MESALAZINA 400 mg Enteric-Coated Tablet

Зміст інструкції

1. MESALAZINA DOC 400 mg gastro-resistant tablets, 800 mg gastro-resistant tablets
   1. What is MESALAZINA DOC and what is it used for
   2. What you need to know before you take MESALAZINA DOC
   3. How to take MESALAZINA DOC
   4. Possible side effects
   5. How to store MESALAZINA DOC
   6. Contents of the pack and other information
2. MESALAZINA DOC 2 g/50 ml rectal suspension
   1. What is MESALAZINA DOC and what is it used for
   2. What you need to know before you use MESALAZINA DOC
   3. How to use MESALAZINA DOC
   4. Possible side effects
   5. How to store MESALAZINA DOC
   6. Contents of the pack and other information
3. MESALAZINA DOC 500 mg suppositories
   1. What is MESALAZINA DOC and what is it used for?
   2. What you need to know before using MESALAZINA DOC
   3. How to use MESALAZINA DOC
   4. Possible side effects
   5. How to store MESALAZINA DOC
   6. Contents of the pack and other information
4. MESALAZINA DOC 1200 mg gastro-resistant tablets
   1. What is MESALAZINA DOC and what is it used for
   2. What you need to know before you take MESALAZINA DOC
   3. How to take MESALAZINA DOC
   4. Possible side effects
   5. How to store MESALAZINA DOC
   6. Contents of the pack and other information

MESALAZINA DOC 400 mg gastro-resistant tablets, 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 DOC is and what it is used for
• 2. What you need to know before you take MESALAZINA DOC
• 3. How to take MESALAZINA DOC
• 4. Possible side effects
• 5. How to store MESALAZINA DOC
• 6. Contents of the pack and other information

1. What is MESALAZINA DOC and what is it used for

MESALAZINA DOC contains the active ingredient mesalazine used to treat inflammatory bowel diseases.
MESALAZINA DOC is used for the treatment of ulcerative colitis and Crohn's disease (long-lasting inflammatory bowel diseases).
This medicine is indicated both in the treatment of the ongoing disease and in the prevention of relapses.

2. What you need to know before you take MESALAZINA DOC

Do not take MESALAZINA DOC

• if you are allergic to mesalazine, to substances closely related chemically, to salicylates or to any of the other components of this medicine (listed in section 6);
• if you have severe kidney problems (severe impairment of renal function, severe nephropathies);
• if you have severe liver problems (severe impairment of hepatic function);
• if you have active lesions of the stomach or the first part of the intestine (peptic ulcer);
• if you have a predisposition to bleeding from blood vessels (haemorrhagic diathesis);
• if you are in the last weeks of pregnancy or if you are breastfeeding (see “Pregnancy and breastfeeding”);
• in children under the age of 6 years.

Warnings and precautions
Talk to your doctor or pharmacist before taking MESALAZINA DOC.
Prolonged use of the medicine may lead to allergic reactions.
Before starting treatment, you must perform clinical investigations necessary to define the diagnosis and therapeutic indications.
Tell 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.

Pay particular attention and talk to your doctor:

• if you have exceptionally slow gastric digestion or have a narrowing of the opening between the stomach and the intestine (pyloric stenosis), as the medicine may cause gastric irritation and may lose its effectiveness;
• if you have liver problems;
• if you have or have had kidney problems. The doctor may decide to have you undergo kidney function tests;
• if you are being treated with one or more of the following medicines: or medicines that lower blood sugar levels (oral hypoglycaemics), or medicines that increase urine production (diuretics), or medicines for blood coagulation disorders (coumarins, e.g. warfarin), or medicines to treat inflammation (corticosteroids) (see “Other medicines and MESALAZINA DOC”);
• if you have lung problems (particularly asthma);
• if you have had adverse effects to preparations containing sulfasalazine in the past (see section 4).

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, 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 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 fluids during treatment with mesalazine.
Following treatment with mesalazine, you may develop some problems (e.g. bruising, unexplained bleeding, anaemia), fever and sore throat. In this case, the doctor will subject you to blood tests and, if necessary, will tell you to stop treatment.
Before starting treatment, your doctor may want to perform blood tests, tests to assess liver enzyme levels (ALT, AST, serum creatinine) and/or urine tests. Your doctor will decide how often to repeat these tests.
A relapse of the disease may occur both after stopping treatment and during inadequate maintenance treatment.
Prolonged use of the medicine may lead to sensitization. The eventual occurrence of allergic reactions requires immediate discontinuation of treatment.

Children and adolescents
Do not use MESALAZINA DOC gastro-resistant tablets in children under the age of 6 years (see “Do not take MESALAZINA DOC”).

Other medicines and MESALAZINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pay particular attention and tell your doctor if you are taking:

• lactulose or other medicines that lower the pH of the colon, as they may slow down the absorption of mesalazine;
• medicines that lower blood sugar levels, such as sulfonylureas;
• methotrexate, a medicine used to treat some cancers and some autoimmune diseases;
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukaemias);
• azathioprine, a medicine used to treat diseases of the immune system;
• probenecid or sulfinpyrazone, medicines used to lower uric acid levels in the blood;
• spironolactone or furosemide, medicines used to increase urine production (diuretics);
• rifampicin, an antibiotic;
• corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for inflammation;
• coumarins (e.g. warfarin), medicines for blood coagulation disorders (anticoagulants).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take MESALAZINA DOC during pregnancy unless strictly necessary. The use of MESALAZINA DOC is contraindicated in the last weeks of pregnancy (see “Do not take MESALAZINA DOC”).
Mesalazine is present in breast milk. Therefore, take MESALAZINA DOC only if absolutely necessary and under the direct supervision of your doctor. If the baby has diarrhoea, stop breastfeeding (see “Do not take MESALAZINA DOC”).

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

MESALAZINA DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant tablet, i.e. it is essentially ‘sodium-free’.

3. How to take MESALAZINA DOC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will tell you what the recommended dose suitable for you is.

Adults:
The recommended dose is 1-2 tablets of 400 mg or 1 of 800 mg, three times a day.
For severe forms, the doctor may increase the dose up to 10 tablets of 400 mg or 5 tablets of
800 mg per day.
In case of first-time treatment, it is advisable to reach the full dose after a few days of treatment,
gradually increasing the dosage.
Use in children and adolescents
Do not use MESALAZINA DOC gastro-resistant tablets in children under 6 years of age (see the
section “Do not take MESALAZINA DOC”).
The doses must be proportionally reduced at the doctor's discretion.
Swallow the tablets whole (without breaking or chewing them), preferably with a glass of water,
away from meals.
The duration of treatment, in the current disease, is 6-12 weeks and may vary, at the doctor's discretion, in
relation to the evolution of the disease.

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

If you forget to take MESALAZINA DOC
Do not take a double dose to compensate for a missed dose and resume the normal dosage of
intake as indicated by your doctor.
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.
Stop treatment with mesalazine and contact your doctor immediately if you experience any of the
following symptoms:

• reddish, non-raised patches on the trunk, target-shaped or circular, often with central blisters, skin exfoliation, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms;
• allergic reactions, with symptoms such as cramps and abdominal pain, bloody diarrhea, fever, severe headache and rash.

The possible side effects are listed below according to frequency:

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

• nausea;
• diarrhea;
• tense abdomen;
• skin lesions (rashes);
• headache;
• high blood pressure (hypertension);
• weakness (asthenia);
• fever (pyrexia).

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

• abdominal pain;
• passing gas from the intestines (flatulence);
• vomiting;
• itching;
• drowsiness;
• tremors;
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• fatigue;
• facial swelling.

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

• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity);
• dizziness;
• nerve disease causing abnormalities of sensation and movement, including internal organs (peripheral neuropathy).

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

• decreased number of blood cells (leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis);
• decreased amount of hemoglobin in the blood due to failure of the bone marrow to produce a type of cell (aplastic anemia);
• hair loss (alopecia);
• kidney disease (impaired kidney function including acute and chronic interstitial nephritis and renal failure);
• muscle and joint pain (myalgia and arthralgia);
• allergic reactions (allergic rash, drug fever, lupus erythematosus, pancolitis);
• decreased number of sperm produced (oligospermia). This side effect is reversible;
• inflammation of the membrane surrounding the heart (pericarditis);
• inflammation of the heart muscle (myocarditis);
• allergic and inflammatory reactions of the lungs (including difficulty breathing, cough, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, including acute);
• inflammation of the liver (hepatitis, cholestatic hepatitis);
• temporary changes in tests to assess liver function;
• gallstones (cholelithiasis);

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

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

With oral forms, gastrointestinal disorders (nausea, diarrhea and abdominal pain)
and headache have been rarely reported in some patients who had previously been intolerant to salicylazosulfapyridine.
There are also sporadic reports of: leukopenia, neutropenia, thrombocytopenia, aplastic anemia,
pancreatitis, hepatitis, interstitial nephritis, nephrotic syndrome and renal failure, pericarditis, myocarditis,
eosinophilic pneumonia and interstitial pneumonia.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. 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 DOC

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.
This medicine does not require any particular storage precautions.
Do not use the medicine if the packaging shows visible signs of deterioration.
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 DOC contains
MESALAZINA DOC 400 mg gastro-resistant tablets

• The active ingredient is mesalazine. One tablet contains 400 mg of mesalazine.
• The other ingredients are: maltodextrin, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, magnesium stearate. Coating: methacrylic acid copolymer - methacrylate and methyl methacrylate copolymer (eudragit FS30D), sodium hydroxide, triethyl citrate, yellow iron oxide, red iron oxide, titanium dioxide, talc, polyethylene glycol 6000.

MESALAZINA DOC 800 mg gastro-resistant tablets

• The active ingredient is mesalazine. One tablet contains 800 mg of mesalazine.
• The other ingredients are: maltodextrin, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, magnesium stearate. Coating: methacrylic acid copolymer - methacrylate and methyl methacrylate copolymer (eudragit FS30D), sodium hydroxide, triethyl citrate, yellow iron oxide, red iron oxide, titanium dioxide, talc, polyethylene glycol 6000.

Description of the appearance of MESALAZINA DOC and contents of the pack
Gastro-resistant tablets, pack of 50 tablets of 400 mg in blisters.
Gastro-resistant tablets, pack of 24 or 60 tablets of 800 mg in blisters.

Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milano

Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano 43 - 24041 Brembate (BG)

MESALAZINA DOC 2 g/50 ml rectal suspension

MESALAZINA DOC 4 g/100 ml rectal suspension
Equivalent 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is MESALAZINA DOC and what is it used for

MESALAZINA DOC contains the active ingredient mesalazine used to treat inflammatory bowel diseases.
MESALAZINA DOC is used for the treatment of ulcerative colitis localized in the rectal region.
This medicine is indicated both for the treatment of the ongoing disease and for the prevention of relapses.

2. What you need to know before you use MESALAZINA DOC

Do not use MESALAZINA DOC

• if you are allergic to mesalazine, to substances closely related from a chemical point of view, to salicylates or to any of the other components of this medicine (listed in section 6); if you suffer from severe kidney problems (severe impairment of renal function, severe nephropathies);
• if you suffer from severe liver problems (severe impairment of hepatic function); if you have active stomach or upper intestinal (peptic ulcer) lesions;
• if you have a predisposition to bleeding from blood vessels (haemorrhagic diathesis);
• if you are in the last weeks of pregnancy or if you are breastfeeding (see “Pregnancy and breastfeeding”);
• in children under the age of 2 years.

Warnings and precautions
Consult your doctor or pharmacist before using MESALAZINA DOC.
Prolonged use of the medicine may lead to allergic reactions.
Before starting treatment, you must undergo clinical investigations necessary to define the diagnosis and therapeutic indications.
Mesalazine may cause a reddish-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.
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.

Take special care and consult your doctor:
if you have liver problems;
if you have or have had kidney problems. Your doctor may decide to have you undergo kidney function tests;
if you are being treated with one or more of the following medicines:
or medicines that lower blood sugar levels (oral hypoglycemic agents),
or medicines that increase urine production (diuretics),
or medicines for blood coagulation disorders (coumarins, e.g. warfarin),
or medicines to treat inflammation (corticosteroids) (see “Other medicines and MESALAZINA DOC”);
if you have lung problems (especially asthma);
if you have had adverse effects to preparations containing sulfasalazine in the past (see section 4).
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 treatment with mesalazine. Stop using mesalazine and consult 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 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 fluids during treatment with mesalazine.
Following treatment with mesalazine, you may develop some problems (e.g., bruising, unexplained bleeding, anemia), fever and sore throat. In this case, your doctor will subject you to blood tests and, if necessary, will tell you to stop treatment.
Before starting treatment, your doctor may want to subject you to blood tests, tests to assess liver enzyme levels (ALT, AST, serum creatinine) and/or urine tests. Your doctor will decide how often to repeat these tests.
Both after discontinuation of treatment and during inadequate maintenance treatment, a relapse of the disease may occur.
Prolonged use of the medicine may lead to sensitization. The eventual occurrence of allergic reactions requires immediate discontinuation of treatment.

Children and adolescents
Do not use MESALAZINA DOC in children under the age of 2 years (see “Do not use MESALAZINA DOC”).

Other medicines and MESALAZINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take special care and inform your doctor if you are taking:

• lactulose or other medicines that lower the pH of the colon, as they may slow down the absorption of mesalazine;
• medicines that lower blood sugar levels, such as sulfonylureas;
• methotrexate, a medicine used to treat some cancers and some autoimmune diseases;
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukemia);
• azathioprine, a medicine used to treat diseases of the immune system;
• probenecid or sulfinpyrazone, medicines used to lower uric acid levels in the blood;
• spironolactone or furosemide, medicines used to increase urine production (diuretics);
• rifampicin, an antibiotic;
• corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for inflammation;
• coumarins (e.g. warfarin), medicines for blood coagulation disorders (anticoagulants);

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 using this medicine.
Do not take MESALAZINA DOC during pregnancy unless strictly necessary. The use of MESALAZINA DOC is contraindicated in the last weeks of pregnancy (see “Do not take MESALAZINA DOC”).
Mesalazine is present in breast milk. Therefore, take MESALAZINA DOC only if absolutely necessary and under the direct supervision of your doctor. If the baby has diarrhea, stop breastfeeding (see “Do not take MESALAZINA DOC”).

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

MESALAZINA DOC contains sodium metabisulfite
This substance can rarely cause serious hypersensitivity reactions and bronchospasm.

MESALAZINA DOC 2 g/50 ml rectal suspension contains sodium benzoate
This medicine contains 50 mg of sodium benzoate per dose equivalent to 1 mg/ml. Sodium benzoate can cause local irritation.

MESALAZINA DOC 4 g/100 ml rectal suspension contains sodium benzoate
This medicine contains 100 mg of sodium benzoate per dose equivalent to 1 mg/ml. Sodium benzoate can cause local irritation.

3. How to use MESALAZINA DOC

Adults
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended doses are 1 single-dose container of 4 g once a
day (preferably in the evening before bedtime), or 1 single-dose container of 2 g one-two times a
day (morning and/or evening before bedtime).
The duration of treatment in the current disease is on average 6-8 weeks and may vary, at the doctor's discretion,
depending on your condition and the evolution of the disease.
In long-term treatments, to prevent relapses, the daily dosage and duration of treatment
will be established by the doctor according to your condition and the evolution of the disease.

Method of administration of the rectal suspension:
Shake well before use, so as to obtain a homogeneous suspension; for the application of the
single-dose container follow these instructions:
exert slight pressure on the cap of the cannula and push it all the way in;
remove the cap from the rectal cannula
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 bottle with gradual and
constant pressure until the contents are completely emptied;
turn over onto both sides several times to facilitate the distribution of the medicine and remain lying down
for at least 30 minutes;
to obtain a better efficacy of the medicine, keep the medication in place for as long as possible
or, better still, leave it in place all night. For this reason, it is advisable that at least one of the
daily applications is carried out at bedtime.

Use in children over two years
MESALAZINA DOC is contraindicated in children under 2 years of age (see the section “Do not
take MESALAZINA DOC”). In children over two years, the doses must be proportionally
reduced, at the doctor's discretion.

If you use more MESALAZINA DOC than you should
No cases of overdose have been reported.
In case of accidental administration of an excessive dose of MESALAZINA DOC, immediately warn
your doctor or go to the nearest hospital.

If you forget to use MESALAZINA DOC
Do not use a double dose to make up for a missed dose and resume the normal dosage as
indicated by your doctor.
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.
Stop treatment with mesalazine and see your doctor immediately if you notice any of the
following symptoms:

• reddish, non-raised patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes, widespread rash, fever and enlarged lymph nodes. These severe skin rashes may be preceded by fever and flu-like symptoms;
• allergic reactions, with symptoms such as cramps and abdominal pain, bloody diarrhoea, fever, severe headache and rash.

The possible side effects are listed below according to frequency:

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

• nausea;
• diarrhoea;
• tense abdomen;
• skin lesions (rashes);
• headache;
• high blood pressure (hypertension);
• weakness (asthenia);
• fever (pyrexia).

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

• abdominal pain;
• passing gas from the intestines (flatulence);
• vomiting;
• itching;
• drowsiness;
• tremors;
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• fatigue;
• facial swelling.

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

• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity);
• dizziness;
• nerve disease causing abnormalities of sensation and movement, including of the internal organs (peripheral neuropathy).

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

• decreased number of blood cells (leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis);
• decreased amount of hemoglobin in the blood due to failure of the bone marrow to produce a type of cell (aplastic anemia);
• hair loss (alopecia);
• kidney disease (impaired kidney function including acute and chronic interstitial nephritis and renal failure);
• muscle and joint pain (myalgia and arthralgia);
• allergic reactions (allergic rash, drug fever, lupus erythematosus, pancolitis);
• decreased number of sperm produced (oligospermia). This side effect is reversible;
• inflammation of the membrane lining the heart (pericarditis);
• inflammation of the heart muscle (myocarditis);
• allergic and inflammatory reactions of the lungs (including difficulty breathing, cough, alveolitis, eosinophilic pneumonia, lung infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, including acute);
• inflammation of the liver (hepatitis, cholestatic hepatitis);
• temporary changes in tests to assess liver function;
• gallstones (cholelithiasis);

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

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

With rectal forms (rectal suspension and suppositories), nausea, diarrhoea, abdominal pain, headache, skin rashes have only been reported sporadically.
There are also sporadic reports of: leukopenia, neutropenia, thrombocytopenia, aplastic anemia, pancreatitis, hepatitis, interstitial nephritis, nephrotic syndrome and renal failure, pericarditis, myocarditis, eosinophilic pneumonia and interstitial pneumonia.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 DOC

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.
Store at a temperature not exceeding 25°C.
Do not use the medicine if the packaging shows visible signs of deterioration.
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 DOC contains
MESALAZINA DOC 2 g/50 ml rectal suspension

• The active ingredient is mesalazine. One single-dose container of 50 ml contains 2 g of mesalazine (5-aminosalicylic acid).
• The other ingredients are: purified water, disodium edetate, tragacanth gum, xanthan gum, sodium metabisulfite, sodium benzoate, sodium acetate.

MESALAZINA DOC 4 g/100 ml rectal suspension

• The active ingredient is mesalazine. One single-dose container of 100 ml contains 4 g of mesalazine (5-aminosalicylic acid).
• The other ingredients are: purified water, disodium edetate, tragacanth gum, xanthan gum, sodium metabisulfite, sodium benzoate, sodium acetate.

Description of the appearance of MESALAZINA DOC and contents of the pack
The 2 g/50 ml rectal suspension is available in a soft polyethylene bottle of 50 ml complete with
a cannula of 7 ready-to-use rectal single-dose containers.
The 4 g/100 ml rectal suspension is available in a soft polyethylene bottle of 100 ml complete with
a cannula of 7 ready-to-use rectal single-dose containers.

Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milano

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

MESALAZINA DOC 500 mg suppositories

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

1. What is MESALAZINA DOC and what is it used for?

MESALAZINA DOC contains the active ingredient mesalazine, used to treat inflammatory bowel diseases.
MESALAZINA DOC is used for the treatment of ulcerative colitis located in the rectum.
This medicine is indicated both for the treatment of the ongoing disease and for the prevention of relapses.

2. What you need to know before using MESALAZINA DOC

Do not use MESALAZINA DOC

• if you are allergic to mesalazine, to substances closely related from a chemical point of view, to salicylates or to any of the other components of this medicine (listed in section 6);
• if you suffer from severe kidney problems (severe impairment of renal function, severe nephropathies);
• if you suffer from severe liver problems (severe impairment of hepatic function);
• if you have active stomach or upper intestinal ulcers (peptic ulcer);
• if you have a predisposition to bleeding from blood vessels (haemorrhagic diathesis);
• if you are in the last weeks of pregnancy or during breastfeeding (see “Pregnancy and breastfeeding”);
• in children under 2 years of age (see “Children and adolescents”).

Warnings and precautions
Consult your doctor or pharmacist before using MESALAZINA DOC.
Prolonged use of the medicine may lead to allergic reactions.
Before starting treatment, you must undergo clinical investigations necessary to define the diagnosis and the
therapeutic indications.
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.

Pay particular attention and consult your doctor:

• if you have liver problems;
• if you have or have had kidney problems. Your doctor may decide to have you undergo kidney function tests;
• if you are being treated with one or more of the following medicines: or medicines that lower blood sugar levels (oral hypoglycemic agents), or medicines that increase urine production (diuretics), or medicines for blood coagulation disorders (coumarins, e.g. warfarin), or medicines for treating inflammation (corticosteroids) (see “Other medicines and MESALAZINA DOC”);
• if you have lung problems (especially asthma);
• if you have previously experienced side effects to preparations containing sulfasalazine (see section 4).

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with mesalazine treatment. Stop using mesalazine and consult 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 flanks and blood in the urine. It is recommended to drink a sufficient amount of fluids during treatment with mesalazine.
Following treatment with mesalazine, you may develop some problems (e.g. bruising, unexplained bleeding, anaemia), fever and sore throat. In this case, your doctor will subject you to blood tests and, if necessary, will tell you to stop treatment.
Before starting treatment, your doctor may want to subject you to blood tests, tests to assess liver enzyme levels (ALT, AST, serum creatinine) and/or urine tests. Your doctor will decide how often to repeat these tests.
Both after stopping treatment and during inadequate maintenance treatment, a relapse of the disease may occur.
The occurrence of allergic reactions requires immediate interruption of treatment.

Children and adolescents
Do not use MESALAZINA DOC in children under 2 years of age (see “Do not use MESALAZINA DOC”).

Other medicines and MESALAZINA DOC
Tell 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:

• lactulose or other medicines that lower the pH of the colon, as they may slow down the absorption of mesalazine;
• medicines that lower blood sugar levels, such as sulfonylureas;
• methotrexate, a medicine used to treat some cancers and some autoimmune diseases;
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukemia);
• azathioprine, a medicine used to treat diseases of the immune system;
• probenecid or sulfinpyrazone, medicines used to lower uric acid levels in the blood;
• spironolactone or furosemide, medicines used to increase urine production (diuretics);
• rifampicin, an antibiotic;
• corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for inflammation;
• coumarins (e.g. warfarin), medicines for blood coagulation disorders (anticoagulants). Pregnancy and breastfeedingIf 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.

Do not use MESALAZINA DOC during pregnancy unless strictly necessary. The use of MESALAZINA DOC is contraindicated in the last weeks of pregnancy (see “Do not use MESALAZINA DOC”).
Mesalazine is present in breast milk. Therefore, take MESALAZINA DOC only if absolutely necessary and under the direct supervision of your doctor. If the baby has diarrhoea, stop breastfeeding (see “Do not use MESALAZINA DOC”).

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

3. How to use MESALAZINA DOC

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.

Adults
Unless otherwise prescribed by your doctor, in the active phase of the disease the recommended dose is 3 suppositories per
day, divided into two-three administrations.
For relapse prevention, the recommended dose is 1-2 suppositories per day.
Use in children and adolescents

MESALAZINA DOC is contraindicated in children under 2 years of age (see “Do not take
MESALAZINA DOC”).In children over two years of age, the doses must be proportionally reduced, at
the doctor's discretion.
To obtain a better therapeutic effect, retain the suppository for at least 30 minutes or, better, for longer
periods (e.g. all night long).
During the warm season, it may be necessary to immerse the container of the suppositories in cold water to
re-solidify suppositories that have become soft.
The duration of treatment, in the ongoing disease, is on average 4-6 weeks and may vary, at the doctor's discretion,
according to your condition and the evolution of the disease.
In long-term treatments, to prevent relapses, the daily dosage and duration of treatment
will be established by your doctor according to your condition and the evolution of the disease.

If you use more MESALAZINA DOC than you should
No cases of overdose have been reported.
In case of accidental ingestion/administration of an excessive dose of MESALAZINA DOC, immediately notify
your doctor or go to the nearest hospital.

If you forget to use MESALAZINA DOC
Do not use a double dose to make up for the missed dose and resume the normal dosage of
as indicated by your doctor.
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.
Stop treatment with mesalazine and contact your doctor immediately if you experience any of the
following symptoms:

• reddish, non-raised patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms;
• allergic reactions, with symptoms such as cramps and abdominal pain, bloody diarrhoea, fever, severe headache and rash.

The possible side effects are listed below according to frequency:

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

• nausea;
• diarrhoea;
• abdominal tension;
• skin lesions (rashes);
• headache;
• high blood pressure (hypertension);
• weakness (asthenia);
• fever (pyrexia).

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

• abdominal pain;
• passing gas from the intestines (flatulence);
• vomiting;
• itching;
• drowsiness;
• tremors;
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• fatigue;
• facial swelling.

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

• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity);
• dizziness;
• nerve disease causing abnormalities of sensation and movement, including internal organs (peripheral neuropathy).

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

• decreased number of blood cells (leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis);
• decreased amount of hemoglobin in the blood due to failure of the bone marrow to produce a type of cell (aplastic anemia);
• hair loss (alopecia); kidney disease (impaired renal function including acute and chronic interstitial nephritis and renal failure);
• muscle and joint pain (myalgia and arthralgia); allergic reactions (allergic rash, drug fever, lupus erythematosus syndrome, pancolitis);
• decreased number of sperm produced (oligospermia). This side effect is reversible;
• inflammation of the membrane surrounding the heart (pericarditis);
• inflammation of the heart muscle (myocarditis);
• allergic and inflammatory reactions of the lungs (including difficulty breathing, cough, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, including acute);
• inflammation of the liver (hepatitis, cholestatic hepatitis);
• temporary changes in tests to assess liver function;
• gallstones (cholelithiasis).

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

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

With rectal forms (rectal suspension and suppositories), nausea, diarrhoea, abdominal pain, headache, and rashes have been reported only sporadically.
There are also sporadic reports of: leukopenia, neutropenia, thrombocytopenia, aplastic anemia, pancreatitis, hepatitis, interstitial nephritis, nephrotic syndrome and renal failure, pericarditis, myocarditis, eosinophilic pneumonia and interstitial pneumonia.

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 DOC

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.
This medicine does not require any particular storage precautions
Do not use the medicine if the packaging shows visible signs of deterioration.
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 DOC contains

• The active ingredient is mesalazine (5-aminosalicylic acid). One suppository contains 500 mg of mesalazine.
• The other ingredients are: semi-synthetic glycerides.

Description of the appearance of MESALAZINA DOC and contents of the pack
The suppositories are available in packs of 20 suppositories.

Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milano

Manufacturer
Special Product’s Line S.p.A – Via Campobello, 15 – 00040 Pomezia (Roma)

MESALAZINA DOC 1200 mg gastro-resistant tablets

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:

• 7. What MESALAZINA DOC is and what it is used for
• 8. What you need to know before you take MESALAZINA DOC
• 9. How to take MESALAZINA DOC
• 10. Possible side effects
• 11. How to store MESALAZINA DOC
• 12. Contents of the pack and other information

1. What is MESALAZINA DOC and what is it used for

MESALAZINA DOC contains the active ingredient mesalazine used to treat inflammatory bowel diseases.
MESALAZINA DOC 1200 mg gastro-resistant tablets are used for the treatment of ulcerative colitis,
a chronic inflammatory disease of the intestine.

2. What you need to know before you take MESALAZINA DOC

Do not take MESALAZINA DOC

• if you are allergic to mesalazine, to substances closely related from a chemical point of view, to salicylates or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe impairment of renal function, severe nephropathies);
• if you have severe liver problems (severe impairment of hepatic function);
• if you have lesions of the stomach or the first part of the intestine (peptic ulcer) in an active phase;
• if you have a predisposition to bleeding from blood vessels (haemorrhagic diathesis);
• if you are in the last weeks of pregnancy or if you are breastfeeding (see “Pregnancy and breastfeeding”);
• in children and adolescents under the age of 18 years.

Warnings and precautions
Talk to your doctor or pharmacist before taking MESALAZINA DOC.
Prolonged use of the medicine may give rise to allergic reactions.
Before starting treatment, you must undergo clinical investigations necessary to define the diagnosis and the
therapeutic indications.
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.
If you experience severe or recurrent headache, vision disturbances, ringing or whistling in the ears, contact
your doctor immediately.
Tell your doctor before using mesalazine:

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

Pay particular attention and talk to your doctor:

• if you have exceptionally slow gastric digestion or have a narrowing of the opening between the stomach and the intestine (pyloric stenosis), as the medicine may cause gastric irritation and may lose its effectiveness;
• if you have liver problems;
• if you have or have had kidney problems. Your doctor may decide to have you undergo kidney function tests;
• if you are being treated with one or more of the following medicines: or medicines that lower blood sugar levels (oral hypoglycemic agents), or medicines that increase urine production (diuretics), or medicines for blood coagulation disorders (coumarins, e.g. warfarin), or medicines to treat inflammation (corticosteroids) (see “Other medicines and MESALAZINA DOC”);
• if you have lung problems (particularly asthma);
• if you have had adverse effects to preparations containing sulfasalazine in the past (see section 4).

Serious skin reactions, including drug-induced 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 serious 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 enough fluids during the
treatment with mesalazine.
Following treatment with mesalazine, you may develop some problems (e.g. bruising, unexplained bleeding, anemia), fever and sore throat. In this case, your doctor will subject you to
blood tests and, if necessary, tell you to stop treatment.
Before starting treatment, your doctor may want to perform blood tests, tests to assess
liver enzyme levels (ALT, AST, serum creatinine) and/or urine tests. Your doctor will decide
how often to repeat these tests.
Both after stopping treatment and during inadequate maintenance treatment, a relapse of the disease may occur.
Prolonged use of the medicine may give rise to sensitization phenomena. The eventual occurrence of
allergic reactions requires immediate interruption of treatment.

Children and adolescents
MESALAZINA DOC 1200 mg gastro-resistant tablets should not be given to children and
adolescents under 18 years of age, as they may have difficulty swallowing the tablets.

Other medicines and MESALAZINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Pay particular attention and tell your doctor if you are taking:

• lactulose or other medicines that lower the pH of the colon, as they may slow down the absorption of mesalazine;
• medicines that lower blood sugar levels, such as sulfonylureas;
• methotrexate, a medicine used to treat some cancers and some autoimmune diseases;
• 6-mercaptopurine and thioguanine, medicines used to treat blood cancers (leukemia);
• azathioprine, a medicine used to treat diseases of the immune system;
• probenecid or sulfinpyrazone, medicines used to lower uric acid levels in the blood;
• spironolactone or furosemide, medicines used to increase urine production (diuretics);
• rifampicin, an antibiotic;
• corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used for inflammation;
• coumarins (e.g. warfarin), medicines for blood coagulation disorders (anticoagulants).

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.
Do not take MESALAZINA DOC during pregnancy unless strictly necessary. The use of
MESALAZINA DOC is contraindicated in the last weeks of pregnancy (see “Do not take
MESALAZINA DOC”).
Mesalazine is present in breast milk. Therefore, take MESALAZINA DOC only if absolutely
necessary and under the direct control of your doctor. If the baby has diarrhea, stop
breastfeeding (see “Do not take MESALAZINA DOC”).

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

MESALAZINA DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant tablet, i.e.
it is essentially ‘sodium-free’.

3. How to take MESALAZINA DOC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will tell you what the recommended dose suitable for you is.

Treatment of ulcerative colitis
Maintenance of remission phase
The average daily dose recommended for adults is 2.4 g of mesalazine (6 tablets of 400 mg,
or 3 tablets of 800 mg, or 2 tablets of 1200 mg), to be taken in two or three doses per day.

Induction of remission phase of ulcerative colitis
In mild acute forms of the disease, the recommended starting daily dose of
MESALAZINA DOC is 2.4 g of mesalazine (6 tablets of 400 mg, or 3 tablets of 800 mg,
or 2 tablets of 1200 mg), to be taken in two or three doses per day.
In moderate acute forms of the disease, the doctor may increase the recommended daily dose of
MESALAZINA DOC up to 4.8 g of mesalazine to be taken in two or three doses per day.

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

If you forget to take MESALAZINA DOC
Do not take a double dose to make up for the missed dose and resume the normal dosage of
intake as indicated by your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking mesalazine and contact your doctor immediately if you notice any of the following symptoms:

• raised, blotchy rash on the trunk, which may be target-shaped or circular, often with a central blister, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes, widespread rash, fever and swollen lymph nodes. These severe skin reactions may be preceded by fever and flu-like symptoms;
• allergic reactions, with symptoms such as stomach cramps and pain, bloody diarrhoea, fever, severe headache and rash.

Tell your doctor immediately if you experience 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 (the frequency cannot be estimated on the basis of the available data)]
Possible side effects are listed below according to frequency:

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

• nausea;
• diarrhoea;
• abdominal tension;
• skin lesions (rashes);
• headache;
• high blood pressure (hypertension);
• weakness (asthenia);
• fever (pyrexia).

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

• abdominal pain;
• passage of gas from the intestines (flatulence);
• vomiting;
• itching;
• drowsiness;
• tremors;
• increased heart rate (tachycardia);
• low blood pressure (hypotension);
• fatigue;
• facial swelling.

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

• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity);
• dizziness;
• disease of the nerves causing abnormalities of sensation and movement, including of the internal organs (peripheral neuropathy).

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

• decreased number of blood cells (leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis);
• decreased amount of haemoglobin in the blood due to failure of a type of cell production by the bone marrow (aplastic anaemia);
• hair loss (alopecia);
• kidney disease (impaired kidney function including acute and chronic interstitial nephritis and renal failure);
• muscle and joint pain (myalgia and arthralgia);
• allergic reactions (allergic rash, drug fever, lupus erythematosus syndrome, pancolitis);
• decreased number of sperm produced (oligospermia). This side effect is reversible;
• inflammation of the membrane surrounding the heart (pericarditis);
• inflammation of the heart muscle (myocarditis);
• allergic and inflammatory reactions of the lungs (including difficulty breathing, cough, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonia);
• inflammation of the pancreas (pancreatitis, including acute);
• inflammation of the liver (hepatitis, cholestatic hepatitis);
• temporary changes in tests to assess liver function;
• gallstones (cholelithiasis);

Not known (frequency cannot be estimated on the basis of the available data):

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

With oral forms, gastrointestinal disorders (nausea, diarrhoea and abdominal pain) and headache have been rarely reported in some patients who previously did not tolerate sulfasalazine.
There are also sporadic reports of: leukopenia, neutropenia, thrombocytopenia, aplastic anaemia, pancreatitis, hepatitis, interstitial nephritis, nephrotic syndrome and renal failure, pericarditis, myocarditis, eosinophilic pneumonia and interstitial pneumonia.

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 DOC

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.
This medicine does not require any particular storage precautions.
Do not use the medicine if the packaging shows visible signs of deterioration.
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 DOC contains
The active ingredient is mesalazine. One gastro-resistant tablet contains 1200 mg of mesalazine.
The other ingredients are: maltodextrin, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, magnesium
stearate.

Coating: methacrylic acid copolymer - methacrylate and methyl methacrylate (eudragit FS30D), sodium
hydroxide, triethyl citrate, yellow iron oxide, red iron oxide, titanium dioxide, talc, polyethylene glycol

• 6000.

Description of the appearance of MESALAZINA DOC and contents of the pack
Oblong gastro-resistant tablet of reddish-brown color with “12” engraved on one side, pack of 60 or 120
tablets in blisters.

Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milano

Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano 43 - 24041 Brembate (BG)