleed (haemorrhagic diathesis);
• if you have severe kidney disease;
• if you are in the last weeks of pregnancy (see section “Pregnancy and breastfeeding”);
• if the child is under 2 years of age (see section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Mesalazina Sandoz.
Pay special attention and consult your doctor if:

• you suffer from conditions that predispose you to inflammation of the heart muscle (myocarditis) or of the membrane surrounding the heart muscle (pericarditis), as rare hypersensitivity reactions affecting the heart (myocarditis and pericarditis) have been reported with mesalazine, including Mesalazina Sandoz and other medicines containing mesalazine. If you suspect such a hypersensitivity reaction,

discontinue treatment immediately and permanently avoid medicines containing
mesalazine.

• you are allergic to sulfasalazine, due to a potential risk of cross-sensitivity reactions between sulfasalazine and mesalazine. Patients with a history of adverse reactions to sulfasalazine-containing preparations must be closely monitored by a physician at the beginning of treatment with Mesalazina Sandoz, as the medicine may cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, bloody diarrhoea, fever, severe headache, and skin rashes. In such cases, discontinue treatment immediately.
• you have liver problems, as increased liver enzyme levels have been reported in patients treated with mesalazine-containing preparations. Before starting treatment, your doctor may wish to perform blood tests, including tests to assess liver enzyme levels (GOT, GPT), serum creatinine, and/or urine analysis. Your doctor will decide how often these tests should be repeated.
• you have kidney problems. If renal function becomes impaired during treatment, mesalazine-induced kidney damage should be considered. Consult your doctor for assessment of kidney function before starting therapy, and at least twice a year during treatment. If you have kidney problems, regular medical check-ups are necessary, as mesalazine may affect kidney function.
• you have unusually slow gastric digestion or a narrowing of the opening between the stomach and intestine (pyloric stenosis), as the medicine may cause gastric irritation and may lose its effectiveness. Symptoms of the disease may reappear either after stopping treatment with Mesalazina Sandoz or during inadequate maintenance therapy.
• you suffer from lung diseases, particularly asthma; in this case, you must be carefully monitored during treatment with Mesalazina Sandoz, as there is a risk of developing sensitisation reactions. Prolonged use of the medicine may lead to allergic phenomena.
• you develop unexplained bleeding, blood collections in tissues (haematomas), reddish spots on the skin (purpura), reduced haemoglobin levels in the blood (anaemia), fever, or sore throat, as rare cases of serious blood disorders have been reported following treatment with mesalazine. If such a disorder is suspected, treatment must be discontinued and comprehensive blood tests performed.
• during treatment you experience cramps, acute abdominal pain and bloody diarrhoea, fever, headache, or erythema, as mesalazine has been associated with an acute intolerance syndrome, which is difficult to distinguish from a relapse of chronic inflammatory bowel disease. In case of suspected acute intolerance syndrome, discontinue treatment immediately and permanently avoid products containing mesalazine.
• if you have ever developed a severe skin rash, skin exfoliation, blisters, and/or mouth ulcers after using mesalazine.

If you experience severe or recurrent headache, visual disturbances, ringing or buzzing in the ears, contact your doctor immediately.
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.
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.
Serious skin 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 serious skin reactions described in section 4.
Children
Do not use Mesalazina Sandoz in children under 6 years of age (see “Do not take Mesalazina Sandoz”).
Other medicines and Mesalazina Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay special attention and inform your doctor if you are taking:

• medicines that lower blood sugar levels (oral hypoglycaemics or sulfonylureas);
• a medicine used to treat certain cancers and autoimmune diseases (methotrexate);
• medicines used to lower uric acid levels in the blood (probenecid);
• medicines used to treat blood circulation disorders (sulfinpyrazone);
• medicines used to increase urine production (diuretics such as spironolactone or furosemide);
• a medicine used to treat infections (rifampicin);
• medicines used for inflammation (corticosteroids);
• medicines for blood clotting disorders (anticoagulants) such as coumarins, particularly warfarin;
• medicines used for constipation (lactulose);
• medicines used to treat inflammation and pain, known as non-steroidal anti-inflammatory drugs (NSAIDs);
• medicines used for immune system disorders (azathioprine or 6-mercaptopurine).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Mesalazina Sandoz during the last weeks of pregnancy.
During the first trimester of pregnancy, take Mesalazina Sandoz only if clearly needed and under direct medical supervision.
Breastfeeding
Mesalazine is excreted in breast milk. During breastfeeding, take Mesalazina Sandoz only if clearly needed and under direct medical supervision.
If the infant develops diarrhoea, discontinue breastfeeding.
Driving and using machines
Mesalazina Sandoz does not affect the ability to drive or use machinery.
Mesalazina Sandoz 500 mg tablets contain lactose and sodium
This medicine contains 1 g of lactose per tablet. If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor 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 Sandoz

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by the doctor, the recommended dose is 1 tablet, three times daily.
For severe cases, the doctor may increase the dose up to 8 tablets per day.
Take the tablets with a generous amount of liquid, before meals.

If you take more Mesalazina Sandoz than you should
In case of accidental ingestion/overdose of Mesalazina Sandoz, contact your doctor immediately or go to the nearest hospital emergency department.
Mesalazina Sandoz contains an aminosalicylate, and symptoms of salicylate toxicity include:

• ringing or buzzing in the ear (tinnitus);
• dizziness;
• headache (cephalalgia);
• confusion;
• drowsiness;
• fluid accumulation in the lungs (pulmonary edema);
• dehydration due to sweating;
• diarrhea;
• vomiting;
• reduction in blood sugar levels (hypoglycemia);
• increased respiratory rate (hyperventilation);
• disturbances in blood electrolyte balance and pH;
• increased body temperature (hyperthermia).

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

Common (may affect up to 1 in 10 people)

• headache (cephalaea);
• increased blood pressure (hypertension);
• abdominal distension;
• indigestion (dyspepsia);
• diarrhoea;
• skin lesions (rashes);
• back pain;
• weakness (asthenia);
• fever (pyrexia).

Uncommon (may affect up to 1 in 100 people)

• drowsiness;
• tremors;
• ear pain (otalgia);
• increased heart rate (tachycardia);
• reduced blood pressure (hypotension);
• sore throat;
• inflammation of the colon (colitis) or pancreas (pancreatitis);
• rectal mucosal growths (rectal polyps);
• abdominal pain;
• skin inflammation with pimple development (acne);
• sudden appearance of skin rash (urticaria);
• itching (pruritus);
• fatigue;
• swelling (oedema) of the face.

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

• dizziness;
• abdominal pain;
• diarrhoea;
• presence of gas in the intestine (flatulence);
• nausea;
• vomiting;
• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).

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

• blood disorders: reduction in the number of red blood cells, white blood cells and platelets (aplastic anaemia), reduction in the number of white blood cells (agranulocytosis, neutropenia, leucopenia), reduction in the number of all blood cells (pancytopenia), reduction in the number of platelets (thrombocytopenia);
• hypersensitivity reactions such as: skin eruption with pustules, blisters and bullae (allergic exanthema); drug fever; autoimmune disease affecting the immune defence system (systemic lupus erythematosus); inflammation of the colon (pancolitis);
• damage to the peripheral nervous system manifesting as numbness or weakness in arms and legs (peripheral neuropathy);
• inflammation of the heart muscle (myocarditis) or of the membrane surrounding the heart muscle (pericarditis);
• allergic and fibrotic lung reactions: difficulty in breathing (dyspnoea), cough, narrowing of the bronchi (bronchospasm), inflammation of the lung alveoli (alveolitis), lung inflammation associated with an increase in a type of white blood cells called eosinophils (pulmonary eosinophilia), lung inflammation (pulmonary infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, acute pancreatitis);
• impaired kidney function, including acute and chronic kidney inflammation (interstitial nephritis) and reduced kidney function (renal failure);
• a group of symptoms characterised by severe kidney dysfunction (nephrotic syndrome);
• loss of hair and body hair (alopecia);
• muscle pain (myalgia) and joint pain (arthralgia);
• changes in certain liver parameters (increase in transaminase levels and cholestasis);
• inflammation of the liver (hepatitis);
• liver inflammation caused by blockage of bile excretion (cholestatic hepatitis);
• formation of stones within the biliary system (cholelithiasis);
• reduction in the number of sperm in the ejaculate (oligospermia), reversible.

Not known (frequency cannot be established from the available data)

• swelling of the skin of the face and mucous membranes (angioedema);
• reactions similar to systemic lupus erythematosus, an autoimmune disease affecting the natural defence system (lupus-like syndrome);
• kidney stones and associated kidney pain (see also section 2).

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 (frequency cannot be established from
the available data)].

Stop treatment with mesalazine and contact your doctor immediately if you notice any of the
following symptoms:

• flat, red, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread rash, fever and swollen lymph nodes. These serious skin rashes may be preceded by fever and flu-like symptoms.

Adverse reactions common to salicylates, including hypersensitivity reactions, may occur, although rarely. If such reactions occur, treatment must be stopped immediately.
Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including ones 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 Sandoz

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.
Store below 30°C.
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 Sandoz contains

• The active substance is mesalazine (5-aminosalicylic acid). One coated tablet contains 500 mg of mesalazine.
• The other ingredients are: triethyl citrate, type B methacrylic acid copolymer, yellow iron oxide (E 172), red iron oxide (E 172), lactose, magnesium stearate, polyvinylpyrrolidone, sodium carboxymethyl starch, polysorbate 80, talc, titanium dioxide.

Description of the appearance of Mesalazina Sandoz and package contents
Coated tablets, 50 coated tablets of 500 mg.
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (Frosinone)
Package leaflet: information for the patient
Mesalazina Sandoz 2 g rectal suspension
Mesalazina Sandoz 4 g rectal suspension
Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as 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:

1. What Mesalazina Sandoz is and what it is used for
2. What you need to know before using Mesalazina Sandoz
3. How to use Mesalazina Sandoz
4. Possible side effects
5. How to store Mesalazina Sandoz
6. Package contents and other information

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

Mesalazina Sandoz is a medicine containing mesalazine as the active substance, which belongs to the class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Mesalazina Sandoz is indicated for the treatment of inflammation of the intestine (ulcerative colitis localized in the rectal region) and for the prevention of relapses.
In some more severe cases, your doctor may advise you to take cortisone together with mesalazine.

2. What you need to know before using Mesalazina Sandoz

Do not use Mesalazina Sandoz

• if you are allergic to mesalazine, to any medicine belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver problems;
• if you have stomach or intestinal ulcers (lesions);
• if you have a tendency to bleeding (haemorrhagic diathesis);
• if you have severe kidney disease;
• if you are in the last weeks of pregnancy (see section “Pregnancy and breastfeeding”);
• if the child is under 2 years of age (see section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before using Mesalazina Sandoz.
Pay special attention and consult your doctor if:

• you suffer from conditions that predispose you to inflammation of the heart muscle (myocarditis) or of the membrane surrounding the heart muscle (pericarditis), as rare cases of cardiac hypersensitivity reactions induced by mesalazine (myocarditis and pericarditis) have been reported with Mesalazina Sandoz and other medicines containing mesalazine. If you suspect such a hypersensitivity reaction, stop treatment immediately and permanently avoid medicines containing mesalazine.
• you are allergic to sulfasalazine, due to a potential risk of cross-sensitivity reactions between sulfasalazine and mesalazine. Patients with a history of adverse reactions to sulfasalazine-containing products should be closely monitored by a physician at the beginning of treatment with Mesalazina Sandoz, as the medicine may cause acute intolerance reactions such as abdominal cramps, acute abdominal pain, bloody diarrhoea, fever, severe headache, and skin rashes. In this case, stop treatment immediately.
• you have liver problems, as increased levels of liver enzymes have been reported in patients treated with mesalazine-containing formulations. Before starting treatment, your doctor may wish to perform blood tests, liver enzyme tests (GOT, GPT), serum creatinine, and/or urine analysis. Your doctor will decide how often these tests should be repeated.
• you have kidney problems. If renal function impairment occurs during treatment, mesalazine-induced kidney damage should be considered. Consult your doctor for assessment of kidney function before starting therapy, and at least twice a year during treatment. If you have kidney problems, regular medical check-ups are necessary, as mesalazine may affect kidney function.
• you suffer from lung diseases, particularly asthma; in this case, you should be carefully monitored during treatment with Mesalazina Sandoz, as there is a risk of developing sensitization reactions. Prolonged use of the medicine may lead to allergic phenomena.
• you develop unexplained bleeding, blood collections in tissues (haematomas), reddish skin spots (purpura), reduced haemoglobin levels in the blood (anaemia), fever, or sore throat, as rare cases of serious blood disorders have been reported following treatment with mesalazine. If such a disorder is suspected, treatment must be stopped and comprehensive blood tests performed.
• during treatment you experience cramps, acute abdominal pain and bloody diarrhoea, fever, headache, or erythema, as mesalazine has been associated with an acute intolerance syndrome that is difficult to distinguish from a relapse of chronic inflammatory bowel disease. In case of suspected acute intolerance syndrome, stop treatment immediately and permanently avoid products containing mesalazine.
• you have previously developed a severe skin rash or skin exfoliation, blisters and/or mouth ulcers after taking mesalazine.

If you experience severe or recurrent headache, vision disturbances, ringing or buzzing in the ears, contact your doctor immediately.
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.
Serious skin adverse reactions have been reported with mesalazine treatment, 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 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.

Children
Do not use Mesalazina Sandoz in children under 2 years of age (see “Do not use Mesalazina Sandoz”).

Other medicines and Mesalazina Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking:

• medicines that lower blood sugar levels (oral hypoglycaemics or sulfonylureas);
• a medicine used to treat certain cancers and autoimmune diseases (methotrexate);
• medicines used to lower uric acid levels in the blood (probenecid);
• medicines used to treat blood circulation disorders (sulfinpyrazone);
• medicines used to increase urine production (diuretics such as spironolactone or furosemide);
• a medicine used to treat infections (rifampicin);
• medicines used for inflammation (corticosteroids);
• medicines for blood clotting disorders (anticoagulants) such as coumarins, especially warfarin;
• medicines used to treat inflammation and pain, known as non-steroidal anti-inflammatory drugs (NSAIDs);
• medicines used for immune system disorders (azathioprine or 6-mercaptopurine).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take Mesalazina Sandoz during the last weeks of pregnancy.
During the first part of pregnancy, take Mesalazina Sandoz only if clearly needed and under direct medical supervision.
Breastfeeding
Mesalazine is excreted in breast milk. During breastfeeding, take Mesalazina Sandoz only if clearly needed and under direct medical supervision.
If the infant develops diarrhoea, stop breastfeeding.

Driving and using machines
Mesalazina Sandoz does not impair the ability to drive or operate machinery.

Mesalazina Sandoz 2 g rectal suspension contains in a single-dose container:

• 0.1405 g of potassium metabisulphite, which rarely may cause severe hypersensitivity reactions and bronchospasm.
• 0.030 g of sodium benzoate, which may increase jaundice (yellowing of the skin and eyes) in neonates (up to 4 weeks of age).
• less than 1 mmol (23 mg) of sodium per suppository, i.e. essentially “sodium-free”.

Mesalazina Sandoz 4 g rectal suspension contains in a single-dose container:

• 0.281 g of potassium metabisulphite, which rarely may cause severe hypersensitivity reactions and bronchospasm.
• 0.060 g of sodium benzoate, which may increase jaundice (yellowing of the skin and eyes) in neonates (up to 4 weeks of age).
• less than 1 mmol (23 mg) of sodium per suppository, i.e. essentially “sodium-free”.

3. How to use Mesalazina Sandoz

Use this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is 1 single-dose container of 4 g once
daily, or 1 single-dose container of 2 g twice daily.
Instructions for administration of the rectal suspension:
Shake well before use to obtain a homogeneous suspension. To administer the single-dose container, follow these instructions:

• Lie on your left side, keeping your left leg straight and bending your right leg;
• Gently insert the cannula into the anal opening and squeeze the container gradually and steadily until completely emptied;
• Turn from side to side several times to help distribute the medicine and remain lying down for at least half an hour;
• To achieve optimal effectiveness, retain the medication as long as possible, preferably overnight.

If you use more Mesalazina Sandoz than you should
In case of accidental ingestion/overdose of Mesalazina Sandoz, contact your doctor immediately or go to the nearest hospital emergency department.
Mesalazina Sandoz contains an aminosalicylate, and symptoms of salicylate toxicity include:

• ringing or buzzing in the ear (tinnitus);
• dizziness;
• headache;
• confusion;
• drowsiness;
• fluid accumulation in the lungs (pulmonary edema);
• dehydration due to sweating;
• diarrhea;
• vomiting;
• reduction in blood sugar levels (hypoglycemia);
• increased respiratory rate (hyperventilation);
• disturbance in the balance of salts and pH in the blood;
• increased body temperature (hyperthermia).

If you forget to use Mesalazina Sandoz
Do not use a double dose to make up for the missed dose.
If you have any doubts 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 everybody gets them.

Common (may affect up to 1 in 10 people)

• headache (cephalaea);
• increased blood pressure (hypertension);
• abdominal distension;
• indigestion (dyspepsia);
• diarrhoea;
• skin lesions (rashes);
• back pain;
• weakness (asthenia);
• fever (pyrexia).

Uncommon (may affect up to 1 in 100 people)

• drowsiness;
• tremor;
• ear pain (otalgia);
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• sore throat;
• inflammation of the colon (colitis) or of the pancreas (pancreatitis);
• rectal mucosal growths (rectal polyps);
• abdominal pain;
• skin inflammation with pimple development (acne);
• sudden onset of skin rash (urticaria);
• itching (pruritus);
• fatigue;
• swelling (oedema) of the face.

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

• dizziness;
• abdominal pain;
• diarrhoea;
• presence of gas in the intestine (flatulence);
• nausea;
• vomiting;
• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity).

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

• blood disorders: reduced number of red blood cells, white blood cells and platelets (aplastic anaemia), reduced number of white blood cells (agranulocytosis, neutropenia, leucopenia), reduced number of all blood cells (pancytopenia), reduced number of platelets (thrombocytopenia);
• hypersensitivity reactions such as: skin rash with pustules, blisters and bullae (allergic exanthema); drug fever; autoimmune disease affecting the immune defence system (systemic lupus erythematosus); inflammation of the colon (pancolitis);
• peripheral nervous system damage presenting as numbness or weakness in arms and legs (peripheral neuropathy);
• inflammation of the heart muscle (myocarditis) or of the membrane surrounding the heart muscle (pericarditis);
• allergic and fibrotic lung reactions: difficulty in breathing (dyspnoea), cough, narrowing of the bronchi (bronchospasm), inflammation of lung alveoli (alveolitis), lung inflammation associated with increased levels of a type of white blood cells called eosinophils (pulmonary eosinophilia), lung inflammation (pulmonary infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, acute pancreatitis);
• impaired kidney function, including acute and chronic kidney inflammation (interstitial nephritis) and reduced kidney function (renal failure);
• a group of symptoms characterised by severe kidney dysfunction (nephrotic syndrome);
• loss of body and scalp hair (alopecia);
• muscle pain (myalgia) and joint pain (arthralgia);
• changes in certain liver parameters (increased transaminase levels and cholestasis);
• liver inflammation (hepatitis);
• liver inflammation caused by blockage of bile excretion (cholestatic hepatitis);
• formation of gallstones within the biliary system (cholelithiasis);
• reduced number of spermatozoa in the ejaculate (oligospermia), reversible.

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

• swelling of the skin of the face and mucous membranes (angioedema);
• lupus erythematosus-like reactions, an autoimmune disease affecting the natural defence system (lupus-like syndrome);
• kidney stones and associated kidney pain (see also section 2);

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 (frequency cannot be estimated from the available data)].

Stop treatment with mesalazine and contact your doctor immediately if you notice any of the following symptoms:

• flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, widespread skin rash, fever and swollen lymph nodes. These serious skin rashes may be preceded by fever and flu-like symptoms.

Adverse effects common to salicylates, including hypersensitivity reactions, may occur, although rarely. If such reactions occur, treatment must be immediately discontinued.

Following the instructions provided in the leaflet reduces the risk of adverse effects.

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 Sandoz

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.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Mesalazina Sandoz contains
Mesalazina Sandoz 2 g rectal suspension

• The active substance is mesalazine. One single-dose container of 30 g contains 2 g of mesalazine (5-aminosalicylic acid).
• The other components are: purified water, carbopolymethylene, disodium edetate dihydrate, xanthan gum, potassium acetate, potassium metabisulfite, sodium benzoate.

Mesalazina Sandoz 4 g rectal suspension

• The active substance is mesalazine. One single-dose container of 60 g contains 4 g of mesalazine (5-aminosalicylic acid).
• The other components are: purified water, carbopolymethylene, disodium edetate dihydrate, xanthan gum, potassium acetate, potassium metabisulfite, sodium benzoate.

Description of the appearance of Mesalazina Sandoz and package contents
Rectal suspension, 7 single-dose containers of 2 g in 30 g + 7 disposable cannulas.
Rectal suspension, 7 single-dose containers of 4 g in 60 g + 7 disposable cannulas.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (Frosinone)